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LDX System Procedure Manual v - Drug testing supplies from CLIA

1. lt TABLE OF CONTENTS GDX INSTRUMENT HISTORY RECORD GDX Instrument Model No Serial No Date Purchased Cost Manufacturer Address City Telephone Contact Person Distributor Address City Telephone Contact Person Warranty Contact Person Notes Technical Service Representative Telephone SERVICE RECORD Comments lt TABLE OF CONTENTS INFORMATION AND SERVICE LOG GDX GDX Instrument Serial No Purchase Date Warranty Expires Customer Service Representative Phone No Technical Service Representative Phone No Sales Representative Phone No PROBLEM ACTION TAKEN OPERATOR lt TABLE OF CONTENTS INITIAL SETUP CHECKLIST GDX GDA Cholestech GDX Serial No Date of Setup Name of Lab Person Performing Initial Setup Signature Approval by Laboratory Director FACILITY SPECIFICATIONS OPERATOR DATE 1 Room temperature 63 86 17 30 C 2 Stable work surface free from vibrations 3 Isolation from direct heat and light sources e g sunlight ovens room heater etc 4 A grounded wall outlet supplying 100 to 240 VAC with the appropriate power supply which will not be int
2. RETEST with sample from a NEW control vial using NEW cartridge YES WITHIN LIMITS NO CALL Cholestech Tech Service 800 733 0404 For Information Only R Recommended Optional Information lt TABLE OF CONTENTS 4 0 1 Test Procedure 20 A1C TEST PROCEDURE Cholestech GDX System Procedure Manual AIC Test Procedure lt TABLE OF CONTENTS 4 1 42 4 3 Introduction The test procedures in this section are designed specifically for tests run on the Cholestech GDX System Instructions are provided for testing fingerstick venipuncture or control samples Medical Importance Diabetes mellitus is a leading cause of kidney failure blindness and amputation in adults It is also a major risk factor for heart disease stroke and birth defects and shortens average life expectancy by up to 15 years It is now well accepted that in patients with diabetes there is a direct relationship between blood sugar levels and complications associated with the disease In a number of studies such as the Diabetes Control and Complications Trial DCCT and the United Kingdom Prospective Diabetes Study it was conclusively shown that a reduction in blood sugar levels significantly delayed the onset and slowed the progression of the most serious complications of diabetes The measurement of A1C is recommended for monitoring the long term care of people with diabetes because th
3. Test Disposition Accept Reject Director Approval Approval Date lt TABLE OF CONTENTS PRECISION CALCULATION FORM WITHIN RUN Date Operator Cartridge Lot No Specimen Identification Cholestech GDX Serial No GDX GDX Analyte Reject 2 Director Approval 4 Result Result X lt TABLE OF CONTENTS Approval Date Record the result of the quality control material in Column 2 RESULT Calculate the MEAN X Add the values Column 2 in the RESULT Column then divide by the number of results n Y Results MEAN X Calculate the difference between each RESULT and the MEAN X and record in Column 3 RESULT X Square each value in Column 3 and record in Column 4 RESULT Add the values in Column 4 Calculate the Standard Deviation SD using the formula Divide the sum of the values calculated in Column 4 by the number of values minus 1 Take the square root of this number SD Y Results X n 1 To calculate the coefficient of variation CV use the following formula ACV 7 x 100 TRAINING CHECKLIST GDX GDX Name Director Signature Date Approved PREPARATION 1 Has read User Manual 2 Has read Procedure Manual 3 Has viewed Cholestech GDX Training CD ROM 4 Has read
4. Cholestech GDX results were shown not to be affected by operating temperatures of 63 86 F 17 30 Hemoglobin and Hematocrit The Cholestech GDX test performs acceptably over a hemoglobin range of 8 20 g dL and hematocrit of 30 to 60 Abnormal Hemoglobins Abnormal hemoglobin Hb variants e g HbS HbC and HbE and chemically modified derivatives e g carbamyl Hb can cause interference and dramatically affect the results of 1 measurement Such problems should be suspected whenever AIC results are not in agreement with results of self monitoring of blood glucose The Cholestech GDX System has virtually no interference from hemoglobin variants because the method uses boronate affinity chromatography to separate the glycated hemoglobin fraction from the nonglycated fraction Nearly 8 of African Americans carry the HbS trait and 2 3 carry HbC In sub Saharan Africa prevalence of these two is up to one third of all patients HbE can be as high as 30 in Southeast Asia HbF can reach 30 in individuals with hereditary persistence Chemically modified Hbs may be chronically present in diabetic patients Carbamylated Hb is the most commonly encountered of these Patients in whom the lifespan of the red blood cell is significantly shortened e g hemolytic anemia affect all A1C testing methods Interfering Substances The following substances at the levels indicated were shown to have no effect on the Cholestec
5. lt TABLE OF CONTENTS PATIENT RESULT LABEL LOG Cholestech GDX Serial No Cartridge Lot No Operator Expiration Date GDX GDX Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here Place Label Here lt TABLE OF CONTENTS QUALITY ASSURANCE RECORD GDX DATE Control Level 1 Lot No Expiration Date OPERATOR Control Level 2 Lot No Expiration Date Cartridge Lot No Expiration Date ROOM TEMP REFRIG TEMP RANGE Results Level 1 Level 1 CHOLESTECH GDX SERIAL NO Level 2 Level 2 OPTICS CHECK OPTICS CHECK LOT NO Result DATE Control Level 1 Lot No Expiration Date OPERATOR Control Level 2 Lot No Expiration Date Cartridge Lot No Expiration Date ROOM TEMP REFRIG TEMP RANGE Results Level 1 Level 1 CHOLESTECH GDX SERIAL NO Level 2 Level 2 OPTICS CHECK OPTICS CHECK LOT NO DATE Control Level 1 Lot No Expiration Date OPERATOR Control Level 2 Lot No Expiration Date Cartridge Lot No Expiration Date ROOM TEMP REFRIG TEMP RANGE Results Level 1 Level 1 CHOLESTECH GDX SERIAL NO Level 2 Level 2 OPTICS CHECK OPTICS CHECK LOT NO Result lt TABLE OF CONTENTS CONTROL RANGE CALCULAT
6. Err 18 Air blank 1 low The Analyzer has detected an unacceptable signal intensity lt TABLE OF CONTENTS For Information Only The test cartridge used may be damaged R Recommended Remove the cartridge turn off the power supply and disconnect the Analyzer Reconnect the Analyzer allow to warm up and insert an Optics Check Cartridge Continued on next page Optional Information TROUBLESHOOTING 51 Cholestech GDX System Procedure Manual ERROR CODE EXPLANATION ACTION TO TAKE Err 18 continued cartridge has been left resting in the Remove the cartridge turn off the power Analyzer supply and disconnect the Analyzer Reconnect the analyzer allow to warm up and insert an Optics Check Cartridge Analyzer failure Power off the Analyzer and power it back on again Try running the Optics Check Cartridge again If the error message persists call Technical Service Err 19 The test cartridge used may be damaged Remove the cartridge turn off the power Air blank 2 low supply and disconnect the Analyzer Reconnect the Analyzer allow to warm up and The Analyzer has detected an unacceptable insert an Optics Check Cartridge signal intensity Analyzer failure Power off the Analyzer and power it back on again Try running the Optics Check Cartridge again If the error message persists call Technical Service Err 20 The test cartridge used may be damaged Remove the cartridge tu
7. NDS NDS NC ME CNE RE NC ROSE NL NS ET RL LENZ REN REN RIESEN PR RO O RE OSO SS OO OR RQ RO RG an EEN tt ee En Be TE os sl E x KA Hi y meer Peston Mere SEA e Ge MESSI ee SI Ir ern ZEN 256 rate tee ie EE SEN oe N St SY te BEE D esse ES ee en Fo SE SR LA PE DNA ete en e eN UN gt BEE E Sette th ee Se a or Fingerstick Blood Collection a Lx PRE ES get Mn ES u ee re el ee Ze E Dez SEEN SEA AS Y a Dr certify that e os a ES 4 e ME y it Be at possesses the necessary skills and competencies to perform skin puncture for fingerstick blood collection Fir a en N z es 1 This person has properly demonstrated to me fingerstick blood collection in accordance with currently accepted FE sn ae ass y i laboratory standards and protocols Proper knowledge of the disposal of biohazardous material and industrial safety has ie been observed and comprehended for subsequent health e
8. GDX TABLE OF CONTENTS gt System Procedure Manual CHOLESTECH TABLE OF CONTENTS gt Table of Contents 1 0 14 12 1 3 1 4 1 5 1 6 1 7 1 8 1 9 1 10 1 11 1 12 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 2 9 2 10 3 0 3 1 3 2 3 3 3 4 4 0 41 42 43 44 45 46 4 8 5 0 5 1 5 2 TABLE OF CONTENTS i Cholestech GDX System Procedure Manual Foreword Procedure Manual Overview iii Introduction Overview of a Quality Assurance Program iv Setup and Maintenance Intr d etion en a ae 2 Environmental Requirements 2 Optics Check Cartridge ssi 24 24 2 ba eS Ha ae ana san 2 Optics Check Cartridge Test 2 Shelf Life Stability 44442 preda eide Shan aaa Be pese 3 Laboratory Temperature Records 4 Instrument History Record 4 Cholestech System Initial Setup 4 Maintenance and Cleaning of the Cholestech System 5 Course of Action If System Becomes Inoperable 5 Procedure Sian Off seb add ecrire 6 Reference s and Bibliography 6 Specimen Collection and Handling Introduction u 242 M
9. Capillary any one of the small vessels that form a network throughout the body for the interchange of substances between the blood and tissue fluid lt TABLE OF CONTENTS GLOSSARY OF TERMS 55 Cholestech GDX System Procedure Manual Capillary capillary action attraction between a liquid and a solid that causes the liquid to rise as for example into a capillary tube Centrifuge instrument that separates the lighter portions of a solution mixture or suspension from the heavier portions by centrifugal force Coagulation how various coagulation factors in the blood interact to form a clot Coefficient of Variation statistical measure of the ratio of the standard deviation of a series of measurements to the mean of the measurements Expressed as a percentage the coefficient of variation CV shows the precision of measurements Colorimeter measurement and analysis of color by comparison with a standard in terms of brightness hue or purity Contaminant microorganism chemical or other material that makes something impure by contact or mixture with it Control material solution lyophilized preparation or pool of collected serum designed to be used in the process of quality control The concentrations of the analytes of the interest in the control material are known within limits ascertained during its preparation and confirmed in use Data numerical or quantitative results of a test that con
10. Policies and standards that govern the laboratory cover elements that affect test quality before patient preparation sample collection etc during and after data transcription errors etc the testing process Training All personnel conducting tests should be properly trained and their training documented Safety policies should be adhered to and a safe working environment provided Procedure manuals should contain operating protocols that are complete up to date and available to laboratory personnel Record keeping All aspects of the quality assurance program should be documented in writing as appropriate Quality control may include initial verification of the test method routine testing of quality control materials and a written procedure for responding to out of control test results All quality control procedures and follow up actions should be documented Participation in proficiency testing program is optional for CLIA waived tests Proficiency testing may be performed and documented when required by local or state regulations Laboratory inspections may be conducted by the appropriate organization to assess quality assurance and suggest possible improvements A successful QA program assures that Policies and procedures are established in writing and followed by all personnel involved in the testing process The test system performs properly at the time patient results are produced Written reco
11. SETUP AND MAINTENANCE Cholestech GDX System Procedure Manual Maintenance and Cleaning of the Cholestech GDX System No maintenance is required other than routine cleaning when necessary e Clean the outside of the Cholestech GDX Analyzer case with a clean damp nonabrasive cloth Most spills and stains will be removed with water or a mild detergent solution of 70 isopropyl alcohol or 5 bleach or any nonstaining commercially available disinfectant are all appropriate cleaning agents Do not immerse the instrument in water or other cleaning fluid Do not use any abrasive cleanser You can record maintenance and cleaning performed on the Cholestech GDX System and other instruments in your laboratory on the Equipment Maintenance Cleaning Log in the Master Forms section of this manual Course of Action If System Becomes Inoperable Course of Action for the Cholestech GDX System If the Cholestech GDX System becomes inoperable call Cholestech Technical Service at 800 733 0404 or 510 732 7200 Until the instrument becomes operable venous specimens will be drawn and sent to the following reference laboratory Laboratory Name 5 Laboratory Address Laboratory Phone No or An alternative Cholestech GDX Analyzer will be used Course of Action for Other Instruments in the Lab Name of Instrument Technical Service Phone Number Written Procedure If the Instrument Fails lt gt For Informat
12. Phone 800 333 0958 Fax 231 941 7287 e Wisconsin State Laboratory of Hygiene Proficiency Testing Program 465 Henry Mall Room Madison WI 53706 1578 Phone 800 462 5261 8 3 Reference s and Bibliography 1 National Committee for Clinical Laboratory Standards Physician s Office Laboratory Guidelines Tentative Guidelines Villanova Pa NCCLS 1989 NCCLS publication POLI T 2 Howanitz PJ Howanitz JH Laboratory Quality Assurance New York N Y McGraw Hill Book Co 1987 3 How to avoid dangerous mistakes a physician s office laboratory Continuing Education Course No 328 American Academy of Family Physicians Scientific Assembly 1989 lt TABLE OF CONTENTS For Information Only R Recommended Optional Information lt TABLE OF CONTENTS 9 0 Troubleshooting 46 TROUBLESHOOTING Cholestech GDX System Procedure Manual Troubleshooting 9 1 Time Sequence Errors It is essential to follow the operational sequence without extensive delays between steps The Analyzer measures time intervals between steps at appropriate points and will give an error message if the time interval exceeds the stated limits ERROR CODE TEST POSITION TIME ALLOWED EXPLANATION Position 0 Position 1 300 seconds 5 minutes A test cartridge is placed into the Analyzer and the prompt for turning to Position 1 is displayed Position 1 Position 2 60 seconds 1 minute The Analyzer is prompting you to turn the test cartr
13. dividing a sample in half and testing half in your laboratory and having the other half tested in another laboratory and then comparing the results This is a technique for testing accuracy Stability ability of a specimen reagent or control to maintain a constant concentration of the analyte Reagents and controls must be handled and stored properly and used before their expiration dates to maintain their stability Specimens must be collected handled and processed properly Standard Primary reference material of fixed and known chemical composition and capable of being prepared in essentially pure form Also any certified reference material generally accepted or officially recognized as the unique standard for the assay regardless of its level of purity of analyte content lt TABLE OF CONTENTS 10 1 GLOSSARY OF TERMS 59 Cholestech GDX System Procedure Manual Standard Secondary reference material the analyte concentration of which has been ascertained by reference to a primary standard Standard Deviation statistical measurement of the degree of variation from the mean of a series of measurements It is a measure of precision or reproducibility Test procedure for detecting the presence or amount of an analyte Titer of a substance required to produce a reaction with a particular amount of another substance The amount of one substance required to correspond with a particular amount of anot
14. 94545 TELEPHONE NUMBER FOR ADDITIONAL INFORMATION CONTACT DATE PREPARED 800 733 0404 Technical Service June 21 2002 COMMON NAME USED ON LABEL CHEMICAL FAMILY Cholestech GDX A1C Controls Does not apply CHEMICAL NAME FORMULA Does not apply Does not apply TRADE NAME amp SYNONYMS Cholestech GDX Trademark of Cholestech Corporation SECTION 2 HAZARDOUS INGREDIENTS HAZARDOUS COMPONENT Product consists of freeze dried whole human blood Product is reconstituted with 500 of purified water PEL Permissible Exposure Limit established by the Occupational Safety amp Health Administration OSHA TLV Threshold Limit Value established by the American Conference of Governmental Industrial Hygienists 1987 88 SECTION 3 PHYSICAL DATA BOILING POINT SPECIFIC GRAVITY VAPOR PRESSURE Not applicable Not determined mm Hg Not determined PERCENT VOLATILE BY VOLUME VAPOR DENSITY AIR 1 EVAPORATION DATE 1 Not determined Not determined Not determined SOLUBILITY IN WATER REACTIVITY IN WATER Soluble 500 uL of purified water is used to reconstitute controls prior to use Not applicable APPEARANCE AND ODOR Form solid powder Color red stored in brown glass bottles Odor none SECTION 4 FIRE AND EXPLOSION DATA FLASH POINT FLAMMABLE LIMITS IN AIR by VOLUME Not applicable LOWER Not applicable UPPER Not applicable EXTINGUISHING MEDIA AUTO IGNITION TEMPERATURE Not flammable or explosive Not applicable UNUSUA
15. CA Ashwood ER eds Tietz Textbook of Clinical Chemistry 3rd ed Philadelphia Pa WB Saunders Co 1999 For Information Only R Recommended Optional Information 3 0 Quality Control 16 QUALITY CONTROL Cholestech GDX System Procedure Manual Quality Control lt TABLE OF CONTENTS 3 1 3 2 3 3 Introduction Quality control refers to the testing done to show that a system is working properly and giving dependable results The quality control materials controls sold by Cholestech are those recommended for use with the Cholestech GDX System Handling Controls e Read the product insert that comes with each box of controls to find out how to use and store them e Check the expiration date before using Do not use control material past its expiration date e Allow an adequate amount of time for the lyophilized control sample to completely dissolve minimum 15 minutes e Verify that the lot number on the control vial and the assay sheet are the same External Quality Control External controls must be used to demonstrate that the reagents and assay procedure perform properly Cholestech A1C Controls are available from Cholestech One set of controls has normal and abnormal A1C control samples Controls must be tested e With each new shipment of test cartridges even if cartridges are from the same lot previously received e With each new lot of test cartridges e As otherwise required by you
16. Date Discontinued Director s Signature Date The procedure is not applicable to this laboratory Director s Signature Date For Information Only R Recommended Optional Information 28 A1C TEST PROCEDURE Cholestech GDX System Procedure Manual lt TABLE OF CONTENTS 4 8 Reference s and Bibliography 1 10 The Diabetes Control and Complications Trial Research Group N Engl J Med 199 329 977 986 United Kingdom Prospective Diabetes Study Group Lancet 1998 352 837 853 Sperling MA et al Physicians Guide to Insulin Dependent Type 1 Diabetes Diagnosis and Treatment Alexandria Va 1966 American Diabetes Association Inc 44 45 Sox Int Ed Common Diagnostic Tests Use and Interpretation 2nd ed Philadelphia Pa 1990 American College of Physicians 122 133 134 139 140 Koenig RJ Peterson CM Jones RL Saudek Lehman M et al Correlation of glucose regulation and hemoglobin 1 in diabetes mellitus N Eng J Med 1976 295 417 420 Gabbay KH Hasty Breslow JL et al Glycosylated hemoglobins and long term blood glucose control in diabetes mellitus J Clin End Metab 1977 44 5 859 864 McCanoe DR Hanson RL et al Comparison of tests for glycated haemoglobin and fasting two hour plasma glucose concentration as diagnostic methods for diabetes Brit Med J 1994 906 1323 1328 Peters AL Davidson MB et al A clinical approach for the diagnosis of Diabetes mellitus An analysis u
17. as needed An icon a letter within a shape will appear at the beginning of each section These icons indicate lt gt The information in the following section is For Information Only R The information in the following section is Recommended by the manufacturer The information in the following section is recommended to comply with OSHA and CLIA 88 Moderately Complex Laboratory Regulations as well as regulations that apply to users in certain states If you need assistance using the manual please contact Cholestech Technical Service at 800 733 0404 Please note The following procedures are outlined as a guide not a substitute for complying with state or federal regulations relevant to your site Cholestech Corporation does not guarantee that following this guide will result in certification or meeting state or federal regulations For further information regarding regulations please refer to your state or federal agencies iv INTRODUCTION Cholestech GDX System Procedure Manual Introduction lt TABLE OF CONTENTS Overview of a Quality Assurance Program Quality assurance is a comprehensive set of policies procedures and practices necessary to ensure the quality of laboratory tests Its purpose is to ensure that over the long term the laboratory provides reliable data that accurately reflect the patient s status Quality assurance in a point of care laboratory covers nine basic areas 1
18. no additive or a serum Separator tube Appropriate for use with the Cholestech GDX System For Information Only Recommended Optional Information 10 SPECIMEN COLLECTION AND HANDLING Cholestech GDX System Procedure Manual lt TABLE OF CONTENTS Performing the Venipuncture 1 2 Identify the patient by asking the patient to state his her full name Label the tube with the patient s name or identification number Reassure the patient to make him or her comfortable Have the patient make a fist to increase blood flow Apply the tourniquet Do not stop blood flowing in the veins for more than a minute before the blood is drawn as it causes venous occlusion If necessary release the tourniquet and reapply Leaving the tourniquet on for more than three minutes may cause erroneous results Select the venipuncture site Clean the venipuncture site with a 70 isopropyl alcohol pad making one smooth circular pass of the venipuncture site Allow the skin to dry to prevent hemolysis of the specimen and to prevent the patient from having a burning sensation when the venipuncture is performed Do not touch the venipuncture site after cleaning it Perform the following procedure e Grasp the patient s arm near the venipuncture site using your thumb to draw the skin tight e With the needle bevel facing up line up the needle with the vein Penetrate the skin and enter the vein at an angle of approximately 45 e Holdi
19. of Proficiency Testing Under 88 all laboratories conducting tests classified moderately complex and highly complex must participate in an approved proficiency testing PT program for each specialty they perform testing in The purpose of this section is to discuss the importance of proficiency testing and describe how proficiency testing is performed When choosing the appropriate agency for your testing it is important to ask the agency if it is certified by the Centers for Medicare amp Medicaid Services CMS to comply with CLIA 88 standard regulations What Is Proficiency Testing Although analyzing quality control specimens provides an internal check on the quality of a laboratory s results proficiency testing serves as an external check Outside agencies send unknown specimens to subscribing laboratories The laboratory performs the required tests and returns the results to the agency The data are analyzed and a summary report is sent to the laboratory indicating the laboratory s performance Why Is Proficiency Testing Necessary Proficiency testing assures the user of quality results and measures the performance of the test system and operators relative to other laboratories using the same test system or a reference method Testing may identify bias in a test system which may not be apparent with an internal daily quality control program Proficiency testing may be necessary for compliance with
20. organ space or tissue caused by a break in the wall of a blood vessel Hematocrit also called packed cell volume volume percentage of erythrocytes red blood cells in whole blood Hemolysis adjective hemolytic breakdown of red blood cells in serum or plasma freeing the hemoglobin from the cells When this happens the serum or plasma becomes reddish Hemolysis interferes with some laboratory tests Beta hemolysis is the production of a clear zone surrounding a bacterial colony on blood agar medium which is characteristic of certain pathogenic bacteria such as Group A Streptococcus Icterus adjective icteric condition in which there is too much bilirubin in the blood jaundice An icteric serum sample looks dark yellow it may even look greenish An icteric sample may produce erroneous test results Immunoassay diagnostic test that uses a specific antibody or antigen to detect the presence of an analyte Inaccuracy see Bias In Control in a testing procedure when the results from a control sample or series of control samples are within the acceptable control range Infectious Agent any microorganism that can invade body tissue and multiply causing infection In Vitro Latin for in glass used to describe diagnostic tests that analyze processes occuring inside the body in vivo from samples of body fluids in glass test tubes or other controlled artificial environments Levey Jenning
21. proficiency testing programs Proficiency Testing program in which samples are sent to a group of laboratories for analysis The results are tabulated by the program s sponsor and a participating laboratory can compare its results with those of other laboratories that use the same method Protocol standard set of procedures for performing a procedure such as a test or an evaluation Quality Assurance comprehensive set of policies procedures and practices necessary to make sure that the laboratory s results are reliable QA includes record keeping calibration and maintenance of equipment quality control proficiency testing and training Quality Control set of laboratory procedures designed to ensure that the test method is working properly and that the results meet the diagnostic needs of the physician QC includes testing control samples charting the results and analyzing them statistically 58 GLOSSARY OF TERMS Cholestech GDX System Procedure Manual lt TABLE OF CONTENTS Quantitative applied to tests that give results expressing the numerical amount of an analyte a specimen This is in contrast to qualitative tests that detect whether a particular analyte constituent or condition is present Reactivity ability of a reagent to produce its proper chemical reaction Reagents can lose their reactivity if they are misused mishandled or are too old Reagent substance that produces a chemica
22. the Cholestech GDX Analyzer is used If you are concerned that your test result is incorrect also run the quality control material Optics Check Cartridge Test Procedure Do not use a Cholestech GDX Optics Cartridge that is expired damaged or altered in any way 1 Plug in the Analyzer and allow to warm up 2 Place the cartridge in the Analyzer when the Insert Cartridge icon flashes e C 0 appears on the display and the Hourglass icon is displayed e The Rotate Cartridge icon is displayed The Analyzer will beep and the light at Position 1 will flash 3 Turn the cartridge to Position 1 e and the Hourglass icon will show on the display e The Rotate Cartridge icon will be displayed The Analyzer will beep and the light at Position 2 will flash 4 Turn the cartridge to Position 2 e C 2 and the Hourglass icon will show on the display e The Rotate Cartridge icon will be displayed The Analyzer will beep and the light at Position 3 will flash amp For Information Only R Recommended Optional Information lt TABLE OF CONTENTS 1 5 SETUP AND MAINTENANCE 3 Cholestech GDX System Procedure Manual 5 Turn the cartridge to Position e 3 and the Hourglass icon will show on the display e The Rotate Cartridge icon will be displayed 6 Turn the cartridge to Position e The Remove and Cartridge icons will be displayed 7 Remove the cartridge The Analyzer will display the result e g 1
23. 0 7 8 Record the results in the Cholestech GDX AIC Result Log each day Note stands for Optics Check Cartridge 9 Press the enter button to clear the Optics Check Cartridge result Storage Always store the Optics Check Cartridge at room temperature in its box This will help to protect it from damage such as scratches which may affect the result The cartridge must not be left in direct sunlight for long periods while not in use The Optics Check Cartridge must be stored at relative humidity of less than 60 Results The results displayed on the Analyzer at the end of Optics Check Cartridge test must be in the range on the cartridge label If the result does not fall within the range displayed do the following e Clean the clear plastic surface of the cartridge with a soft lint free cloth Do this on the inside and outside of the cartridge Follow the test from point 2 e If the result is still not in the correct range restart the Analyzer by unplugging and replugging it and run the Optics Check Cartridge e If the result is still not in range contact Cholestech Technical Service e If the cartridge is physically scratched dirty or damaged replace the cartridge with a new Optics Check Cartridge Warning For n Vitro Diagnostic Use When the test is finished the Optics Check Cartridge should be returned to its protective packaging for storage Do not use the Optics Check Cartridge if it has been stored i
24. CONTINUE gt TABLE OF 5 Cholestech GDX System Procedure Manual 6 0 Training 0 1 lntroduelion eu 32 6 2 Cholestech GDX Training Checklist 32 6 3 Certificate of Training Fingerstick Blood Collection 32 5 4 Online Training ai suse er na rare een 32 1 0 Material Safety Data Sheets 34 8 0 Proficiency Testing 8 1 Overview of Proficiency Testing 42 8 2 Proficiency Testing Agencies nananana annann 43 8 3 Reference s and Bibliography 43 9 0 Troubleshooting 91 Time amp SeqgueneeErf rs dede ee dame dant gent eh tue i 46 92 Analyzer Test Errors 47 10 0 Glossary of Terms 54 10 1 Reference s and Bibliography 59 Master Forms ag asien ah la 61 AIC Result Log Temperature Chart Instrument History Record Information and Service Log Initial Setup Checklist Equipment Maintenance Cleaning Log Instruments In Use Record Patient Result Label Log Quality Assurance Record Control Range Calculation Form Accuracy Study Data Precision Calculation Form Training Checklist Certificate of Training for Fingerstick Blood Collection lt TABLE OF CONTENTS Foreword lt TABLE OF CONTENTS FO
25. Cholestech GDX package insert 5 Understands room temperature storage procedures for test cartridges 6 Has been properly trained in procedure for handling biohazardous waste THE CHOLESTECH GDX ANALYZER 7 Correctly connects the Analyzer to the power supply 8 Correctly connects the Analyzer to the printer if applicable 9 Understands and demonstrates Analyzer functions 10 Understands the meaning of all LCD display icons 11 Demonstrates how to clean Analyzer QUALITY ASSURANCE Correctly performs the optics check procedure Correctly performs the quality control procedure Understands what actions are to be taken if the quality control results are outside acceptable limits Understands Proficiency Testing 16 Understands appropriate record keeping QC patient logs temperature monitoring etc PERFORMING A TEST 17 Properly prepares supplies for patient testing alcohol swabs gauze lancets MicoSafe Pipette latex gloves biohazardous waste container 18 Explains the procedure to the patient 19 Handles cartridge properly 20 Performs fingerstick using correct techniques 21 Performs test properly 22 Records results lt TABLE OF CONTENTS A II NP VER RTS RSS RS IS US CUS US TS IS US ANS US EE
26. ION FORM Control Name Cartridge Lot No Lot No Cholestech GDX Serial No GDX GDX Analyte Accept L Reject Director Approval 6 Result Result X NOTES lt TABLE OF CONTENTS Approval Date Record the date in Column 2 and the initials in Column 3 Record the results of the quality control material in Column 4 RESULT Calculate the MEAN X Add the values Column 4 in the RESULT Column then divide by the number of results n Y Results MEAN X Calculate the difference between each RESULT and the MEAN X and record in Column 5 RESULT Square each value in Column 5 record in Column 6 RESULT X Add the values in Column 6 Calculate the standard deviation SD using the formula Divide the sum of the values calculated in Column 6 by the number of values minus 1 Take the square root of this number Y Results X n 1 SD The control range is the MEAN X 25D record above ACCURACY STUDY DATA GDX GDX Operator Analyte Cholestech GDX Serial No Cartridge Lot No Cartridge Expiration Date REFERENCE METHOD CHOLESTECH GDX Sample Date Reference Method 1 2 X Difference Acceptable Accuracy Range is Cholestech GDX Result Ref Result Difference x 100 Ref Result
27. L FIRE AND EXPLOSION HAZARDS Not flammable or explosive SPECIAL FIRE FIGHTING PROCEDURES None SECTION 5 HEALTH INFORMATION PRIMARY ROUTES OF EXPOSURE Skin eye ingestion SIGNS AND SYMPTOMS OF EXPOSURE MEDICAL CONDITIONS GENERALLY AGGRAVATED BY EXPOSURE None CHEMICAL COMPONENT LISTED AS CARCINOGEN OR POTENTIAL CARCINOGEN None OTHER EXPOSURE LIMITS None EMERGENCY amp FIRST AID PROCEDURES Eye Contact Irrigate with copious amount of water Week medical advice Skin Contact Wash off thoroughly with soap and water Seek medical advice Ingestion Wash out mouth thoroughly with water Seek medical advice Inhalation Not applicable 403 12408 Rev A DCN 2897 07 15 02 Continued n next page lt TABLE OF CONTENTS 38 MATERIAL SAFETY DATA SHEETS Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET CONTINUED CHOLESTECH SECTION 6 REACTIVITY DATA STABILITY CONDITIONS TO AVOID Unstable __ Stable _X_ Not determined Non reactive INCOMPATIBILITY MATERIALS TO AVOID Not determined HAZARDOUS DECOMPOSITION PRODUCTS Not determined HAZARDOUS POLYMERIZATION CONDITIONS TO AVOID May Occur __ Will Not Occur _X_ Not determined SECTION 7 SPILL OR LEAK PROCEDURES STEPS TO BE TAKEN IN CASE MATERIAL IS LEAKED OR SPILLED Clean up spills with an absorbent material Dispose of this material in biohazard container Wipe down the area of the spill with 10 bleach All cleaning items and gloves
28. N HAZARDS Combustible SPECIAL FIRE FIGHTING PROCEDURES None SECTION 5 HEALTH INFORMATION PRIMARY ROUTES OF EXPOSURE VAPOR DENSITY AIR 1 Not determined SPECIFIC GRAVITY H 0 1 Not determined VAPOR PRESSURE mm Hg Not determined EVAPORATION DATE 1 Not determined REACTIVITY IN WATER Not determined FLAMMABLE LIMITS IN AIR by VOLUME LOWER Not determined UPPER Not determined AUTO IGNITION TEMPERATURE Not determined Note contact with the silicone elastomer can only be made if the unit is broken Skin ingestion The material is a solid No contact with the eye is possible under normal circumstances SIGNS AND SYMPTOMS OF EXPOSURE 1 ACUTE OVEREXPOSURE None 2 CHRONIC OVEREXPOSURE None MEDICAL CONDITIONS GENERALLY AGGRAVATED BY EXPOSURE None CHEMICAL COMPONENT LISTED AS CARCINOGEN OR POTENTIAL CARCINOGEN None OTHER EXPOSURE LIMITS None EMERGENCY amp FIRST AID PROCEDURES Inhalation not applicable Skin contact Wash off thoroughly with soap and water Ingestion Wash out mouth thoroughly with water 403 12380 Rev A DCN 2869 07 01 02 lt TABLE OF CONTENTS Continued on next page 40 MATERIAL SAFETY DATA SHEETS Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET CONTINUED CHOLESTECH SECTION 6 REACTIVITY DATA STABILITY CONDITIONS TO AVOID Unstable ___ Stable X_ Not determined INCOMPATIBILITY MATERIALS TO AVOID Not determined HAZARDOU
29. Optional Information lt TABLE OF CONTENTS A1C TEST PROCEDURE 23 Cholestech GDX System Procedure Manual IMPORTANT Gloves should be worn whenever working with samples that are potentially biohazardous 2 Hold the white rim of the test cartridge and rotate it clockwise through 90 to Position 1 see Figure 3 The test cartridge will click into its new position The first sample tube will rise from the cartridge Remove the sample tube from the test cartridge and unscrew the cap e Choose a spot that is on the side of one of the center or ring fingers of either hand The fingers and hands should be warm to the touch To warm the hand you can a Wash the patient s hand with warm water or b Apply a warm not hot compress to the hand for several minutes or c Gently massage the finger from the base to the tip several times to bring the blood to the fingertip Clean the site with an alcohol swab Dry thoroughly before pricking the finger Firmly prick the selected site with a lancet Squeeze the finger gently to obtain a large drop of blood Wipe off the first drop of blood Hold the MicroSafe Pipette next to the blood drop on your finger see Figure 4 leaving the pipette in contact with the blood until the blood reaches the fill line see Figure 5 Do not squeeze the bulb while filling the capillary as this will lead to an overfilled MicroSafe Pipette see Figure 6 Do not cover the air hole before the sampling
30. REWORD iii Cholestech GDX System Procedure Manual Procedure Manual Overview This Procedure manual has been designed to instruct Cholestech GDX users in how to comply with good laboratory practices and assist in complying with applicable regulations The Cholestech GDX System Procedure Manual covers Setup and Maintenance Procedure to properly run an optics check and record the values for the Cholestech GDX System In addition the section provides specific information about recording laboratory environment conditions Specimen Collection and Handling General procedures applicable to obtaining a suitable specimen and running a test on the Cholestech GDX System Quality Control Discusses laboratory activities designed to ensure that each test system is working properly and that the test results satisfy quality standards Testing Procedures A test procedure that covers the Cholestech GDX Safety Allows you to file your safety guidelines as recommended by OSHA Training A checklist as a guideline to train personnel on the Cholestech GDX System Material Safety Data Sheets A copy of Cholestech Corporation s MSDS for the Cholestech GDX test cartridges controls and Optics Check Cartridge You can add MSDSs as required Proficiency Testing Guidance Discusses the importance of proficiency testing how testing is performed and lists agencies offering proficiency testing Master Forms Master forms are provided for you to copy and use
31. S DECOMPOSITION PRODUCTS Not determined HAZARDOUS POLYMERIZATION CONDITIONS TO AVOID May Occur ___ Will Not Occur _X_ Not determined SECTION 7 SPILL OR LEAK PROCEDURES STEPS TO BE TAKEN IN CASE MATERIAL IS LEAKED OR SPILLED Contact with the silicone elastomer can only be made if the unit is broken No environmental hazard is anticipated provided the materials are handled and disposed of with due care and attention WASTE DISPOSAL METHOD Chemical residues are generally classified as special waste and as such are covered by Federal State or local laws SECTION 8 PERSONAL PROTECTION INFORMATION RESPIRATORY PROTECTION Not applicable VENTILATION Not applicable PROTECTIVE GLOVES EYE PROTECTION Required to protect product Not required OTHER PROTECTIVE CLOTHING OR EQUIPMENT Not required SECTION 9 SPECIAL PRECAUTIONS PRECAUTIONS TO BE TAKEN IN HANDLING amp STORING Store at room temperature in a box away from direct sunlight and moisture No special transportation requirements Product does not present any hazards during shipment OTHER PRECAUTIONS No environmental hazard is anticipated provided the materials are handled and disposed of with due care and attention NOTES 403 12380 Rev A DCN 2869 07 01 02 lt TABLE OF CONTENTS 8 0 Proficiency Testing 42 PROFICIENCY TESTING Cholestech GDX System Procedure Manual Proficiency Testing lt TABLE OF CONTENTS 8 1 Overview
32. SICAL DATA BOILING POINT SPECIFIC GRAVITY VAPOR PRESSURE Not determined H 0 1 mm Hg Boronate Agarose 6XL N A Not determined Sodium Azide 1 85 Triton X 100 1 07 Hepes Sodium Hepes N A Magnesium Chloride 1 57 Phenoxyethanol 1 10 Ammonium Acetate 1 07 Ultrawet 60 1 02 PERCENT VOLATILE BY VOLUME VAPOR DENSITY AIR 1 EVAPORATION DATE 1 Not determined Not determined Not determined SOLUBILITY IN WATER REACTIVITY IN WATER Some components are soluble Not determined APPEARANCE AND ODOR Clear no odor SECTION 4 FIRE AND EXPLOSION DATA FLASH POINT FLAMMABLE LIMITS IN AIR by VOLUME Not determined LOWER Not determined UPPER Not determined EXTINGUISHING MEDIA AUTO IGNITION TEMPERATURE Sample Wash and Elution Buffers Not determined Water dry powder carbon dioxide or appropriate foam may be used to extinguish Plastic Mouldings Water dry powder carbon dioxide or appropriate foam may be used to extinguish UNUSUAL FIRE AND EXPLOSION HAZARDS Aqueous solution is not flammable but residue may emit toxic fumes on combustion Plastic components are flammable SPECIAL FIRE FIGHTING PROCEDURES None 403 12379 Rev DCN 2967 09 09 02 Continued oh nexe page lt TABLE OF CONTENTS 36 MATERIAL SAFETY DATA SHEETS Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET CONTINUED CHOLESTECH SECTION 5 HEALTH INFORMATION PRIMARY ROUTES OF EXPOSURE Skin eye ingestion SIGNS AND SYMPTOMS OF EXPOSURE 1 AC
33. UTE OVEREXPOSURE None 2 CHRONIC OVEREXPOSURE None MEDICAL CONDITIONS GENERALLY AGGRAVATED BY EXPOSURE None CHEMICAL COMPONENT LISTED AS CARCINOGEN OR POTENTIAL CARCINOGEN None OTHER EXPOSURE LIMITS None EMERGENCY amp FIRST AID PROCEDURES Eye Contact Irrigate eye for 10 minutes with water Obtain medical attention Skin Contact Wash off shin with water Remove and wash contaminated clothing Ingestion Harmful if swallowed Wash out mouth with water Drink plenty of water Obtain medical attention SECTION 6 REACTIVITY DATA STABILITY CONDITIONS TO AVOID Unstable ___ Stable X_ Not determined INCOMPATIBILITY MATERIALS TO AVOID Not determined HAZARDOUS DECOMPOSITION PRODUCTS Not determined HAZARDOUS POLYMERIZATION CONDITIONS TO AVOID May Occur ___ Will Not Occur _X_ Product performance will be impaired if stored for over 2 weeks at temperatures above ambient temperature Functionality is not impaired after short periods lt 2 days at temperatures up to 131 F 55 C SECTION 7 SPILL OR LEAK PROCEDURES STEPS TO BE TAKEN IN CASE MATERIAL IS LEAKED OR SPILLED Sample Wash and Elution Buffers Wear protective gloves If local regulations permit mop up and rinse to waste with copious flow of water Otherwise absorb on inert absorbent and transfer to biohazardous waste container for collection by waste contractor Sample Wash and Elution Buffers contaminated with blood Wear protective glo
34. bstance taken as a sample representing the whole Analysis laboratory procedure that enables measurement of the amount of an analyte in a specimen Analyte substance or constituent being measured e g cholesterol triglycerides glucose Antibody substance formed in the body in response to a foreign substance an antigen and that interacts only with that substance Anticoagulant chemical used to prevent blood from clotting Antigen any substance that injected into an organism causes the development of antibodies Antiserum serum that contains antibodies Aseptic free from infection or septic material sterile Assay measurement of the amount of an analyte in a specimen a test Autoclave instrument that sterilizes material by subjecting it to steam under pressure Bias inaccuracy measure of the departure from accuracy A numerical difference between the mean of a set of replicate measurements and the true value of the sample Calibrated of a measuring device e g a pipette graduated into appropriate units Calibration taking readings from an instrument or other measuring device and relating them to known concentrations of an analyte or true value Calibrator material solution or freeze dried preparation used in calibration The concentration of the analytes in a calibrator is known to be within a particular range Calibrators may be a primary or a secondary standard
35. clusions are made from Diagnostic Test laboratory test or measurement that helps determine the cause or nature of a disease Laboratory tests are often called in vitro diagnostic tests Diluent liquid usually distilled water used to reconstitute a freeze dried control or reagent Dilution mixing of a diluent and a calibrator or control or patient sample A serial dilution is the progressive dilution of a substance in a Series of tubes in predetermined ratios ELISA enzyme linked immunosorbent assay a diagnostic test used to detect either antigens or antibodies in a patient s specimen Enzyme compound produced in a cell and capable of greatly increasing the rate of a chemical reaction Erythrocyte red blood cell one of the elements in peripheral blood Etiologic Agent agent that causes disease False Negative Result negative test result for a patient who is positive for the condition or constituent in question False Positive Result positive test result for a patient who is negative for the constituent or condition in question Glycolysis lowering of glucose concentration in a blood sample by the action of enzymes in the red blood cells 56 GLOSSARY OF TERMS Cholestech GDX System Procedure Manual lt TABLE OF CONTENTS Gravimetry measurement of a substance by determining its weight or specific gravity Hematoma mass of blood usually clotted under the skin in an
36. d 1 Test Cartridges have been manufactured to deliver an 1 result This is calibrated to the recommendations of the Diabetes Control and Complications Trial DCCT This result is traceable to the NGSP National Glycohemoglobin Standardization Program an internationally accepted method of standardization The DCCT was a landmark multicenter clinical study that conclusively linked elevated A1C levels to the complications associated with diabetes Further information on calibration can be found in the Cholestech GDX Analyzer User Manual Procedure Materials Required Cholestech GDX Analyzer and power supply A1C test cartridge MicroSafe Pipette 10 uL Alcohol swabs and gauze for cleaning puncture site Lancets for capillary blood collection Latex gloves Biohazard waste containers Quality control material MiniPet Pipette 10 uL micropipetter that will deliver 10 uL for use with venipuncture samples and quality control material e Vacuum collection tubes needles and tube holders if sample is to be collected by venipuncture For Information Only Recommended Optional Information 22 A1C TEST PROCEDURE Cholestech GDX System Procedure Manual lt TABLE OF CONTENTS Running a Test For more information see the test cartridge package inserts The Quick Reference Guide gives a brief summary of the procedures Note If the Cholestech GDX Analyzer has not been plugged in and has not been stored at room temperat
37. dge or an Analyzer failure To eliminate Analyzer failure as the cause run the Optics Check Cartridge The test cartridge has been damaged Run the Optics Check Cartridge If the Optics Check Cartridge fails remove it from the Analyzer and check that the cartridge is not scratched dirty or covered in fingerprints If the Optics Check Cartridge looks dirty clean with lint free cloth and retest If the Optics Check Cartridge is damaged or scratched contact your distributor for a replacement The Analyzer has been damaged Power off the Analyzer and power it back on again Try running the Optics Check Cartridge again If the error message persists call Technical Service Dirt on in cartridge Repeat the test using a new test cartridge Dirt or obstruction in Analyzer Check the cartridge well and optical window for dirt Err 10 This may be caused by an insufficient blood sample being taken Err 11 Absorbance 1 calculation too high This may be caused by too much blood being taken or in rare cases a hematocrit value that is very high or a combination of the two A faulty blood collection pipette and or not enough blood added to the first tube Repeat the test using a new test cartridge and a new blood collection pipette User error the user is unfamiliar with the blood collection pipette and has underfilled the pipette A faulty blood collection pipette is used and or too much blood added t
38. dge out and push the enter button The screen will then indicate for a new cartridge Repeat the test with a new test cartridge making sure that all timed sequence steps are performed according to the manufacturer s instructions Err 5 Sequence time out It is essential to follow the operational sequence without delays between steps The Analyzer measures time intervals between steps at appropriate points and will error if the interval is above certain limits test cartridge is placed in the Analyzer and advanced to Position 1 If the prompt for pressing the enter button is ignored for more than 300 seconds Error 5 will be displayed Atest cartridge is advanced to Position 2 If the prompt for pressing the enter button is ignored for more than 60 seconds Error 5 will be displayed Repeat the test with a new test cartridge making sure that all timed sequence steps are performed according to the manufacturer s instructions If the error message persists call Technical Service Analyzer failure Call Technical Service Err 6 Addition of sample not detected The Analyzer has failed to detect a meniscus flow within the defined time limit It is essential to follow the operational sequence without extensive delays between steps The test procedure has been followed up to the Analyzer prompt for the remixing of blood in the sample tube and for it to be poured into the funnel If the blood sample is not
39. e concentration of A1C within a red blood cell reflects the average level of blood sugar over the previous 120 days The level of A1C therefore rises proportionately in patients with higher levels of blood sugar such as those with uncontrolled or undiagnosed diabetes It has been proposed that the measurement of A1C may be useful in the diagnosis of diabetes Principle of the Test The Cholestech GDX Analyzer uses boronate affinity chromatography to separate the glycated hemoglobin fraction from the nonglycated fraction Both fractions are measured and an algorithm converts the results into the percentage 1 hemoglobin A1C in the sample After a GDX test cartridge has been placed into the instrument a small sample of blood is added to the first red capped sample tube which contains the boronate affinity resin The red blood cells are instantly lysed to release the hemoglobin and the boronate affinity resin binds the glycated hemoglobin After a short incubation step the liquid is poured into the funnel of the test cartridge and the non glycated fraction is collected in an optical chamber cuvette where the hemoglobin concentration is photometrically measured The glycated hemoglobin remains bound to the boronate affinity resin which sits at the bottom of the test cartridge funnel The boronate affinity resin glycated hemoglobin is then washed with the contents of the second blue capped tube The final step is the elution of the
40. e to tip until a large drop of blood forms 7 Wipe off any excess blood and have the patient apply pressure to the puncture until the bleeding stops amp For Information Only R Recommended Optional Information lt TABLE OF CONTENTS 2 3 2 4 SPECIMEN COLLECTION AND HANDLING Cholestech GDX System Procedure Manual Procedure Sign Off 9 Approved Director s Signature Date Adopted Director s Signature Date Revised Director s Signature Date Discontinued Director s Signature Date The procedure is not applicable to this laboratory Director s Signature Date Venipuncture Procedure Precautions This procedure should be conducted only by a qualified phlebotomist When handling patient samples follow appropriate biohazard precautions Venipuncture Setup 1 Identify appropriate specimen type types for the tests you are performing e Whole blood Anticoagulated whole blood containing white blood cells red blood cells platelets and plasma 2 Select appropriate tubes and needles needed for the tests COLOR CODED TUBES Color Use Additive Green Plasma or Whole Blood Heparin Lavender Plasma or Whole Blood EDTA Gray Plasma or Whole Blood Oxalate fluoride glycolysis inhibition Blue Plasma or Whole Blood Citrate Red Serum None Red or Red Black Serum Serum separator gel 3 When collecting several samples during a venipuncture start with the tubes that have
41. ection NOTES 403 12403 Rev A DCN 2897 07 15 02 lt TABLE OF CONTENTS MATERIAL SAFETY DATA SHEET Cholestech GDX Optics Check Cartridge SECTION 1 IDENTITY NAME Cholestech GDX System TELEPHONE NUMBER 800 733 0404 COMMON NAME USED ON LABEL Cholestech GDX Optics Check Cartridge CHEMICAL NAME Does not apply TRADE NAME amp SYNONYMS Cholestech GDX Trademark of Cholestech Corporation SECTION 2 HAZARDOUS INGREDIENTS HAZARDOUS COMPONENT None Technical Service CAS FOR ADDITIONAL INFORMATION CONTACT MATERIAL SAFETY DATA SHEETS 39 Cholestech GDX System Procedure Manual CHOLESTECH ADDRESS 3347 Investment Blvd Hayward CA 94545 DATE PREPARED June 21 2002 CHEMICAL FAMILY Does not apply FORMULA Does not apply wt PEL Permissible Exposure Limit established by the Occupational Safety amp Health Administration OSHA TLV Threshold Limit Value established by the American Conference of Governmental Industrial Hygienists 1987 88 SECTION 3 PHYSICAL DATA BOILING POINT Not determined PERCENT VOLATILE BY VOLUME Not determined SOLUBILITY IN WATER Insoluble APPEARANCE AND ODOR Colorless plastic housing with red orange dye in 2 wells Odor none SECTION 4 FIRE AND EXPLOSION DATA FLASH POINT gt 212 F 100 C EXTINGUISHING MEDIA Foam dry powder carbon dioxide of vaporizing liquids Not determined UNUSUAL FIRE AND EXPLOSIO
42. ely removed again Press the round enter button to start another test This error may be caused by a problem with the microswitches in the Analyzer Check the Analyzer using an Optics Check Cartridge Call Technical Service if message reappears Err 2 Test cartridge not present Analyzer has failed to detect a cartridge There may be a problem with the microswitches or the cartridge is damaged Damage to the Analyzer has caused microswitch failure Check the Analyzer using an Optics Check Cartridge Test cartridge is damaged Retest using a new cartridge Test cartridge was turned from Position 0 to Position 1 before the Analyzer prompt Repeat the test making sure that all timed sequence steps are performed according to the manufacturer s instructions Error persists Call Technical Service Err 3 Cartridge not rotated in time It is essential to follow the operational sequence without extensive delays between steps The Analyzer measures time intervals between steps at appropriate points and will error if the interval is above certain limits lt TABLE OF CONTENTS For Information Only A test cartridge is placed into the Analyzer and the prompt for turning to Position 1 is displayed If the prompt is ignored for greater than 300 seconds Error 3 is displayed If the test cartridge is at Position 1 and the prompt for turning to Position 2 is ignored for greater than 60 sec
43. en run up to the Analyzer prompt for the enter button to be pressed after the contents of the second tube are poured down the funnel Error 7 will be displayed if the enter button is pressed immediately or within 4 seconds Recommended Optional Information TROUBLESHOOTING 49 Cholestech GDX System Procedure Manual ERROR CODE EXPLANATION ACTION TO TAKE Err 8 Position 1 blank reading out of range The Analyzer has detected unacceptable through beam intensity This may result from a dirty or damaged cartridge or an Analyzer failure The test cartridge has been damaged Run the Optics Check Cartridge If the Optics Check Cartridge fails remove it from the Analyzer and check that the cartridge is not scratched dirty or covered in fingerprints If the Optics Check Cartridge looks dirty clean with lint free cloth and retest If the Optics Check Cartridge is damaged or scratched contact your distributor for a replacement The Analyzer has been damaged Power off the Analyzer and power it back on again Try running the Optics Check Cartridge again If the error message persists call Technical Service Dirt on in cartridge Repeat the test using a new test cartridge Dirt or obstruction in Analyzer Check the cartridge well and optical window for dirt Err 9 Position 3 blank reading out of range The Analyzer has detected an unacceptable signal This may result from a dirty or damaged cartri
44. errupted during use INSTALLATION 1 Verify that the wall outlet corresponds to the voltage requirements of the power supply 2 Connect the power plug to the power supply both to the inlet on the back of the instrument 3 Plug the power supply into the wall socket 4 The Analyzer will run through a check stage All the red positional indicator lights on the Analyzer will flash the beep will sound and the display will show all icons and characters momentarily 5 A number will appear on the display This is the version of software in the Analyzer for example 2 06 6 The Hourglass icon will flash to tell you to wait The maximum time required for warm up is 10 minutes 7 The Insert and Cartridge icons will flash when the Analyzer is ready for use The right and left arrows will be solid 8 You can now use the Analyzer to run an Optics Check Cartridge or an A1C Test Cartridge NOTES lt TABLE OF CONTENTS EQUIPMENT MAINTENANCE CLEANING LOG GDX INSTRUMENT MAINTENANCE NOTES problems reported dates solutions Serial No Quarterly Cleaning Schedule Dates lt TABLE OF CONTENTS INSTRUMENTS IN USE RECORD GDX GDX INSTRUMENT SERIAL MANUFACTURER DATE OPERATOR MODEL NUMBER INSTALLED
45. glycated hemoglobin off the boronate affinity resin using the third clear capped tube The glycated hemoglobin concentration is measured and the Analyzer calculates the A1C in the sample Active Ingredients M amino phenyl boronic acid coupled to 6 beaded agarose 100 mg amp For Information Only Recommended Optional Information lt TABLE OF CONTENTS 44 A1C TEST PROCEDURE 21 Cholestech GDX System Procedure Manual Cartridge Storage Cartridges must not be stored upside down Cartridges may be used until the date printed on the rim when stored at 59 77 F 15 25 C Do not freeze the test cartridges Sample Handling Sample Volume 10 uL of whole blood Fingerstick whole blood sample with MicroSafe Pipette MicroSafe Pipettes included with each box of test cartridges No anticoagulant in the MicroSafe Pipettes Venous whole blood in heparin and EDTA tubes only For venous samples or controls use the 10 uL MiniPet Pipette supplied with the system uses 11 010 pipette tips Venous samples can be used up to 4 days after collection when stored at 36 46 F 2 8 C Hemolyzed or packed red blood cells samples must not be used Precaution All blood samples and containers capillary tubes and materials that have come in contact with blood should be handled as if capable of transmitting infectious disease and discarded into a biohazard waste container after use Calibration The Cholestech GDX Analyzer an
46. h GDX test results Substance Concentration mg dL Bilirubin 8 5 mg dL Acetylsalicylic acid 30 0 mg dL Caffeine 30 0 mg dL Acetaminophen 30 0 mg dL Hydroxyzine dihydrochloride 30 0 mg dL For Information Only R Recommended Optional Information lt TABLE OF CONTENTS 4 6 4 1 A1C TEST PROCEDURE 21 Cholestech GDX System Procedure Manual Triglycerides at 761 mg dL showed no effect on the Cholestech GDX test result but elevated lipid concentrations may interfere and cause low results in this type of assay Expected Results Nondiabetic children and adults have an average A1C of 5 with a range of 3 to 7 People with diabetes can have values that are much higher and the AIC level reflects the degree of control of the disease Accuracy and Precision The Cholestech GDX has met the accuracy and precision requirements set by the NGSP in each year it has been tested Cholestech GDX 1 results are certified as traceable to the DCCT NGSP precision lt 4 coefficient of variation CV by NCCLS EP5 A protocol NGSP bias 95 confidence interval of differences between Cholestech GDX and NGSP reference laboratory values are within 1 of NGSP reference laboratory values Technical Assistance For technical assistance please call Cholestech Technical Service at 800 733 0404 Procedure Sign Off Approved Director s Signature Date Adopted Director s Signature Date Revised Director s Signature
47. her substance Agglutination titer is the highest dilution of a serum that causes clumping of particulate antigens Throughput applied to analytical instruments specifying the number of tests that can be performed in a given time Toxicology study of the origin nature and effects of poison Toxicological analyses are used to detect the amount of a substance that can be poisonous at a particular concentration Turbidity adjective turbid cloudiness distribution of a substance in a solution making it unclear or cloudy Value number in units of the method obtained for an analyte in a particular sample See Result Venipuncture procedure for collecting a blood sample from a vein venous blood Whole Blood blood mixed with an anticoagulant but not spun down in a centrifuge Reference s and Bibliography 1 National Committee for Clinical Laboratory Standards Physician s Office Laboratory Procedure Manual Tentative Guideline Villanova Pa NCCLS 1989 NCCLS publication POL2 T Vol 12 No 5 lt TABLE OF CONTENTS 11 0 Master Forms 1 RESULT LOG GDX GDX Cholestech GDX Serial No Test Cartridge Lot No Expiration Date Optics Check Cartridge Lot No Expiration Date Range Control Lot No Expiration Date Level 1 Range Level 2 Range SAMPLE DATE IDENTIFIER PATIENT OPTICS LEVEL 1 LEVEL2 INITIALS DNO RESULTS CHECK ac ac
48. holestech Corporation MKT 12587 Rev A www cholestech com lt TABLE OF CONTENTS
49. i ain Adam AMI an 8 Fingerstick Procedure 8 Proc dure een Aa 9 Venipuncture Procedure 9 Procedure Sign Off 11 Reporting Results Properly 12 Procedure Sign Off 13 Proper S p cime nStOrABe ee 13 Procedure to Properly Remove a Rubber Stopper from an Evacuated Tube 13 Reference s and Bibliography 14 Quality Control nr a Es 16 Handling Controls ara Bent A eg ER od alas 16 External Quality ques de pada ea 16 Control u ar Santana 17 A1C Test Procedure Introduction sita iaa rias edhe a 20 Medical Importance 0 20 Principlerof the Test 22 6 ran iui elon a de cken 20 Procedure 21 Test Interpretation a ad da aa dad 26 Technical Assistance 27 Proc dure coreia Roanne ma a ee eae eR Ah Eee RRL at 27 Reference s and Bibliography 28 Safety RE Rd DE Mater anette 30 Reference s and Bibliography 30 TABLE OF CONTENTS
50. idge to Position 2 Position 2 Position 3 300 seconds 5 minutes The Analyzer is prompting you to turn the test cartridge to Position 3 Between Positions 10 seconds A test cartridge is turned to a position halfway between any of the positions Time allowed pouring sample and incubating Position 2 60 seconds 1 minute Prompt for pressing the enter button is ignored Time allowed pouring buffer Position 1 30 seconds After incubation the allowed time to remix and pour the sample into the funnel 60 seconds 1 minute The solution third tube was not poured into the funnel in time 3 3 Position 1 300 seconds 5 minutes Prompt for pressing the enter button is ignored lt TABLE OF CONTENTS amp For Information Only R Recommended Optional Information 9 2 Analyzer Test Errors TROUBLESHOOTING 4 Cholestech GDX System Procedure Manual The Cholestech GDX Analyzer has been programmed to detect any Analyzer or test problems An error message will appear on the display if any mistakes arise during the test Look at the following table to see the cause of the error message and the possible correction In the event of technical difficulty or Analyzer failure contact Cholestech Technical Service 800 733 0404 ERROR CODE EXPLANATION ACTION TO TAKE Err 1 Test abandoned by the user Atest cartridge was placed in the reader and immediately removed again Atest cartridge was placed in the reader and immediat
51. ion Only R Recommended Optional Information 6 SETUP AND MAINTENANCE Cholestech GDX System Procedure Manual Course of Action for Other Instruments in the Lab Name of Instrument Technical Service Phone Number Written Procedure If the Instrument Fails 1 11 Procedure Sign Off Approved Director s Signature Date Adopted Director s Signature Date Revised Director s Signature Date Discontinued Director s Signature Date The procedure is not applicable to this laboratory Director s Signature Date 1 12 Reference s and Bibliography 1 National Committee for Clinical Laboratory Standards Physician s Office Laboratory Procedure Manual Tentative Guideline Villanova Pa NCCLS 1989 NCCLS publication POL2 T Vol 12 No 5 lt TABLE OF CONTENTS amp For Information Only Recommended Optional Information 2 0 Specimen Collection and Handling 8 SPECIMEN COLLECTION AND HANDLING Cholestech GDX System Procedure Manual Specimen Collection and Handling lt TABLE OF CONTENTS 2 1 2 2 Introduction Since the collection of the patient s specimen is the beginning of the analytical process the use of proper collection techniques is essential to obtaining accurate results It is imperative that laboratories follow appropriate biohazard and safety procedures Many laboratory errors can be traced to such nonanalytical factors as misidentifying or mishandli
52. ional Information lt TABLE OF CONTENTS SPECIMEN COLLECTION AND HANDLING 11 Cholestech GDX System Procedure Manual 10 Remove the needle and bandage the site e Aftert from t and te e Apply bleedi he tube has been withdrawn from the holder gently remove the needle he venipuncture site Immediately apply a sterile gauze pad to the site ll the patient to keep pressure on the site for two minutes an adhesive or gauze bandage over the venipuncture site after the ng has stopped The patient should leave the bandage on for a minimum of 15 minutes 11 Dispose of the puncture unit To prevent injury and to be sure needles are not reused promptly dispose of the needle and the blood tube holder in an appropriate biohazard container Do not recap the needle 2 5 Procedure Sign Off Approved Director s Signature Date Adopted Director s Signature Date Revised Director s Signature Date Discontinued Director s Signature Date The procedure is not applicable to this laboratory Director s Signature Date lt p For Information Only R Recommended Optional Information 12 SPECIMEN COLLECTION AND HANDLING Cholestech GDX System Procedure Manual 2 6 Reporting Results Properly You may wish to establish a procedure that will prevent any misidentification when giving the results to the physician or patient The following space is available to record the laboratory procedure that will be used to rep
53. is complete as this will cause incorrect filling of the pipette see Figure 7 e Place the tip of the MicroSafe Pipette of blood into the liquid of the sample tube Squeeze the bulb to release the blood Replace the cap and mix the contents by gently turning upside down 5 TIMES see Figure 8 Start the wait time by IMMEDIATELY PRESSING the round Enter button see Figure 9 A 60 second countdown will appear on the display Overfilled Figure 4 Figure 5 Figure 6 Underfilled Figure 7 Figure 8 Figure 9 lt p For Information Only R Recommended Optional Information 24 A1C TEST PROCEDURE Cholestech GDX System Procedure Manual lt TABLE OF CONTENTS 3 Put everything that touched the blood sample or control in a biohazard waste container 4 The end of the countdown is indicated by a beep The Insert Mix and Pour Tube icons will appear on the display Mix the contents of the tube by turning upside down 3 TIMES see Figure 10 Remove the cap Pour the entire contents into the gray funnel of the test cartridge see Figure 11 5 The Analyzer senses the sample No button press is necessary e 50 second countdown will appear on the display e At the end of the countdown the Hourglass icon will appear e A beep will sound The light will flash at Position 2 and the Rotate Cartridge icon will appear on the display Note Some liquid may stay in the funnel at the end of the 50 second countdown Continue and turn the car
54. l reaction in a sample that allows an analyte to be detected and measured Reconstitute to add a diluent to a freeze dried calibrator control or reagent Reference Interval see Normal Values Replicate to repeat an experiment and or analysis to check the accuracy of the results Each repeat is a replicate pronounced rep li kit test or measurement Reproducibility see Precision Result value obtained by analysis for a particular analyte in a particular sample Run analytical run group of measurements by a particular method over a period of time during which the accuracy and precision of the method are expected to be stable Sample part of a specimen used for an analysis Sensitivity ability of a test to give a positive result for patients who have the disease or condition they are tested for measured as the ratio of positive tests to the total number of tests in those who have the disease expressed as a percentage Serum liquid part of the blood after it has coagulated and then been spun down a centrifuge Specificity ability of a test to give a negative result for patients who do not have the disease or condition they are tested for measured as the ratio of negative tests to the total number of tests in those who do not have the disease or condition expressed as a percentage Specimen portion of body fluid e g blood or urine collected from the patient Split Sample Testing
55. may waive their right to the vaccine by signing a form but they are entitled to change their minds and receive the vaccine as soon as possible You may use this section to file any training material forms or guidelines regarding lab safety practices For further information or to obtain training material regarding these regulations contact OSHA Reprints of the final rule Occupational Exposures to Blood Borne Pathogens can be obtained by contacting this organization OSHA Office of Publications U S Department of Labor Box 37535 Washington DC 20013 7535 Web site www osha gov Another excellent source of reference is the National Committee for Clinical Laboratory Standards NCCLS The NCCLS is a U S organization developing standards for clinical laboratory testing For further information you may contact this organization National Committee for Clinical Laboratory Standards 940 West Valley Road Suite 1400 Wayne PA 19087 1898 610 688 0100 Fax 610 688 0700 e mail exoffice nccls org Web site www ncels org Reference s and Bibliography 1 Brown JW Blackwell H Complying with the new OSHA regs on HIV and HBV protection Medical Laboratory Observer June 1992 21 amp For Information Only R Recommended Optional Information 6 0 Training 32 TRAINING Cholestech GDX System Procedure Manual Training lt TABLE OF CONTENTS 6 1 6 2 6 3 6 4 Introduction In the Master Fo
56. ncorrectly and is scratched or damaged in any way For technical help and troubleshooting please refer to the Cholestech GDX AIC Test Cartridge package insert and the User Manual If technical help is required please contact Cholestech Technical Service at 800 733 0404 Shelf Life Stability Optics Check Cartridges have a shelf life date The expiration date is printed on the top of the Optics Check Cartridge Do not use the Optics Check Cartridge after the end of the shelf life date amp For Information Only Recommended Optional Information 4 SETUP AND MAINTENANCE Cholestech GDX System Procedure Manual lt TABLE OF CONTENTS 1 6 1 7 1 8 Laboratory Temperature Records Forms are included in this manual see Master Forms section to record the temperature of the laboratory room and refrigerator Each form is designed for a daily record to be recorded There is space for the site identification the acceptable temperature range and daily temperature records Record the temperature and your initials in the allocated spaces Instrument History Record Proper continuing care for a laboratory instrument has primary importance as it minimizes breakdowns and ensures proper results The Instrument History Record allows lab personnel to communicate effectively with Cholestech Technical Service You should have a record for your Cholestech GDX System as well as records for any other instruments in the lab refer to the Ma
57. nd of the countdown the Hourglass icon will appear on the display Do not turn the cartridge until the beep sounds and the Rotate Cartridge icon appears on the display e Turn the test cartridge clockwise to Position O see Figure 16 e Remove it from the Analyzer see Figure 17 Put the test cartridge in a biohazard waste container When the test cartridge is removed the Analyzer displays the percentage AIC value for the sample e Push the enter button to clear the display Please call Cholestech Technical Service at 800 733 0404 if you have any questions about the operation of the Cholestech GDX System Wi Figure 14 Figure 15 Figure 16 Figure 17 For Information Only Recommended Optional Information 26 A1C TEST PROCEDURE Cholestech GDX System Procedure Manual lt TABLE OF CONTENTS 4 5 Test Interpretation The ADA recommends that the goal of therapy should be A1C result lt 7 and that physicians should reevaluate and in most cases significantly change the treatment regimen in patients with AIC test results consistently gt 8 These specific 1 values apply only to assay methods that are certified as traceable to the DCCT reference method Limitations Linearity and Temperature Effects The Cholestech GDX test has been shown to give a linear response from 4 15 AIC using patient samples In addition the theoretical performance of the test indicates a linear range of 2 to gt 25
58. nd repeat the test using an Optics Check Cartridge If the Optics Check cartridge gives the correct result repeat the test using a new test cartridge Test cartridge malfunction Contamination of solutions in the tubes would prevent a stable signal from being achieved Repeat the test using a new test cartridge If error message persists record lot number and contact Technical Service Err 16 Blank reading not completed in time The optical system is not stable Repeat the test Analyzer malfunction The Analyzer has experienced a rapid change in temperature from very cold to room temperature This may happen when left in a cold car overnight and taken into a warm room Allow the Analyzer to warm up to room temperature Power Analyzer off power back on again and repeat the test using an Optics Check Cartridge If the Optics Check cartridge gives the correct result repeat the test using a new test cartridge Test cartridge malfunction although this is unlikely Repeat the test with new test cartridge Err 17 Blue LED failed Test cartridge not removed A test cartridge or Optics Check Cartridge has been left in the Analyzer while the Analyzer is connected to the power supply but not in use Remove the cartridge turn off the power supply and disconnect the Analyzer Reconnect the Analyzer allow to warm up and insert an Optics Check Cartridge LED photodiode has failed Call Technical Service
59. ng specimens Nonanalytical error can be prevented by using careful collection and processing procedures Fingerstick Procedure Precautions When handling patient samples appropriate biohazard precautions should be taken The Cholestech GDX A1C test is carried out on a fingerstick blood sample 1 Choose a spot on the side of one of the center or ring fingers of either hand The fingers and hands should be warm to the touch To warm the hand you can a Wash the patient s hand with warm water or b Apply a warm not hot compress to the hand for several minutes or c Gently massage the finger from the base to the tip several times to bring the blood to the fingertip 2 Clean the site with an alcohol swab Dry thoroughly before pricking the finger 3 Firmly prick the selected site with a lancet 4 Squeeze the finger gently to obtain a large drop of blood Wipe away this first drop of blood as it may contain tissue fluid 5 Squeeze the finger gently again while holding it downward until a second large drop of blood forms Do not milk the finger The puncture should provide a free flowing drop of blood 6 collect the capillary blood sample hold the MicroSafe Pipette horizontally Touch the tip to the blood sample Do not squeeze The pipette will fill automatically to the black fill line Do not collect air bubbles If it is necessary to collect another drop of blood wipe the finger with gauze then massage again from bas
60. ng the flange of the needle holder push the tube forward until the back end of the needle punctures the stopper While the needle is in the vein keep the tube below the puncture site e When the blood starts flowing into the tube release the tourniquet and open the patient s hand This allows circulation to return to normal and reduces bleeding at the venipuncture site When drawing multiple tubes keep the tourniquet in place until the last tube is being collected e Keep constant forward pressure on the tube in the direction of the needle this prevents the shutoff valve from closing and stopping the flow of blood e When the blood stops flowing remove the tube from the holder The needle s shutoff valve will stop the blood flow until the next tube 15 inserted e Tubes containing an anticoagulant should be allowed to fill until the vacuum is exhausted and blood flow ceases this assures the correct ratio of anticoagulant to blood volume Gently invert the tube five to ten times to mix the blood and anticoagulant Do not shake the tube vigorously e Insert the next tube into the holder and repeat the collection procedure If a blood sample cannot be obtained change the position of the needle If the needle has penetrated too far into the vein pull it back a bit If it has not penetrated far enough move it farther into the vein If this does not help try inserting another evacuated tube d For Information Only R Recommended Opt
61. o high Values above a certain level of glycation are extremely rare Repeat the test User error The user is unfamiliar with the blood collection pipette and has overfilled the pipette Check blood sampling technique with user instructions If necessary practice using the pipette before running a test Analyzer error In rare circumstances this may be an Analyzer problem Power Analyzer off power back on again and repeat the test using an Optics Check Cartridge If the Optics Check cartridge gives the correct result repeat the test using a new test cartridge Contamination of solution in third tube Repeat the test using a new test cartridge If error message persists record lot number and contact Technical Service Err 14 Reading not stable This may be caused by contamination of the fluid with extraneous fibers or the Analyzer is not physically stable Err 15 Reading not completed in time The final reading must be obtained within 10 seconds If a stable signal is not achieved contamination is likely Analyzer malfunction Check the Analyzer using an Optics Check Cartridge Check that the bench table is not vibrating or moving due to other laboratory equipment Test cartridge malfunction Analyzer malfunction If the Analyzer is working correctly repeat the test with a new cartridge If the error message persists contact Technical Service Power Analyzer off power back on again a
62. o the sample tube Check the blood sampling technique with user instructions If necessary practice using the pipette before running a test Repeat the test using a new test cartridge and a new blood collection pipette User error the user is unfamiliar with the blood collection pipette and has overfilled the pipette Check blood sampling technique with user instructions If necessary practice using the pipette before running a test A blood sample has a high hematocrit Establish whether the patient has a high hematocrit value Err 12 Absorbance 3 calculation too low This may be caused by an insufficient blood sample being taken initially Repeat the test taking care to fill the blood collection pipette correctly lt TABLE OF CONTENTS For Information Only faulty blood collection pipette is used and not enough blood is added to sample tube Repeat the test using a new test cartridge and new blood collection pipette User error the user is unfamiliar with the blood collection pipette and has underfilled the pipette Check blood sampling technique with user instructions If necessary practice using the pipette before running a test faulty cartridge R Recommended Repeat the test with a new test cartridge Optional Information 50 TROUBLESHOOTING Cholestech GDX System Procedure Manual ERROR CODE EXPLANATION ACTION TO TAKE Err 13 Absorbance 3 calculation to
63. onds Error 3 is displayed If the test cartridge is at Position 2 and the prompt for turning to Position 3 is ignored for greater than 300 seconds Error 3 is displayed A test cartridge is placed in the Analyzer and the prompt for turning to any of the positions is flashing The cartridge is turned to a position halfway between and left for 10 seconds Error 3 is displayed Run the Optics Check Cartridge to check that there are no problems with the Analyzer Repeat the test with a new test cartridge making sure that all timed sequence steps are performed correctly according to the manufacturer s instructions If the error message persists call Technical Service The error may be caused by a problem with the microswitches in the Analyzer R Recommended Run the Optics Check Cartridge to check that there are no problems with the Analyzer If the error message persists call Technical Service Optional Information 48 TROUBLESHOOTING Cholestech GDX System Procedure Manual ERROR CODE EXPLANATION ACTION TO TAKE Err 4 Cartridge in the wrong position The cartridge has been moved out of sequence i e moved when not prompted A test cartridge is turned between Positions 1 and 2 before being prompted by the Analyzer test cartridge is turned between Positions 3 and 0 before being prompted by the Analyzer Complete the rotation of the cartridge clockwise to the beginning position Take the cartri
64. ort results from the Cholestech GDX System Or you may use the A1C Result Log in the Master Forms section The additional space that follows is available to document the procedures for other instruments in the laboratory Cholestech GDX System Instrument Name Manufacturer lt TABLE OF CONTENTS For Information Only R Recommended Optional Information lt TABLE OF CONTENTS 2 7 2 8 2 9 SPECIMEN COLLECTION AND HANDLING 13 Cholestech GDX System Procedure Manual Procedure Sign Off Approved Director s Signature Date Adopted Director s Signature Date Revised Director s Signature Date Discontinued Director s Signature Date The procedure is not applicable to this laboratory Director s Signature Date Proper Specimen Storage 1 Anticoagulated blood may be sampled directly from the tube after mixing Use a MiniPet Pipette and tips or micropipetter calibrated to deliver 10 UL 2 Mix all samples thoroughly by gentle inversion 7 8 times before testing Procedure to Properly Remove a Rubber Stopper from an Evacuated Tube 1 All blood samples and blood products are potentially biohazardous and should be treated as such Latex gloves goggles and a completely buttoned long sleeve lab coat should be worn when handling these materials 2 When removing rubber stoppers from evacuated tubes cover the stopper with a piece of gauze o
65. poured into the funnel after 30 seconds the liquid will not be detected and Error 6 will be displayed Atest cartridge has been run up to the stage of the Analyzer prompt for the pouring of the contents of the third tube into the funnel After 60 seconds it cannot be detected and Error 6 will be displayed Repeat the test with a new test cartridge making sure that all timed sequence steps are performed correctly according to the manufacturer s instructions Err 7 Enter button depressed too early It is essential to follow the procedure according to the instruction manual The Analyzer measures time intervals between steps and will error if the interval is so short that the user could not have performed the particular operation lt TABLE OF CONTENTS For Information Only During the normal testing procedure the display prompts the user to take the blood sample tube and press the enter button to start the incubation period Error 7 will be displayed when the enter button is pressed immediately after the prompt message is displayed Check the Analyzer using an Optics Check Cartridge Retest using a new cartridge and ensuring the timing sequence is correct If the above has been performed but the time elapsed before the enter button is pressed is between 1 and 9 seconds Error 7 will be displayed If the enter button is pressed after 10 seconds no error message will be displayed Atest cartridge has be
66. r Forms section If a result for an 1 test cartridge is within the expected ranges patient samples may be tested and the results reported Results Outside the Control Range If results of one or both levels of control tested are outside the established ranges 1 2 Verify that you have the correct assay sheet for the control being tested Check that the expiration date for the test cartridge and quality control materials have not passed Verify that the lot number on the control vial and the assay sheet are the same Retest the control level that is out of range using a new sample from the same control vial Pay careful attention to possible errors in technique a Ifthe control is within acceptable limits patient samples may be tested and results reported b Ifthe control is outside the acceptable limits retest with a sample of control from a new vial elf results are in range continue testing patient samples e If the control is still outside the acceptable limits contact Cholestech Technical Service Do not use the Analyzer for testing patient samples until the problem is resolved QUALITY CONTROL FLOW DIAGRAM BEGIN TESTING of quality control material Are RESULTS within ACCEPTABLE LIMITS YES NO RECORD results on VERIFY expiration date on Cholestech GDX Quality control material Result Log Cartridge RETEST with sample from SAME control vial using NEW cartridge LJ VES WITHIN LIMITS
67. r laboratory s standard quality control procedures e If you are not running the Cholestech under CLIA waived status or if your local or state regulations require more frequent testing of quality control material then quality control must be performed in compliance with those regulations Good Laboratory Practice principles suggest that external controls must be run whenever the laboratory director has any question about test system integrity or operator technique e g when reagents may have been stored or handled in a way that can degrade their performance or when operators have not performed a particular test in recent weeks If the controls do not perform as expected repeat the test or contact Cholestech Technical Service before testing patient samples The quality control results must be in range before testing patient samples See Section 3 4 that follows if quality control results are not within range Please call Cholestech Technical Service at 800 733 0404 if you have any questions about quality control amp For Information Only R Recommended Optional Information lt TABLE OF CONTENTS QUALITY CONTROL 17 Cholestech GDX System Procedure Manual 3 4 Control Range Results for Cholestech GDX AIC Controls must be within the ranges included with the controls before patient samples are tested Results Within the Control Range QC results can be logged on the Quality Assurance Record template found in the Maste
68. r remove with an evacuated tube stopper remover 3 Always point the tops of any sample tubes away from anyone when removing the caps Pipette tips are pointed away from people while the tips are being ejected 4 For cleanup of spilled blood and blood products observe the safety policies in the lab and the Universal Precautions recommended by the Occupational Safety amp Health Administration OSHA For Information Only Recommended Optional Information 14 SPECIMEN COLLECTION AND HANDLING Cholestech GDX System Procedure Manual 2 10 Reference s and Bibliography lt TABLE OF CONTENTS 1 National Committee for Clinical Laboratory Standards Physician s Office Laboratory Procedure Manual Tentative Guideline Villanova Pa NCCLS 1989 NCCLS publication POL2 T Vol 12 No 5 National Committee for Clinical Laboratory Standards Procedure for the Collection of Diagnostic Blood Specimens by Skin Puncture 2nd ed Approved Standards NCCLS Tietz NW ed Fundamentals of Clinical Chemistry Philadelphia Pa WB Saunders 1987 National Committee for Clinical Laboratory Standards Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue Tentative Guideline Villanova Pa NCCLS 1991 NCCLS document M29 T2 ISBN 1 56238 123 7 Davidsohn Henry JB eds Todd Sanford Clinical Diagnosis by Laboratory Methods Philadelphia Pa WB Saunders Co 1969 Burtis
69. rds are available to demonstrate that uniform procedures have been established and are followed The material in this procedure manual can assist in assuring that the quality of test results in the laboratory or at a testing site are satisfactory over time 1 0 Setup and Maintenance 2 SETUP AND MAINTENANCE Cholestech GDX System Procedure Manual Setup and Maintenance lt TABLE OF CONTENTS 1 1 1 2 1 3 1 4 Introduction This section contains the procedure to properly run an optics check and specific information about proper maintenance A sample copy of each form referred to is included in the Master Forms section of this manual Environmental Requirements Use your Cholestech GDX System in a location that has Temperature 63 86 F 17 30 C A stable work surface No direct heat oven or room heater No bright light sunlight or a spotlight It is important to prevent dust and dirt from getting into the Analyzer Keep the Analyzer covered when not in use If the temperature or light requirements not acceptable the Analyzer will shut down until they are met Optics Check Cartridge The Optics Check Cartridge is reusable It is designed to check that the Analyzer is working correctly The cartridge contains a resin with a dye that acts like your blood sample The Analyzer will automatically recognize when an Optics Check Cartridge is being used The Optics Check Cartridge should be run every day
70. rmation Special Precautions MSDSs for Cholestech GDX test cartridges controls and Optics Check Cartridges are included here MATERIAL SAFETY DATA SHEETS 35 Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET CHOLESTECH Cholestech GDX A1C Test Cartridges SECTION 1 IDENTITY NAME ADDRESS Cholestech GDX System 3347 Investment Blvd Hayward CA 94545 TELEPHONE NUMBER FOR ADDITIONAL INFORMATION CONTACT DATE PREPARED 800 733 0404 Technical Service June 21 2002 COMMON NAME USED ON LABEL CHEMICAL FAMILY Cholestech GDX A1C Test Cartridges Does not apply CHEMICAL NAME FORMULA Does not apply Does not apply TRADE NAME amp SYNONYMS Cholestech GDX Trademark of Cholestech Corporation SECTION 2 HAZARDOUS INGREDIENTS HAZARDOUS COMPONENT CAS wt Sample Buffer Sodium Azide 26628 22 8 0 1 w v Triton X 100 9002 93 1 0 02 w v Hepes sodium Hepes 7365 45 9 0 5 w v Magnesium Chloride 7791 18 6 lt 1 wv Wash Buffers Sodium Azide 26628 22 8 0 1 w v Hepes sodium Hepes 7365 45 9 0 5 w v Magnesium Chloride 7791 18 6 lt 1 wv Elution Buffer Phenoxyethanol 64 19 7 0 5 v v Ammonium Acetate 631 61 8 2 wiv Magnesium Chloride 7791 18 6 1 w v Ultrawet 60 lt 0 001 PEL Permissible Exposure Limit established by the Occupational Safety amp Health Administration TLV Threshold Limit Value established by the American Conference of Governmental Industrial Hygienists 1987 88 SECTION 3 PHY
71. rms section of this manual Cholestech has included various forms to support your training requirements Cholestech GDX Training Checklist This checklist is designed to assist the trainer in training users of the Cholestech GDX System There is room to date and sign each procedure as the task is completed Certificate of Training Fingerstick Blood Collection This certificate can be used to document that fingerstick training has been completed and approved by a physician You can file the certificates in this section as proof of documented training if it is required by regulations in your area Online Training Training is available at the Cholestech Web site www cholestech com lt p For Information Only R Recommended Optional Information 7 0 Material Safety Data Sheets 34 MATERIAL SAFETY DATA SHEETS Cholestech GDX System Procedure Manual Material Safety Data Sheets lt TABLE OF CONTENTS OSHA requires all businesses that manufacture chemical based products and distribute them through interstate shipment to have Material Safety Data Sheet MSDS The information contained on an MSDS describes any potential hazards and any special handling required for chemical products The standard format for an MSDS is as follows 1 2 8 9 Identity Hazardous Ingredients Physical Data Fire amp Explosion Data Health Information Reactivity Data Spill or Leak Procedures Personal Protection Info
72. rn off the power Air blank 3 low supply and disconnect the Analyzer Reconnect the Analyzer allow to warm up and The Analyzer has detected unacceptable insert an Optics Check Cartridge through beam intensity Analyzer failure Power off the Analyzer and power it back on again Try running the Optics Check Cartridge again If the error message persists call Technical Service Err 21 The test cartridge used may be damaged Remove the cartridge turn off the power Air blank 1 high supply and disconnect the Analyzer Reconnect the Analyzer allow to warm up and The Analyzer has detected unacceptable insert an Optics Check Cartridge through beam intensity Analyzer failure Power off the Analyzer and power it back on again Try running the Optics Check Cartridge again If the error message persists call Technical Service Err 22 The test cartridge used may be damaged Check the test cartridge for the presence of a Air blank 2 high solid white pad If this pad is missing record the lot number for the box and call Technical The Analyzer has detected unacceptable Service through beam intensity Analyzer failure Power off the Analyzer and power it back on again Try running the Optics Check Cartridge again If the error message persists call Technical Service Err 23 The test cartridge used may be damaged Remove the cartridge turn off the power Air blank 3 high supply and disconnect the Analyzer Reconnect the Anal
73. s Chart quality control chart a graph or table that shows results of control tests over a period of time used in a quality control program Linearity measure of the range the linear range of concentration of an analyte over which a measure or test produces consistent i e linear straight line and accurate results Lipemia adjective ipemic condition of too much fat or lipids in the blood A lipemic serum sample looks milky and turbid and may produce erroneous results Lyophilized freeze dried a lyophilized calibrator control or reagent has been specially dried to make its analytes more stable It must be refrigerated to maintain its stability and is reconstituted by adding an appropriate diluent Matrix physical and chemical properties that describe a fluid Often used to describe the effect of differences seen when lyophilized freeze dried samples such as control material behave differently than patient specimens when analyzed Mean average of the numerical results obtained from a series of analyses lt TABLE OF CONTENTS GLOSSARY OF TERMS 57 Cholestech GDX System Procedure Manual Method analytical method the instructions including procedures material equipment and everything else needed for an analyst to perform an analysis Normal Values Expected Values Reference Values range of values established for each analyte which includes the results expected when performing a test on a health
74. should be discarded into a biohazardous container ECOLOGICAL INFORMATION No environmental hazard is anticipated provided the materials are handled and disposed of with due care and attention WASTE DISPOSAL METHOD Dispose in a biohazardous waste container for collection by waste contractor Additional items that have come into contact with the controls e g pipette tips test cartridges should also be disposed of in a biohazardous waste container SECTION 8 PERSONAL PROTECTION INFORMATION RESPIRATORY PROTECTION Not required under normal and intended uses VENTILATION Not applicable PROTECTIVE GLOVES EYE PROTECTION Wear protective gloves during reconstitution and testing Not required OTHER PROTECTIVE CLOTHING OR EQUIPMENT Wear laboratory coat for personal protection SECTION 9 SPECIAL PRECAUTIONS PRECAUTIONS TO BE TAKEN IN HANDLING amp STORING Controls should be transported unopened at 36 46 F 2 8 C Store unopened controls at 2 8 C Expiration date is shown on the outside of the box After reconstitution the controls are stable for up to five days at 36 46 F 2 8 C OTHER PRECAUTIONS All donors have been screened by Food and Drug Administration USA FDA approved tests and found to be negative for HbsAg HCA and HIV Antibodies However as no testing can claim total absence of infections agents they should be handled as though they are capable of transmitting an infectious disease Very slight risk of biological inf
75. sing glycosylated haemoglobin levels JAMA 1998 276 15 1246 1252 Goldstein DE Little RR Lorenz RA Malone JI et al Tests of glycemia in diabetes Diabetes Care 1995 18 896 909 Roberts WL De BK Brown D Hanbury CM et al Effects of hemoglobin C and S traits on eight glycohemoglobin methods Clin Chem 2002 48 383 385 lt p For Information Only Recommended Optional Information 5 0 Safety 30 SAFETY Cholestech GDX System Procedure Manual Safety lt TABLE OF CONTENTS 5 1 5 2 Introduction The Occupational Safety amp Health Administration OSHA ruled that beginning March 6 1992 all labs must undergo training to protect the workers from bloodborne pathogens The new regulations outline in detail what employees must be taught about the hazards of working with potentially infectious materials and what precautions must be taken to prevent or minimize exposure All biosafety training must be documented with dates summary of content per each class names and qualifications of all instructors and the names and job titles of employees who attend OSHA also has required that as of May 5 1992 every employer will have a written plan designed to eliminate or minimize worker exposure This includes an outline of the employer s hepatitis vaccination program Employers are required to offer at their expense a vaccine to any worker who may at any time be exposed to potential infectious materials Staff members
76. state or federal law e g CLIA 88 How Does Proficiency Testing Work Proficiency testing is one aspect of a quality assurance program The method works in conjunction with a daily internal quality control program When properly controlled it indicates the laboratory s accuracy performance on the test system being evaluated A number of agencies offer proficiency testing surveys The surveys vary by the analytes offered for testing number of challenges per analyte number of mailings per year report format sample preparation and result evaluation 1 Surveys are offered for most routine tests performed 2 Under 88 proficiency testing is required three times per year testing five samples each time for moderately complex and highly complex labs 3 specimen of choice for the Cholestech GDX System is a specimen of human whole blood with no stabilizers In Section 8 2 of this manual a list of agencies offering CMS approved proficiency surveys is provided These agencies are the ones Cholestech has evaluated and found to demonstrate acceptable performance on the Cholestech GDX For testing other For Information Only R Recommended Optional Information PROFICIENCY TESTING 43 Cholestech GDX System Procedure Manual instruments in your laboratory it is important to contact the manufacturer and request the names of agencies that run compatible surveys with no matrix interferences on these instruments or
77. ster Forms section of this manual Several general guidelines are helpful in ensuring satisfactory preventive maintenance e Select one person to have principal responsibility for a given instrument e Make sure that this person is familiar with the user manual the procedure manual and the package insert for each test system e Perform all required preventive maintenance called for in the Cholestech GDX Analyzer User Manual e Keep all spare parts recommended by the manufacturer on hand Cholestech GDX System Initial Setup The Initial Setup Checklist is provided to assure that all of the environmental conditions are met and that the Cholestech GDX System runs properly during the initial setup in the laboratory Refer to the Master Forms section of this manual The Instrument History Record can be used to record any service performed on the Cholestech GDX System or other instruments in your laboratory Both forms can be found in the Master Forms section of this manual Cholestech Corporation will provide technical support to each Cholestech GDX System user Any questions regarding the operation of the Cholestech GDX System may be directed to Cholestech Corporation Technical Service Department 3347 Investment Blvd Hayward CA 94545 U S A Tel 800 733 0404 Fax 510 732 7227 www cholestech com techservice cholestech com lt gt For Information Only R Recommended Optional Information lt TABLE OF CONTENTS 1 9 1 10
78. systems 4 The survey samples are mailed to the participating laboratories according to a schedule set by the proficiency testing agency Within the time limit set by the agency the laboratory personnel perform the required tests on the survey specimens Only tests performed in the laboratory should be analyzed Survey specimens are handled and analyzed using the same procedure as that for patient specimens 5 Results on the survey specimens are entered on a preprinted form coded according to reagent instrument method and returned to the proficiency testing agency e After evaluation statistics have been calculated a summary report of results is sent to all participating laboratories e Laboratories may also request that a proficiency testing agency send a copy of its results to state or federal regulatory agencies e In general regulatory agencies require documented evidence of corrective action taken when survey results fall outside acceptable limits The director of a point of care laboratory will review all proficiency testing results and document the review and responses to unacceptable results e Cholestech Technical Service can provide assistance in troubleshooting proficiency testing failures 8 2 Proficiency Testing Agencies e The College of American Pathologists EXCEL Program 325 Waukegan Road Northfield IL 60093 Phone 800 323 4040 e American Proficiency Institute 1159 Business Park Drive Traverse City 49686
79. tridge to Position 2 Wait until the liquid disappears from the funnel before adding the contents of the second tube 6 Hold the white rim of the cartridge and turn it clockwise to Position 2 see Figure 12 The test cartridge will click into its new position and the second tube will rise from the cartridge e Remove the tube from the cartridge e Unscrew the cap e Pour the entire contents into the funnel of the test cartridge see Figure 13 e Now press the enter button 40 second countdown will appear on the display The liquid will gradually disappear into the test cartridge Figure 10 Figure 12 Figure 13 amp For Information Only R Recommended Optional Information lt TABLE OF CONTENTS A1C TEST PROCEDURE 25 Cholestech GDX System Procedure Manual At the end of the countdown a beep is heard The light will flash at Position 3 The Rotate Cartridge icon will appear on the display e Hold the white rim of the test cartridge and turn it clockwise to Position 3 see Figure 14 The cartridge will click into its new position The third tube will rise from the cartridge e When prompted by the Pour Tube icon remove the tube from the cartridge see Figure 15 Pour the entire contents into the funnel Again the Analyzer senses the liquid The beep continues for up to 20 seconds while the Analyzer takes a reading The final 80 second countdown will then appear on the display At the e
80. uction Reconnect the power supply and run an Optics Check Cartridge If the result is within specification run a test cartridge If the error message persists call Technical Service Err 27 Programmed Analyzer shutdown The Analyzer has reached the limit of 9 999 test operations lt TABLE OF CONTENTS amp For Information Only The Analyzer is programmed to perform 9 999 readings R Recommended This has been programmed into the Analyzer so that there will never be two results with the same ID code generated on the same Analyzer Optional Information 10 0 Glossary of Terms 54 GLOSSARY OF TERMS Cholestech GDX System Procedure Manual Glossary of Terms lt TABLE OF CONTENTS Acceptable Control Range range of results that indicate adequate performance when analyzing a control sample The range is shown in the control s assay sheet Accuracy correctness freedom from error The accuracy of results can be measured by comparing them with those from another laboratory this is relative accuracy Additive chemical added to a blood collection tube usually to prevent the blood from clotting anticoagulant Aerosol fine mist that solid or liquid particles are dispersed in Agglutination clumping together of antigen bearing cells bacteria or particles in the presence of specific antibodies Also called clumping Aliquot small portion of a measured volume of a su
81. ure a warm up period will occur at initial setup The maximum time required for warm up is 10 minutes If the Analyzer fails to warm up in this period an error message will appear on the display See the Troubleshooting section of this manual When the Analyzer is ready for use the Insert and Cartridge icons will flash The left and right arrows will be solid You can now use the Analyzer to run an Optics Check Cartridge or perform an test Procedure A1C Test 1 Unpack a Cholestech GDX 1 Test Cartridge Hold the cartridge by the white rim only and place it into the Analyzer ensuring that the protruding tab on the test cartridge is aligned with the corresponding notched guide on the cartridge well Push it down until it clicks into place see Figure 1 The Analyzer will then check that the test cartridge is OK During this time the Hourglass icon will appear on the display When this check is complete a beep is heard and the light will flash at Position 1 The Analyzer will show the Identification Number icon with a test identification number see Figure 2 This unique identification number will be stored in the Analyzer s memory with the test result You can access this information at a later date if required see instructions in the Cholestech GDX Analyzer User Manual Write down the identification number with your test result Figure 1 Figure 2 Figure 3 For Information Only R Recommended
82. vents es EN RS ee 17 i See m Authorization herein is limited to any nondiagnostic health program for general health assessment and does not include N on venipuncture arterial puncture or any other procedure for obtaining a blood specimen Be ie Date re ae ician ON Physician s Name N HS Vers St Pos DEA No EN a Cholestech CHOLESTECH se 4 ee Sone Sore et We m gt EN WON ee EN Rs a ee AA EAU EU AS NU EU A EAU a A EU BA A A EU AU oe AN A A A A u A A A At AR AA A seh RESE RN AS REES ENON AO ARE DEREN LEER I HELEN HELEN AUG HELEN ARD HERRN ARD HERRN AOC ARD REES SAD REES ARE SEIEN DEREN SR NENNEN DENN RM ON NENNEN NENNEN WENN ode las CNN gt 02207 GE A RS SE SE SE gt Tey RES gt ri N EEE ASA KE SE lt TABLE OF CONTENTS lt TABLE OF CONTENTS lt TABLE OF CONTENTS GDX GDX System Procedure Manual CHOLESTECH 3347 Investment Blvd Hayward CA 94545 U S A Cholestech GDX is a trademark of Cholestech Corporation Tel 800 733 0404 MiniPet is a trademark of TriContinent Scientific Inc MicroSafe is a trademark of Safe Tec Clinical Products Inc Fax 510 732 7227 2002 C
83. ves Absorb on inert absorbent and transfer to biohazardous waste container for collection by waste contractor Clean surfaces with disinfectant WASTE DISPOSAL METHOD Dispose of wastes in accordance with Federal State and Local codes Used test cartridges are biohazardous as the infectivity of the blood sample cannot be known before use The product must be disposed of as biohazardous waste SECTION 8 PERSONAL PROTECTION INFORMATION RESPIRATORY PROTECTION Not required under normal and intended uses VENTILATION General room ventilation PROTECTIVE GLOVES EYE PROTECTION During the test procedures and while collection or handling Not required patient s blood sample wear protective gloves OTHER PROTECTIVE CLOTHING OR EQUIPMENT None SECTION 9 SPECIAL PRECAUTIONS PRECAUTIONS TO BE TAKEN IN HANDLING amp STORING Store and handle according to packaged instructions The product is not classified as requiring any special considerations and does not present any hazards during shipment OTHER PRECAUTIONS No environmental hazard is anticipated provided the materials are handled and disposed of with due care and attention 403 12379 Rev B DCN 2967 09 09 02 lt TABLE OF CONTENTS MATERIAL SAFETY DATA SHEETS 37 Cholestech GDX System Procedure Manual MATERIAL SAFETY DATA SHEET CHOLESTECH Cholestech GDX A1C Controls SECTION 1 IDENTITY NAME ADDRESS Cholestech GDX System 3347 Investment Blvd Hayward CA
84. y person Out of Control in a testing procedure when the results from a control sample are outside the acceptable control range Pathogen adjective pathogenic microorganism that causes a disease Phlebotomy puncture of vein to collect blood A phlebotomist collects blood by venipuncture venous blood Photometry measurement or analysis of light emitted by a substance Reflectance photometry is the principle used in most instruments that read dry reagent strips Pipette glass or transparent plastic tube used to measure small quantities of liquid volumetric pipette is an extremely accurate single line pipette used to reconstitute calibrators and controls Plasma liquid part of blood after it has been mixed with an anticoagulant and spun down in a centrifuge Precision reproducibility measure of the closeness of the results obtained when analyzing the same sample more than once the measure of agreement between replicate measurements Procedure Manual laboratory manual that contains the methods materials and other information needed to do a test Product Insert informational material that comes with instruments reagents and other laboratory products giving instructions for the use of the product and other information required of the manufacturer by the U S Food and Drug Administration Proficiency Samples analytes of unknown concentration that are sent to laboratories participating in
85. yzer allow to warm up The Analyzer has detected unacceptable and insert an Optics Check Cartridge through beam intensity Continued on next page lt TABLE OF CONTENTS For Information Only Recommended Optional Information 52 TROUBLESHOOTING Cholestech GDX System Procedure Manual ERROR CODE EXPLANATION ACTION TO TAKE Err 23 continued Analyzer failure Power off the Analyzer and power it back on again Try running the Optics Check Cartridge again If the error message persists call Technical Service Err 24 Supply voltage out of range The Analyzer must be run with 11 4 12 6 volts DC Transformer malfunction Call Technical Service Err 25 Stirrer not responding The system detects the current drawn when operating the electromagnet If there is an Analyzer failure there will be no voltage drop therefore the mixing paddle in the cartridge will not work Power off the Analyzer and power it back on again Try running the Optics Check Cartridge again If the error message persists call Technical Service Err 26 Warm up cycle not completed in time The Analyzer has been removed from a cold environment and not given time to warm up to ambient temperature This will result in condensation forming on the Analyzer optics Disconnect the Analyzer Leave the Analyzer in a warm dry place for at least one hour Check the optics windows in the testing well for dust fluff or other obstr

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