S TEST Reagent Cartridge Cholesterol (CHO (
Contents
1. 1 00x 3 0 correlation coefficient r 0 99 95 confidence interval of the slope 0 99 to 1 01 95 confidence interval of the y intercept 5 5 to 0 6 Detection limit per CLSI EP17 A The detection limit was determined to be 0 7 mg dL The quantitation limit was determined to be 4 mg dL Reportable range 4 mg dL to 400 mg dL Routine Maintenance and Troubleshooting For complete information on operation see the User Manual for the HITACHI Clinical Analyzer E40 Technical Support Instrument Service 1 First contact your local distributor 2 Hitachi Chemical Co Ltd Japan References 1 Sasaki M and coauthors Sampling of chemical components of the human body 1972 Kodansha p 249 1972 2 Itakura H Japan Medical Association Journal 105 9 1991 3 Third Report of National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Cholesterol in Adults Adult Treatment Panel Ill Executive Summary 2002 4 CLSI Document EP5 A2 Evaluation of Precision Performance of Quantitative Measurement Methods Approved Guideline 5 CLSI Document EP6 A Evaluation of Linearity of Quantitative Measurement Procedures Approved Guideline 6 CLSI Document EP7 A2 Interference Testing in Clinical Chemistry Approved Guideline 7 CLSI Document EP17 A Protocols for the Determination of Limits of Detection and Limits of Quantitation Approved Guideline 80 7869 00 01 04 13 Hitachi Che2. kits that arrive opened 4 Avoid direct sunlight during storage and measurement 5 This product is intended for use on HITACHI Clinical Analyzer E40 The reagent cartridges should not be used for any other purposes Disposal Precautions 1 When handling blood and used cartridges use disposable gloves to avoid the danger of infection 2 The samples and reagent cartridges should be disposed of as medical wastes in accordance with local regulations Warnings 1 Samples used reagents and other waste are potentially infectious and capable of transmitting human immunodeficiency virus HIV hepatitis B virus HBV and other infectious diseases Avoid immediate contact The handling and disposal of patient samples reagents and liquid waste must be performed according to local national and international laboratory safety and waste disposal regulations This includes wearing gloves and appropriate splash protection etc If these substances come in contact with skin rinse with ample water disinfect and consult a physician 2 CHO Reagent 1 and 2 contain sodium azide an antiseptic which may be irritating to eyes skin and mucous membranes Sodium azide may react with copper and lead plumbing to produce explosive metal azide flush with copious amounts of water if disposing down the drain 3 CHO Reagent 1 also contains Proclin an antiseptic which may be irritating to eyes skin and mucous membranes Storage and Stability The S
3. procedures Controls should be run at least once every 30 days and When test results do not match patient symptoms or clinical findings When using a new lot or shipment of reagents When laboratory environmental conditions have significantly changed When training or retraining of personnel occurs After specific maintenance on trouble shooting steps described in the User Manual for the HITACHI Clinical Analyzer E40 aRWON Reading and Reporting Results Expected Value e Reportable range 4 400 mg dL e Reference range 130 220 mg dL e Desirable lt 200 mg dL Borderline 200 239 mg dL High gt 239 mg dL e It is recommended that each laboratory determine the expected values for its particular population Interpretation of Results There may be reactions with non target substances or interfering reactions If measured results seem unreliable repeat the measurement if necessary after dilution or try another analytical measurement Handling Critical Values If the result of a sample exceeds the measurement range dilute the sample with physiological saline solution and repeat the measurement Performance Characteristics Please note this assay has not been certified by the Cholesterol Reference Method Laboratory Network CRMLN but is traceable to the CRMLN method Interference per CLSI EP7 A2 The data demonstrated that the CHO test system was not affected by high levels of the following s
4. HitachiChemical vo S TEST Reagent Cartridge Cholesterol CHO 96310 10 10S TEST Cartridges 96310 100 10x 10 S TEST Boxes 100 Tests Kit for the determination of total Cholesterol on HITACHI Clinical Analyzer E40 2012 11 Rev 1 Intended Use The S TEST Reagent Cartridge Cholesterol CHO is intended for the quantitative determination of total cholesterol concentration in serum or heparin plasma using the HITACHI Clinical Analyzer E40 The S TEST Reagent Cartridge Cholesterol CHO is intended for use in clinical laboratories or physician office laboratories For in vitro diagnostic use only Method Enzymatic method COD POD method Test Summary and Explanation Blood cholesterol is not only derived from food but also synthesized in the liver Its measurement is important as a parameter of abnormal lipid metabolism and is also considered a useful tool in the diagnosis of disorders such as hepatic diseases and metabolic diseases Principle of the Test Cholesterol in samples can be classified as esterified cholesterol and free cholesterol Esterified cholesterol is converted into free cholesterol by the action of cholesterol esterase CE and free cholesterol is oxidized by cholesterol oxidase COD to produce hydrogen peroxide In the presence of peroxidase POD 4 aminoantipyrine and N ethyl N sulfobutyl m toluidine ESBmT are subjected to oxidation condensation by the hydrogen peroxide to form a purple red pigment The conce
5. TEST Reagent Cartridge Cholesterol CHO is stable until the expiration date shown on the box labels when stored in the refrigerator at2 8 C Specimen Requirements Patient Preparation No special patient preparation is required Collect specimen by standard laboratory technique Specimen Collection 1 Use clear unhemolyzed serum or heparin plasma 2 Care should be taken to preserve the chemical integrity of the blood specimen from the time it is collected until the time it is assayed see SPECIMEN HANDLING AND STORAGE Specimen Identification Label each specimen tube with the patient s identification name and or number Specimen Handling and Storage If not tested on the day of collection store as follows e For testing within 1 week 2 10 C For testing after 1 week or longer below 20 C Before the measurement the sample must be brought back to room temperature 15 30 C Test Procedure For complete information on operation see the User Manual for the HITACHI Clinical Analyzer E40 Equipment Required HITACHI Clinical Analyzer E40 Reagent Required S TEST Reagent Cartridge Cholesterol CHO Material Required but not provided 1 Two levels of controls 2 Sample cups 3 Disposable transfer pipettes 4 Washing water 5 Alkali detergent 6 Waste container Assay Procedure Prior to performing each run check system status to determine the need to replace washing water or empty waste co
6. holesterol values ranging from 60 to 334 mg dL were assayed on the HITACHI Clinical Analyzer E40 at three sites using the S TEST Reagent Cartridge Cholesterol CHO y and a comparative method as the reference method x Linear regression analysis least squares yielded the following results Site Range Regression ae Cl Cl mg dL Equation Slope Intercept 60 to 329 y 0 97x 2 5 0 99 0 95 to 0 98 1 1 to 6 1 2 so e0to334 y 0 98x 41 0 99 09510100 101093 95 Confidence Interval Patient Correlation laboratory site A series of 113 serum specimens with total cholesterol values ranging from 5 to 374 mg dL were assayed on the HITACHI Clinical Analyzer E40 using the S TEST Reagent Cartridge Cholesterol CHO y and a comparative method as the reference method x Linear regression analysis least squares yielded the following results Range Regression u CI CI mg dL Equation Slope Intercept 5 to 374 y 0 98x 2 2 0 99 0 96 to 1 00 1 7 to 6 1 95 Confidence Interval Serum Plasma Comparison Study A study was performed to validate the use of heparinized plasma as well as serum for the Hitachi Clinical Analyzer E40 with the S TEST Reagent Cartridge Cholesterol CHO 40 matched serum plasma samples that spanned the dynamic range were assayed in singleton and the results were compared using least squares liner regression plasma y axis The performance characteristics were as follows y
7. mical Co Ltd 2 1 1 Nishi Shinjuku Shinjuku ku Tokyo 163 0449 Japan
8. ntainer See the User Manual for detailed operating instructions Measurement Measurement 600 800 nm 600 800 nm Reagent 1 Sample y Reagent 2 v Conc Calculation 210 uL 10 uL 70 uL 0 7 0 7 5 12 5 min Wavelength main sub Presentation of Result Each patient report includes the data and time sample ID number as programmed the test abbreviation the test results normal ranges and result flags For detailed explanations on flags and error messages refer to the User Manual for the HITACHI Clinical Analyzer E40 Calibration Each lot of S TEST Reagent Cartridge Cholesterol CHO is calibrated by the manufacturer prior to shipment using material traceable to NIST Standard Reference Material SRM 911c The 2D code printed on each cartridge provides the analyzer with lot specific calibration data Calculation Cholesterol concentration is directly determined by multiplying the change in absorbance of the unknown samples by the calibrator factor on the 2D code Patient and control results appear on the display Quality Control Users should follow federal state and local regulatory requirements regarding quality control practices See instrument manual for procedures on how to run controls Good laboratory practice includes the use of at least two levels of control material to ensure the test performance The frequency and limits of QC testing should be determined according to individual laboratory standard QC
9. ntration of total cholesterol can be determined by measuring the absorbance of the resulting purple red pigment CE Cholesterol esters _ Free cholesterol Fatty acid COD Free cholesterol Delta 4 cholestenone H202 O H202 ESBmT 4 Aminoantipyrine Purple red pigment Reagent Requirements one cartridge per patient sample Reagent Composition The S TEST Reagent Cartridge Cholesterol CHO has the following composition CHO Reagent 1 e 4 Aminoantipyrine 1 6 mmol L e Cholesterol esterase Microbial gt 0 2 U mL e Peroxidase Horseradish gt 1 6 U mL CHO Reagent 2 e Cholesterol oxidase Microbial 2 U mL e N ethyl N sulfobutyl m toluidine sodium salt 1 5 mmol L Preparation and Labeling The S TEST Reagent Cartridge Cholesterol CHO is provided in a ready to use cartridge The 2D code label on the front of each cartridge automatically identifies the reagent to the system Reagent Cartridge Le Z M Reagent 1 Reagent cells Reagent 2 gt ees 2D code Photometric cuvette Reaction cell Precautions 1 This product should be stored to avoid freezing Frozen reagent should not be used 2 Reagent exceeding the expiration date should not be used 3 Reagent kits are intended for single use only Do not attempt to reuse reagent kits Discard any damaged reagent kits or
10. ubstances at the levels noted Hemoglobin no interference up to 1000 mg dL Unconjugated bilirubin no interference up to 50 mg dL Lipemia no interference up to 2000 mg dL Ascorbic acid no interference up to 50 mg dL Lack of interference was defined as recoveries between 90 and 110 of the neat value and assay performance claims were established on the HITACHI Clinical Analyzer E40 by testing two serum pools containing approximately 100 mg dL and 200 mg dL cholesterol The information presented is based on results from Hitachi studies and is current at the date of publication Hitachi makes no representation about the completeness or accuracy of results generated by future studies Precision per CLSI EP5 A2 Three levels of serum samples were assayed 2 times per run 2 runs per day for total of 20 days The precision was found to be Mean mg dL SD mg dL ee ee 2 eee n 80 per level Precision POL sites Three levels of samples A B and C were tested by three POL sites six times a day for five days The precision estimates are described below nee mga a 080s P08 or Ca a ea oo or n2 mo Ca ea e j o l a o a a f oe 13 or C s is o os ns o7 sf s s 12 os 13 o7 7 e 22 09 04 4a 05 2 c 12 os ia oo s e a e or e e n 30 replicates per sample per site eter Patient Correlation POL sites A series of approximately 50 serum specimens with total c
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