S TEST Reagent Cartridge Glucose (GLU (
Contents
1. HitachiChemical vo S TEST Reagent Cartridge Glucose GLU 96308 10 10 S TEST Cartridges 96308 100 10 x 10 S TEST Boxes 100 Tests Kit for the determination of Glucose on HITACHI Clinical Analyzer E40 2012 11 Rev 1 Intended Use The S TEST Reagent Cartridge Glucose GLU is intended for the quantitative determination of glucose concentration in serum lithium heparin plasma K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40 The S TEST Reagent Cartridge Glucose GLU is intended for use in clinical laboratories or physician office laboratories For in vitro diagnostic use only Method Enzymatic method Hexokinase method Test Summary and Explanation The blood glucose level is increased by absorption from the intestine breakdown of glycogen in the liver and neogenesis from other substances and decreased by glycogenesis oxidative degradation in tissues and conversion into fat In addition since the glucose metabolism in the living human body is regulated and controlled by the endocrine system and the autonomic nervous system abnormalities in the blood glucose level are considered significant in diagnosing diseases in these systems and assessing their courses Principle of the Test Glucose is phosphorylated to glucose 6 phosphate by hexokinase HK in the presence of ATP When the glucose 6 phosphate is converted into 6 phosphogluconic acid by glucose 6 phosphate dehydrogenase G6PD NADP is co2. al Co Ltd 2 1 1 Nishi Shinjuku Shinjuku ku Tokyo 163 0449 Japan
3. en stored in the refrigerator at 2 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 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 Remove the blood cells immediately from the blood specimen that has been collected If not tested on the day of collection store as follows e For testing within 1 week 2 10 C e 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 Glucose GLU 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 container See the User Manual
4. for detailed operating instructions Measurement Measurement 340 450 nm 340 450 nm Reagent 1 Sample Reagent 2 v Conc Calculation 200 uL 5 uL 50 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 Glucose GLU is calibrated by the manufacturer prior to shipment using material traceable to ReCCS Reference Material Institute for Clinical Chemistry Standards standard serum JCCRM 521 The 2D code printed on each cartridge provides the analyzer with lot specific calibration data Calculation Glucose 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 laborator
5. ged reagent kits or 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 GLU 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 Storage and Stability The S TEST Reagent Cartridge Glucose GLU is stable until the expiration date shown on the box labels wh
6. nverted into NADPH with an increase in absorbance at 340 nm The concentration of glucose can be determined by measuring the amount of change in absorbance of NADPH HK Glucose ATP Mg Glucose 6 phosphate ADP G6PD l Glucose 6 phosphate NADP gt 6 Phosphogluconic acid NADPH Reagent Requirements one cartridge per patient sample Reagent Composition The S TEST Reagent Cartridge Glucose GLU has the following composition GLU Reagent 1 e Hexokinase Yeast 4 0 U mL e Nicotinamide adenine dinucleotide phosphate oxidized form 3 0 g L e Glucose 6 phosphate dehydrogenase E coli 2 0 U mL e 2 Amino 2 hydroxymethyl 1 3 propanediol buffer H7 2 0 1 mol L GLU Reagent 2 e Adenosine 5 triphosphate disodium salt 5 0 mmol L e 2 Amino 2 hydroxymethyl 1 3 propanediol buffer 0 H8 4 0 1 mol L Preparation and Labeling The S TEST Reagent Cartridge Glucose GLU 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 j Reagent 1 Reagent 2 Ig amp amp 2D code Photometric cuvette Reagent cells 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 dama
7. on the HITACHI Clinical Analyzer E40 at three sites using the S TEST Reagent Cartridge Glucose GLU y and a comparative method as the reference method x Linear regression analysis least squares yielded the following results Site Range Regression upr Cl Cl mg dL Equation Slope Intercept 75 to 375 y 1 01x 1 1 0 99 0 99 to 1 02 2 7 to 0 6 2 s2 69t0361 y 097 0 1 099 08610098 211019 e 51 75t0 909 y 105x 25 099 10310107 511001 95 Confidence Interval Patient Correlation laboratory site A series of 100 serum specimens with glucose values ranging from 12 to 441 mg dL were assayed on the HITACHI Clinical Analyzer E40 using the S TEST Reagent Cartridge Glucose GLU y and a comparative method as the reference method x Linear regression analysis least squares yielded the following results Range Regression u CI OlF mg dL Equation Slope Intercept 12 to 441 y 0 99x 2 7 0 99 0 98 to 1 02 5 5 to 0 8 95 Confidence Interval Serum Plasma Comparison Study A study was performed to validate the use of lithium heparin plasma K3 EDTA plasma and sodium citrate plasma as alternatives to serum for the HITACHI Clinical Analyzer E40 with the S TEST Reagent Cartridge Glucose GLU 38 matched serum plasma samples that spanned the glucose dynamic range were assayed in singleton and the results were compared using least squares liner regression plasma y axis The performance charac
8. rference up to 50 mg dL for glucose samples around 200 mg dL and up to 6 25 mg dL for glucose samples around 50 mg dL Lipemia no interference from triglycerides up to 800 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 50 mg dL and 200 mg dL glucose 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 total imprecision was found to be Mean mga SD mg dl 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 T mg l a7 as 26 a5 26 46 2 ase o7 aa 10 47 A sa 40 34 aa a7 Ce m os os 13 11 s e ns e ta tt C c ss 10 638 19 c aa replicates per sample per site Nh oo N hes O Patient Correlation POL sites A series of approximately 50 serum specimens with glucose values ranging from 69 to 399 mg dL were assayed
9. teristics were as follows Lithium K3 EDTA Plasma Na Citrate Plasma Heparin Plasma CI Slope CI 1 00 0 98 to 1 02 1 00 0 99 to 1 02 0 98 0 96 to 1 00 r n 38 Range serum 12 to 441 mg dL 95 Confidence Interval y intercept CI 2 1 5 8 to 1 6 0 3 3 1 to 2 6 4 6 8 2 to 0 8 Detection limit per CLSI EP17 A The analytical detection limit was determined to be 0 3 mg dL The quantitation limit was determined to be 5 mg dL Reportable range 5 mg dL to 500 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 Reference 1 Sasaki M and coauthors Sampling of chemical components of the human body Kodansha p 237 1972 2 Tietz Tietz Fundamentals of Clinical Chemistry 4 Edition WB Saunders Company 1996 3 CLSI Document EP5 A2 Evaluation of Precision Performance of Quantitative Measurement Methods Approved Guideline 4 CLSI Document EP6 A Evaluation of Linearity of Quantitative Measurement Procedures Approved Guideline 5 CLSI Document EP7 A2 Interference Testing in Clinical Chemistry Approved Guideline 6 CLSI Document EP17 A Protocols for the Determination of Limits of Detection and Limits of Quantitation Approved Guideline 80 7891 00 01 04 13 Hitachi Chemic
10. y standard QC 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 aRWOAN Reading and Reporting Results Expected Value e Reportable range 5 500 mg dL e Reference range fasting serum 60 95 mg dL 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 Interference per CLSI EP7 A2 The data demonstrated that the GLU test system was not affected by high levels of the following substances at the levels noted Hemoglobin no interference up to 1000 mg dL for glucose samples around 200 mg dL and up to 500 mg dL for glucose samples around 50 mg dL Unconjugated bilirubin no inte
Download Pdf Manuals
Related Search