INTENDED USE For the In Vitro quantitative determination of glucose in human serum or plasma. INTRODUCTION Glucose is the major carbohydrate present in the peripheral blood. The oxidation of glucose is the major source


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  \n   (Glucose Hexokinase Reagent Set) \r  HTI G240 100 HTI G240K 100 HTI G7517 100 HTI G240 500 HTI G240K 500 HTI G7517 500 G240-INS, Rev. 14.3 Page 1 of 3 Reagent is stable for 21 days after opening. � G-6-P + ADP G-6-P + NAD G6PDH   \n 21  \r\n     \n   \n    \r in vitro       \r   \n   \n   .  \n  \n      5,55 $   \n   (Glucose Hexokinase Reagent Set) \r  HTI G240 100 HTI G240K 100 HTI G7517 100 HTI G240 500 HTI G240K 500 HTI G7517 500 G240-INS, Rev. 14.3 Page 2 of 3 INTERFERING SUBSTANCES Grossly lipemic or icteric sera may cause falsely e levated glucose values, and may require the use of a serum blank. Young et al. give a complete list of drug and other substances that may affect glucose values .6 MATERIALS PROVIDED 1. Glucose HK Reagent 2. Glucose standard (100 mg/dl) MATERIALS REQUIRED BUT NOT PROVIDED 1. Accurate pipetting devices. 2. Timer. 3. Test tubes and rack. 4. Spectrophotometer capable of reading at 340 nm. 5. Heating block or water bath (37C). AUTOMATED PROCEDURE Refer to specific instrument application instructio ns. MANUAL PROCEDURE 1. Appropriately label tubes: reagent blank, standa rd, patient sample, etc. 2. Pipette 1.0 ml of the glucose reagent into all t ubes and prewarm to 37C. 3. Add 0.005 ml (5 l) of sample to respective tubes. Mix well. Incubat e all tubes at 37C for five minutes. 4. After incubation, zero the spectrophotometer wit h reagent blank at 340 nm. 5. Read and record the absorbance of all tubes. MULTI-CALIBRATOR MAY BE USED TO REPLACE STANDARD. LIMITATIONS The procedure is linear to 500 mg/dl (27.8 mmol/L) Specimens above this limit must be diluted 1:1 with saline, re-run and the res ult multiplied by two (2) to compensate for the dilution. CALIBRATION An aqueous based standard is provided. The use of a serum-based calibrator is recommended. QUALITY CONTROL It is recommended that both normal and abnormal qua lity control sera be used routinely. CALCULATIONS Glucose results are expressed as mg/dl (mmol/L) Abs. = absorbance at 340 nm Note: To convert the results into SI units (mmol/L) , multiply the result (mg/dl) by 0.0556. EXPECTED VALUES Normal range is reported to be 65-110 mg/dl. This r ange should serve only as a guideline. It is recommended that each laboratory e stablish its own range of expected values, since differences exist between in struments, laboratories, and local populations. In a study of 50 samples, the ex pected values were found to be 65 - 112 mg/dl. PERFORMANCE CHARACTERISTICS 1. Linearity: 500 mg/dl. 2. Sensitivity: Based on an instrument resolution of 0.001 absorban ce, this procedure has a sensitivity of 0.30 mg/dl. 3. Comparison: Glucose (HK) was compared to a commercially availab le glucose hexokinase method with the resulting linear regression equation of Y = 0.999x + 0.44. Coefficient of correlation R 2 = 0.999. Thirty-two patient sera and controls ranging from 46 mg/dl to 376 mg/d l were assayed by the two methods. 4. Precision:    24   25 \n \n #\n$ \n  \n -       \r \r\r    \n# ! \n  \n \r     \n ,      \r !   . Young  .        !  ,  \r!  \n    \r     \n 6    \n 1.  \n     \n 2. 0   \n (100   ) "$\n ,      \n 1. (   2. ) 3. " 4. 0 , \n\r     340  . 5. )     \r \r  \r (37 ) %\n \n   \n "  \r  .     \n . #    \n 1. \n    : ! \r    ,   , \n   2. -  1,0     \n       !  37 . 3. -  0,005  (5  ) \n   . 4# # . /     37    5   . 4. "    \r ,      !      340  . 5. /\n \n     ! ! . ./-1*0(5678 %(5/9*()* $:1) /0"562-()60; -$10) 0)('(*)( . & \n \n 5  \r \n \n   \r  \r     \n  500   (27,8  ). \n    \n   500       \n  1:1    , \n \r     ,    \n  !    2  \r  \n \r . \r '   * \r  \n       !      \n     \r   \r   \n  . #' 0   \n     (  ) bs. = "    340  %  \r   (   ) = %  \r  \n   )  : (   ) = 0,155 (   ) = 0,164 165,0 155,0 100 = 93    : ' \r  \n  SI   (  ), !   \n  (   )  0,0556. &\n   \n   \n \n    65-100   . '  \n \n           . * \r       !  !       \n , .  \n  \r   , \r    \r\r . "    50 \n     \n \n    65-112   . ( 3,61-6,22 $ ). \n \n\n   1. \n \r 500   (  27,75 $ 2.  \r\r \r . \r \n#    0,001,      0,30   . 3.  \n    \r \n  ,    !  \n      %   %            : =0,999 +0,44. %   \r R = 0,999. !   \r     \n  32       , \n    ! \n     46    376   . 4.   \r  #\n \n\n 0 1 0 2 0  (   ) 93 301 0 .     (   ) 1,58 2,59   \n   (Glucose Hexokinase Reagent Set) \r  HTI G240 100 HTI G240K 100 HTI G7517 100 HTI G240 500 HTI G240K 500 HTI G7517 500 G240-INS, Rev. 14.3 Page 3 of 3 REFERENCES 1. Cooper, G.R., CRC Crit. Rev. Clin. Lab. Sci. 4:1 01 (1973). 2. Henry, J.B., "Clinical Diagnosis and Management by Laboratory Method." W.B. Saunders and Company, Philadelphia, PA, p. 153 (1979). 3. Barthelmai, W., and Czek, R., Klin. Wochenscht., 40:585 (1962). 4. A Proposed Method for Determining Glucose Using Hexokinase and Glucose- 6-phosphate Dehydrogenase, Public Health Service, C enter for Disease Control, (1976). 5. Tietz, N.W., Fundamentals of Clinical Chemistry , 2nd. Ed., W.B. Saunders Co., Philadelphia, PA 243 (1976). 6. Young, D.S. et. al.: Clin. Chem. 21:5 (1975). C.V.(%) 1,70 0,90 & \n\n \n\n 0 1 0 2 0  (   ) 93 300 0 .     (   ) 1,12 2,91 C.V.(%) 1,20 1,00

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