The detection methods for glucose in clinical have been developed and currently most laboratories measure the glucose level by enzymatic procedures in automated analytical instrument to increase analytical specificity. The most frequently used
procedures are glucose oxidase and hexokinase reactions. Beckman Chemistry Autoanalyzer(ASTRA-8(r) and Glucose Analyzer-2(r))adopted glucose oxidase-oxygen rate method employing Oxygen Electrode in glucose module. The Oxygen Electrode senses
oxygen
concentration and solid state--circuits in the instrument system electronics determine the rate of oxygen consumption and calculate glucose concentration for each sample. Reagent for glucose analysis in ASTRA module is composed of glucose
oxidase,
alcohol, iodide and buffer solution.
Because all reagents used in Korea have been imported from the Beckman or other foreign companies, in this study the author developed and evaluated the new reagent for glucose oxidase-oxygen rate method. The reagent is composed of glucose
oxidase,
mercuric iodide, propanol and phosphate buffer(pG 6.0).
In the evaluation of the newly developed reagent as useful as clinical analytical reagent, the accuracy, precision and linearity tests were performed and compared the results with those obtained by Beckman original method.
@ES The results were summarized as follows:
@EN 1. The imprecision of newly developed reagent was 0.59 to 2.80% (CV)in the range of 40 to 200 mg/dL.
2. Day-to-day variance for one month was 1.25 to 2.20% in the range of 40 to 400mg/dL.
3. The accuracy by patient comparison study was excellent with high correlation coefficient(r=0.9994) with the result by original reagent.
4. The recovery rate was in the range of 94.7 to 101.2%.
5. The linearity measured by aqueous standards was good in the range of 0 to 450 mg/dL.
6. The newly-developed reagent was stable for 30 days during evaluation period after mixing the reagent at room temperature.
In conclusion, the new reagent is satisfactory in precision. accuracy and linearity and may be used for routine laboratory test.
|