定量分析可报告范围评估方案的优化探讨

Optimization discussions for assessment programmes on quantitative analysis report range

目的在极限浓度值样本来源困难的条件下，优化现有实验方案，以获得实验室定量项目的可报告范围。方法采用IRC法对谷丙转氨酶（ALT）、直接胆红素（DBIL）、淀粉酶（AMY）的分析测量范围进行评估，根据相对稀释浓度、分析测量范围、预期稀释相对浓度进行预期稀释结果的计算，比较稀释结果和预期结果，最后根据校准曲线参数和分析测量范围、最大稀释倍数得到可报告范围。结果ALT、DBIL、AMY的分析测量范围分别为6．5～553．5U／L、1．7～117．1／amol／L、27．0～1260．5U／L，AI。T和DBIL的最大稀释倍数分别为11倍和2倍，ALT、DBIL、AMY的可报告范围分别为：4．0～6600．0U／L、1.0～257．6μmol／L、13．5～1386．5U／L。结论优化的线性评估、稀释验证、校准验证、极限测试的联合使用对于实验室定量项目可报告范围的制订是非常关键的。

Objective With the condition of lack limiting concentration sample source, to optimize the existing linearity evalua- tion,diluted verification,calibration verification and proximity limits plans, and finally get a reportable range of quantitative tests. Methods For ALT,DBIL and AMY,the IRC method was used to evaluate its analytical measurement range. The expected dilution results were calculated by using the data of relative concentration,analytical measurement range and expected relative concentra- tion, and the diluted result and expected result were compared. According to the calibration curve parameters, analytical measure- ment range and maximum dilution,reportable range of ALT,DBIL and AMY were obtained. Results The analytical measurement range of ALT,DBIL and AMY were 6.5-553.5 U/L,1. 7-117.1 μmol/L,27.0-1 260.5 U/L respectively. The maximum dilu- tion of ALT and DBIL were 11 and 2 times each. Reportable range of ALT,DBIL and AMY were 4.0-6 600.0 U/L,1.0-257.6 μmol/L,13.5-1 386.5 U/L respectively. Conclusion It is very critical to combine optimal linearity evaluation,diluted verification and calibration verification with proximity limits in making reportable range for quantitative tests.