摘要: 目的 以谷丙转氨酶（ALT）、乳酸脱氢酶（LDH）、尿素氮（BUN）、肌酐（CRE）四个检测项目为例探讨可报告范围的测定方法。方法 通过测定定量检测下限（LoQ）、定量检测上限和最大稀释倍数，进而确定可报告范围。计算( 检测低限样品-1.645SD检测低限样品) –LoB≥ 0的最小浓度且CV值小于或等于试剂说明书给定的精密度为实验室验证得到的定量检测下限；定量检测上限测定时选取待检项目的高浓度标本，将样本稀释成11个浓度，选取5个点进行回归方程分析，推算出其余点的理论浓度，实际测定值/理论值×100%在95%～105%之间的最大浓度为定量检测上限。最大稀释倍数检测选择线性范围可以测量的高值标本即可以完成。定量下限和最大稀释倍数乘以定量上限为可报告范围。结果ALT、LDH、BUN、CRE 可报告范围分别为4.55～2466.3U/L 、4.74～2438.7U/L、0.93～72.6 mmol/L、3.75～9926.9 μmol/L。 结论 本研究中探讨的方法可操作行强、简便易实施。

Abstract: Objective To investigate determining methods of the reportable range by using ALT, LDH, BUN and CRE as sample. Methods The reportable range was assured through detection of LoQ, upper limit of linear range, and maximum dilution times. Based on the ( low concentration of speciman-1.645SDlow concentration of speciman) –LoB ≥ 0 to calculate all low concentration of specimen. During the detection of upper limit of linear range, the high concentrations samples were diluted into 11 concentrations in different ratios (from 0∶10 to 10∶10), then the regression analysis was carried out using 5 concentration, then according the regression equation, high values were calculated and compared with the actual measured results. The highest value with the bias lower than 5% was the upper limit of linear range. And then, in detecting high value sample, the linear range relying on the maximum dilution detection was determined. Maximum dilution times can be detected by the samples with high concentration in the linear range. The reportable range was from LoQ to upper limit of linear range multiplied by maximum dilution times. Results The reportable ranges of ALT, LDH, BUN and CRE were 4.55-2466.3 U/L, 4.74-2438.7 U/L, 0.93-72.6 mmol/L and 3.75-9926.9 μmol/L respectively. Conclusion The method in this study is convenient and easy to implement.