Performance evaluation and validation of the ECLIA serum calcitonin detection kit
ECLIA血清降钙素检测试剂盒的性能评价与验证

摘要

目的 验证及评价电化学发光法（ECLIA）人降钙素（CT）检测试剂盒的分析性能。方法 根据医学实验室的国际标准要求，对新开展项目需进行性能验证。采用ROCHE电化学发光仪，以电化学发光法体外定量检测血清中人降钙素来验证该方法正确度、精密度、定量检出限、线性范围、参考区间等性能指标。结果 精密度方面：高，低浓度水平血清降钙素标本检测结果批内变异系数CV分别为3.080%和4.014%，批间变异系数CV分别为6.6%和6.0%，均小于15%；正确度方面：一，二水平的标准物质样本偏倚计算结果分别为4.43%，2.58%均在允许范围内；定量检出限，为1 pg/ml；线性范围方面：高，低浓度混合血清样本预期值与实测值的相关系数r为0.991，回归方程为y=0.9962x-25.705；生物学参考区间方面：各20名年龄相近的健康男女血清降钙素检测值范围为：男性4.9～8.7pg/ml，女性3.5～5.7pg/ml。结论 电化学发光法降钙素试剂盒的精密度，正确度，定量检出限，线性范围，生物学参考区间均能达到临床试验的要求，各项性能指标的验证结果均可为相关实验室提供参考。

Abstract

Objective To verify and evaluate the analytical performance of the electrochemiluminescence (ECLIA) human calcitonin (CT) detection kit.
Methods According to the international standards for medical laboratories, performance verification is required for newly launched projects. The ROCHE electrochemiluminescence instrument was used to quantitatively detect human calcitonin in serum in vitro by electrochemiluminescence to verify the accuracy, precision, quantitative detection limit, linear range, reference interval and other performance indicators of this method.
Results In terms of precision: The intra-batch coefficient of variation (CV) of serum calcitonin specimens at high and low concentration levels was 3.080% and 4.014% respectively, and the inter-batch coefficient of variation (CV) was 6.6% and 6.0% respectively, both less than 15%. In terms of accuracy: The bias calculation results of the reference material samples at levels one and two are 4.43% and 2.58% respectively, both within the allowable range. The quantitative detection limit is 1 pg/ml. In terms of linear range: The correlation coefficient r between the expected values and the measured values of high and low concentration mixed serum samples is 0.991, and the regression equation is y=0.9962x-25.705. In terms of the biological reference range: The serum calcitonin detection values of 20 healthy men and women of similar age were as follows: 4.9-8.7pg/ml for men and 3.5-5.7pg/ml for women.
Conclusion   The precision, accuracy, quantitative detection limit, linear range, and biological reference interval of the electrochemiluminescence calcitonin kit all meet the requirements of clinical trials. The verification results of all performance indicators can provide references for relevant laboratories.