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Abstract：
BACKGROUND: Verification of new reagent lots is a part of the crucial tasks in clinical laboratories. The Clinical and Laboratory Standards Institute (CLSI) EP26-A guideline provides laboratories with an evaluation method for reagent verification. The purpose of this study was to compare the performance of EP26-A with our laboratory reagent lot verification protocol and get the final scheme.
METHODS: 16 chemiluminescence analytes including estradiol (E2), progesterone (P), ferritin (FER), cortisol (COR),carbohydrate antigen 153 (CA153), and free prostate-specific antigen (FPSA). were prospectively evaluated in two reagent lots. The laboratory\'s lot verification process included evaluating 5 patient samples with the current and new lots and acceptability according to a predefined criteria. For EP26-A, method imprecision data and critical differences at medical decision points were important factors affecting the sample size requirements and rejection limits.
RESULTS: The number of samples required for EP26-A was 3 to 12, of which P, CA153, and FPSA had increased by more than 5 samples compared with the current protocol. Of the 16 chemiluminescence analytes, 11 had higher rejection limits when using EP26-A than the current laboratory scheme. Our current protocol and EP26-A were in agreement in 32 of the 32 (100%) paired verifications.
CONCLUSIONS: The EP26-A protocol is an important tool to find the differences between reagent lots, and it makes up for the loopholes in the statistical efficiency, sample concentration and quantity, and the selection of rejection limits in the current protocol.
METHODS: 16 chemiluminescence analytes including estradiol (E2), progesterone (P), ferritin (FER), cortisol (COR),carbohydrate antigen 153 (CA153), and free prostate-specific antigen (FPSA). were prospectively evaluated in two reagent lots. The laboratory\'s lot verification process included evaluating 5 patient samples with the current and new lots and acceptability according to a predefined criteria. For EP26-A, method imprecision data and critical differences at medical decision points were important factors affecting the sample size requirements and rejection limits.
RESULTS: The number of samples required for EP26-A was 3 to 12, of which P, CA153, and FPSA had increased by more than 5 samples compared with the current protocol. Of the 16 chemiluminescence analytes, 11 had higher rejection limits when using EP26-A than the current laboratory scheme. Our current protocol and EP26-A were in agreement in 32 of the 32 (100%) paired verifications.
CONCLUSIONS: The EP26-A protocol is an important tool to find the differences between reagent lots, and it makes up for the loopholes in the statistical efficiency, sample concentration and quantity, and the selection of rejection limits in the current protocol.
摘要：
背景：新试剂批次的验证是临床实验室关键任务的一部分。临床和实验室标准协会（CLSI）EP26-A指南为实验室提供了试剂验证的评估方法。这项研究的目的是将EP26-A的性能与我们的实验室试剂批次验证协议进行比较，并获得最终方案。
方法：16种化学发光分析物，包括雌二醇（E2），孕酮（P），铁蛋白(FER),皮质醇（COR），糖类抗原153(CA153),和游离前列腺特异性抗原（FPSA）。在两个试剂批次中进行了前瞻性评估。实验室的批次验证过程包括根据预定义标准评估具有当前批次和新批次的5个患者样本以及可接受性。对于EP26-A，方法的不精确数据和医疗决策点的关键差异是影响样本量要求和排斥限制的重要因素。
结果：EP26-A所需的样品数量为3至12，其中P，与当前方案相比,CA153和FPSA增加了5个以上的样品。在16种化学发光分析物中,与当前的实验室方案相比，使用EP26-A时，11具有更高的排斥极限。我们目前的方案和EP26-A在32个(100%)配对验证中的32个是一致的。
结论：EP26-A方案是发现试剂批次之间差异的重要工具，弥补了统计效率的漏洞，样品浓度和数量，以及当前协议中拒绝限制的选择。
方法：16种化学发光分析物，包括雌二醇（E2），孕酮（P），铁蛋白(FER),皮质醇（COR），糖类抗原153(CA153),和游离前列腺特异性抗原（FPSA）。在两个试剂批次中进行了前瞻性评估。实验室的批次验证过程包括根据预定义标准评估具有当前批次和新批次的5个患者样本以及可接受性。对于EP26-A，方法的不精确数据和医疗决策点的关键差异是影响样本量要求和排斥限制的重要因素。
结果：EP26-A所需的样品数量为3至12，其中P，与当前方案相比,CA153和FPSA增加了5个以上的样品。在16种化学发光分析物中,与当前的实验室方案相比，使用EP26-A时，11具有更高的排斥极限。我们目前的方案和EP26-A在32个(100%)配对验证中的32个是一致的。
结论：EP26-A方案是发现试剂批次之间差异的重要工具，弥补了统计效率的漏洞，样品浓度和数量，以及当前协议中拒绝限制的选择。
