磁微粒化学发光分析法检测血清降钙素原的性能验证  

Verification of the performance of magnetic particle chemiluminescence assay for the detection of serum procalcitonin

作　　者：石巍 荣艺伟 严开斌 Shi Wei;Rong Yiwei;Yan Kaibin(Department of Laboratory,Hongze District People′s Hospital,Huai′an City,Jiangsu 223100,China)

机构地区：[1]江苏省淮安市洪泽区人民医院检验科,223100

出　　处：《实用医技杂志》2021年第10期1181-1184,共4页Journal of Practical Medical Techniques

摘　　要：目的对采用磁微粒化学发光分析法的AutoLumo A2000 PLUS化学发光分析仪检测血清降钙素原(PCT)进行性能验证。方法参照美国临床和实验室标准化协会(CLSI)系列文件和国家卫生行业标准要求,验证磁微粒化学发光分析法检测血清PCT的精密度、准确度、线性范围、参考区间、携带污染率等。结果AutoLumo A2000 PLUS化学发光分析仪检测血清PCT的批内、批间精密度变异系数(CV)值分别为3.35%、6.80%、5.65%、7.28%,符合试剂说明书CV<10.0%的要求;检测定值校准品的相对偏倚分别为4.5%、4%,均在偏倚允许范围内;PCT在18.02~115.85 ng/ml测量范围内,r≥0.9900符合试剂说明书的要求;参考区间和携带污染率均符合要求。结论采用磁微粒化学发光分析法的AutoLumo A2000 PLUS化学发光分析仪检测血清PCT的主要性能指标均符合厂家和相关文件的要求,能够达到临床检测要求的标准。Objective The performance of AautoLumo A2000 PLUS chemiluminescent analyzer with magnetic particle chemiluminescent analysis was verified.Methods According to Clinical and Laboratory Standards Institute(CLSI)series documents and national health industry standards,the precision,accuracy,linear range,reference range and carrying pollution rate of Procalcitonin(PCT)in serum detected by magnetic particle chemiluminescence analysis were verified.Results The Coefficient of Variation(CV)value of the precision of autolumo a 2000 plus chemilumines-cence analyzer was 3.35%,6.80%,5.65%and 7.28%,respectively,which met the requirements of reagent specification CV<10.0%;the relative bias of the calibrator was 4.5%and 4%,respectively,which were within the allowable range of bias;the PCT was in the range of 18.02-115.85 ng/ml,r≥0.9900 met the requirements of reagent specification;reference range and carrying pollution rate met the requirements.Conclusion The main performance indexes of AutoLumo A2000 PLUS chemiluminescent analyzer using magnetic particle chemiluminescent analysis method to detect serum PCT meet the requirements of manufacturers and relevant documents,and can meet the requirements of clinical detection.

关 键 词：化学发光测定法 降钙素原 性能验证 

分 类 号：R446.1[医药卫生—诊断学]