PMID: 20646652Jul 22, 2010Paper

National external quality assessment and comparability of assays for tumor markers measurements

Zhonghua yi xue za zhi
Jiang-tao ZhangWen-xiang Chen

Abstract

To evaluate the performance of tumor markers (TM) measurements in clinical laboratories by external quality assessment (EQA) and investigate the comparability of assays for TM. Ten quality control sera specimens were distributed to 586 laboratories by global Express Mail Services (EMS) in March 2008 and tested twice with 5 specimens each time. Analytes were total prostate specific antigen (PSA), free PSA, carcinoembryonic antigen (CEA), alpha fetoprotein (AFP), human chorionic gonadotrophin (HCG), beta-HCG, carbohydrate antigen 19-9 (CA19-9), cancer antigen 15-3 (CA 15-3), cancer antigen 125 (CA125), beta-2-microglobulin and ferritin. The collected data were divided into peer groups according to analyzers or methods and the median of peer group was adopted as the target value (TV) separately after outlier removal. Two standard deviations of the median were set as the limit of difference. The first TM EQA results of 2008 showed that the pass percentage of all participating laboratories ranged from 87.3% (CA125) to 95.5% (beta-2-microglobulin). And the second batch ranged from 83.5% (HCG) to 94.0% (beta-2-microglobulin). The coefficient variances (CVs) of intra-group values determined by automatic analyzers were lesser than 15% f...Continue Reading

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