Performance evaluation of two chemiluminescent systems for HBsAg in blood screening

CHEN Jianfeng;WANG Lunan;CHANG Le;LI Hongtao;WANG Fengtian;YAN Xin;CHEN Fuqiang;ZHANG Chuanxing;Blood Center of Shandong Province;National Center for Clinical Laboratories,Beijing Engineering Research Center of Laboratory Medicine,Beijing Hospital,National Center of Gerontology;  

Objective To evaluate the performance of chemiluminescent immune assay(CLIA) system and electrochemiluminescence immune assay(ECLIA) system for HBsAg in blood screening. Methods Different blood screening methods were assessed in this study following the technical operation procedure of blood bank(2015). HBsAg sero-panels from NCCL including individual donor samples, precision control samples and mutant samples were used to evaluate the screening performance of one CLIA assay, one ECLIA assay as well as two routine ELISA assays. Screening sensitivity, specificity, accuracy, positive predict value, and negative predict value were calculated in the study. Meanwhile the precision, the detection capacity of different serotype samples and mutations were assessed. Results 1) The sensitivity of 4 assays from high to low: ECLIA(100%), ELISA B(95.74%), ELISA A(89.60%) and CLIA(58.34%); 2) The specificity from high to low: CLIA(100%),ECLIA(99.47%), ELISA B(98.40%) and ELISA A(94.15%); 3) The accuracy of ECLIA,ELISA B,ELISA A and CLIA was 99.84%, 96.56%, 91.00% and 71.85% respectively from high to low. 4) ECLIA has a best reproducibility with 1.27%—3.44% CVs of within-run precision and 5.57%/7.08% CVs of between-run precision. The CVs of within-run precision for CLIA reagent were 6.32%—14.62%, and the between-run CVs were 6.75% and 16.06%. 5) Among the serial dilutions of different HBsAg serotype samples, ECLIA assay can detect the diluted samples with HBsAg concentration down to 0.05 IU/mL, while CLIA assay missed all. 6) In the detection of the 20 recombinant antigen samples of different dilutions, all samples were detected by B assay, 16 samples by A, 12 samples by ECLIA, and 9 by CLIA. 7) In the detection of the 32 native mutation samples after serial dilution, all of 32 samples were detected by ECLIA and B assay, 25 samples were detected by A assay, and CLIA assay missed all. Conclusion Compared to both ELISA assays, ECLIA assay showed a better performance with higher screening sensitivity, specificity and accuracy. Therefore, ECLIA assay is recommended to be used in HBsAg screening for blood donor. The sensitivity of the CLIA system is significantly lower than that of the 2 ELISA assays(P0.01). In additional, due to its potential risk of false negative in the detection of different serotype samples and mutations samples, CLIA assay′s application in blood screening needs to confirmed by further improvement.

【CateGory Index】： R512.62;R446

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