Analytical performance evaluation of HBsAg ELISA kit using CLSI EP1 2-A2 document
10.3969/j.issn.1673-4130.2014.12.043
- VernacularTitle:应用CLSI EP12-A2文件评价HBsAg酶联免疫吸附试验试剂盒的分析性能
- Author:
Chao WANG
- Publication Type:Journal Article
- Keywords:
hepatitis B surface antigen;
performance evaluation;
enzyme-linked immunosorbent assay
- From:
International Journal of Laboratory Medicine
2014;(12):1622-1623
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the performance of enzyme linked immunosorbent assay(ELISA)reagent kit of hepatitis B surface antigen(HBsAg)with Clinical and Laboratory Standards Institute(CLSI)document EP12-A2,and to compare two different manufacturer kits′performance.Methods According to CLSI document EP12-A2,to evaluate the performance of two different manufacturers′HBsAg ELISA kits.Results The positive rates both were ≥95% by using the kits of two manufacturers to detect the same sample with 120%of the critical concentration.The negative rates were both ≥95%by using the kits of two manufactur-ers to detect the same sample with 80% of the critical concentration.The intra assay coefficients of variation were ≤15%,and the interassay coefficients of variation were ≤20%.The sensitivities of two manufacturers′kits were respectively 94.2%(95%CI:84.3%-98.0%)and 92.3%(95%CI:81.8%-97.0%),and the specificities were 98.0%(95%CI:89.5%-99.6%)and 100.0%(95%CI:92.8%-100.0%).The 95%interval of sensitivity of two manufacturers′s kits was 5.46%-10.19%,and which of specificity of two manufacturers′s kits was -2.00%-5.32%.Conclusion The kits of two manufacturers can provide stable re-sults of HBsAg detection with concentrations ±20% outside the critical concentrations at the cutoff point with high sensitivity and specificity.Both of the kits have no significant differences in sensitivity and specificity.
