摘要
目的：应用CLSI EP12-A2文件评价乙型肝炎病毒表面抗原（HBsAg）的酶联免疫吸附试验（ELISA）试剂盒的性能，并比较2个不同厂家试剂盒之间的性能差异。方法按照CLSI发布的EP12-A2文件，对实验室使用的2个不同厂家的 HBsAg ELISA试剂盒的性能进行评价。结果2个厂家的试剂盒对分析物浓度为120％临界值的标本的检测阳性率均大于或等于95％，对分析物浓度为80％临界值浓度的标本的检测阴性率大于或等于95％，批内变异系数小于或等于15％，批间变异系数小于或等于20％。2个厂家试剂盒的灵敏度分别为94．2％（95％CI：84．3％∽98．0％）和92．3％（95％CI：81．8％∽97．0％）；特异性分别为98．0％（95％CI：89．5％∽99．6％）和100．0％（95％CI：92．8％∽100．0％）。2个厂家试剂盒灵敏度差值95％区间为-5．46％∽10．19％，特异性差值95％区间为-2．00％∽5．32％。结论2个厂家试剂盒检测 HBsAg 临界值＆#177;20％的浓度范围之外标本，能够得到稳定、可靠的检测结果，并具有较高的灵敏度和特异性，两者的检测灵敏度和特异性相近。
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 ＆#177;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.
出处
《国际检验医学杂志》
CAS
2014年第12期1622-1623,共2页
International Journal of Laboratory Medicine
关键词
乙型肝炎表面抗原
性能评价
酶联免疫吸附测定
hepatitis B surface antigen
performance evaluation
enzyme-linked immunosorbent assay
