国际检验医学杂志
國際檢驗醫學雜誌
국제검험의학잡지
INTERNATIONAL JOURNAL OF LABORATORY MEDICINE
2014年
12期
1622-1623
,共2页
韩弋戟%郭明琴%刘梦%侯爵%王钞
韓弋戟%郭明琴%劉夢%侯爵%王鈔
한익극%곽명금%류몽%후작%왕초
乙型肝炎表面抗原%性能评价%酶联免疫吸附测定
乙型肝炎錶麵抗原%性能評價%酶聯免疫吸附測定
을형간염표면항원%성능평개%매련면역흡부측정
hepatitis B surface antigen%performance evaluation%enzyme-linked immunosorbent assay
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±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。
目的：應用CLSI EP12-A2文件評價乙型肝炎病毒錶麵抗原（HBsAg）的酶聯免疫吸附試驗（ELISA）試劑盒的性能，併比較2箇不同廠傢試劑盒之間的性能差異。方法按照CLSI髮佈的EP12-A2文件，對實驗室使用的2箇不同廠傢的 HBsAg ELISA試劑盒的性能進行評價。結果2箇廠傢的試劑盒對分析物濃度為120％臨界值的標本的檢測暘性率均大于或等于95％，對分析物濃度為80％臨界值濃度的標本的檢測陰性率大于或等于95％，批內變異繫數小于或等于15％，批間變異繫數小于或等于20％。2箇廠傢試劑盒的靈敏度分彆為94．2％（95％CI：84．3％～98．0％）和92．3％（95％CI：81．8％～97．0％）；特異性分彆為98．0％（95％CI：89．5％～99．6％）和100．0％（95％CI：92．8％～100．0％）。2箇廠傢試劑盒靈敏度差值95％區間為-5．46％～10．19％，特異性差值95％區間為-2．00％～5．32％。結論2箇廠傢試劑盒檢測 HBsAg 臨界值±20％的濃度範圍之外標本，能夠得到穩定、可靠的檢測結果，併具有較高的靈敏度和特異性，兩者的檢測靈敏度和特異性相近。
목적：응용CLSI EP12-A2문건평개을형간염병독표면항원（HBsAg）적매련면역흡부시험（ELISA）시제합적성능，병비교2개불동엄가시제합지간적성능차이。방법안조CLSI발포적EP12-A2문건，대실험실사용적2개불동엄가적 HBsAg ELISA시제합적성능진행평개。결과2개엄가적시제합대분석물농도위120％림계치적표본적검측양성솔균대우혹등우95％，대분석물농도위80％림계치농도적표본적검측음성솔대우혹등우95％，비내변이계수소우혹등우15％，비간변이계수소우혹등우20％。2개엄가시제합적령민도분별위94．2％（95％CI：84．3％～98．0％）화92．3％（95％CI：81．8％～97．0％）；특이성분별위98．0％（95％CI：89．5％～99．6％）화100．0％（95％CI：92．8％～100．0％）。2개엄가시제합령민도차치95％구간위-5．46％～10．19％，특이성차치95％구간위-2．00％～5．32％。결론2개엄가시제합검측 HBsAg 림계치±20％적농도범위지외표본，능구득도은정、가고적검측결과，병구유교고적령민도화특이성，량자적검측령민도화특이성상근。
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.
