临床肝胆病杂志
臨床肝膽病雜誌
림상간담병잡지
CHINESE JOURNAL OF CLINICAL HEPATOLOGY
2014年
10期
1042-1044
,共3页
肝炎抗体,丙型%试剂盒,诊断%酶联免疫吸附测定
肝炎抗體,丙型%試劑盒,診斷%酶聯免疫吸附測定
간염항체,병형%시제합,진단%매련면역흡부측정
hepatitis C antibodies%reagent kits,diagnostic%enzyme -linked immunosorbent assay
目的：对国产双抗原夹心酶联免疫法和间接酶联免疫法丙型肝炎抗原检测试剂进行诊断性能评价与选择。方法选择1种夹心法和3种间接法国产检测试剂，同时对60份血清盘标本和40份血液筛查标本进行检测，血液筛查标本的检测结果为阳性或灰区，并经确认试验确认。试剂间比较采用配对卡方检验；对假阴性率进行 R ×C 列联表检验。结果3种间接法试剂和夹心法试剂的灵敏度分别为90．2％、78．0％、95．1％和97．6％；特异度分别为78．1％、72．6％、94．1％和100％。夹心法的分析灵敏度比间接法高4～8倍，不同试剂及试剂组合的 R ×C 列联表检验结果：χ2＝29．898，P ＜0．05。结论夹心法试剂诊断特性优于间接法试剂，夹心法与间接法试剂搭配，可明显降低假阴性率，有效防止漏检。
目的：對國產雙抗原夾心酶聯免疫法和間接酶聯免疫法丙型肝炎抗原檢測試劑進行診斷性能評價與選擇。方法選擇1種夾心法和3種間接法國產檢測試劑，同時對60份血清盤標本和40份血液篩查標本進行檢測，血液篩查標本的檢測結果為暘性或灰區，併經確認試驗確認。試劑間比較採用配對卡方檢驗；對假陰性率進行 R ×C 列聯錶檢驗。結果3種間接法試劑和夾心法試劑的靈敏度分彆為90．2％、78．0％、95．1％和97．6％；特異度分彆為78．1％、72．6％、94．1％和100％。夾心法的分析靈敏度比間接法高4～8倍，不同試劑及試劑組閤的 R ×C 列聯錶檢驗結果：χ2＝29．898，P ＜0．05。結論夾心法試劑診斷特性優于間接法試劑，夾心法與間接法試劑搭配，可明顯降低假陰性率，有效防止漏檢。
목적：대국산쌍항원협심매련면역법화간접매련면역법병형간염항원검측시제진행진단성능평개여선택。방법선택1충협심법화3충간접법국산검측시제，동시대60빈혈청반표본화40빈혈액사사표본진행검측，혈액사사표본적검측결과위양성혹회구，병경학인시험학인。시제간비교채용배대잡방검험；대가음성솔진행 R ×C 렬련표검험。결과3충간접법시제화협심법시제적령민도분별위90．2％、78．0％、95．1％화97．6％；특이도분별위78．1％、72．6％、94．1％화100％。협심법적분석령민도비간접법고4～8배，불동시제급시제조합적 R ×C 렬련표검험결과：χ2＝29．898，P ＜0．05。결론협심법시제진단특성우우간접법시제，협심법여간접법시제탑배，가명현강저가음성솔，유효방지루검。
Objective To compare the sensitivity and specificity between indirect enzyme -linked immunosorbent assay (ELISA)and double -antibody sandwich ELISA kits produced in China and to select the best ELISA kit.Methods Samples for evaluation included 60 serum plates and 40 serum samples positive or weakly positive for antibody to hepatitis C virus (anti -HCV)which were confirmed by re-combinant immunoblot assay.These samples were tested with a sandwich ELISA kit and three indirect ELISA kits,all of which were pro-duced in China.Comparison between ELISA kits was made by paired chi -square test;comparison of false negative rate was made by R × C contingency table test.Results The sensitivities of three indirect ELISA kits and a sandwich ELISA kit were 90.2%,78.0%,95.1%, and 97.6%,respectively,and the specificities were 78.1%,72.6%,94.1%,and 100%,respectively.The sandwich ELISA kit had a 4-8 times higher sensitivity than indirect ELISA kits.The R ×C contingency table test revealed significant differences in false negative rate between ELISA kits and combinations of ELISA kits (χ2 =29.898,P <0.05).Conclusion Sandwich ELISA kit has higher sensitivity and specificity than indirect ELISA kits.Combined use of sandwich ELISA and indirect ELISA kits can significantly reduce the false negative rate and effectively prevent missed anti -HCV detection.
