中华预防医学杂志
中華預防醫學雜誌
중화예방의학잡지
CHINESE JOURNAL OF
2010年
3期
247-250
,共4页
周晖%江楚文%李世坚%李珩%黄美群%梁健群%肖伟欢
週暉%江楚文%李世堅%李珩%黃美群%樑健群%肖偉歡
주휘%강초문%리세견%리형%황미군%량건군%초위환
HIV抗体%试剂盒,诊断%普查%对比研究%敏感性与特异性%试验预期值
HIV抗體%試劑盒,診斷%普查%對比研究%敏感性與特異性%試驗預期值
HIV항체%시제합,진단%보사%대비연구%민감성여특이성%시험예기치
HIV antibodies%Reagent kits,diagnostic%Mass screening%Comparative study%Sensitivity and specificity%Predictive value of tests
目的 通过对比分析艾滋病病毒(HIV)抗体筛查阳性结果与免疫印迹试验(WB)结果,评价4种HIV抗体筛查试剂检测性能.方法 2004年1月至2009年6月,分别用中山生物工程有限公司、荷兰生物梅里埃有限公司、珠海丽珠有限公司生产的3种酶联免疫吸附试验(enzyme linked immunasorbent assay,ELISA)试剂初筛血清HIV抗体,用美国雅培Determine HIV-1/2胶体硒标试剂、原试剂复检.筛查阳性样本用WB法进行确认.结果 共检测206 151例患者血清HIV抗体,确认HIV抗体阳性193例(0.094%).3种ELISA试剂敏感度、阴性预期值均为100%;雅培试剂分别为93.93%、91.67%,其漏检的样本均为WB不确定.中山、梅里埃、丽珠、雅培试剂的特异度分别为99.88%、99.89%、99.96%、89.38%;阳性预期值(study predictive value of a positive test result,PVP)分别为35.58%、46.46%、76.61%、92.20%;功效分别为99.88%、99.89%、99.96%、91.98%;3种ELISA试剂ROC曲线下面积分别为0.93、0.99、0.95.丽珠的PVP明显高于中山(X~2=45.804,P=0.000)、梅里埃(X~2=25.231,P=0.000);梅里埃的PVP比中山高,但无统计学意义(X~2=2.488,P=0.115);雅培PVP最高(与丽珠相比,X~2=18.633,P=0.000).在WB确认阳性、不确定、阴性组,均存在S/CO值[样本(sample)吸光度值/临界值(cut off)]＜6或≥6的样本.中山试剂确认阳性组S/CO值(14.29±2.63)明显高于阳性-阴性组(2.80±3.25)(t=17.652,P=0.000).梅里埃试剂确认阳性组S/CO值(16.09±2.35)明显高于阳性-阴性组(2.14±1.91)(t=31.622,P=0.000).丽珠试剂确认阳性组S/CO值(11.54±1.95)明显高于阳性-不确定组(5.54±3.57)(t=6.386,P=0.000)、阳性-阴性组(3.25±2.41)(t=21.772,P=0.000);阳性-不确定组S/CO值则高于阳性-阴性组(t=2.301,P=0.033).结论 4种筛查试剂性能良好,根据S/CO值不能准确估计WB确认结果,筛查阳性后必须进行确认.
目的 通過對比分析艾滋病病毒(HIV)抗體篩查暘性結果與免疫印跡試驗(WB)結果,評價4種HIV抗體篩查試劑檢測性能.方法 2004年1月至2009年6月,分彆用中山生物工程有限公司、荷蘭生物梅裏埃有限公司、珠海麗珠有限公司生產的3種酶聯免疫吸附試驗(enzyme linked immunasorbent assay,ELISA)試劑初篩血清HIV抗體,用美國雅培Determine HIV-1/2膠體硒標試劑、原試劑複檢.篩查暘性樣本用WB法進行確認.結果 共檢測206 151例患者血清HIV抗體,確認HIV抗體暘性193例(0.094%).3種ELISA試劑敏感度、陰性預期值均為100%;雅培試劑分彆為93.93%、91.67%,其漏檢的樣本均為WB不確定.中山、梅裏埃、麗珠、雅培試劑的特異度分彆為99.88%、99.89%、99.96%、89.38%;暘性預期值(study predictive value of a positive test result,PVP)分彆為35.58%、46.46%、76.61%、92.20%;功效分彆為99.88%、99.89%、99.96%、91.98%;3種ELISA試劑ROC麯線下麵積分彆為0.93、0.99、0.95.麗珠的PVP明顯高于中山(X~2=45.804,P=0.000)、梅裏埃(X~2=25.231,P=0.000);梅裏埃的PVP比中山高,但無統計學意義(X~2=2.488,P=0.115);雅培PVP最高(與麗珠相比,X~2=18.633,P=0.000).在WB確認暘性、不確定、陰性組,均存在S/CO值[樣本(sample)吸光度值/臨界值(cut off)]＜6或≥6的樣本.中山試劑確認暘性組S/CO值(14.29±2.63)明顯高于暘性-陰性組(2.80±3.25)(t=17.652,P=0.000).梅裏埃試劑確認暘性組S/CO值(16.09±2.35)明顯高于暘性-陰性組(2.14±1.91)(t=31.622,P=0.000).麗珠試劑確認暘性組S/CO值(11.54±1.95)明顯高于暘性-不確定組(5.54±3.57)(t=6.386,P=0.000)、暘性-陰性組(3.25±2.41)(t=21.772,P=0.000);暘性-不確定組S/CO值則高于暘性-陰性組(t=2.301,P=0.033).結論 4種篩查試劑性能良好,根據S/CO值不能準確估計WB確認結果,篩查暘性後必鬚進行確認.
목적 통과대비분석애자병병독(HIV)항체사사양성결과여면역인적시험(WB)결과,평개4충HIV항체사사시제검측성능.방법 2004년1월지2009년6월,분별용중산생물공정유한공사、하란생물매리애유한공사、주해려주유한공사생산적3충매련면역흡부시험(enzyme linked immunasorbent assay,ELISA)시제초사혈청HIV항체,용미국아배Determine HIV-1/2효체서표시제、원시제복검.사사양성양본용WB법진행학인.결과 공검측206 151례환자혈청HIV항체,학인HIV항체양성193례(0.094%).3충ELISA시제민감도、음성예기치균위100%;아배시제분별위93.93%、91.67%,기루검적양본균위WB불학정.중산、매리애、려주、아배시제적특이도분별위99.88%、99.89%、99.96%、89.38%;양성예기치(study predictive value of a positive test result,PVP)분별위35.58%、46.46%、76.61%、92.20%;공효분별위99.88%、99.89%、99.96%、91.98%;3충ELISA시제ROC곡선하면적분별위0.93、0.99、0.95.려주적PVP명현고우중산(X~2=45.804,P=0.000)、매리애(X~2=25.231,P=0.000);매리애적PVP비중산고,단무통계학의의(X~2=2.488,P=0.115);아배PVP최고(여려주상비,X~2=18.633,P=0.000).재WB학인양성、불학정、음성조,균존재S/CO치[양본(sample)흡광도치/림계치(cut off)]＜6혹≥6적양본.중산시제학인양성조S/CO치(14.29±2.63)명현고우양성-음성조(2.80±3.25)(t=17.652,P=0.000).매리애시제학인양성조S/CO치(16.09±2.35)명현고우양성-음성조(2.14±1.91)(t=31.622,P=0.000).려주시제학인양성조S/CO치(11.54±1.95)명현고우양성-불학정조(5.54±3.57)(t=6.386,P=0.000)、양성-음성조(3.25±2.41)(t=21.772,P=0.000);양성-불학정조S/CO치칙고우양성-음성조(t=2.301,P=0.033).결론 4충사사시제성능량호,근거S/CO치불능준학고계WB학인결과,사사양성후필수진행학인.
Objective To Evaluate four kits for screening HIV antibody by comparing and analyzing the HIV antibody screening positive results and Western Blot (WB) test results.Methods From January 2004 to June 2009,three ELISA kits (Zhongshan,Biomérieux and Livzon) were used for initial screening HIV antibody.The reactive positive samples were reexamed by initial ELISA kit and a rapid kit (Abbot Determine HIV-1/2) .All repeatedly reactive positive screening results were followed by WB test.Results A total of 193 (0.094%) WB confirmed positive results were obtained from 206 151 specimens.The sensitivities and predictive values of negative test result (PVN) of three ELISA kits were all 100% and those of Abbot Determine HIV-1/2 were 93.93%,and 91.67% respectively.All false negative results from Abbot were WB indeterminate.The specificities of Zhongshan,Biomérieux,Livzon and Abbot were 99.88% ,99.89% ,99.96% and 89.38% ; the study predictive values of a positive test result (PVP)were 35.58%,46.46%,76.61% and 92.20% ; the efficieucies were 99.88%,99.89%,99.96% and 91.98% ; the areas under ROC curve of the three ELISA kits were 0.93,0.99,and 0.95 respectively.PVP of Livzon was obviously higher than those of Zhongshan (X~2 = 45.804,P = 0.000) ,Biomérieux (X~2=25.231,P =0.000) and Biomérieux was higher than Zhongshan (X~2=2.488,P=0.115) .PVP of Abbot was highest (X~2=18.633 ,P =0.000,vs Livzon) .There were some specimens with S/CO (optical density of sample/cut off) ratio ＜6 or≥6 in all three groups with positive,indeterminate and negative WB results.The S/CO ratio from Zhongshan in confirmed positive group (14.29±2.63) was higher than in positive-negative group (2.80±3.25)(t=17.652,P=0.000) .The S/CO ratio from Biomérieux in confirmed positive group (16.09±2.35) was higher than in positive-negative group (2.14±1.91)(t=31.622,P=0.000) .The S/CO ratio from Livzon in confirmed positive group (11.54±1.95) was higher than in positive-indeterminate group (5.54±3.57)(t=6.386,P=0.000) ,positive-negative group (3.25±2.41)(t=21.772,P=0.000) and positive-indeterminate group was higher than positive-negative group (t=2.301,P=0.033) .Conclusion The performances of four HIV antibody screening kits are good but estimating WB confirming result in line with S/CO ratio is not available.All repeated screening positive results should be followed by confirmatory tests.
