出 处:《按摩与康复医学》2020年第10期60-62,共3页Chinese Manipulation and Rehabilitation Medicine
摘 要:目的:对比3种不同免疫检验方法检测HIV抗体结果的可靠性。方法:选取本院住院及门诊患者136例,其中HIV初筛阴性68例,HIV初筛阳性68例,用CLIA法、ELISA法及胶体金法检测HIV抗体,对其中一种方法检测出HIV抗体阳性的标本用其它两种方法同时复查,并送检HIV确证实验室用WB法(金标准)进行确证试验。结果:136例患者中,初筛阳性患者68例,以免疫印迹法检测作为金标准,确证阳性患者32例,其中ELISA初筛出36例,灵敏度100%,特异度96.2%,误诊率3.8%,漏诊率0,可用度0.94,可靠度0.96,kappa值为0.922,与WB法比较具有诊断一致性(P>0.05);胶体金法初筛出36例,胶体金法灵敏度100%,特异度96.2%,误诊率3.8%,漏诊率0,可用度0.94,可靠度0.96,kappa值为0.922,与WB法比较具有诊断一致性(P>0.05);CLIA初筛出64例,CLIA灵敏度100%,特异度69.2%,误诊率30.8%,漏诊率0,可用度0.58,可靠度0.69,kappa值为0.514,与WB法比较不具有诊断一致性(P<0.05)。以CLIA法血清HIV抗体S/CO≥1作为HIV初筛阳性的临界判断,对64例CLIA初筛阳性的患者分别用ELISA、胶体法及WB法进行复查,发现S/CO为1~10组,WB法、ELISA阳性符合率为0,胶体金法阳性符合率为13.3%;S/CO为11~50组,WB法、ELISA及胶体金法阳性符合率均为66.7%,S/CO>50组,WB法、ELISA及胶体金法阳性符合率均为100%;以WB法为诊断基准,三组随着S/CO越大,真阳性率越高,三组比较具有统计学意义(P<0.05),ELISA、胶体金法复查初筛阳性的患者随着S/CO值越大,其阳性符合率越高,三组比较均具有统计学意义(P<0.05)。结论:三种免疫检测方法检测HIV抗体各有优势,医院可结合自身情况选择检测方法,对初筛阳性的标本可采取另一种方法复检,相互结合,及时对患者做出诊断,采取措施保护职业暴露人员。Objective:Comparison the reliability of three different immunoassay methods for HIV antibody detection.Methods:136 patients in our hospital and outpatient department were selected to detect HIV antibody by CLIA,ELISA and colloidal gold method,68 patients with initial screening positive,and 68 patients with initial screening negative.The samples that had been tested positive for HIV antibodies with one of these methods were retested by the other two methods and WB method as confirmatory test.Results:A total of 68 patients were screened in 136 samples,with the WB method as the diagnostic benchmark,32 patients were confirmed positive 36 cases were initial screened by ELISA,the sensitivity was 100%,the specificity was 96.2%,the misdiagnosis was 3.8%and the missed diagnosis was 0,the availability was 0.94,the reliability was 0.96,the kappa value was0.922,there was diagnostic consistency with WB method(P>0.05);36 cases were initial screened by colloidal gold method,the sensitivity was100%,the specificity was 96.2%,the misdiagnosis was 3.8%and the missed diagnosis was 0,the availability was 0.94,the reliability was 0.96,the kappa value was 0.922,there was diagnostic consistency with WB method(P>0.05);64 cases were initial screened by CLIA,the sensitivity was100%,the specificity was 69.2%,the misdiagnosis was 30.8%and the missed diagnosis was 0,the availability was 0.58,the reliability was 0.69,the kappa value was 0.514,there was not diagnostic consistency with WB method(P>0.05).64 patients with initial screening positive by CLIA screening were rechecked with ELISA,colloidal gold methods and WB method.The positive coincidence rate was 0 with ELISA and WB method,13.3%with colloid gold for patients whose S/CO were 1~10;The positive coincidence rate were all 66.7%with ELISA,WB method and colloid gold for patients whose S/CO were 1~50;The positive coincidence rate were all 100%with ELISA,WB method and colloid gold for patients whose S/CO>50,with the WB method as the diagnostic benchmark,the higher S/CO,the higher the true po
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