三种不同技术原理的第4代HIV诊断试剂的临床检测性能比较研究

A comparative study on the clinical performance of three fourth generation HIV diagnostic reagents

目的 比较3种HIV第4代抗原/抗体联合诊断试剂针对HIV早期感染者标本、国际血清盘标本及临床常规标本的检测性能.方法 横断面研究.收集2009至2011年沈阳市男男同性恋人群随访中发现的HIV早期感染者标本37份、4套美国BBI公司、NABI公司和英国NIBSC的不同类型国际血清盘标本66份以及703份中国医科大学附属第一医院2011年10月间常规就诊患者的HIV筛查标本,分别采用化学发光试验（CLIA）、电化学发光试验（ECLIA）和酶联免疫吸附试验（ELISA）3种HIV第4代血清学诊断试剂进行检测,比较3种试剂的检测敏感度和特异度,通过x^2检验进行统计学分析.结果 37份早期HIV-1感染者标本及22份HIV-1阳转血清盘标本中,ECLIA和CLIA试剂的敏感性均为96.61％ （95％ CI 91.5％ ～ 100.0％）,高于ELISA试剂的敏感性83.93％（95％ CI 75.0％ ～92.9％）（x^2=5.341,P＜0.05）；3种试剂对12份不同亚型的抗体血清盘标本的敏感性：ECLIA试剂＞ELISA试剂＞CLIA试剂；3种试剂对25份不同亚型的病毒裂解物血清盘标本的敏感性：CLIA试剂＞ECLIA试剂＞ELISA试剂；3种试剂对7份P24抗原定量血清盘标本的检出下限分别为：CLIA试剂0.705 IU/ml,ECLIA试剂0.843 IU/ml,ELISA试剂6.691 IU/ml;703份临床常规筛查标本中,3种试剂的特异性分别为100％ （CLIA）、99.86％ （ECLIA）和99.71％ （ELISA）,差异无统计学意义（P=0.914）.结论 HIV第4代CLIA和ECLIA血清学诊断试剂的检测敏感性优于ELISA试剂,其检测特异性未受到临床常见干扰因素的影响,两者更适用于临床常规筛查以及高危人群的HIV早期感染的筛查.

Objective To compare the performance of fourth generation HIV antigen/antibody combined detection reagents for HIV early infection samples, international HIV seroconversion panel samples and routine clinical screening samples. Methods Thirty seven early HIV infected samples from the follow- up gays in Shen Yang between 2009 and 2011, 66 seroconversion panel samples from BBI company （U. S. A）, NABI company（ U. S. A） and NIBSC company（ U. K） and 703 routine HIV screening samples in the first hospital of China medical university in October 2010 were collected. All kinds of samples were tested by three diagnostic reagents based on chemiluminescence assay （ CLIA ） , electrochemiluminescence assay （ECLIA） and enzyme-linked immunosorbent assay （ELISA） respectively. The detection sensitivity and specificity of these assays were analyzed. Results For 59 early infected and seroconversion samples, the sensitivities of both ECLIA and CLIA reagent were 96. 61% （95% （2191.5% -100. 0% ）, higher than that of the ELISA kit （95% CI 75.0% -92. 9% ） （x^2 = 5. 341, P 〈 0. 05 ）, which is 83.93% ; Comparison among the three reagents for different subtypes of the antibody seroconversion samples showed that ECLIA had the highest sensitivity while CLIA was the lowest; Detection sensitivity of the three reagents for the P24 antigen is CLIA 〉 ECLIA 〉 ELISA; With detection of 703 clinical routine screening samples, the specificities of three reagents were 100% （CLIA）, 99.86% （ECLIA）and 99. 71% （ELISA）respectively. Conclusions For the sensitivity of the fourth HIV diagnostic reagents CLIA and ECLIA are better than ELISA. The former two reagents are more suitable for identifying earlier HIV infection in clinic.