两种第四代人类免疫缺陷病毒（HIV）筛查检测方法在华西医院的临床应用评估
Clinical application evaluation of two fourth-generation human immunodeficiency virus (HIV) screening assays in West China Hospital.
作者信息
Liu Yongming, Li Dongdong, Wang Tingting, Yan Kening, Zhu Siyuan, Yang Tingfu, Luo Lan, Tao Chuanmin
机构信息
Division of Clinical Microbiology, Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, China.
出版信息
J Clin Lab Anal. 2015 Mar;29(2):146-52. doi: 10.1002/jcla.21743. Epub 2014 May 5.
BACKGROUND
Fourth-generation human immunodeficiency virus (HIV) screening assays have been used in many laboratories. The Elecsys® HIV combi PT assay is a new kind of fourth-generation HIV screening assay developed to allow earlier detection of seroconversion.
METHODS
A total of 271,845 routine specimens were detected using the Elecsys® HIV combi assay and Elecsys® HIV combi PT assay from September 2010 to December 2012 in a large university hospital. Repeatedly, reactive screening samples were confirmed according to recommended confirmatory algorithms.
RESULTS
The false-positive rate and positive predictive value (PPV) of two assays are 0.08 and 78.35%, respectively, for the Elecsys® HIV combi assay and 0.07 and 82.21% for the Elecsys® HIV combi PT assay. Ninety-four percent cases with cutoff index ratio <15.0 were false-positive. When we set the specificity as 95.0 and 99.0%, PPV could increase to 98.7, 99.6, 98.8, and 99.7%, and sensitivity reduced to 99.2, 98.4, 98.5, and 96.8% for the Elecsys® HIV combi assay and the Elecsys® HIV combi PT assay, respectively.
CONCLUSIONS
The Elecsys® HIV combi PT assay shows a better performance in specificity than the Elecsys® HIV combi assay. Most weakly reactive results were false-positive, this means it still need to be improved and it will need laboratory personnel to communicate with the clinical doctor and patients more properly about the result of the assay.
背景
第四代人类免疫缺陷病毒（HIV）筛查检测方法已在许多实验室中使用。Elecsys® HIV 组合 PT 检测是一种新型的第四代 HIV 筛查检测方法，旨在更早地检测到血清转化。
方法
2010 年 9 月至 2012 年 12 月期间，在一家大型大学医院使用 Elecsys® HIV 组合检测和 Elecsys® HIV 组合 PT 检测对总共 271,845 份常规标本进行了检测。对反复出现反应性的筛查样本，根据推荐的确认算法进行确认。
结果
Elecsys® HIV 组合检测的假阳性率和阳性预测值（PPV）分别为 0.08 和 78.35%，Elecsys® HIV 组合 PT 检测的假阳性率和阳性预测值分别为 0.07 和 82.21%。临界指数比值<15.0 的病例中有 94%为假阳性。当将特异性设定为 95.0%和 99.0%时，Elecsys® HIV 组合检测和 Elecsys® HIV 组合 PT 检测的 PPV 可分别提高到 98.7%、99.6%、98.8%和 99.7%，敏感性分别降至 99.2%、98.4%、98.5%和 96.8%。
结论
Elecsys® HIV 组合 PT 检测在特异性方面比 Elecsys® HIV 组合检测表现更好。大多数弱阳性结果为假阳性，这意味着该检测仍需改进，并且需要实验室人员就检测结果与临床医生和患者进行更恰当的沟通。
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