[HIV-1/2抗体确证试验的比较研究：Geenius™与INNO-LIA™]
[Comparative study of HIV-1/2 antibody confirmatory assay: Geenius™ versus INNO-LIA™].
作者信息
Aguinaga A, Navascués A, Polo I, Ezpeleta C
机构信息
Aitziber Aguinaga Pérez, Servicio de Microbiología Clínica. Complejo Hospitalario de Navarra, Calle de Irunlarrea 3, Pamplona, Navarra (CP: 31008). Spain.
出版信息
Rev Esp Quimioter. 2017 Feb;30(1):40-44. Epub 2016 Dec 23.
OBJECTIVE
The aim of the study is to compare two confirmatory tests for HIV-1/2 infection.
METHODS
A prospective study was carried out between 01/01/2015 and 12/31/2015. Serum samples with repeatedly positive results in the Antibody-Antigen-HIV-1/2 (Architect, Abbott) screening assay were included. The serum samples corresponding to new diagnosed cases were selected and were used to compare the two confirmatory assays: Geenius™ HIV-1/2 (Bio-Rad) and INNO-LIA™ HIV-1/2 score line-immunoassay (Innogene-tics®). The HIV-1 viral load (Cobas® AmpliPrepHIV, Ro-che) was performed in discordant or indeterminate cases.
RESULTS
Eight five samples were included. The results of both confirmatory assays were concordant in 80/85 samples: 53 HIV-1, 1 HIV-2, 25 negative and one indeterminate. Cohen's Kappa concordance coefficient between Geenius™ and INNO-LIA™ techniques was very high (0.878).
CONCLUSIONS
The concordance between the two assays is high. The procedure for Geenius™ is simple and fast. Geenius™ is a good alternative to include in the HIV-1/2 diagnostic algorithm.
目的
本研究旨在比较两种用于HIV-1/2感染的确证试验。
方法
于2015年1月1日至2015年12月31日进行了一项前瞻性研究。纳入在抗体-抗原-HIV-1/2（Architect，雅培公司）筛查试验中反复呈阳性结果的血清样本。选取与新诊断病例对应的血清样本，用于比较两种确证试验：Geenius™ HIV-1/2（伯乐公司）和INNO-LIA™ HIV-1/2评分线免疫分析（Innogenetics®）。对结果不一致或不确定的病例进行HIV-1病毒载量检测（Cobas® AmpliPrepHIV，罗氏公司）。
结果
共纳入85份样本。两种确证试验在80/85份样本中的结果一致：53份为HIV-1，1份为HIV-2，25份为阴性，1份不确定。Geenius™和INNO-LIA™技术之间的Cohen卡帕一致性系数非常高（0.878）。
结论
两种试验之间的一致性很高。Geenius™的操作程序简单快速。Geenius™是HIV-1/2诊断流程中一个很好的替代方法。
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