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一种用于检测口腔液标本中HIV抗体的自动化化学发光测定法的验证研究。

Validation study of an automated chemiluminiscence assay to detect HIV antibodies in oral fluid specimens.

作者信息

González Victoria, López Nalia, Grifols Joan, Egea Laia, Rivaya Belén, Wang Jun Hao Wang, Casabona Jordi, Cardona Pere Joan

机构信息

Centre for Epidemiological Studies On Sexually Transmitted Diseases and HIV/AIDS of Catalonia (CEEISCAT), Health Department, Generalitat de Catalunya, Barcelona, Spain.

Microbiology Department, Laboratori Clínic Metropolitana Nord, University Hospital "Germans Trias I Pujol", Badalona, Spain.

出版信息

Eur J Clin Microbiol Infect Dis. 2022 Jun;41(6):907-911. doi: 10.1007/s10096-022-04450-3. Epub 2022 May 7.

DOI:10.1007/s10096-022-04450-3
PMID:35524829
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9078087/
Abstract

Oral fluid specimens (OF) have been widely used to know the HIV prevalence in several key populations. Here, we aim to validate in OF specimens an existing HIV chemiluminiscence assay for serum specimens. Paired OF and serum specimens were collected from 83 known HIV-positives and 83 known HIV-negatives in order to validate the performance characteristics of the automated chemiluminiscence Liaison XL Murex HIV Ag/Ab assay (Diasorin Inc, Iberia) for HIV antibody detection in OF specimens. Among the previously known HIV-seropositive group, HIV antibodies were detected in 69 out of 83 OF specimens. All serum and OF specimens collected from 83 HIV seronegative individuals were negative. The sensitivity and specificity of this assay were 83.13% and 100% respectively in OF. The PPV and NPV values were 100% and 85.57% respectively. The correlation obtained between both specimens was (K: 0.83, [95% CI: 0.748-0.915]) according to the kappa index. The ROC curve analysing the optimal cut-off of the Liaison XL Murex HIV Ag/Ab to detect positive OF specimens revealed that a cut-off of 0.497 showed sensitivity and specificity values of 98.8% and 97.59% respectively. Taking into account this cut-off, the overall sensitivity and NPV of the Liaison XL Murex HIV Ag/Ab assay could rise from 83.1 to 98.8% and from 85.5 to 97.7%, respectively. Our results suggest that the Liaison XL HIV Ag/Ab assay is suitable for the detection of HIV antibodies in OF specimens.

摘要

口腔液标本(OF)已被广泛用于了解几个关键人群中的艾滋病毒流行情况。在此,我们旨在验证一种现有的用于血清标本的艾滋病毒化学发光检测方法在OF标本中的有效性。收集了83例已知艾滋病毒阳性者和83例已知艾滋病毒阴性者的配对OF和血清标本,以验证用于OF标本中艾滋病毒抗体检测的自动化化学发光Liaison XL Murex HIV Ag/Ab检测方法(迪亚索林公司,伊比利亚)的性能特征。在先前已知的艾滋病毒血清阳性组中,83份OF标本中有69份检测到艾滋病毒抗体。从83名艾滋病毒血清阴性个体收集的所有血清和OF标本均为阴性。该检测方法在OF中的敏感性和特异性分别为83.13%和100%。阳性预测值(PPV)和阴性预测值(NPV)分别为100%和85.57%。根据kappa指数,两种标本之间的相关性为(K:0.83,[95%置信区间:0.748 - 0.915])。分析Liaison XL Murex HIV Ag/Ab检测阳性OF标本最佳临界值的ROC曲线显示,临界值为0.497时,敏感性和特异性值分别为98.8%和97.59%。考虑到该临界值,Liaison XL Murex HIV Ag/Ab检测方法的总体敏感性和NPV可分别从83.1%提高到98.8%,从85.5%提高到97.7%。我们的结果表明,Liaison XL HIV Ag/Ab检测方法适用于检测OF标本中的艾滋病毒抗体。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e93/9078087/00a536b2da80/10096_2022_4450_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e93/9078087/00a536b2da80/10096_2022_4450_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e93/9078087/00a536b2da80/10096_2022_4450_Fig1_HTML.jpg

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