The variable sensitivity of HIV Ag/Ab combination assays in the detection of p24Ag according to genotype could compromise the diagnosis of early HIV infection

Autor: Syria Laperche, Jean-Christophe Plantier, Sylvie Gonzalo, Lionel Leballais, Thoai Duong Ly, Véronique Lemée
Rok vydání: 2012
Předmět:
Zdroj: Journal of Clinical Virology. 55:121-127
ISSN: 1386-6532
DOI: 10.1016/j.jcv.2012.06.012
Popis: Background In France, HIV infection diagnosis was modified by a decree, published in 2010, that requires the use of HIV Ag/Ab assays able to detect at least 2 IU/ml of p24Ag. This measure raises the concern of the capacity of these assays to equally detect all HIV variants. Objectives To assess the performance of HIV Ag/Ab assays for the detection of p24Ag from diverse HIV isolates. Study design Ten HIV Ag/Ab assays were compared using two p24Ag reference standards, 297 samples from 99 HIV-1 and HIV-2 cell-culture derived isolates including various subtypes and groups, and 9 native specimens from subjects with primary HIV infection. Results The p24Ag limit of detection (LOD) ranged from 0.505 IU/ml to 1.901 IU/ml and, from 11.9 pg/ml to 33.5 pg/ml when using WHO and French national standards, respectively. The overall percentage of positive samples ranged from 26.8% to 74.5%. Five assays failed to detect all dilutions of at least one group M subtype, three missed all group O and six all the group P samples. Three assays were able to detect 2–10 of the 30 HIV-2 samples. The distribution of LODs for each group M isolate showed a wide dispersion between the assays. Percentage of isolates detected at a p24Ag level less than 2 IU/ml varied from 22% to 98.7%. Conclusion This study demonstrated that, even though their analytical sensitivity fulfills the requirements, many of HIV Ag/Ab assays could fail to detect HIV primary infection due to HIV-1 non-B, non-M and HIV-2 strains.
Databáze: OpenAIRE
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