Abstract
Since May 2010, human immunodeficiency virus (HIV) screening in France has been performed using a single combined fourth-generation assay. One of our major concerns is to verify that this screening strategy is able to diagnose HIV primary infection as soon as possible. Thus, the sensitivity and specificity of this strategy were evaluated on 49,623 serum samples, including 29 primary infections, received for routine HIV testing between September 2010 and November 2011. Specimens were screened using the Enzygnost HIV Integral II enzyme-linkedimmunosorbent assay (ELISA) kit. All positive sera, according to the manufacturer’s recommendations [signal-to-cutoff ratio (S/CO) ≥ 1] were retested using the Architect HIV Ag/Ab Combo. Moreover, we defined a grey zone (0.5 < S/CO < 1) and sera within this grey zone were retested using the VIDAS HIV DUO Ultra test and HIV-1 RNA was checked by the Abbott RealTime PCR kit. Screening tests were positive for all primary infections. All samples within the grey zone proved VIDAS HIV DUO Ultra and HIV-1 RNA negative. Overall, the ELISA test sensitivity and specificity were 100 and 99.79 %, respectively. The false-positive rate was higher when S/CO was in the low range (1 to 5). Adding a second screening test for positive sera reduced the false-positive rate from 0.20 to 0.02 %. HIV screening with a single combined assay did not miss any documented primary infection during this evaluation period, even without extending the positivity zone.
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Acknowledgements
The authors would like to thank all the virology laboratory staff of the Croix-Rousse Hospital, Lyon, France, especially the serological staff for their helpful participation and dedication to this work.
The study was supported by Agence Nationale de Recherche sur le Sida et les Hépatites (ANRS) and the Hospices Civils de Lyon.
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The authors declare they have no conflict of interest.
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Fanmi, A.N., Ramière, C., Tardy, J.C. et al. Real-life evaluation of a human immunodeficiency virus screening algorithm using a single combined p24 antigen–antibody assay. Eur J Clin Microbiol Infect Dis 32, 425–430 (2013). https://doi.org/10.1007/s10096-012-1760-1
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DOI: https://doi.org/10.1007/s10096-012-1760-1