Relevance of cutoff on a 4th generation ELISA performance in the false positive rate during HIV diagnostic in a low HIV prevalence setting |
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| Institution: | 1. Molecular Epidemiology Laboratory, Microbiology Department, Ramón y Cajal Health Research Institute (IRYCIS), Spain;2. Microbiology Department, Hospital Ramón y Cajal, Madrid, Spain;1. Institute of Tropical Medicine, Antwerp, Belgium;2. Setshaba Research Centre, Soshanguve, Pretoria, South Africa;3. Impact Research and Development Organization, Kisumu, Kenya;4. JOSHA Research, Bloemfontein, South Africa;5. FHI-360, Research Triangle Park, NC, USA;6. Bill & Melinda Gates Foundation, Seattle, USA;1. Université Montpellier 1, INSERM U 1058, 34394 Montpellier, France;2. Laboratoire de Virologie, Unité VIH et Maladies Associées, Centre Muraz, Bobo-Dioulasso, Burkina Faso;3. CHU Montpellier, Département d’Information Médicale, 34295 Montpellier, France;4. CHU Montpellier, Département de Bactériologie-Virologie, 34295 Montpellier, France;1. Erasmus Medical Center, Department of Viroscience, Rotterdam, The Netherlands;2. Department of Infectious Disease Control, Municipal Public Health Service Rotterdam-Rijnmond, Rotterdam, The Netherlands;3. Department of Public Health, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands;1. Clinical Prevention Services, BC Centre for Disease Control, 655 West 12th Ave, Vancouver, BC V5Z 4R4, Canada;2. Faculty of Medicine, University of British Columbia, 2194 Health Sciences Mall, Vancouver, BC V6 T 1Z3, Canada;3. Public Health Microbiology & Reference Laboratory, BC Centre for Disease Control, 655 West 12th Ave Vancouver, BC V5Z 4R4, Canada;4. Faculty of Health Sciences, Simon Fraser University, 8888 University Drive, Burnaby, BC V5A 1S6, Canada;1. National HIV Reference Laboratory, Central Virology Laboratory, Ministry of Health, Tel-Hashomer, Ramat-Gan, Israel;2. Israel Center for Disease Control, Ministry of Health, Tel-Hashomer, Ramat-Gan, Israel;3. HIV Laboratory, Infectious Diseases Unit, Sheba Medical Center, Ramat-Gan, Israel;4. Virology Laboratory, Rambam Medical Center, Haifa, Israel;5. HIV Laboratory, Kaplan Medical Center, Rehovot, Israel;6. Virology Laboratory, Rabin Medical Center, Petach Tikva, Israel;7. Maccabi Health Services, Mega Laboratory, Rehovot, Israel;8. Virology Laboratory, Hadassah Medical Center, Jerusalem, Israel;9. Hadassah University Medical School, Jerusalem, Israel;10. Virology Laboratory, Soroka Medical Center, Beer-Sheva, Israel;11. Department of Tuberculosis and AIDS, Ministry of Health, Jerusalem, Israel;12. Faculty of Medicine, Braun School of Public Health & Community Medicine, Hebrew University-Hadassah Medical School, Jerusalem, Israel;13. School of Public Health, Sackler Faculty of Medicine, Tel-Aviv University, Ramat-Aviv, Israel |
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| Abstract: | BackgroundDespite the high specificity of fourth-generation enzyme immunoassays (4th-gen-EIA) for screening during HIV diagnosis, their positive predictive value is low in populations with low HIV prevalence. Thus, screening should be optimized to reduce false positive results.ObjectivesThe influence of sample cutoff (S/CO) values by a 4th-gen-EIA with the false positive rate during the routine HIV diagnosis in a low HIV prevalence population was evaluated.Study designA total of 30,201 sera were tested for HIV diagnosis using Abbott Architect® HIV-Ag/Ab-Combo 4th-gen-EIA at a hospital in Spain during 17 months. Architect S/CO values were recorded, comparing the HIV-1 positive results following Architect interpretation (S/CO ≥ 1) with the final HIV-1 diagnosis by confirmatory tests (line immunoassay, LIA and/or nucleic acid test, NAT). ROC curve was also performed.ResultsAmong the 30,201 HIV performed tests, 256 (0.85%) were positive according to Architect interpretation (S/CO ≥ 1) but only 229 (0.76%) were definitively HIV-1 positive after LIA and/or NAT. Thus, 27 (10.5%) of 256 samples with S/CO ≥ 1 by Architect were false positive diagnose. The false positive rate decreased when the S/CO ratio increased. All 19 samples with S/CO ≤10 were false positives and all 220 with S/CO > 50 true HIV-positives. The optimal S/CO cutoff value provided by ROC curves was 32.7. No false negative results were found.ConclusionsWe show that very low S/CO values during HIV-1 screening using Architect can result HIV negative after confirmation by LIA and NAT. The false positive rate is reduced when S/CO increases. |
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| Keywords: | HIV Diagnostic test Architect S/CO False positive result |
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