Relevance of cutoff on a 4th generation ELISA performance in the false positive rate during HIV diagnostic in a low HIV prevalence setting

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
Lucía ChacónÁfrica Holguín

Abstract

Despite 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. The 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. A 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. Among 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 wi...Continue Reading

Citations

Aug 26, 2020·Journal of Clinical Laboratory Analysis·Zhuoyun TangChuanmin Tao
Jun 5, 2018·European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology·Lisa LiMichael Payne
Jun 21, 2019·Journal of Clinical Microbiology·Mark M ManakUNKNOWN RV254/SEARCH010 and the RV217 Study Teams
Nov 10, 2020·The Pediatric Infectious Disease Journal·Zachary M MostAmanda S Evans
Apr 14, 2019·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Jayme ParkerJack Chen
Aug 7, 2021·Pathogens·José de Jesús Guerrero-GarcíaDaniel Ortuño-Sahagún

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