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. 2023 Aug 22;77(4):615-619.
doi: 10.1093/cid/ciad264.

Increase in False-Positive Fourth-Generation Human Immunodeficiency Virus Tests in Patients With Coronavirus Disease 2019

Smitha Gudipati  1   2   3 , Anita Shallal  1   2   3 , Edward Peterson  3 , Bernard Cook  4 , Norman Markowitz  1   3
Affiliations

Increase in False-Positive Fourth-Generation Human Immunodeficiency Virus Tests in Patients With Coronavirus Disease 2019

Smitha Gudipati et al. Clin Infect Dis. .

Abstract

Background: We observed an increase in the frequency of false-positive (FP) human immunodeficiency virus (HIV) test results that correlated with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) prevalence. We measured FP rates of laboratory-based fourth-generation HIV antigen/antibody test among those with polymerase chain reaction (PCR)-confirmed infection with SARS-CoV-2 compared with FP rate of those who tested SARS-CoV-2 PCR-negative.

Methods: All patients PCR tested for SARS-CoV-2 within 2 weeks of an HIV fourth-generation assay were selected. Positive HIV fourth-generation assays were reviewed and divided into groups of FP, true positive (TP), and presumptive negative (PN). Variables included age, race, ethnicity, gender, pregnancy, and Coronavirus Disease 2019 (COVID-19) immunization status. Associations with positive SARS-CoV-2 tests were assessed using linear logistic regression. Multivariate logistic regression was used to assess sets of variables.

Results: There were 31 910 medical records that met criteria. The frequency of SARS-CoV-2 positive tests was calculated in groups of HIV TP, FP, and PN. In total, 31 575 patients had PN HIV test result, 248 patients had TP, and 87 patients had FP. Those with HIV FP tests had the highest percentage of COVID-19-positive test results at 19.5%, which was significantly higher than HIV PN (11.3%; P = .016) and HIV TP (7.7%; P = .002). After adjustment for all covariates, only FP HIV was significantly associated with COVID-19 (odds ratio, 4.22; P = .001).

Conclusions: This study reveals that patients with positive SARS-CoV-2 PCR tests are significantly more likely to have an FP fourth-generation HIV test than those with negative SARS-CoV-2 PCR tests.

Keywords: HIV fourth-generation test; HIV-2; SARS-CoV-2.

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Conflict of interest statement

Potential conflicts of interest. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
HIV antigen COIs of true-positive and false-positive results in patients with and without COVID-19 infection. Gray box represents interquartile limits; horizontal line indicates the median. Abbreviations: COI, cutoff indices; COVID-19, Coronavirus Disease 2019; HIV, human immunodeficiency virus.
See this image and copyright information in PMC

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References

    1. Hardie DR, Korsman SN, Hsiao NY, Morobadi MD, Vawda S, Goedhals D. Contamination with HIV antibody may be responsible for false positive results in specimens tested on automated platforms running HIV 4th generation assays in a region of high HIV prevalence. PLoS One 2017; 12:e0182167. - PMC - PubMed
    1. Reid J, Van Zyl G, Linstrom M, Korsman S, Marais G, Preiser W. High positive HIV serology results can still be false positive. IDCases 2020; 21:e00849. - PMC - PubMed
    1. Dodig S. Interferences in quantitative immunochemical methods. Biochemia Medica 2009; 19:50–62.
    1. Tate J, Ward G. Interferences in immunoassay. Clin Biochem Rev 2004; 25:105–20. - PMC - PubMed
    1. Bhattacharya R, Barton S, Catalan J. When good news is bad news: psychological impact of false positive diagnosis of HIV. AIDS Care 2008; 20:560–4. - PubMed