Failures in the Detection of HIV p24 Antigen With the Determine HIV-1/2 Ag/Ab Combo Rapid Test

Laperche, Syria; Leballais, Lionel; Ly, Thoai Duong; Plantier, Jean‐Christophe

doi:10.1093/infdis/jis616

Cited by 29 publications

(29 citation statements)

References 6 publications

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“…Similarly, the circulation of M + O dual infections and/or mosaic strains including group O fragments could have deleterious consequences. Thus, recombinant forms with a group O envelope (in absence of parental forms) will not be diagnosed by serological tests that are not adapted to this group due to antigenic variability [17, 18, 37], thus enabling silent spreading of these viruses. Moreover, if M + O dual infections and recombinants with group O fragments (particularly in RT) are unknown, unadapted therapeutic management could lead to rapid virological failure of the cART due to the natural resistance of group O to NNRTIs, and subsequently to the emergence of strains resistant to other partner drugs.…”

Section: Discussionmentioning

confidence: 99%

Multiple HIV-1/M + HIV-1/O dual infections and new HIV-1/MO inter-group recombinant forms detected in Cameroon

et al. 2017

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Background Due to the prevalence of HIV-1 group M and the endemicity of HIV-1 group O infections in Cameroon, patients may be infected with both viruses and/or with HIV-1/MO recombinant forms. Such atypical infections may be deleterious in terms of diagnosis and therapeutic management due to the high divergence of HIV-1/O. The aim of this study was to identify prospectively such atypical infections in Cameroon.Results Based on serological screening by env-V3 serotyping and a molecular strategy using group-specific (RT)-PCRs, we identified 10 Cameroonian patients harboring three different profiles of infection: (1) 4 HIV-1/M + O dual infections without evidence of recombinant; (2) 5 recombinants associated with one or both parental strains; and (3) 1 new recombinant form without parental strains.ConclusionsThis work highlights the dynamic co-evolution of these two HIV groups in Cameroon that could lead to the emergence of a circulating recombinant form MO, and the need for accurate identification of such atypical infections for precise diagnosis, virological monitoring and therapeutic management with adapted tools.

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Section: Discussionmentioning

confidence: 99%

Multiple HIV-1/M + HIV-1/O dual infections and new HIV-1/MO inter-group recombinant forms detected in Cameroon

et al. 2017

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“…The poor sensitivity of commercial serological tests for HIV-O variants was first noted in 1994 (75,76), as all these tests are based on group M antigens. The addition of group O-specific antigens and development of fourthgeneration enzyme-linked immunosorbent assay (ELISA) detection tests (combining the detection of p24 antigens and antibodies) have substantially improved the situation (77), but there is still a risk of false-negative HIV-O results (78)(79)(80)(81)(82)(83)(84), because test performance is evaluated by using restricted panels that do not cover the broad antigenic diversity of group O and because specific antigens are lacking in some kits.…”

Section: Hiv-omentioning

confidence: 99%

Non-M Variants of Human Immunodeficiency Virus Type 1

2013

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SUMMARY The AIDS pandemic that started in the early 1980s is due to human immunodeficiency virus type 1 (HIV-1) group M (HIV-M), but apart from this major group, many divergent variants have been described (HIV-1 groups N, O, and P and HIV-2). The four HIV-1 groups arose from independent cross-species transmission of the simian immunodeficiency viruses (SIVs) SIVcpz, infecting chimpanzees, and SIVgor, infecting gorillas. This, together with human adaptation, accounts for their genomic, phylogenetic, and virological specificities. Nevertheless, the natural course of non-M HIV infection seems similar to that of HIV-M. The virological monitoring of infected patients is now possible with commercial kits, but their therapeutic management remains complex. All non-M variants were principally described for patients linked to Cameroon, where HIV-O accounts for 1% of all HIV infections; only 15 cases of HIV-N infection and 2 HIV-P infections have been reported. Despite improvements in our knowledge, many fascinating questions remain concerning the origin, genetic evolution, and slow spread of these variants. Other variants may already exist or may arise in the future, calling for close surveillance. This review provides a comprehensive, up-to-date summary of the current knowledge on these pathogens, including the historical background of their discovery; the latest advances in the comprehension of their origin and spread; and clinical, therapeutic, and laboratory aspects that may be useful for the management and the treatment of patients infected with these divergent viruses.

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“…Therefore, the baseline HIV prevalence in the population influences the negative and PPV and needs to be taken into account in the interpretation of HIV RDTs results. On the other hand, it is not certain that the currently available 4 th generation HIV RDTs would perform better based on recent published data showing that the HIV p24 antigen detection component of some 4 th generation RDTs also lacks analytical and diagnostic sensitivity [21][22][23][24][25].…”

Section: Discussionmentioning

confidence: 99%

Field accuracy of HIV rapid diagnostic tests for blood donors screening, Bukavu, Eastern Democratic Republic of the Congo

Kashosi

Kyambikwa

Mulongo

et al. 2018

J Infect Dev Ctries

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Introduction: Rapid diagnostic tests (RDTs) are widely used for point-of-care diagnosis of HIV infection in resource-limited settings. However, there are no data about their field diagnostic performance in Eastern Democratic Republic of the Congo (DRC), especially in the context of blood banks screening for transfusion safety purpose. Methodology: Blood specimens were collected from blood donors in Bukavu, Eastern DRC, from May the 1 st to June the 30 th , 2015, to evaluate the accuracy of Alere Determine HIV-1/2, Trinity Biotech Uni-Gold HIV, and DoubleCheckGold Ultra HIV 1&2 compared to the laboratorybased 4 th generation ELISA apDia HIV Ag/Ab assay. Sensitivity, specificity, positive and negative predictive values, and related 95% confidence intervals were calculated using MedCalc statistical software version 15.1. Reliability was evaluated using Cohen's Kappa Statistic, κ. Results: Of 312 participants who donated blood, 96/312 (30.7%) were female and the mean age (SD) was 31.7 years (± 8.1 years). Sensitivity for the three tests was 57.1% (95% CI: 18.4-90.1). The specificity was 99.7% (95% CI: 18.4-90.1) for Alere Determine HIV-1/2, 100% (95% CI: 98.8-100.0) for Uni-Gold HIV, and 100% (95% CI: 98.8-100.0) for DoubleCheckGold Ultra HIV 1&2. Cohen's Kappa Statistic showed moderate agreement between the 4 th generation ELISA apDia HIV Ag/Ab and either Alere Determine HIV-1/2 and Uni-Gold HIV (κ = 0.66; 95% CI: 0.55-0.76) but good agreement for DoubleCheckGold Ultra HIV1&2 (κ = 0.72; 95% CI: 0.61 -0.82). Conclusions: Compared to the laboratory-based ELISA apDia HIV Ag/Ab assay, the currently used 3 rd generation HIV RDTs showed poor field accuracy results for blood donor screening. These data support the need for 4 th generation Ag-Ab RDTs in transfusion blood qualification.

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Failures in the Detection of HIV p24 Antigen With the Determine HIV-1/2 Ag/Ab Combo Rapid Test

Cited by 29 publications

References 6 publications

Multiple HIV-1/M + HIV-1/O dual infections and new HIV-1/MO inter-group recombinant forms detected in Cameroon

Multiple HIV-1/M + HIV-1/O dual infections and new HIV-1/MO inter-group recombinant forms detected in Cameroon

Non-M Variants of Human Immunodeficiency Virus Type 1

Field accuracy of HIV rapid diagnostic tests for blood donors screening, Bukavu, Eastern Democratic Republic of the Congo

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