Detection of acute and early HIV-1 infections in an HIV hyper-endemic area with limited resources

Simnikiwe H. Mayaphi, Desmond J. Martin, Thomas C Quinn, Oliver B. Laeyendecker, Steve A S Olorunju, Gregory R. Tintinger, Anton C. Stoltz

Research output: Contribution to journalArticle

Abstract

Background Two thirds of the world's new HIV infections are in sub-Saharan Africa. Acute HIV infection (AHI) is the time of virus acquisition until the appearance of HIV antibodies. Early HIV infection, which includes AHI, is the interval between virus acquisition and establishment of viral load set-point. This study aimed to detect acute and early HIV infections in a hyper-endemic setting. Methods This was a cross-sectional diagnostic study that enrolled individuals who had negative rapid HIV results in five clinics in South Africa. Pooled nucleic acid amplification testing (NAAT) was performed, followed by individual sample testing in positive pools. NAAT-positive participants were recalled to the clinics for confirmatory testing and appropriate management. HIV antibody, p24 antigen, Western Blot and avidity tests were performed for characterization of NAAT-positive samples. Results The study enrolled 6910 individuals with negative rapid HIV results. Median age was 27 years (interquartile range {IQR}: 23±31). NAAT was positive in 55 samples, resulting in 0.8% newly diagnosed HIV-infected individuals (95% confidence interval {CI}: 0.6±1.0). The negative predictive value for rapid HIV testing was 99.2% (95% CI: 99.0±99.4). Characterization of NAAT-positive samples revealed that 0.04% (95% CI: 0.000±0.001) had AHI, 0.3% (95% CI: 0.1±0.4) had early HIV infection, and 0.5% (95% CI: 0.5±0.7) had chronic HIV infection. Forty-seven (86%) of NAAT-positive participants returned for follow- up at a median of 4 weeks (IQR: 2±8). Follow-up rapid tests were positive in 96% of these participants. Conclusions NAAT demonstrated that a substantial number of HIV-infected individuals are misdiagnosed at South African points-of-care. Follow-up rapid tests done within a 4 week interval detected early and chronic HIV infections initially missed by rapid HIV testing. This may be a practical and affordable strategy for earlier detection of these infections in resource-constrained settings. Newer molecular tests that can be used at the points-of-care should be evaluated for routine diagnosis of HIV in hyper-endemic settings.

Original languageEnglish (US)
Article numbere0164943
JournalPLoS One
Volume11
Issue number10
DOIs
StatePublished - Oct 1 2016

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HIV infections
Human immunodeficiency virus 1
HIV Infections
HIV-1
HIV
Nucleic Acids
Amplification
Testing
nucleic acids
Confidence Intervals
testing
Point-of-Care Systems
confidence interval
HIV Antibodies
Viruses
HIV Core Protein p24
Africa South of the Sahara
South Africa
Diagnostic Errors
Viral Load

ASJC Scopus subject areas

  • Medicine(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

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Detection of acute and early HIV-1 infections in an HIV hyper-endemic area with limited resources. / Mayaphi, Simnikiwe H.; Martin, Desmond J.; Quinn, Thomas C; Laeyendecker, Oliver B.; Olorunju, Steve A S; Tintinger, Gregory R.; Stoltz, Anton C.

In: PLoS One, Vol. 11, No. 10, e0164943, 01.10.2016.

Research output: Contribution to journalArticle

Mayaphi, Simnikiwe H. ; Martin, Desmond J. ; Quinn, Thomas C ; Laeyendecker, Oliver B. ; Olorunju, Steve A S ; Tintinger, Gregory R. ; Stoltz, Anton C. / Detection of acute and early HIV-1 infections in an HIV hyper-endemic area with limited resources. In: PLoS One. 2016 ; Vol. 11, No. 10.
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title = "Detection of acute and early HIV-1 infections in an HIV hyper-endemic area with limited resources",
abstract = "Background Two thirds of the world's new HIV infections are in sub-Saharan Africa. Acute HIV infection (AHI) is the time of virus acquisition until the appearance of HIV antibodies. Early HIV infection, which includes AHI, is the interval between virus acquisition and establishment of viral load set-point. This study aimed to detect acute and early HIV infections in a hyper-endemic setting. Methods This was a cross-sectional diagnostic study that enrolled individuals who had negative rapid HIV results in five clinics in South Africa. Pooled nucleic acid amplification testing (NAAT) was performed, followed by individual sample testing in positive pools. NAAT-positive participants were recalled to the clinics for confirmatory testing and appropriate management. HIV antibody, p24 antigen, Western Blot and avidity tests were performed for characterization of NAAT-positive samples. Results The study enrolled 6910 individuals with negative rapid HIV results. Median age was 27 years (interquartile range {IQR}: 23±31). NAAT was positive in 55 samples, resulting in 0.8{\%} newly diagnosed HIV-infected individuals (95{\%} confidence interval {CI}: 0.6±1.0). The negative predictive value for rapid HIV testing was 99.2{\%} (95{\%} CI: 99.0±99.4). Characterization of NAAT-positive samples revealed that 0.04{\%} (95{\%} CI: 0.000±0.001) had AHI, 0.3{\%} (95{\%} CI: 0.1±0.4) had early HIV infection, and 0.5{\%} (95{\%} CI: 0.5±0.7) had chronic HIV infection. Forty-seven (86{\%}) of NAAT-positive participants returned for follow- up at a median of 4 weeks (IQR: 2±8). Follow-up rapid tests were positive in 96{\%} of these participants. Conclusions NAAT demonstrated that a substantial number of HIV-infected individuals are misdiagnosed at South African points-of-care. Follow-up rapid tests done within a 4 week interval detected early and chronic HIV infections initially missed by rapid HIV testing. This may be a practical and affordable strategy for earlier detection of these infections in resource-constrained settings. Newer molecular tests that can be used at the points-of-care should be evaluated for routine diagnosis of HIV in hyper-endemic settings.",
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AU - Mayaphi, Simnikiwe H.

AU - Martin, Desmond J.

AU - Quinn, Thomas C

AU - Laeyendecker, Oliver B.

AU - Olorunju, Steve A S

AU - Tintinger, Gregory R.

AU - Stoltz, Anton C.

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N2 - Background Two thirds of the world's new HIV infections are in sub-Saharan Africa. Acute HIV infection (AHI) is the time of virus acquisition until the appearance of HIV antibodies. Early HIV infection, which includes AHI, is the interval between virus acquisition and establishment of viral load set-point. This study aimed to detect acute and early HIV infections in a hyper-endemic setting. Methods This was a cross-sectional diagnostic study that enrolled individuals who had negative rapid HIV results in five clinics in South Africa. Pooled nucleic acid amplification testing (NAAT) was performed, followed by individual sample testing in positive pools. NAAT-positive participants were recalled to the clinics for confirmatory testing and appropriate management. HIV antibody, p24 antigen, Western Blot and avidity tests were performed for characterization of NAAT-positive samples. Results The study enrolled 6910 individuals with negative rapid HIV results. Median age was 27 years (interquartile range {IQR}: 23±31). NAAT was positive in 55 samples, resulting in 0.8% newly diagnosed HIV-infected individuals (95% confidence interval {CI}: 0.6±1.0). The negative predictive value for rapid HIV testing was 99.2% (95% CI: 99.0±99.4). Characterization of NAAT-positive samples revealed that 0.04% (95% CI: 0.000±0.001) had AHI, 0.3% (95% CI: 0.1±0.4) had early HIV infection, and 0.5% (95% CI: 0.5±0.7) had chronic HIV infection. Forty-seven (86%) of NAAT-positive participants returned for follow- up at a median of 4 weeks (IQR: 2±8). Follow-up rapid tests were positive in 96% of these participants. Conclusions NAAT demonstrated that a substantial number of HIV-infected individuals are misdiagnosed at South African points-of-care. Follow-up rapid tests done within a 4 week interval detected early and chronic HIV infections initially missed by rapid HIV testing. This may be a practical and affordable strategy for earlier detection of these infections in resource-constrained settings. Newer molecular tests that can be used at the points-of-care should be evaluated for routine diagnosis of HIV in hyper-endemic settings.

AB - Background Two thirds of the world's new HIV infections are in sub-Saharan Africa. Acute HIV infection (AHI) is the time of virus acquisition until the appearance of HIV antibodies. Early HIV infection, which includes AHI, is the interval between virus acquisition and establishment of viral load set-point. This study aimed to detect acute and early HIV infections in a hyper-endemic setting. Methods This was a cross-sectional diagnostic study that enrolled individuals who had negative rapid HIV results in five clinics in South Africa. Pooled nucleic acid amplification testing (NAAT) was performed, followed by individual sample testing in positive pools. NAAT-positive participants were recalled to the clinics for confirmatory testing and appropriate management. HIV antibody, p24 antigen, Western Blot and avidity tests were performed for characterization of NAAT-positive samples. Results The study enrolled 6910 individuals with negative rapid HIV results. Median age was 27 years (interquartile range {IQR}: 23±31). NAAT was positive in 55 samples, resulting in 0.8% newly diagnosed HIV-infected individuals (95% confidence interval {CI}: 0.6±1.0). The negative predictive value for rapid HIV testing was 99.2% (95% CI: 99.0±99.4). Characterization of NAAT-positive samples revealed that 0.04% (95% CI: 0.000±0.001) had AHI, 0.3% (95% CI: 0.1±0.4) had early HIV infection, and 0.5% (95% CI: 0.5±0.7) had chronic HIV infection. Forty-seven (86%) of NAAT-positive participants returned for follow- up at a median of 4 weeks (IQR: 2±8). Follow-up rapid tests were positive in 96% of these participants. Conclusions NAAT demonstrated that a substantial number of HIV-infected individuals are misdiagnosed at South African points-of-care. Follow-up rapid tests done within a 4 week interval detected early and chronic HIV infections initially missed by rapid HIV testing. This may be a practical and affordable strategy for earlier detection of these infections in resource-constrained settings. Newer molecular tests that can be used at the points-of-care should be evaluated for routine diagnosis of HIV in hyper-endemic settings.

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