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Comparative Study
. 2010 Dec;49(4):299-302.
doi: 10.1016/j.jcv.2010.08.013. Epub 2010 Sep 19.

Using a simplified human immunodeficiency virus type 1 p24 antigen assay to diagnose pediatric HIV-infection in Malawi

Victor Mwapasa  1 , Ada Cachafeiro, Yohane Makuta, David J Beckstead, Michael L Pennell, Ben Chilima, Beatrice Mwagomba, Susan A Fiscus, Jesse J Kwiek
Affiliations
Comparative Study

Using a simplified human immunodeficiency virus type 1 p24 antigen assay to diagnose pediatric HIV-infection in Malawi

Victor Mwapasa et al. J Clin Virol. 2010 Dec.

Abstract

Background: There is a worldwide need for a pediatric HIV-1 diagnostic test that has a high diagnostic accuracy, is technically simple and cost efficient. The Up24 HIV-1 assay, which requires both the HIV-1 p24 ELISA and the ELAST signal amplification kit, has previously been shown to be a robust tool to diagnose pediatric HIV-1 from dried whole blood spots (DBS) (Cachafeiro et al., JCM 2009;47:459-62(13)). In order to make the assay more accessible to a resource-limited clinical setting, we eliminated the ELAST system, which simplified the Up24 assay, reduced its cost, and tested the accuracy of the modified assay in a rural Malawian hospital.

Objectives: In this proof of concept study, we tested the ability of a simplified Up24 antigen assay, without ELAST, to detect HIV-1 on DBS obtained via heel prick from 6-week-old Malawian infants.

Study design: A case-control study of DBS collected from 113 HIV-infected and 109 HIV-negative infants, using the HIV-1 DNA PCR assay as the reference standard.

Results: The simplified HIV-1 Up24 assay had a sensitivity and specificity of 84% and 98%, respectively. When HIV-1 prevalence is 15%, the positive- and negative-predictive values are 89% and 97%, respectively.

Conclusion: The simplified Up24 assay has a good positive- and a robust negative-predictive values, is easier to perform and has a reduced cost compared to both HIV DNA PCR and Up24 assays. With additional testing, the simplified Up24 assay has the potential to increase global access to pediatric HIV-1 diagnostics.

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Figures

Fig. 1
Fig. 1
Variation in positive-predictive value (PPV, top panel) and negative-predictive value (NPV, bottom panel) of the HIV-1 p24 antigen detection assay over a theoretical range of pediatric HIV-1 prevalence values. PPV and NPV were calculated according to the formulas listed in the text. NC: average of negative controls; SD: standard deviation.
See this image and copyright information in PMC

References

    1. Violari A, Cotton MF, Gibb DM, Babiker AG, Steyn J, Madhi SA, et al. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med. 2008;359(21):2233–44. - PMC - PubMed
    1. World Health Organization, UNAIDS UNICEF Towards universal access: scaling up priority HIV/AIDS interventions in the health sector. 2010. http://www.who.int/hiv/pub/tuapr_2009_en.pdf.
    1. National AIDS Commission . Malawi HIV and AIDS monitoring and evaluation report: 2008–2009. UNGASS Country Progress Report; Lilongwe: 2010.
    1. ITAD . Final report of the independent review of Malawi national response of HIV and AIDS for fiscal year 2008–2009. ITAD; Lilongwe: 2009.
    1. National Statistics Office Malawi population and housing census. [on 10th July 2010]. 2008. accessed from http://www.nso.malawi.net/

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