Evaluation of a 4th generation rapid HIV test for earlier and reliable detection of HIV infection in pregnancy

Chetty, Vani; Moodley, Dhayendre; Chuturgoon, Anil A.

doi:10.1016/j.jcv.2012.02.021

Cited by 40 publications

(30 citation statements)

References 11 publications

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“…The findings of this study correlate with two recently published evaluations of the Determine TM Combo assay in Lilongwe, Malawi (Rosenberg et al, 2012) and KwaZulu-Natal, South Africa (Chetty et al, 2012), both of which reported poor sensitivity of the assay for the detection of p24 antigen. The confirmed positive p24 antigen sample size was small in the abovementioned studies though.…”

Section: Resultssupporting

confidence: 85%

Evaluation of the Determine™ fourth generation HIV rapid assay

Brauer

Villiers

Mayaphi

2013

Journal of Virological Methods

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Assays that detect p24 antigen reduce the diagnostic window period of HIV testing. Most point-of-care HIV assays have poor sensitivity to diagnose acute HIV infection as they only detect antibodies against HIV-1 and HIV-2 (HIV-1/2). This was a cross-sectional laboratorybased study that evaluated the performance of the Determine TM HIV-1/2 Ag/Ab Combo fourth generation rapid strip -currently the only rapid assay that detects both HIV-1/2 antibodies and p24 antigen. A total of 79 serum specimens (29 positive for HIV antibodies only, 14 positive for HIV antibodies and p24 antigen, 20 HIV-negative, and 16 positive for p24 antigen only) were used for the evaluation. Results were compared with those from validated fourth generation HIV ELISAs. The Determine TM Combo rapid strips had a sensitivity of 90.7% and a specificity of 100% for the detection of HIV-1/2 antibodies. Its sensitivity for the detection of p24 antigen was only 10% (3 out of 30 p24 antigen positive specimens). This implies that most acute HIV infections will be missed with this assay. The need for a point-of-care assay which can detect acute HIV infection reliably still remains, particularly for use in a high prevalence setting such as South Africa.

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Section: Resultssupporting

confidence: 85%

Evaluation of the Determine™ fourth generation HIV rapid assay

Brauer

Villiers

Mayaphi

2013

Journal of Virological Methods

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“…[7] Consent for 'storage of plasma intended for use in further research' was obtained from participants at enrolment into the original study. The process of participant recruitment, eligibility criteria and HIV testing procedures have been described previously.…”

Section: Methodsmentioning

confidence: 99%

“…The process of participant recruitment, eligibility criteria and HIV testing procedures have been described previously. [7] Plasma aliquots from 570 stored specimens were selected based on an estimated HBV prevalence of 5.5%. [8] The participants' ages, HIV status and CD4 + counts were extracted from the original study database.…”

Section: Methodsmentioning

confidence: 99%

Hepatitis B and HIV co-infection in pregnant women: Indication for routine antenatal hepatitis B virus screening in a high HIV prevalence setting

et al. 2014

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Background. Sub-Saharan Africa is endemic for hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections. HBV/HIV co-infection in women of reproductive age is of clinical and public health importance because these women constitute a significant reservoir for horizontal and perinatal HBV transmission. Childhood HBV vaccination from 6 weeks of age protects most children against chronic HBV infection. However, infants born to HBV/HIV co-infected women are more likely to be infected perinatally, with an increased risk of chronic hepatitis, than infants born to HBV mono-infected women. Objectives. The aim of our study was to establish the prevalence of HBV infection and HBV/HIV co-infection in pregnant women in KwaZulu-Natal, South Africa, to inform antenatal HBV screening and childhood immunisation policies in South Africa. Methods. Stored plasma specimens obtained from 570 pregnant women were tested for hepatitis B surface antigen (HBsAg) and HBV infectivity, as characterised by the presence of hepatitis B e antigen (HBeAg) and/or HBV DNA load. Results. The antenatal HIV prevalence and HBsAg prevalence in this study were 41.6% and 5.3% (95% confidence interval (CI) 3.4 -7.1), respectively. Overall, 3.1% (95% CI 1.7 -4.6) of pregnant women were HBV/HIV co-infected, with HBeAg positivity and the HBV DNA load being significantly higher in co-infected women. Conclusion. We report a 5.3% HBV prevalence and a 3.1% HBV/HIV co-infection prevalence in pregnant women from this HIV-endemic region. Routine antenatal HBV screening will allow early identification of neonates who require HBV active-passive immunoprophylaxis at birth. This strategy, together with antenatal antiretrovirals, will reduce the risk of perinatal HBV transmission, especially in high-risk HBV/ HIV co-infected pregnant women.

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“…The fourth-generation tests, screening for both p24 antigen and antibodies against HIV, show better sensitivity for antibody responses than ‘antibody-only’ based third-generation rapid tests in case of established HIV infections 6. The sensitivity for early infections without antibody response is poor, however, with no more than 0%–2% antigen detections 6–8.…”

Section: Methodsmentioning

confidence: 99%