Evaluation of a rapid and simple fourth-generation HIV screening assay for qualitative detection of HIV p24 antigen and/or antibodies to HIV-1 and HIV-2

Beelaert, Greet; Fransen, Katrien

doi:10.1016/j.jviromet.2010.06.002

Cited by 61 publications

(60 citation statements)

References 12 publications

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“…The local evaluation was performed on serum, not on whole blood as would typically be used for point-of-care testing. In concordance with previous literature the Determine TM Combo assay was highly specific for the detection of HIV-1/2 antibodies, (Beelaert and Fransen, 2010;Rosenberg et al, 2012).…”

Section: Resultssupporting

confidence: 90%

“…In another evaluation of the Determine TM Combo assay, the p24 antigen sensitivity of the assay was 86.6% (58/67) when compared to the reference p24 antigen assay, namely the Innotest HIV Antigen mAb (Innogenetics, Ghent, Belgium) followed by neutralisation of HIV antigens using the Innotest HIV Antigen mAb Neutralisation Reagents kit (Innogenetics) (Beelaert and Fransen, 2010). In this study the investigators made use of primary HIV infection serum samples, supernatants from cultures of different HIV subtypes, as well as an HIV-1 p24 antigen standard to evaluate the p24 antigen component of the Determine TM Combo assay.…”

Section: Resultsmentioning

confidence: 99%

“…According to the evaluation the Determine TM Combo assay could not detect p24 antigen in one subtype F and one group O strain. The authors mention that the results of the p24 antigen detection in the different HIV-1 subtype supernatants were dependent on the strain used in the evaluation, and cannot be generalised to all the different members of a particular subtype (Beelaert and Fransen, 2010). It should also be noted that although the Determine TM Combo assay could detect the subtype C supernatants, this may not accurately reflect test performance on patient specimens.…”

Section: Resultsmentioning

confidence: 99%

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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: 90%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of the Determine™ fourth generation HIV rapid assay

Brauer

Villiers

Mayaphi

2013

Journal of Virological Methods

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“…In two independent studies, the Determine HIV-1/2 Ag/Ab Combo showed sensitivities of 50% and 86% for antigen detection. 24,25 Although ELISA has higher sensitivity, the Determine HIV-1/2 Ag/Ab Combo test is still able to detect early HIV infection. Larger studies are needed to confirm whether the Determine HIV-1/2 Ag/Ab Combo test is a suitable alternative to ELISA in low-resource locations.…”

Section: 21mentioning

confidence: 99%

Low-cost tools for diagnosing and monitoring HIV infection in low-resource settings

Zaman

2012

Bull. World Health Organ.

155

103

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“…It is also worth mentioning the possibility of human error, such as the addition of insufficient specimen or too much buffer when procedures are handled by non-trained or unsupervised staff [27], transportation or storage of test kits outside of recommended conditions, leading to possible denaturation of reagents or test devices, and the use of expired reagents or test devices [26]. Of note, these latter factors were unknown in our study but would add to potential problems in real-life situations in developing countries.…”

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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Evaluation of a rapid and simple fourth-generation HIV screening assay for qualitative detection of HIV p24 antigen and/or antibodies to HIV-1 and HIV-2

Cited by 61 publications

References 12 publications

Evaluation of the Determine™ fourth generation HIV rapid assay

Evaluation of the Determine™ fourth generation HIV rapid assay

Low-cost tools for diagnosing and monitoring HIV infection in low-resource settings

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

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