Diagnostic accuracy of HIV test kits, Genscreen Ultra and Bioelisa

Saro Abdella Abrahim, Mulu Girma, Abebe Habteselassie, Nigussie Gezahegn, Altaye Feleke, Tezera Moshago Berheto, Minilik Demissie, Wudnesh Belete, Tekalign Deressa HIV/TB Research and Reference Laboratory Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia Purpose: Genetic diversit...

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Autores principales: Abrahim SA, Girma M, Habteselassie A, Gezahegn N, Feleke A, Berheto TM, Demissie M, Belete W, Deressa T
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Publicado: Dove Medical Press 2019
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spelling oai:doaj.org-article:9e5693fb529b4c6c9fb12967be53a1ff2021-12-02T04:37:13ZDiagnostic accuracy of HIV test kits, Genscreen Ultra and Bioelisa1179-1373https://doaj.org/article/9e5693fb529b4c6c9fb12967be53a1ff2019-02-01T00:00:00Zhttps://www.dovepress.com/diagnostic-accuracy-of-hiv-test-kits-genscreen-ultra-and-bioelisa-peer-reviewed-article-HIVhttps://doaj.org/toc/1179-1373Saro Abdella Abrahim, Mulu Girma, Abebe Habteselassie, Nigussie Gezahegn, Altaye Feleke, Tezera Moshago Berheto, Minilik Demissie, Wudnesh Belete, Tekalign Deressa HIV/TB Research and Reference Laboratory Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia Purpose: Genetic diversities in different countries affect the performance of HIV test kits. Therefore, WHO recommends evaluation of every HIV test kit in countries’ context before its use. Therefore, this study aimed to evaluate the performance of Genscreen ULTRA HIV Ag–Ab and Bioelisa.Materials and methods: The study had used 400 characterized plasma samples obtained from CDC Atlanta bio-bank derived from Africa, USA, and Thailand.Results: Diagnostic performance of both test kits under evaluation was assessed at 95% CI. Genscreen ULTRA HIV Ag–Ab had sensitivity and negative predictive value of 99.5% [95% CI, 97.2–99.9] and the specificity and positive predictive value of 98.5% [95% CI, 95.7–99.7]. Bioelisa HIV test kit had exhibited sensitivity and negative predictive value of 99% [95% CI, 96.4–99.7] and specificity and positive predictive value of 98.5% [95% CI, 95.7–99.7]. Both test kits were able to detect almost all samples with HIV-2, dual infections, and seroconversion.Conclusion: Both the test kits were highly sensitive and specific in detecting HIV. However, there are still few samples containing HIV antibody which were not identified by both kits. Therefore, additional screening measures should be done in using these assays for blood transfusion and organ transplantation. In addition, the study can be used as a reference by other African countries. Keywords: ELISA, sensitivity, positive predictive, specificity, validation  Abrahim SAGirma MHabteselassie AGezahegn NFeleke ABerheto TMDemissie MBelete WDeressa TDove Medical PressarticleELISASensitivityPositive PredictiveBioelisaGenScreenImmunologic diseases. AllergyRC581-607ENHIV/AIDS: Research and Palliative Care, Vol Volume 11, Pp 17-22 (2019)
institution DOAJ
collection DOAJ
language EN
topic ELISA
Sensitivity
Positive Predictive
Bioelisa
GenScreen
Immunologic diseases. Allergy
RC581-607
spellingShingle ELISA
Sensitivity
Positive Predictive
Bioelisa
GenScreen
Immunologic diseases. Allergy
RC581-607
Abrahim SA
Girma M
Habteselassie A
Gezahegn N
Feleke A
Berheto TM
Demissie M
Belete W
Deressa T
Diagnostic accuracy of HIV test kits, Genscreen Ultra and Bioelisa
description Saro Abdella Abrahim, Mulu Girma, Abebe Habteselassie, Nigussie Gezahegn, Altaye Feleke, Tezera Moshago Berheto, Minilik Demissie, Wudnesh Belete, Tekalign Deressa HIV/TB Research and Reference Laboratory Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia Purpose: Genetic diversities in different countries affect the performance of HIV test kits. Therefore, WHO recommends evaluation of every HIV test kit in countries’ context before its use. Therefore, this study aimed to evaluate the performance of Genscreen ULTRA HIV Ag–Ab and Bioelisa.Materials and methods: The study had used 400 characterized plasma samples obtained from CDC Atlanta bio-bank derived from Africa, USA, and Thailand.Results: Diagnostic performance of both test kits under evaluation was assessed at 95% CI. Genscreen ULTRA HIV Ag–Ab had sensitivity and negative predictive value of 99.5% [95% CI, 97.2–99.9] and the specificity and positive predictive value of 98.5% [95% CI, 95.7–99.7]. Bioelisa HIV test kit had exhibited sensitivity and negative predictive value of 99% [95% CI, 96.4–99.7] and specificity and positive predictive value of 98.5% [95% CI, 95.7–99.7]. Both test kits were able to detect almost all samples with HIV-2, dual infections, and seroconversion.Conclusion: Both the test kits were highly sensitive and specific in detecting HIV. However, there are still few samples containing HIV antibody which were not identified by both kits. Therefore, additional screening measures should be done in using these assays for blood transfusion and organ transplantation. In addition, the study can be used as a reference by other African countries. Keywords: ELISA, sensitivity, positive predictive, specificity, validation  
format article
author Abrahim SA
Girma M
Habteselassie A
Gezahegn N
Feleke A
Berheto TM
Demissie M
Belete W
Deressa T
author_facet Abrahim SA
Girma M
Habteselassie A
Gezahegn N
Feleke A
Berheto TM
Demissie M
Belete W
Deressa T
author_sort Abrahim SA
title Diagnostic accuracy of HIV test kits, Genscreen Ultra and Bioelisa
title_short Diagnostic accuracy of HIV test kits, Genscreen Ultra and Bioelisa
title_full Diagnostic accuracy of HIV test kits, Genscreen Ultra and Bioelisa
title_fullStr Diagnostic accuracy of HIV test kits, Genscreen Ultra and Bioelisa
title_full_unstemmed Diagnostic accuracy of HIV test kits, Genscreen Ultra and Bioelisa
title_sort diagnostic accuracy of hiv test kits, genscreen ultra and bioelisa
publisher Dove Medical Press
publishDate 2019
url https://doaj.org/article/9e5693fb529b4c6c9fb12967be53a1ff
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