Discriminatory rapid tests cause HIV-type misclassification-evaluation of three rapid tests using clinical samples from Guinea-Bissau.

Bioline First Response Genie III Guinea-Bissau HIV type HIV-2

Journal

Transactions of the Royal Society of Tropical Medicine and Hygiene
ISSN: 1878-3503
Titre abrégé: Trans R Soc Trop Med Hyg
Pays: England
ID NLM: 7506129

Informations de publication

Date de publication:
06 Sep 2019
Historique:
received: 16 02 2019
revised: 24 04 2019
accepted: 29 04 2019
medline: 5 6 2019
pubmed: 5 6 2019
entrez: 5 6 2019
Statut: ppublish

Résumé

Discrimination among HIV types is important because HIV-2 is naturally resistant to some of the first-line drugs used in the treatment of HIV-1. We evaluated three assays for HIV-type discriminatory capacity: SD Bioline HIV 1/2 3.0 (Bioline), First Response HIV 1-2-0 Card Test (First Response) and Genie III HIV-1/HIV-2 (Genie III). Based on results from the Bioline assay, samples from 239 HIV-infected patients from the Bissau HIV cohort in Guinea-Bissau were retrospectively selected for evaluation. Genie III and First Response were scored by three independent readers and compared with a reference test (INNO-LIA HIV I/II Score) confirmed by HIV RNA as well as DNA detection. The best performing test was Genie III, with an average agreement with the reference test of 93.4%, followed by First Response (86.1%) and Bioline (72.4%). First Response and Bioline were scored with a false high number of HIV-1/2 dual infections. For both First Response and Genie III, there were discrepancies among independent readers, and some tests were scored as HIV non-reactive. Using these rapid tests with a suboptimal performance will presumably result in a high rate of false HIV-1/2 dual diagnoses, depriving patients of alternative treatment options in cases of treatment failure.

Sections du résumé

BACKGROUND BACKGROUND
Discrimination among HIV types is important because HIV-2 is naturally resistant to some of the first-line drugs used in the treatment of HIV-1. We evaluated three assays for HIV-type discriminatory capacity: SD Bioline HIV 1/2 3.0 (Bioline), First Response HIV 1-2-0 Card Test (First Response) and Genie III HIV-1/HIV-2 (Genie III).
METHODS METHODS
Based on results from the Bioline assay, samples from 239 HIV-infected patients from the Bissau HIV cohort in Guinea-Bissau were retrospectively selected for evaluation. Genie III and First Response were scored by three independent readers and compared with a reference test (INNO-LIA HIV I/II Score) confirmed by HIV RNA as well as DNA detection.
RESULTS RESULTS
The best performing test was Genie III, with an average agreement with the reference test of 93.4%, followed by First Response (86.1%) and Bioline (72.4%). First Response and Bioline were scored with a false high number of HIV-1/2 dual infections. For both First Response and Genie III, there were discrepancies among independent readers, and some tests were scored as HIV non-reactive.
CONCLUSIONS CONCLUSIONS
Using these rapid tests with a suboptimal performance will presumably result in a high rate of false HIV-1/2 dual diagnoses, depriving patients of alternative treatment options in cases of treatment failure.

Identifiants

pubmed: 31162598
pii: 5510699
doi: 10.1093/trstmh/trz041
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

555-559

Investigateurs

Amabelia Rodrigues (A)
David da Silva (D)
Zacarias José da Silva (ZJ)
Candida Medina (C)
Ines Oliviera-Souto (I)
Lars Østergaard (L)
Alex Laursen (A)
Peter Aaby (P)
Anders Fomsgaard (A)
Christian Erikstrup (C)
Bo Langhoff Hønge (BL)
Christian Wejse (C)
Sanne Jespersen Chair (S)

Informations de copyright

© The Author(s) 2019. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Auteurs

Bo Langhoff Hønge (BL)

Bandim Health Project, Indepth Network, Apartado Bissau, Guinea-Bissau.
Department of Clinical Immunology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.

Sanne Jespersen (S)

Bandim Health Project, Indepth Network, Apartado Bissau, Guinea-Bissau.
Department of Infectious Diseases, Aarhus University Hospital, Denmark.

Candida Medina (C)

National HIV Programme, Ministry of Health, Bissau, Guinea-Bissau.

David da Silva Té (DDS)

National HIV Programme, Ministry of Health, Bissau, Guinea-Bissau.

Zacarias José da Silva (ZJ)

Bandim Health Project, Indepth Network, Apartado Bissau, Guinea-Bissau.
National Public Health Laboratory, Bissau, Guinea-Bissau.

Mette Christiansen (M)

Department of Clinical Immunology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.

Bertram Kjerulff (B)

Department of Clinical Immunology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.

Alex Lund Laursen (AL)

Department of Infectious Diseases, Aarhus University Hospital, Denmark.

Christian Wejse (C)

Bandim Health Project, Indepth Network, Apartado Bissau, Guinea-Bissau.
Department of Infectious Diseases, Aarhus University Hospital, Denmark.
GloHAU, Center for Global Health, Department of Public Health, Aarhus University, Bartholins Alle 2, Aarhus C, Denmark.

Henrik Krarup (H)

Section of Molecular Diagnostics, Department of Clinical Biochemistry, Aalborg University Hospital, Reberbansgade 15, Aalborg, Denmark.

Christian Erikstrup (C)

Department of Clinical Immunology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark.

Classifications MeSH