HIV rapid tests Immunological internal control can be misleading.

HIV immunologic control internal control invalid test rapid test self-testing

Journal

Annales pharmaceutiques francaises
ISSN: 0003-4509
Titre abrégé: Ann Pharm Fr
Pays: France
ID NLM: 2985176R

Informations de publication

Date de publication:
30 May 2024
Historique:
received: 05 03 2024
revised: 27 05 2024
accepted: 27 05 2024
medline: 2 6 2024
pubmed: 2 6 2024
entrez: 1 6 2024
Statut: aheadofprint

Résumé

To assess whether internal controls (IC) of HIV rapid tests (HRT) and a rapid confirmatory assay (Geenius) were designed to solely prevent procedural missteps or wether they can also alert for insufficient sample quantity. Thirteen tests were evaluated using distilled water, phosphate buffered saline, and HIV-1 positive serum samples : Autotest VIH® (Autotest) (AAZ-LMB), INSTI Among the 13 tests, 4 were invalid when tested without human serum sample: Autotest, Geenius, INSTI and MULTISURE. The Autotest and INSTI accurately labelled diluted samples, with a Test line positive at least one dilution below the IC. Geenius test line and IC were positive up to the same dilution with automated reading. However, MULTISURE IC was positive up to 1000-fold dilution higher than its test line, making it unsuitable to alert for low sample quantity.

Identifiants

pubmed: 38823441
pii: S0003-4509(24)00092-0
doi: 10.1016/j.pharma.2024.05.009
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024. Published by Elsevier Masson SAS.

Auteurs

Vincent Guiraud (V)

AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix, Service de Virologie, F-75013 Paris, France.

Valentine Gauthier (V)

AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix, Service de Virologie, F-75013 Paris, France.

Hadjer Lazga (H)

AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix, Service de Virologie, F-75013 Paris, France.

Isabelle Leroy (I)

AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix, Service de Virologie, F-75013 Paris, France.

Agnès Gautheret Dejean (AG)

AP-HP, Hôpitaux Universitaires La Pitié Salpêtrière-Charles Foix, Service de Virologie, F-75013 Paris, France; Université Paris cité, INSERM UMR-S 1139 Physiopathologie et pharmacotoxicologie placentaire humaine: microbiote pré & post-natal, F-75006 Paris, France. Electronic address: agnes.gautheret@aphp.fr.

Classifications MeSH