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
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.