Evaluation of a Novel Semiquantitative Cryptococcal Antigen Lateral Flow Assay in Patients with Advanced HIV Disease.
Cryptococcal meningitis
HIV
cryptococcal antigen
diagnostic accuracy
lateral flow assay
validation study
Journal
Journal of clinical microbiology
ISSN: 1098-660X
Titre abrégé: J Clin Microbiol
Pays: United States
ID NLM: 7505564
Informations de publication
Date de publication:
24 08 2020
24 08 2020
Historique:
received:
06
03
2020
accepted:
22
05
2020
pubmed:
29
5
2020
medline:
24
6
2021
entrez:
29
5
2020
Statut:
epublish
Résumé
Higher cryptococcal antigen (CrAg) titers are strongly associated with mortality risk in individuals with HIV-associated cryptococcal disease. Rapid tests to quantify CrAg levels may provide important prognostic information and enable treatment stratification. We performed a laboratory-based validation of the IMMY semiquantitative cryptococcal antigen (CrAgSQ) lateral flow assay (LFA) against the current gold standard CrAg tests. We assessed the diagnostic accuracy of the CrAgSQ in HIV-positive individuals undergoing CrAg screening, determined the relationship between CrAgSQ scores and dilutional CrAg titers, assessed interrater reliability, and determined the clinical correlates of CrAgSQ scores. A total of 872 plasma samples were tested using both the CrAgSQ LFA and the conventional IMMY CrAg LFA, of which 692 were sequential samples from HIV-positive individuals undergoing CrAg screening and an additional 180 were known CrAg-positive plasma samples archived from prior studies. Interrater agreement in CrAgSQ reading was excellent (98.17% agreement, Cohen's kappa 0.962,
Identifiants
pubmed: 32461286
pii: JCM.00441-20
doi: 10.1128/JCM.00441-20
pmc: PMC7448662
pii:
doi:
Substances chimiques
Antigens, Fungal
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Department of Health
ID : RP-2017-08-ST2-012
Pays : United Kingdom
Organisme : NIAID NIH HHS
ID : T32 AI007044
Pays : United States
Organisme : NIAID NIH HHS
ID : P30 AI045008
Pays : United States
Organisme : NIAID NIH HHS
ID : F32 AI140511
Pays : United States
Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 212638
Pays : United Kingdom
Informations de copyright
Copyright © 2020 Jarvis et al.
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