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
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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Auteurs

Joseph N Jarvis (JN)

Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana joseph.jarvis@lshtm.ac.uk.
Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
Botswana University of Pennsylvania Partnership, Gaborone, Botswana.

Mark W Tenforde (MW)

Botswana University of Pennsylvania Partnership, Gaborone, Botswana.
Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA.
Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington, USA.

Kwana Lechiile (K)

Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.
Botswana University of Pennsylvania Partnership, Gaborone, Botswana.

Thandi Milton (T)

Botswana University of Pennsylvania Partnership, Gaborone, Botswana.

Amber Boose (A)

Botswana University of Pennsylvania Partnership, Gaborone, Botswana.

Tshepo B Leeme (TB)

Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.
Botswana University of Pennsylvania Partnership, Gaborone, Botswana.

Leabaneng Tawe (L)

Botswana University of Pennsylvania Partnership, Gaborone, Botswana.

Charles Muthoga (C)

Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.
Botswana University of Pennsylvania Partnership, Gaborone, Botswana.

Ivy Rukasha (I)

National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.

Fredah Mulenga (F)

Botswana National Health Laboratory, Gaborone, Botswana.

Ikanyeng Rulaganyang (I)

Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.
Botswana University of Pennsylvania Partnership, Gaborone, Botswana.

Mooketsi Molefi (M)

Faculty of Medicine, University of Botswana, Gaborone, Botswana.

Síle F Molloy (SF)

Centre for Global Health, Institute of Infection and Immunity, St George's University of London, London, UK.

Julia Ngidi (J)

National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.

Thomas S Harrison (TS)

Centre for Global Health, Institute of Infection and Immunity, St George's University of London, London, UK.

Nelesh P Govender (NP)

National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.
School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

Madisa Mine (M)

Botswana National Health Laboratory, Gaborone, Botswana.

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