Evaluation of a Novel Semiquantitative Cryptococcal Antigen Lateral Flow Assay in Patients with Advanced HIV Disease

Author:

Jarvis Joseph N.123ORCID,Tenforde Mark W.345,Lechiile Kwana13,Milton Thandi3,Boose Amber3,Leeme Tshepo B.13,Tawe Leabaneng3,Muthoga Charles13,Rukasha Ivy6,Mulenga Fredah7,Rulaganyang Ikanyeng13,Molefi Mooketsi8,Molloy Síle F.9,Ngidi Julia6,Harrison Thomas S.9,Govender Nelesh P.610ORCID,Mine Madisa7

Affiliation:

1. Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana

2. Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK

3. Botswana University of Pennsylvania Partnership, Gaborone, Botswana

4. Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA

5. Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington, USA

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

7. Botswana National Health Laboratory, Gaborone, Botswana

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

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

10. School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

Abstract

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.

Funder

CDC Foundation

HHS | NIH | National Institute of Allergy and Infectious Diseases

National Institute for Health Research

Wellcome Trust

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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