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Mycology

Diagnostic Accuracy of the Biosynex CryptoPS Cryptococcal Antigen Semiquantitative Lateral Flow Assay in Patients with Advanced HIV Disease

Mark W. Tenforde, Timothée Boyer-Chammard, Charles Muthoga, Leabaneng Tawe, Thandi Milton, Ikanyeng Rulaganyang, Kwana Lechiile, Ivy Rukasha, Tshepo B. Leeme, Nelesh P. Govender, Julia Ngidi, Madisa Mine, Síle F. Molloy, Thomas S. Harrison, Olivier Lortholary, Joseph N. Jarvis
Daniel J. Diekema, Editor
Mark W. Tenforde
aDivision of Allergy and Infectious Diseases, Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA
bDepartment of Epidemiology, University of Washington School of Public Health, Seattle, Washington, USA
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Timothée Boyer-Chammard
cInstitut Pasteur, CNRS, Molecular Mycology Unit, UMR2000, Paris, France
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Charles Muthoga
dBotswana-UPenn Partnership, Gaborone, Botswana
eBotswana Harvard AIDS Institute Partnership, Gaborone, Botswana
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Leabaneng Tawe
dBotswana-UPenn Partnership, Gaborone, Botswana
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Thandi Milton
dBotswana-UPenn Partnership, Gaborone, Botswana
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Ikanyeng Rulaganyang
dBotswana-UPenn Partnership, Gaborone, Botswana
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Kwana Lechiile
dBotswana-UPenn Partnership, Gaborone, Botswana
eBotswana Harvard AIDS Institute Partnership, Gaborone, Botswana
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Ivy Rukasha
fNational Institute for Communicable Diseases, a Division of the National Health Laboratory Service and School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
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Tshepo B. Leeme
eBotswana Harvard AIDS Institute Partnership, Gaborone, Botswana
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Nelesh P. Govender
fNational Institute for Communicable Diseases, a Division of the National Health Laboratory Service and School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
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  • ORCID record for Nelesh P. Govender
Julia Ngidi
gBotswana National Health Laboratory, Gaborone, Botswana
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Madisa Mine
gBotswana National Health Laboratory, Gaborone, Botswana
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Síle F. Molloy
hCentre for Global Health, Institute for Infection and Immunity, St George's, University of London, London, United Kingdom
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Thomas S. Harrison
hCentre for Global Health, Institute for Infection and Immunity, St George's, University of London, London, United Kingdom
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Olivier Lortholary
cInstitut Pasteur, CNRS, Molecular Mycology Unit, UMR2000, Paris, France
iUniversité de Paris, Centre d’Infectiologie Necker-Pasteur, APHP, IHU Imagine, Hôpital Necker Enfants Malades, Paris, France
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Joseph N. Jarvis
dBotswana-UPenn Partnership, Gaborone, Botswana
eBotswana Harvard AIDS Institute Partnership, Gaborone, Botswana
jDepartment of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom
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Daniel J. Diekema
University of Iowa College of Medicine
Roles: Editor
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DOI: 10.1128/JCM.02307-20
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ABSTRACT

High cryptococcal antigen (CrAg) titers in blood are associated with subclinical meningitis and mortality in CrAg-positive individuals with advanced HIV disease (AHD). We evaluated a novel semiquantitative lateral flow assay (LFA), CryptoPS, that may be able to identify individuals with high CrAg titers in a cohort of AHD patients undergoing CrAg screening. In a prospective cohort of patients with AHD (CD4 cell count, ≤200/μl) receiving CD4 count testing, whole blood was tested for CrAg by CryptoPS and the IMMY LFA; the two assays were conducted by two different operators, each blind to the results of the other assay. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of CryptoPS were assessed against the IMMY LFA as a reference. CryptoPS low-titer (T1 band) and high-titer (T2 band) results were compared with IMMY LFA titers obtained through serial dilution. A total of 916 specimens were tested. The sensitivity of the CryptoPS assay was 61.0% (25/41) (95% confidence interval [95% CI], 44.5 to 75.8%), its specificity was 96.6% (845/875) (95% CI, 95.1 to 97.7%), its PPV was 45.5% (95% CI, 32.0 to 59.4%), and its NPV was 98.1% (95% CI, 97.0 to 98.9%). All (16/16) CryptoPS false-negative results were obtained for samples with IMMY titers of ≤1:160. Of 29 patients (30 specimens) who tested positive by CryptoPS but negative by the IMMY LFA, none developed cryptococcal meningitis over 3 months of follow-up without fluconazole. Median CrAg titers were 1:20 (interquartile range [IQR], 0 to 1:160) in CryptoPS T1-positive samples and 1:2,560 (IQR, 1:1,280 to 1:10,240) in T2-positive samples. We conclude that the diagnostic accuracy of the CryptoPS assay was suboptimal in the context of CrAg screening, with poor sensitivity at low CrAg titers. However, the CryptoPS assay reliably detected individuals with high titers, which are associated with poor outcomes.

FOOTNOTES

    • Received 4 September 2020.
    • Returned for modification 9 October 2020.
    • Accepted 14 October 2020.
    • Accepted manuscript posted online 21 October 2020.
  • Supplemental material is available online only.

  • Copyright © 2020 Tenforde et al.

This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.

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Diagnostic Accuracy of the Biosynex CryptoPS Cryptococcal Antigen Semiquantitative Lateral Flow Assay in Patients with Advanced HIV Disease
Mark W. Tenforde, Timothée Boyer-Chammard, Charles Muthoga, Leabaneng Tawe, Thandi Milton, Ikanyeng Rulaganyang, Kwana Lechiile, Ivy Rukasha, Tshepo B. Leeme, Nelesh P. Govender, Julia Ngidi, Madisa Mine, Síle F. Molloy, Thomas S. Harrison, Olivier Lortholary, Joseph N. Jarvis
Journal of Clinical Microbiology Dec 2020, 59 (1) e02307-20; DOI: 10.1128/JCM.02307-20

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Diagnostic Accuracy of the Biosynex CryptoPS Cryptococcal Antigen Semiquantitative Lateral Flow Assay in Patients with Advanced HIV Disease
Mark W. Tenforde, Timothée Boyer-Chammard, Charles Muthoga, Leabaneng Tawe, Thandi Milton, Ikanyeng Rulaganyang, Kwana Lechiile, Ivy Rukasha, Tshepo B. Leeme, Nelesh P. Govender, Julia Ngidi, Madisa Mine, Síle F. Molloy, Thomas S. Harrison, Olivier Lortholary, Joseph N. Jarvis
Journal of Clinical Microbiology Dec 2020, 59 (1) e02307-20; DOI: 10.1128/JCM.02307-20
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KEYWORDS

cryptococcal meningitis
CrAg
semiquantitative
HIV
lateral flow assay
Botswana
cryptococcal antigen
Cryptococcosis
diagnostics

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