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Author Notes:

Kristin R. V. Harrington, BS, Department of Epidemiology, Rollins School of Public Health, Emory University, 3rd Floor, Claudia Nance Rollins Building, 1518 Clifton Road, Atlanta, Georgia, USA 30322 kristin.harrington@emory.edu

We acknowledge IMMY, Inc. (Norman, OK) for donating the lateral flow assay kits for this study.

No reported conflicts of interest.


Research Funding:

This work was funded by the HIV Medical Association, IDSA Medical Student’s Award, and National Institutes of Health/National Institute of General Medical Sciences (T32GM008169; to K. R. V. H.).


  • Cryptococcus
  • diagnostics
  • meningitis
  • HIV

Evaluation of a Cryptococcal Antigen Lateral Flow Assay and Cryptococcal Antigen Positivity at a Large Public Hospital in Atlanta, Georgia


Journal Title:

Open Forum Infectious Diseases


Volume 8, Number 6


Type of Work:

Article | Final Publisher PDF


Background Cryptococcus neoformans is a major cause of morbidity and mortality among human immunodeficiency virus (HIV)-infected persons worldwide, and there are scarce recent data on cryptococcal antigen (CrAg) positivity in the United States We sought to determine the frequency of cryptococcal disease and compare the performance of a CrAg lateral flow assay (LFA) versus latex agglutination (LA) test. Methods All patients from Grady Health System in Atlanta who had a serum or cerebrospinal fluid (CSF) sample sent for CrAg testing as part of clinical care from November 2017 to July 2018 were included. Percentage positivity and test agreement were calculated. Results Among 467 patients, 557 diagnostic tests were performed; 413 on serum and 144 on CSF. The mean age was 44 years, and most were male (69%) and had HIV (79%). Twenty-four (6.4%, 95% confidence interval [CI] = 4.1–9.4) patients were serum CrAg positive, and 8 (5.8%, 95% CI = 2.6–11.2) individuals tested positive for CSF CrAg. Although overall agreement between the LA and LFA was substantial to high for CSF (κ = 0.71, 95% CI = 0.51–0.91) and serum (κ = 0.93, 95% CI = 0.86–1.00), respectively, there were important discrepancies. Five patients had false-positive CSF LA tests that affected clinical care, and 4 patients had discordant serum tests. Conclusions We found a moderately high proportion of cryptococcal disease and important discrepancies between the LA test and LFA. Clinical implications of these findings include accurate detection of serum CrAg and averting unnecessary treatment of meningitis with costly medications associated with high rates of adverse events.

Copyright information:

© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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