Abstract
Background
Cryptococcus neoformans is a major cause of morbidity and mortality among HIV-infected persons worldwide, and there is scarce recent data on cryptococcal antigen (CrAg) positivity in the U.S. 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 – July 2018 were included. Percent positivity and test agreement were calculated.
Results
Among 467 patients, 557 diagnostic tests were performed; 413 on serum and 144 on CSF. Mean age was 44 years, most were male (69%) and had HIV (79%). Twenty-four (6.4%, CI95% = 4.1, 9.4) patients were serum CrAg positive, and eight (5.8%, CI95% = 2.6, 11.2) individuals tested positive for CSF CrAg. While overall agreement between the LA and LFA was substantial to high for CSF (κ= 0.71, CI95% = 0.51, 0.91) and serum (κ= 0.93, CI95% = 0.86, 1.00), respectively, there were important discrepancies. Five patients had false-positive CSF LA tests which affected clinical care, and four 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.
Dye-Loaded Polymersome-Based Lateral Flow Assay: Rational Design of a COVID-19 Testing Platform by Repurposing SARS-CoV-2 Antibody Cocktail and Antigens Obtained from Positive Human Samples
