ArticleJournal of clinical microbiology2026
Test performance of a commercial cryptococcal antigen lateral flow assay: a retrospective and prospective study at five Canadian sites.
Article in Journal of clinical microbiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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18 authors.
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Abstract
Cryptococcal antigen (CrAg) lateral flow assay (LFA) enables the rapid and sensitive detection of cryptococcal infection. The FungiXpert CrAg LFA is a Health Canada-licensed product that currently lacks evaluation in the North American setting. This retrospective and prospective study across five Canadian laboratories aimed to evaluate the FungiXpert CrAg LFA compared to the IMMY CrAg LFA for serum and cerebrospinal fluid (CSF) samples. Positive percent agreement (PPA) and negative percent agreement (NPA), precision, and cross-reactivity were assessed. A retrospective data review was performed for demographics, clinical data, and additional diagnostic testing results. A total of 141 serum samples and 93 CSF samples from 192 individuals were included. In the overall retrospective cohort, the FungiXpert CrAg LFA demonstrated qualitative detection PPA of 90.2% (95% confidence interval [95% CI], 87.3%-93.1%), and NPA of 100% (95% CI, 97.7%-100%). By sample type, the CSF PPA was 93.9% (95% CI, 79.8%-99.3%), and the serum PPA was 90.7% (95% CI, 79.7%-96.9%). The prospective cohort consisted of 58 samples, including two serum samples that were positive; of these, one was a low titer (1:1) and missed by FungiXpert. Both assays showed cross-reactivity with
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