The Dynamiker cryptococcal antigen lateral flow assay is an accurate, rapid and cost effective test comparable to culture for detection of cryptococcal meningitis

Introduction: Cryptococcal meningitis (CM) is a leading cause of mortality among people living with human immunodeficiency virus (HIV) in Sub-Saharan Africa, requiring rapid diagnosis. Although the Food and Drug Administration (FDA)-approved Dynamiker cryptococcal antigen lateral flow assay (CrAg LFA) offers a potential point-of-care solution, its use remains limited in high-burden settings. Hypothesis/Gap statement: Despite FDA approval of Dynamiker CrAg LFA for the diagnosis of CM, the underutilization of the test in settings with a high burden of CM is of particular concern. Therefore, there is a need to validate its performance for the diagnosis of CM. Aim: To evaluate the diagnostic performance, turnaround time and cost-effectiveness of the Dynamiker CrAg LFA for CM, using cerebrospinal fluid (CSF) culture as the reference standard. Methodology: Stored CSF samples from 200 HIV-positive patients with suspected or confirmed CM ( n =245) were tested using the Dynamiker CrAg LFA. Diagnostic metrics were calculated and compared to CSF fungal culture. Time to result and average test cost were also assessed. Results: The Dynamiker CrAg LFA showed a sensitivity of 100% and specificity of 84.9%, with strong agreement (κ=0.83) with CSF culture. Median time to result was 30 s compared to 3 days for culture. The average cost per test was USD 3.41 versus USD 19.80–22.40 for CSF culture. Conclusion: The Dynamiker CrAg LFA is a rapid, accurate and affordable diagnostic tool for CM and holds promise for broader implementation in resource-limited settings.