Background: Cryptococcal meningitis is a leading cause of meningitis in sub-Saharan Africa. Given the need for rapid point of care testing, we evaluated the diagnostic performance of the Dynamiker cryptococcal antigen (CrAg) lateral flow assay (LFA).
Methods: We assessed the diagnostic performance of the Dynamiker CrAg-LFA compared to the IMMY CrAg-LFA as the reference standard. We tested 150 serum, 115 plasma, 100 cerebrospinal fluid (CSF) samples from HIV patients with symptomatic meningitis and 113 serum samples from patients with suspected asymptomatic cryptococcal antigenemia.
Results: Compared to the IMMY CrAg-LFA, sensitivity of Dynamiker CrAg-LFA was 98% in serum, 100% in plasma, 100% in CSF from symptomatic patients and 96% in serum from asymptomatic patients. Specificity was 66% in serum, 61% in plasma, 91% in CSF from symptomatic patients, and 86% in serum from asymptomatic patients. The positive predictive value was 85% in serum, 82% in plasma, 96% in CSF from symptomatic patients, and 69% in serum from asymptomatic patients. The negative predictive value was 94% in serum, 100% in plasma, 100% in CSF from symptomatic patients, and 99% in serum from asymptomatic patients. The inter-assay reproducibility was 100% across the four sample types with no observed discordant results when Dynamiker CrAg-LFA was tested in duplicate. However, a high number of false positives were observed on serum of symptomatic patients (11%), serum of asymptomatic patients (11%) and plasma of symptomatic patients (14%).
Conclusion: The Dynamiker CrAg-LFA had excellent sensitivity but poor specificity, particularly when tested on serum and plasma.
Point-of-Care Diagnosis and Prognostication of Cryptococcal Meningitis With the Cryptococcal Antigen Lateral Flow Assay on Cerebrospinal Fluid
