Evaluation of the Diagnostic Performance of a Semiquantitative Cryptococcal Antigen Point-of-Care Assay among HIV-Infected Persons with Cryptococcal Meningitis

A newly developed cryptococcal antigen (CrAg) semiquantitative (SQ) lateral flow assay (LFA) provides a semiquantitative result in a rapid one-step test instead of performing serial dilutions to determine CrAg titer. We prospectively compared the diagnostic performance of the CrAgSQ assay (IMMY) wit...

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Bibliographic Details
Published in:Journal of clinical microbiology 2021-07, Vol.59 (8), p.e0086021-e0086021
Main Authors: Tadeo, Kiiza Kandole, Nimwesiga, Audrey, Kwizera, Richard, Apeduno, Lucy, Martyn, Emily, Okirwoth, Michael, Nalintya, Elizabeth, Rajasingham, Radha, Williams, Darlisha A, Rhein, Joshua, Meya, David B, Kafufu, Bosco, Boulware, David R, Skipper, Caleb P
Format: Article
Language:English
Subjects:
Antigens, Fungal
Cryptococcus
HIV Infections - complications
Humans
Meningitis, Cryptococcal - diagnosis
Mycology
Point-of-Care Systems
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Summary:A newly developed cryptococcal antigen (CrAg) semiquantitative (SQ) lateral flow assay (LFA) provides a semiquantitative result in a rapid one-step test instead of performing serial dilutions to determine CrAg titer. We prospectively compared the diagnostic performance of the CrAgSQ assay (IMMY) with the CrAg LFA (IMMY) on cerebrospinal fluid (CSF) samples collected from persons with HIV-associated meningitis. The CrAgSQ grades (1+ to 5+) were compared with CrAg LFA titers and quantitative CSF fungal cultures. Among 87 participants screened for HIV-associated meningitis, 60 had cryptococcal meningitis (59 CrAg positive [CrAg ] by LFA and 1 false negative due to prozone with CrAg LFA titer of 1:1,310,000 and culture positivity), and 27 had no cryptococcal meningitis by CrAg LFA or culture. The CrAgSQ on CSF had 100% (60/60) sensitivity and 100% specificity (27/27). CSF CrAg titers ranged from 1:5 to 1:42 million. CrAgSQ grades of 1+, 2+, 3+, 4+, and 5+ corresponded to median CrAg LFA titers of 1:
ISSN:0095-1137
1098-660X
DOI:10.1128/JCM.00860-21