Evaluation of a point-of-care immunoassay test kit 'StrongStep' for cryptococcal antigen detection.

Autor: Mpoza E; Infectious Diseases Institute, Kampala, Uganda., Mukaremera L; Infectious Diseases Institute, Kampala, Uganda.; University of Minnesota, Minneapolis, Minnesota, United States of America., Kundura DA; Makerere University Johns Hopkins University Research Collaboration, Kampala, Uganda., Akampurira A; Department of Microbiology, Makerere University, Kampala, Uganda., Luggya T; Department of Microbiology, Makerere University, Kampala, Uganda., Tadeo KK; Infectious Diseases Institute, Kampala, Uganda., Pastick KA; University of Minnesota, Minneapolis, Minnesota, United States of America., Bridge SC; University of Minnesota, Minneapolis, Minnesota, United States of America., Tugume L; Infectious Diseases Institute, Kampala, Uganda., Kiggundu R; Infectious Diseases Institute, Kampala, Uganda., Musubire AK; Infectious Diseases Institute, Kampala, Uganda., Williams DA; Infectious Diseases Institute, Kampala, Uganda.; University of Minnesota, Minneapolis, Minnesota, United States of America., Muzoora C; Mbarara University of Science and Technology, Mbarara, Uganda., Nalintya E; Infectious Diseases Institute, Kampala, Uganda., Rajasingham R; University of Minnesota, Minneapolis, Minnesota, United States of America., Rhein J; Infectious Diseases Institute, Kampala, Uganda.; University of Minnesota, Minneapolis, Minnesota, United States of America., Boulware DR; University of Minnesota, Minneapolis, Minnesota, United States of America., Meya DB; Infectious Diseases Institute, Kampala, Uganda.; University of Minnesota, Minneapolis, Minnesota, United States of America., Abassi M; Infectious Diseases Institute, Kampala, Uganda.; University of Minnesota, Minneapolis, Minnesota, United States of America.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2018 Jan 05; Vol. 13 (1), pp. e0190652. Date of Electronic Publication: 2018 Jan 05 (Print Publication: 2018).
DOI: 10.1371/journal.pone.0190652
Abstrakt: Background: HIV-associated cryptococcal meningitis is the leading cause of adult meningitis in Sub-Saharan Africa, accounting for 15%-20% of AIDS-attributable mortality. The development of point-of-care assays has greatly improved the screening and diagnosis of cryptococcal disease. We evaluated a point-of-care immunoassay, StrongStep (Liming Bio, Nanjing, Jiangsu, China) lateral flow assay (LFA), for cryptococcal antigen (CrAg) detection in cerebrospinal fluid (CSF) and plasma.
Methods: We retrospectively tested 143 CSF and 77 plasma samples collected from HIV-seropositive individuals with suspected meningitis from 2012-2016 in Uganda. We prospectively tested 90 plasma samples collected from HIV-seropositive individuals with CD4 cell count <100 cells/μL from 2016-2017 as part of a cryptococcal antigenemia screening program. The StrongStep CrAg was tested against a composite reference standard of positive Immy CrAg LFA (Immy, Norman, OK, USA) or CSF culture with statistical comparison by McNemar's test.
Results: StrongStep CrAg had a 98% (54/55) sensitivity and 90% (101/112) specificity in plasma (P = 0.009, versus reference standard). In CSF, the StrongStep CrAg had 100% (101/101) sensitivity and 98% (41/42) specificity (P = 0.99). Adjusting for the cryptococcal antigenemia prevalence of 9% in Uganda and average cryptococcal meningitis prevalence of 37% in Sub-Saharan Africa, the positive predictive value of the StrongStep CrAg was 50% in plasma and 96% in CSF.
Conclusions: We found the StrongStep CrAg LFA to be a sensitive assay, which unfortunately lacked specificity in plasma. In lower prevalence settings, a majority of positive results from blood would be expected to be false positives.
Databáze: MEDLINE
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