Multisite Validation of Cryptococcal Antigen Lateral Flow Assay and Quantification by Laser Thermal Contrast

作者：David R. Boulware, Melissa A R Rolfes, Radha Rajasingham, Maximilian von Hohenberg, Zhenpeng Qin, Kabanda Taseera, Charlotte Schutz, Richard Kwizera, Elissa K. Butler, Graeme Meintjes, Conrad K. Muzoora, John C. Bischof, David B. Meya · 发表于：Emerging infectious diseases · 年份：2013 · DOI：10.3201/eid2001.130906 · 被引用次数：324 · 研究领域：Fungal Infections and Studies、Antifungal resistance and susceptibility、Cytomegalovirus and herpesvirus research

Cryptococcal meningitis is common in sub-Saharan Africa. Given the need for data for a rapid, point-of-care cryptococcal antigen (CRAG) lateral flow immunochromatographic assay (LFA), we assessed diagnostic performance of cerebrospinal fluid (CSF) culture, CRAG latex agglutination, India ink microscopy, and CRAG LFA for 832 HIV-infected persons with suspected meningitis during 2006-2009 (n = 299) in Uganda and during 2010-2012 (n = 533) in Uganda and South Africa. CRAG LFA had the best performance (sensitivity 99.3%, specificity 99.1%). Culture sensitivity was dependent on CSF volume (82.4% for 10 μL, 94.2% for 100 μL). CRAG latex agglutination test sensitivity (97.0%-97.8%) and specificity (85.9%-100%) varied between manufacturers. India ink microscopy was 86% sensitive. Laser thermal contrast had 92% accuracy (R = 0.91, p<0.001) in quantifying CRAG titers from 1 LFA strip to within <1.5 dilutions of actual CRAG titers. CRAG LFA is a major advance for meningitis diagnostics in resource-limited settings.