WP3: Development of new diagnostic methods

Diagnostic Performance of the Fujifilm SILVAMP TB-LAM in Children with Presumptive Tuberculosis

Patricia Comella-del-Barrio, Bárbara Molina-Moya, Jacqueline Gautier, Raquel Villar-Hernández, Mariette Jean Coute Doresca, Beatriz Sallés-Mingels, Lydia Canales-Aliaga, Margareth Narcisse, Tomás M. Pérez-Porcuna, Jacob Creswell, Luis E. Cuevas and José Domínguez

 J. Clin. Med. 2021, 10(9), 1914; https://doi.org/10.3390/jcm10091914

Abstract

Current diagnostics for tuberculosis (TB) only manage to confirm a small proportion of children with TB and require respiratory samples, which are difficult to obtain. There is a need for non-invasive biomarker-based tests as an alternative to sputum testing. Fujifilm SILVAMP TB lipoarabinomannan (FujiLAM), a lateral-flow test to detect lipoarabinomannan in urine, is a novel non-sputum-based point-of-care diagnostic reported to have increased sensitivity for the diagnosis of TB among human immunodeficiency virus (HIV)-infected adults. We evaluate the performance of FujiLAM in children with presumptive TB. Fifty-nine children attending a paediatric hospital in Haiti with compatible signs and symptoms of TB were examined using Xpert MTB/RIF, smear microscopy and X-rays, and classified according to the certainty of diagnosis into bacteriologically confirmed TB (n = 5), unconfirmed TB (bacteriologically negative, n = 50) and unlikely TB (n = 4). Healthy children (n = 20) were enrolled as controls. FujiLAM sensitivity and specificity were 60% and 95% among children with confirmed TB. FujiLAM’s high specificity and its characteristics as a point-of-care indicate the test has a good potential for the diagnosis of TB in children.