title: Microchip-based ultrafast serodiagnostic assay for tuberculosis.
abstract: Access to point-of-care (POC), rapid, inexpensive, sensitive, and instrument-free tests for the diagnosis of tuberculosis (TB) remains a major challenge. Here, we report a simple and low-cost microchip-based TB ELISA (MTBE) platform for the detection of anti-mycobacterial IgG in plasma samples in less than 15 minutes. The MTBE employs a flow-less, magnet-actuated, bead-based ELISA for simultaneous detection of IgG responses against multiple mycobacterial antigens. Anti-trehalose 6,6'-dimycolate (TDM) IgG responses were the strongest predictor for differentiating active tuberculosis (ATB) from healthy controls (HC) and latent tuberculosis infections (LTBI). The TDM-based MTBE demonstrated superior sensitivity compared to sputum microscopy (72% vs. 56%) with 80% and 63% positivity among smear-positive and smear-negative confirmed ATB samples, respectively. Receiver operating characteristic analysis indicated good accuracy for differentiating ATB from HC (AUC = 0.77). Thus, TDM-based MTBE can be potentially used as a screening device for rapid diagnosis of active TB at the POC.
authors: Singapore Immunology Network, Agency for Science, Technology and Research (A*STAR), Singapore.
authors: Vigneshwaran
authors: V
authors: Mani
authors: Singapore Immunology Network, Agency for Science, Technology and Research (A*STAR), Singapore.
authors: Bhairav
authors: B
authors: Paleja
authors: Singapore Immunology Network, Agency for Science, Technology and Research (A*STAR), Singapore.
authors: Karima
authors: K
authors: Larbi
authors: Singapore Immunology Network, Agency for Science, Technology and Research (A*STAR), Singapore.
authors: Pavanish
authors: P
authors: Kumar
authors: Singapore Immunology Network, Agency for Science, Technology and Research (A*STAR), Singapore.
authors: Jo Ann
authors: JA
authors: Tay
authors: Singapore Immunology Network, Agency for Science, Technology and Research (A*STAR), Singapore.
authors: Jie Yee
authors: JY
authors: Siew
authors: Demirci Bio-Acoustic-MEMS in Medicine (BAMM) Laboratory, Stanford University School of Medicine, Department of Radiology, Canary Center at Stanford for Cancer Early Detection, Palo Alto, California, USA.
authors: Fatih
authors: F
authors: Inci
authors: State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, First Affliliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.|Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China.|Institute for Translational Medicine, Zhejiang University, China.
authors: ShuQi
authors: S
authors: Wang
authors: Tuberculosis Control Unit (TBCU), Tan Tock Seng Hospital, Singapore.
authors: Cynthia
authors: C
authors: Chee
authors: Tuberculosis Control Unit (TBCU), Tan Tock Seng Hospital, Singapore.
authors: Yee Tang
authors: YT
authors: Wang
authors: Demirci Bio-Acoustic-MEMS in Medicine (BAMM) Laboratory, Stanford University School of Medicine, Department of Radiology, Canary Center at Stanford for Cancer Early Detection, Palo Alto, California, USA.
authors: Utkan
authors: U
authors: Demirci
authors: Singapore Immunology Network, Agency for Science, Technology and Research (A*STAR), Singapore.|Department of Biomedicine, University of Basel, Switzerland.
authors: Gennaro
authors: G
authors: De Libero
authors: Singapore Immunology Network, Agency for Science, Technology and Research (A*STAR), Singapore.
authors: Amit
authors: A
authors: Singhal