Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications

• Published in: PloS one 2016-01, Vol.11 (1), p.e0146961-e0146961
• Main Authors: Nair, Chandrasekhar Bhaskaran, Manjula, Jagannath, Subramani, Pradeep Annamalai, Nagendrappa, Prakash B, Manoj, Mulakkapurath Narayanan, Malpani, Sukriti, Pullela, Phani Kumar, Subbarao, Pillarisetti Venkata, Ramamoorthy, Siva, Ghosh, Susanta K
• Format: Article
• Language: English
• Subjects: Acids; Adolescent; Adult; Child; Child, Preschool; Cross-Sectional Studies; Diagnosis, Differential; Diagnostic software; Diagnostic systems; Diagnostic Tests, Routine - instrumentation; Differential diagnosis; Early Diagnosis; Epidemiology; Evaluation; Humans; India; Infections; Interactive computer systems; Laboratories; Malaria; Malaria, Falciparum - diagnosis; Malaria, Falciparum - parasitology; Malaria, Vivax - diagnosis; Malaria, Vivax - parasitology; Medical diagnosis; Microscopy; Middle Aged; Mortality; Parasites; Parasitic diseases; Plasmodium; Plasmodium falciparum; Plasmodium falciparum - genetics; Plasmodium vivax; Plasmodium vivax - genetics; Point-of-Care Systems; Polymerase chain reaction; Polymerase Chain Reaction - instrumentation; Portable equipment; Real time; Sensitivity; Sensitivity analysis; Sensitivity and Specificity; Systematic review; Thermal cycling; Vector-borne diseases; Young Adult
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0146961

Sensitive and specific detection of malarial parasites is crucial in controlling the significant malaria burden in the developing world. Also important is being able to identify life threatening Plasmodium falciparum malaria quickly and accurately to reduce malaria related mortality. Existing methods such as microscopy and rapid diagnostic tests (RDTs) have major shortcomings. Here, we describe a new real-time PCR-based diagnostic test device at point-of-care service for resource-limited settings. Truenat® Malaria, a chip-based microPCR test, was developed by bigtec Labs, Bangalore, India, for differential identification of Plasmodium falciparum and Plasmodium vivax parasites. The Truenat Malaria tests runs on bigtec's Truelab Uno® microPCR device, a handheld, battery operated, and easy-to-use real-time microPCR device. The performance of Truenat® Malaria was evaluated versus the WHO nested PCR protocol. The Truenat® Malaria was further evaluated in a triple-blinded study design using a sample panel of 281 specimens created from the clinical samples characterized by expert microscopy and a rapid diagnostic test kit by the National Institute of Malaria Research (NIMR). A comparative evaluation was done on the Truelab Uno® and a commercial real-time PCR system. The limit of detection of the Truenat Malaria assay was found to be