Differential Diagnosis of Malaria on Truelab Uno registered , a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications: e0146961

• Published in: PloS one Vol. 11; no. 1
• 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: Journal Article
• Language: English
• Published: 01.01.2016
• Subjects: Plasmodium falciparum; Plasmodium vivax; India
• ISSN: 1932-6203
• DOI: 10.1371/journal.pone.0146961

Background 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. Methods Truenat registered 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 registered microPCR device, a handheld, battery operated, and easy-to-use real-time microPCR device. The performance of Truenat registered Malaria was evaluated versus the WHO nested PCR protocol. The Truenat registered 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 registered and a commercial real-time PCR system. Results The limit of detection of the Truenat Malaria assay was found to be <5 parasites/Ml for both P. falciparum and P. vivax. The Truenat registered Malaria test was found to have sensitivity and specificity of 100% each, compared to the WHO nested PCR protocol based on the evaluation of 100 samples. The sensitivity using expert microscopy as the reference standard was determined to be around 99.3% (95% CI: 95.5-99.9) at the species level. Mixed infections were identified more accurately by Truenat Malaria (32 samples identified as mixed) versus expert microscopy and RDTs which detected 4 and 5 mixed samples, respectively. Conclusion The Truenat registered Malaria microPCR test is a valuable diagnostic tool and implementation should be considered not only for malaria diagnosis but also for active surveillance and epidemiological intervention.