ArticlePloS one2016
Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications.
Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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Who cites it
24 citing papers in PubMed, 45 citations in OpenAlex.
- Head-to-head evaluation of a commercial real-time PCR assay targeting plasmodial species causing human malaria against a composite reference standard.European journal of microbiology & immunology · 2026Article
- Technologies for the point-of-care diagnosis of malaria: a scoping review.Infectious diseases of poverty · 2025Article
- The development, evaluation, performance, and validation of micro-PCR and extractor for the quantification of HIV-1 &-2 RNA.Scientific reports · 2024Article
- Review
- Truenat: An affordable and user-friendly option for screening of sub-microscopicThe Lancet regional health. Southeast Asia · 2022Article
- Truenat® forThe Lancet regional health. Southeast Asia · 2022Article
- Polymerase Chain Reaction-Based Malaria Diagnosis Can Be Increasingly Adopted during Current Phase of Malaria Elimination in India.The American journal of tropical medicine and hygiene · 2022Article
- An Ultracompact Real-Time Fluorescence Loop-Mediated Isothermal Amplification (LAMP) Analyzer.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Assessing the diagnostic performance of a novel RT-PCR fluorescence method for the detection of human plasmodium species.PloS one · 2022Article
- TruenatThe Indian journal of medical research · 2021Article
- Review
- Internet of medical things (IoMT)-integrated biosensors for point-of-care testing of infectious diseases.Biosensors & bioelectronics · 2021Review
- Review
- Spatial and temporal village-level prevalence of Plasmodium infection and associated risk factors in two districts of Meghalaya, India.Malaria journal · 2021Article
- Assessing a chip based rapid RTPCR test for SARS CoV-2 detection (TrueNat assay): A diagnostic accuracy study.PloS one · 2021Article
- Diagnostic Methods for Non-Falciparum Malaria.Frontiers in cellular and infection microbiology · 2021Review
- Towards PCB-Based Miniaturized Thermocyclers for DNA Amplification.Micromachines · 2020Article
- Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response.Clinical microbiology reviews · 2019Review
- Performance and workflow assessment of six nucleic acid extraction technologies for use in resource limited settings.PloS one · 2019Article
- Molecular diagnosis of protozoan parasites by Recombinase Polymerase Amplification.Acta tropica · 2018Article
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSensitive 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.
methodsTruenat® 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.
resultsThe limit of detection of the Truenat Malaria assay was found to be <5 parasites/μl for both P. falciparum and P. vivax. The Truenat® 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.
conclusionThe Truenat® 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.
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