Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications.
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. Exis...
Main Authors: | , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Public Library of Science (PLoS)
2016-01-01
|
Series: | PLoS ONE |
Online Access: | http://europepmc.org/articles/PMC4718663?pdf=render |
id |
doaj-a5739024c4204bb79ce452b79fcd6d31 |
---|---|
record_format |
Article |
spelling |
doaj-a5739024c4204bb79ce452b79fcd6d312020-11-25T00:05:34ZengPublic Library of Science (PLoS)PLoS ONE1932-62032016-01-01111e014696110.1371/journal.pone.0146961Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications.Chandrasekhar Bhaskaran NairJagannath ManjulaPradeep Annamalai SubramaniPrakash B NagendrappaMulakkapurath Narayanan ManojSukriti MalpaniPhani Kumar PullelaPillarisetti Venkata SubbaraoSiva RamamoorthySusanta K GhoshBACKGROUND: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® 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. RESULTS:The 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. CONCLUSION:The 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.http://europepmc.org/articles/PMC4718663?pdf=render |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Chandrasekhar Bhaskaran Nair Jagannath Manjula Pradeep Annamalai Subramani Prakash B Nagendrappa Mulakkapurath Narayanan Manoj Sukriti Malpani Phani Kumar Pullela Pillarisetti Venkata Subbarao Siva Ramamoorthy Susanta K Ghosh |
spellingShingle |
Chandrasekhar Bhaskaran Nair Jagannath Manjula Pradeep Annamalai Subramani Prakash B Nagendrappa Mulakkapurath Narayanan Manoj Sukriti Malpani Phani Kumar Pullela Pillarisetti Venkata Subbarao Siva Ramamoorthy Susanta K Ghosh Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications. PLoS ONE |
author_facet |
Chandrasekhar Bhaskaran Nair Jagannath Manjula Pradeep Annamalai Subramani Prakash B Nagendrappa Mulakkapurath Narayanan Manoj Sukriti Malpani Phani Kumar Pullela Pillarisetti Venkata Subbarao Siva Ramamoorthy Susanta K Ghosh |
author_sort |
Chandrasekhar Bhaskaran Nair |
title |
Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications. |
title_short |
Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications. |
title_full |
Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications. |
title_fullStr |
Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications. |
title_full_unstemmed |
Differential Diagnosis of Malaria on Truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care Applications. |
title_sort |
differential diagnosis of malaria on truelab uno®, a portable, real-time, micropcr device for point-of-care applications. |
publisher |
Public Library of Science (PLoS) |
series |
PLoS ONE |
issn |
1932-6203 |
publishDate |
2016-01-01 |
description |
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® 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. RESULTS:The 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. CONCLUSION:The 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. |
url |
http://europepmc.org/articles/PMC4718663?pdf=render |
work_keys_str_mv |
AT chandrasekharbhaskarannair differentialdiagnosisofmalariaontruelabunoaportablerealtimemicropcrdeviceforpointofcareapplications AT jagannathmanjula differentialdiagnosisofmalariaontruelabunoaportablerealtimemicropcrdeviceforpointofcareapplications AT pradeepannamalaisubramani differentialdiagnosisofmalariaontruelabunoaportablerealtimemicropcrdeviceforpointofcareapplications AT prakashbnagendrappa differentialdiagnosisofmalariaontruelabunoaportablerealtimemicropcrdeviceforpointofcareapplications AT mulakkapurathnarayananmanoj differentialdiagnosisofmalariaontruelabunoaportablerealtimemicropcrdeviceforpointofcareapplications AT sukritimalpani differentialdiagnosisofmalariaontruelabunoaportablerealtimemicropcrdeviceforpointofcareapplications AT phanikumarpullela differentialdiagnosisofmalariaontruelabunoaportablerealtimemicropcrdeviceforpointofcareapplications AT pillarisettivenkatasubbarao differentialdiagnosisofmalariaontruelabunoaportablerealtimemicropcrdeviceforpointofcareapplications AT sivaramamoorthy differentialdiagnosisofmalariaontruelabunoaportablerealtimemicropcrdeviceforpointofcareapplications AT susantakghosh differentialdiagnosisofmalariaontruelabunoaportablerealtimemicropcrdeviceforpointofcareapplications |
_version_ |
1725424448782204928 |