Innovative point-of-care molecular diagnostic test for COVID-19 in India

Gupta, Nivedita; Rana, Salaj; Singh, Harpreet

doi:10.1016/s2666-5247(20)30164-6

Cited by 13 publications

(6 citation statements)

References 2 publications

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“…This chip-based portable PCR is intended to facilitate quick and affordable molecular pathogen detection by low infrastructure health facilities in developing countries (63). The Truenat Beta CoV E-gene screening assay and Truenat SARS-CoV-2 RdRp gene-confirmatory assay have demonstrated concordance with the reference standard RT-PCR (159). In a small validation study, this PoC assay exhibited 100% sensitivity and specificity and no cross-reactivity with other respiratory pathogens with LOD 486 copies/mL (160,161).…”

Section: Point Of Care Molecular Diagnostic Testsmentioning

confidence: 99%

Review of Current COVID-19 Diagnostics and Opportunities for Further Development

Mardian¹,

Kosasih²,

et al. 2021

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Diagnostic testing plays a critical role in addressing the coronavirus disease 2019 (COVID-19) pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Rapid and accurate diagnostic tests are imperative for identifying and managing infected individuals, contact tracing, epidemiologic characterization, and public health decision making. Laboratory testing may be performed based on symptomatic presentation or for screening of asymptomatic people. Confirmation of SARS-CoV-2 infection is typically by nucleic acid amplification tests (NAAT), which requires specialized equipment and training and may be particularly challenging in resource-limited settings. NAAT may give false-negative results due to timing of sample collection relative to infection, improper sampling of respiratory specimens, inadequate preservation of samples, and technical limitations; false-positives may occur due to technical errors, particularly contamination during the manual real-time polymerase chain reaction (RT-PCR) process. Thus, clinical presentation, contact history and contemporary phyloepidemiology must be considered when interpreting results. Several sample-to-answer platforms, including high-throughput systems and Point of Care (PoC) assays, have been developed to increase testing capacity and decrease technical errors. Alternatives to RT-PCR assay, such as other RNA detection methods and antigen tests may be appropriate for certain situations, such as resource-limited settings. While sequencing is important to monitor on-going evolution of the SARS-CoV-2 genome, antibody assays are useful for epidemiologic purposes. The ever-expanding assortment of tests, with varying clinical utility, performance requirements, and limitations, merits comparative evaluation. We herein provide a comprehensive review of currently available COVID-19 diagnostics, exploring their pros and cons as well as appropriate indications. Strategies to further optimize safety, speed, and ease of SARS-CoV-2 testing without compromising accuracy are suggested. Access to scalable diagnostic tools and continued technologic advances, including machine learning and smartphone integration, will facilitate control of the current pandemic as well as preparedness for the next one.

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Section: Point Of Care Molecular Diagnostic Testsmentioning

confidence: 99%

Review of Current COVID-19 Diagnostics and Opportunities for Further Development

Mardian¹,

Kosasih²,

et al. 2021

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“…In another study targeting malaria parasite TrueNat was 99% sensitive compared to gold standard microscopy. Recently it has been approved by WHO for testing drug resistant tuberculosis [ 11 – 14 ].…”

Section: Resultsmentioning

confidence: 99%

Assessing a chip based rapid RTPCR test for SARS CoV-2 detection (TrueNat assay): A diagnostic accuracy study

et al. 2021

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COVID-19 testing is required before admission of a patient in the hospitals, invasive procedures, major and minor surgeries etc. Real Time Polymerase chain reaction is the gold standard test for the diagnosis, but requires well equipped biosafety laboratory along with trained manpower. In this study we have evaluated the diagnostic accuracy of novel TrueNat molecular assay for detecting SARS CoV-2. TrueNat is a chip-based real time PCR test and works on portable, light weight, battery powered equipment and can be used in remote areas with poor infrastructure. In this study 1807 patients samples were collected for both TrueNat and RTPCR COVID-19 testing during study period. Of these 174 (9.7%) and 174 (15%) were positive by RTPCR and TrueNat respectively and taking results of RTPCR as gold standard TrueNat test showed a sensitivity, specificity and diagnostic accuracy of 69.5, 90.9% and 89.2% respectively. It can be concluded that TrueNat is a simple, easy to use, good rapid molecular diagnostic test for diagnosis of COVID-19 especially in resource limited settings and will prove to be a game changer of molecular diagnostics in future.

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“…The Truenat MTB had good sensitivity and specificity in case of detection with hands-on time of fewer than three hours as well as fits the requirements in resource-limited health care settings [7]. During the current COVID-19 pandemic, Truenat was one tool that was utilized for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in India with more than 2500 Truelab workstations currently operational at 1008 sites in 530 districts of India [8]. This technological infrastructure built for the COVID-19 pandemic may be leveraged for ramping up the diagnosis of other major diseases like TB, HIV, etc [9].…”

Section: Discussionmentioning

confidence: 99%

A Rare Case of Sternoclavicular Tuberculosis Diagnosed Using Microchip-Based Polymerase Chain Reaction in a Diabetic Female

Kumar¹,

Mohanty²,

Hada³

et al. 2021

Cureus

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Osteoarticular tuberculosis (TB) accounts for almost 10% of all extrapulmonary TB cases. In the majority of cases, the spine, knee, hip, and large bones are involved; other sites like the sternoclavicular joint, elbow, wrist, and smaller joints are infrequently involved. Uncommon locations of extrapulmonary TB pose a challenge in diagnosis due to lack of clinical suspicion, non-availability of samples, and unavailability of suitable diagnostic modalities. Here we report a case of uncommon location of osteoarticular TB diagnosed through microchip-based real-time polymerase chain reaction (PCR).

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Innovative point-of-care molecular diagnostic test for COVID-19 in India

Cited by 13 publications

References 2 publications

Review of Current COVID-19 Diagnostics and Opportunities for Further Development

Review of Current COVID-19 Diagnostics and Opportunities for Further Development

Assessing a chip based rapid RTPCR test for SARS CoV-2 detection (TrueNat assay): A diagnostic accuracy study

A Rare Case of Sternoclavicular Tuberculosis Diagnosed Using Microchip-Based Polymerase Chain Reaction in a Diabetic Female

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