Performance Evaluation of Truenat rtPCR assay with COBAS -6800 in SARS COV-2 detection: A diagnostic accuracy study
DOI:
https://doi.org/10.22270/ijmspr.v11i3.157Keywords:
cobas 6800, TrueNet, COVID 19, Point of care testAbstract
Context: Diagnostic testing plays a critical role in early and accurate detection of SARS-COV-2. Real-time PCR is the Gold standard test for the diagnosis of SARS-COV-2 which requires well equipped BSL-2 Lab along with skilled manpower. There is a need for a rapid point of care test for diagnosis. TrueNat is one such testing system that is approved by Govt. of India.
Aims: To find out the performance of the TrueNat assay in comparison to cobas 6800.
Settings and Design: The Cross-sectional study was conducted in a COVID 19 Testing Laboratory in Central India.
Methods and Material: A total of 122 COVID-19 positive samples in cobas 6800 were analysed in TrueNat assay.
Results: Of the total of cobas positive122 sample TrueNat system were able to detect 116 samples with the viral load of high(n=18), medium(n=28 ), low(n=44),very low(n=26). Considering cobas 6800 as a Gold standard assay TrueNat test showed a sensitivity and specificity of 95% and 100%respectively.
Conclusions: Based on our findings we believe that TrueNat assay is equally effective for the diagnosis of SARS-COV-2 compared to a highly sophisticated instrument such as cobas 6800. Hence, it should be installed in all healthcare setups with a limited setting for rapid and reliable diagnosis of SARS-COV-2.
Keywords: cobas 6800, TrueNat, COVID-19, Point of care test.
References
Tang YW, Schmitz JE, Persing DH, Stratton CW. Laboratory Diagnosis of COVID-19: Current Issues and Challenges. J Clin Microbiol. 2020 May 26;58(6) https://doi.org/10.1128/JCM.00512-20 PMid:32245835 PMCid:PMC7269383
Assessing a chip based rapid RTPCR test for SARS CoV-2 detection (TrueNat assay): A diagnostic accuracy study Ghoshal U, Garg A, Vasanth S, Arya AK, Pandey A, et al. Assessing a chip based rapid RTPCR test for SARS CoV-2 detection (TrueNat assay): A diagnostic accuracy study. PLOS ONE. 2021: 16(10). https://doi.org/10.1371/journal.pone.0257834 PMid:34644333 PMCid:PMC8513858
Guidelines for Storage Specimens Collected for COVID-19 Diagnosis by RTPCR Platforms in Government Laboratories. Available from: http//www.icmr.gov.in/pdf/covid/labs/Govt_labs_sample_retention_advisory_25062020.pdf
https://www.molbiodiagnostics.com/product_details
https://diagnostics.roche.com/us/en/products/instruments/cobas-6800.html
Basawarajappa SG, Rangaiah A, Padukone S, Yadav PD, Gupta N, Shankar SM. Performance evaluation of Truenat™ Beta CoV & Truenat™ SARS-CoV-2 point-of-care assays for coronavirus disease 2019. Indian J Med Res 2021;153:144 50 https://doi.org/10.4103/ijmr.IJMR_2363_20 PMid:33818471 PMCid:PMC8184085
Gupta N, Rana S, Singh H. Innovative point of care molecular diagnostic test for COVID 19 in India. Lancet Microbe 2020;1:e277. https://doi.org/10.1016/S2666-5247(20)30164-6 PMid:33521725
Ajayi B, Trompeter AJ, Umarji S, Saha P, Arnander M, Lui DF. Catching the second wave: clinical characteristics and nosocomial infection rates in major trauma and orthopaedic patients during the COVID-19 pandemic. Bone Jt Open. 2021 Aug;2(8):661-670. https://doi.org/10.1302/2633-1462.28.BJO-2021-0078.R1 PMid:34405683 PMCid:PMC8384451
Nigam JS, Kumar A, Sinha R, H H, Kumar N, Surabhi, Kumar T, Bharti S, Bhadani PP. Association of Peripheral Blood Parameters With Outcomes of COVID-19 Infection in a Tertiary Care Setting of Eastern India: An Institute-Based Study. Cureus. 2021 Dec 27;13(12):e20745. https://doi.org/10.7759/cureus.20745
Jimeno S, Ventura PS, Castellano JM, García-Adasme SI, Miranda M, Touza P, Lllana I, López-Escobar A. Prognostic implications of neutrophil-lymphocyte ratio in COVID-19. Eur J Clin Invest. 2021 Jan;51(1):e13404. https://doi.org/10.1111/eci.13404 PMid:32918295
Sun S., Cai X., Wang H., He G., Lin Y., Lu B., Chen C., Pan Y., Hu X. Abnormalities of peripheral blood system in patients with COVID-19 in Wenzhou, China. Clin. Chim. Acta. 2020;507:174-180. https://doi.org/10.1016/j.cca.2020.04.024 PMid:32339487 PMCid:PMC7194694
Chen N., Zhou M., Dong X., Qu J., Gong F., Han Y., Qiu Y., Wang J., Liu Y., Wei Y., Xia J., Yu T., Zhang X., Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395(10223):507-513. https://doi.org/10.1016/S0140-6736(20)30211-7 PMid:32007143
tícia de Oliveira Toledo S, Sousa Nogueira L, das Graças Carvalho M, Romana Alves Rios D, de Barros Pinheiro M. COVID-19: Review and hematologic impact. Clin Chim Acta. 2020 Nov;510:170-176. https://doi.org/10.1016/j.cca.2020.07.016 PMid:32659224 PMCid:PMC7351669
Sadhna S, Hawaldar R. Evaluation of truenat RTPCR for diagnosis of SARS CoV2 infection -An observational study.Indian J Microbiol Res 2020;7:265-269. https://doi.org/10.18231/j.ijmr.2020.047
Jaiswal A, Singh M, Chakraborty A. Comparative Evaluation of Truenat Reverse Transcription Polymerase Chain Reaction with Commercially Available Reverse Transcription Polymerase Chain Reaction Kits for COVID 19 Diagnosis. Advances in Human Biology 2022;12 (1) :34-37. https://doi.org/10.4103/aihb.aihb_120_21
Published
How to Cite
Issue
Section
Copyright (c) 2025 Arindam Chakraborty , Monica Singh , Amod Kumar

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.