Performance Evaluation of Truenat rtPCR assay with COBAS -6800 in SARS COV-2 detection: A diagnostic accuracy study

Authors

  • Arindam Chakraborty Associate Professor. Department of Microbiology. Autonomous state Medical College, Kaushambi, Uttar Pradesh, India
  • Monica Singh Associate Professor. Department of Microbiology. Motilal Nehru Medical College. Prayagraj. Uttar Pradesh. India
  • Amod Kumar Associate Professor. Department of Pathology. Nalanda Medical College, Patna. Bihar. India

DOI:

https://doi.org/10.22270/ijmspr.v11i3.157

Keywords:

cobas 6800, TrueNet, COVID 19, Point of care test

Abstract

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.

Author Biographies

Arindam Chakraborty , Associate Professor. Department of Microbiology. Autonomous state Medical College, Kaushambi, Uttar Pradesh, India

Associate Professor. Department of Microbiology. Autonomous state Medical College, Kaushambi, Uttar Pradesh, India

Monica Singh , Associate Professor. Department of Microbiology. Motilal Nehru Medical College. Prayagraj. Uttar Pradesh. India

Associate Professor, Department of Microbiology. Motilal Nehru Medical College. Prayagraj, Uttar Pradesh. India

Amod Kumar , Associate Professor. Department of Pathology. Nalanda Medical College, Patna. Bihar. India

Associate Professor. Department of Pathology. Nalanda Medical College, Patna. Bihar. India

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

15-09-2025

How to Cite

Chakraborty , A. ., Singh, M. ., & Kumar , A. . (2025). Performance Evaluation of Truenat rtPCR assay with COBAS -6800 in SARS COV-2 detection: A diagnostic accuracy study. International Journal of Medical Sciences and Pharma Research, 11(3), 13–16. https://doi.org/10.22270/ijmspr.v11i3.157