Diagnostic Accuracy of The TrueNat MTB/RIF Assay And Comparison With The Reference Standards To Detect Pulmonary Tuberculosis And Rifampicin Resistance in Sputum Samples From Patients Attending A Tertiary Care Hospital in Bhubaneswar, India

Authors

  • Braja Barik ICMR-Regional Medical Research Centre, Bhubaneswar, India
  • Shritam Das ICMR-Regional Medical Research Centre, Bhubaneswar, India
  • Khusbu Singh ICMR-Regional Medical Research Centre, Bhubaneswar, India
  • Sudatta Chandan ICMR-Regional Medical Research Centre, Bhubaneswar, India
  • Subrat Kumar Swain ICMR-Regional Medical Research Centre, Bhubaneswar, India
  • Prasanti Nayak ICMR-Regional Medical Research Centre, Bhubaneswar, India
  • Omkar Abadesh Mishra ICMR-Regional Medical Research Centre, Bhubaneswar, India
  • Tahziba Hussain ICMR-Regional Medical Research Centre, Bhubaneswar, India
  • Dasarathi Das ICMR-Regional Medical Research Centre, Bhubaneswar, India
  • Sanghamitra Pati ICMR-Regional Medical Research Centre, Bhubaneswar, India

DOI:

https://doi.org/10.55489/njcm.150320243413

Keywords:

Diagnostic accuracy, TrueNAT MTB/RIF Assay, pulmonary tuberculosis, RIF resistance, patients

Abstract

Background: A rapid and accurate diagnostic tool is necessary for correct diagnosis and treatment of TB. This study evaluated and compared the sensitivity, specificity and concordance of TrueNAT MTB/RIF assay with smear microscopy, Xpert MTB/RIF and MGIT culture.

Methods: In all, 4500 patients (1500 each of patients with Diabetes, elderly and HIV-positive patients) attending the Chest and TB department of Capital Hospital, Bhubaneswar were screened. 392 sputum samples were collected from presumptive TB patients. Standard diagnostic procedures (Smear Microscopy, Xpert MTB/RIF, TrueNAT MTB tests and MGIT culture) were performed.

Results: This diagnostic efficiency of rapid molecular TrueNAT MTB/RIF assays have similar properties as Xpert MTB/RIF and may be used for the diagnosis of TB and Rifampicin resistance. Among participants, the TrueNAT MTB shows the sensitivity of 80%, 100% and 78.26% while the specificity was 97.9%, 95.83% and 100%. The concordance rates between all tests were calculated and the TrueNAT MTB showed good agreement with the culture method among study participants (κ = 0.793, 0.554, and 0.862, respectively).

Conclusion: The TrueNAT assays are sensitive for diagnosis of TB patients with faster turnabout time from testing to treatment and economical.

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Published

2024-03-01

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1.
Barik BS, Das S, Singh K, Chandan S, Kumar Swain S, Nayak P, Mishra OA, Hussain T, Das D, Pati S. Diagnostic Accuracy of The TrueNat MTB/RIF Assay And Comparison With The Reference Standards To Detect Pulmonary Tuberculosis And Rifampicin Resistance in Sputum Samples From Patients Attending A Tertiary Care Hospital in Bhubaneswar, India. Natl J Community Med [Internet]. 2024 Mar. 1 [cited 2024 Apr. 28];15(03):175-81. Available from: https://www.njcmindia.com/index.php/file/article/view/3413

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