Evaluation of Truenat MTB/RIF Test in Comparison with Microscopy and Culture for Diagnosis of Extrapulmonary Tuberculosis in a Tertiary Care Centre

Introduction: Worldwide, Extrapulmonary Tuberculosis (EPTB) accounts for 15-20% of all cases of TB. The diagnosis of EPTB is a big challenge, as the number of Mycobacterium tuberculosis(MTB) bacilli in the tissues and other organs is often very low. Truenat MTB/RIF (rifampicin) is a novel method, wh...

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Main Authors: Reena Anie Jose, Krishna Gopal, Abel K Samuel Johnson, Jennie Ann Johnson Samuel, Sherin Susan Abraham, Tribeni Goswami, Marina Thomas, Renu Mathew
Format: Article
Language:English
Published: JCDR Research and Publications Private Limited 2021-01-01
Series:Journal of Clinical and Diagnostic Research
Subjects:
Online Access:https://jcdr.net/articles/PDF/14432/46815_CE(Ra1)_P(AK)_PF1(AG_SHU)_PFA(AG_KM)_PB(AG_KM)_PN(KM).pdf
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author Reena Anie Jose
Krishna Gopal
Abel K Samuel Johnson
Jennie Ann Johnson Samuel
Sherin Susan Abraham
Tribeni Goswami
Marina Thomas
Renu Mathew
author_facet Reena Anie Jose
Krishna Gopal
Abel K Samuel Johnson
Jennie Ann Johnson Samuel
Sherin Susan Abraham
Tribeni Goswami
Marina Thomas
Renu Mathew
author_sort Reena Anie Jose
collection DOAJ
description Introduction: Worldwide, Extrapulmonary Tuberculosis (EPTB) accounts for 15-20% of all cases of TB. The diagnosis of EPTB is a big challenge, as the number of Mycobacterium tuberculosis(MTB) bacilli in the tissues and other organs is often very low. Truenat MTB/RIF (rifampicin) is a novel method, which is battery operated, point-of-care and chip-based Real Time Polymerase Chain Reaction (RT-PCR) micro device. Aim: To evaluate Truenat as a screening test in the diagnosis of EPTB in comparison with microscopy and culture.Materials and Methods: A prospective cross-sectional study was carried out over a year in which samples from suspected cases of EPTB fitting in the inclusion criteria were subjected to Ziehl-Neelsen (ZN) staining for smear microscopy, culture on Lowenstein Jensen (LJ) medium and PCR for MTB by Truenat. Comparisons were made between the tests and the data was presented using summary statistics with 95% Confidence Interval (CI).Results: A total of 248 samples were received from suspected cases of EPTB. Out of the different samples tested, 9 (3.6%) were positive with Truenat MTB. The predominant type of EPTB observed in the study was lymph node Tuberculosis (TB) (66.6%) followed by intestinal, pleural and skeletal TB. Out of the 106 samples tested for culture, four were culture positive for MTB and out of 178 samples tested for microscopy, three were positive for acid fast bacilli. Sensitivity, specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV), observed agreement of Truenat with culture and microscopy were 100%, 95.1%, 100%, 44.4%, 95.3% and 100%, 96.6%, 100%, 33.3%, 96.6%, respectively.Conclusion: Truenat MTB test is a cost-effective rapid molecular test with good sensitivity and specificity for the diagnosis of EPTB in low resource settings.
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spelling doaj.art-ba1a315373514496b61617405e8424572022-12-21T18:56:50ZengJCDR Research and Publications Private LimitedJournal of Clinical and Diagnostic Research2249-782X0973-709X2021-01-01151DC05DC0910.7860/JCDR/2021/46815.14432Evaluation of Truenat MTB/RIF Test in Comparison with Microscopy and Culture for Diagnosis of Extrapulmonary Tuberculosis in a Tertiary Care CentreReena Anie Jose0Krishna Gopal1Abel K Samuel Johnson2Jennie Ann Johnson Samuel3Sherin Susan Abraham4Tribeni Goswami5Marina Thomas6Renu Mathew7Assistant Professor, Department of Microbiology, Believers Church Medical College Hospital, Thiruvalla, Kerala, India.MBBS Student, Believers Church Medical College Hospital, Thiruvalla, Kerala, IndiaAssistant Professor, Department of Community Medicine, Believers Church Medical College Hospital, Thiruvalla, Kerala, India.Assistant Professor, Department of Microbiology, Believers Church Medical College Hospital, Thiruvalla, Kerala, India.Assistant Professor, Department of Microbiology, Believers Church Medical College Hospital, Thiruvalla, Kerala, India.Assistant Professor, Department of Microbiology, Believers Church Medical College Hospital, Thiruvalla, Kerala, IndiaProfessor, Department of Microbiology, Believers Church Medical College Hospital, Thiruvalla, Kerala, India.Professor and Head, Department of Microbiology, Believers Church Medical College Hospital, Thiruvalla, Kerala, India.Introduction: Worldwide, Extrapulmonary Tuberculosis (EPTB) accounts for 15-20% of all cases of TB. The diagnosis of EPTB is a big challenge, as the number of Mycobacterium tuberculosis(MTB) bacilli in the tissues and other organs is often very low. Truenat MTB/RIF (rifampicin) is a novel method, which is battery operated, point-of-care and chip-based Real Time Polymerase Chain Reaction (RT-PCR) micro device. Aim: To evaluate Truenat as a screening test in the diagnosis of EPTB in comparison with microscopy and culture.Materials and Methods: A prospective cross-sectional study was carried out over a year in which samples from suspected cases of EPTB fitting in the inclusion criteria were subjected to Ziehl-Neelsen (ZN) staining for smear microscopy, culture on Lowenstein Jensen (LJ) medium and PCR for MTB by Truenat. Comparisons were made between the tests and the data was presented using summary statistics with 95% Confidence Interval (CI).Results: A total of 248 samples were received from suspected cases of EPTB. Out of the different samples tested, 9 (3.6%) were positive with Truenat MTB. The predominant type of EPTB observed in the study was lymph node Tuberculosis (TB) (66.6%) followed by intestinal, pleural and skeletal TB. Out of the 106 samples tested for culture, four were culture positive for MTB and out of 178 samples tested for microscopy, three were positive for acid fast bacilli. Sensitivity, specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV), observed agreement of Truenat with culture and microscopy were 100%, 95.1%, 100%, 44.4%, 95.3% and 100%, 96.6%, 100%, 33.3%, 96.6%, respectively.Conclusion: Truenat MTB test is a cost-effective rapid molecular test with good sensitivity and specificity for the diagnosis of EPTB in low resource settings.https://jcdr.net/articles/PDF/14432/46815_CE(Ra1)_P(AK)_PF1(AG_SHU)_PFA(AG_KM)_PB(AG_KM)_PN(KM).pdfmicrochipmycobacterium tuberculosisnovel testsensitivityspecificity
spellingShingle Reena Anie Jose
Krishna Gopal
Abel K Samuel Johnson
Jennie Ann Johnson Samuel
Sherin Susan Abraham
Tribeni Goswami
Marina Thomas
Renu Mathew
Evaluation of Truenat MTB/RIF Test in Comparison with Microscopy and Culture for Diagnosis of Extrapulmonary Tuberculosis in a Tertiary Care Centre
Journal of Clinical and Diagnostic Research
microchip
mycobacterium tuberculosis
novel test
sensitivity
specificity
title Evaluation of Truenat MTB/RIF Test in Comparison with Microscopy and Culture for Diagnosis of Extrapulmonary Tuberculosis in a Tertiary Care Centre
title_full Evaluation of Truenat MTB/RIF Test in Comparison with Microscopy and Culture for Diagnosis of Extrapulmonary Tuberculosis in a Tertiary Care Centre
title_fullStr Evaluation of Truenat MTB/RIF Test in Comparison with Microscopy and Culture for Diagnosis of Extrapulmonary Tuberculosis in a Tertiary Care Centre
title_full_unstemmed Evaluation of Truenat MTB/RIF Test in Comparison with Microscopy and Culture for Diagnosis of Extrapulmonary Tuberculosis in a Tertiary Care Centre
title_short Evaluation of Truenat MTB/RIF Test in Comparison with Microscopy and Culture for Diagnosis of Extrapulmonary Tuberculosis in a Tertiary Care Centre
title_sort evaluation of truenat mtb rif test in comparison with microscopy and culture for diagnosis of extrapulmonary tuberculosis in a tertiary care centre
topic microchip
mycobacterium tuberculosis
novel test
sensitivity
specificity
url https://jcdr.net/articles/PDF/14432/46815_CE(Ra1)_P(AK)_PF1(AG_SHU)_PFA(AG_KM)_PB(AG_KM)_PN(KM).pdf
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