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Diagnostic accuracy of GeneXpert MTB/RIF assay for detection of tubercular pleural effusion

India has been engaged in tuberculosis (TB) control activities for over 50 years and yet TB continues to remain India’s important public health problem. The present study was conducted to compare the performance of GeneXpert MTB/RIF (GXpert) assay with composite reference standard in diagnosing case...

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Autores principales: Jain, Jyoti, Jadhao, Pooja, Banait, Shashank, Salunkhe, Preetam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8202948/
https://www.ncbi.nlm.nih.gov/pubmed/34125834
http://dx.doi.org/10.1371/journal.pone.0251618
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author Jain, Jyoti
Jadhao, Pooja
Banait, Shashank
Salunkhe, Preetam
author_facet Jain, Jyoti
Jadhao, Pooja
Banait, Shashank
Salunkhe, Preetam
author_sort Jain, Jyoti
collection PubMed
description India has been engaged in tuberculosis (TB) control activities for over 50 years and yet TB continues to remain India’s important public health problem. The present study was conducted to compare the performance of GeneXpert MTB/RIF (GXpert) assay with composite reference standard in diagnosing cases of tubercular pleural effusion (TPE) and to evaluate the reliability of rifampicin resistance. A cross-sectional study was performed in a Department of Medicine of a rural teaching tertiary care hospital in central India. In all consecutive patients with pleural effusion on chest radiograph presenting to Department of Medicine, GXpert assay and composite reference standard was performed to evaluate the diagnostic accuracy of GXpert assay for detecting TPE in comparison to composite reference standard. Standard formulae were used to calculate the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV), positive likelihood ratios (LR+) and negative likelihood ratios (LR-). Mc-Nemar’s test was applied to compare variables. All comparisons were two-tailed. We considered the difference to be statistically significant if the P value was less than 0.05. The sensitivity of the GXpert assay in diagnosing TPE was 16.6% among 158 study participants, the specificity was 100% and diagnostic accuracy was 52.5% which was statistically significant (p value < 0.05). It had a PPV of 100% (95%CI: 88.3% - 100%) and a NPV of 47.5% (95%CI: 39.3% - 55.7%). The LR+ and LR-were 23.5 (95%CI: 1.43–38.6) and 0.83 (95%CI: 0.76–0.91) respectively. GXpert assay has a very high specificity in diagnosing TPE but has a low sensitivity. In comparison to composite reference standard Thus its clinical utility is limited when used as a standalone test. A physician’s clinical acumen in combination with routine pleural fluid analysis should be the key factor in the diagnosis of TPE in clinically and radiologically suspected patients, especially in high TB burden countries.
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spelling pubmed-82029482021-06-29 Diagnostic accuracy of GeneXpert MTB/RIF assay for detection of tubercular pleural effusion Jain, Jyoti Jadhao, Pooja Banait, Shashank Salunkhe, Preetam PLoS One Research Article India has been engaged in tuberculosis (TB) control activities for over 50 years and yet TB continues to remain India’s important public health problem. The present study was conducted to compare the performance of GeneXpert MTB/RIF (GXpert) assay with composite reference standard in diagnosing cases of tubercular pleural effusion (TPE) and to evaluate the reliability of rifampicin resistance. A cross-sectional study was performed in a Department of Medicine of a rural teaching tertiary care hospital in central India. In all consecutive patients with pleural effusion on chest radiograph presenting to Department of Medicine, GXpert assay and composite reference standard was performed to evaluate the diagnostic accuracy of GXpert assay for detecting TPE in comparison to composite reference standard. Standard formulae were used to calculate the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV), positive likelihood ratios (LR+) and negative likelihood ratios (LR-). Mc-Nemar’s test was applied to compare variables. All comparisons were two-tailed. We considered the difference to be statistically significant if the P value was less than 0.05. The sensitivity of the GXpert assay in diagnosing TPE was 16.6% among 158 study participants, the specificity was 100% and diagnostic accuracy was 52.5% which was statistically significant (p value < 0.05). It had a PPV of 100% (95%CI: 88.3% - 100%) and a NPV of 47.5% (95%CI: 39.3% - 55.7%). The LR+ and LR-were 23.5 (95%CI: 1.43–38.6) and 0.83 (95%CI: 0.76–0.91) respectively. GXpert assay has a very high specificity in diagnosing TPE but has a low sensitivity. In comparison to composite reference standard Thus its clinical utility is limited when used as a standalone test. A physician’s clinical acumen in combination with routine pleural fluid analysis should be the key factor in the diagnosis of TPE in clinically and radiologically suspected patients, especially in high TB burden countries. Public Library of Science 2021-06-14 /pmc/articles/PMC8202948/ /pubmed/34125834 http://dx.doi.org/10.1371/journal.pone.0251618 Text en © 2021 Jain et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Jain, Jyoti
Jadhao, Pooja
Banait, Shashank
Salunkhe, Preetam
Diagnostic accuracy of GeneXpert MTB/RIF assay for detection of tubercular pleural effusion
title Diagnostic accuracy of GeneXpert MTB/RIF assay for detection of tubercular pleural effusion
title_full Diagnostic accuracy of GeneXpert MTB/RIF assay for detection of tubercular pleural effusion
title_fullStr Diagnostic accuracy of GeneXpert MTB/RIF assay for detection of tubercular pleural effusion
title_full_unstemmed Diagnostic accuracy of GeneXpert MTB/RIF assay for detection of tubercular pleural effusion
title_short Diagnostic accuracy of GeneXpert MTB/RIF assay for detection of tubercular pleural effusion
title_sort diagnostic accuracy of genexpert mtb/rif assay for detection of tubercular pleural effusion
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8202948/
https://www.ncbi.nlm.nih.gov/pubmed/34125834
http://dx.doi.org/10.1371/journal.pone.0251618
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