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Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda
BACKGROUND: Stool is a potential sample for diagnosing Mycobacterium tuberculosis (Mtb) in patients with difficulty in expectorating. However, high mycobacterial culture contamination rates and Xpert MTB/RIF Ultra test error rates on stool samples have limited its use. OMNIgene SPUTUM (OM-S) is a sa...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10121033/ https://www.ncbi.nlm.nih.gov/pubmed/37083706 http://dx.doi.org/10.1371/journal.pone.0284041 |
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author | Sessolo, Abdulwahab Musisi, Emmanuel Kaswabuli, Sylvia Zawedde, Josephine Byanyima, Patrick Sabiiti, Wilber Walimbwa, Stanley Ola, Joseph Sanyu, Ingvar Lalitha, Rejani Kamya, Moses Davis, Lucian Worodria, William Huang, Laurence |
author_facet | Sessolo, Abdulwahab Musisi, Emmanuel Kaswabuli, Sylvia Zawedde, Josephine Byanyima, Patrick Sabiiti, Wilber Walimbwa, Stanley Ola, Joseph Sanyu, Ingvar Lalitha, Rejani Kamya, Moses Davis, Lucian Worodria, William Huang, Laurence |
author_sort | Sessolo, Abdulwahab |
collection | PubMed |
description | BACKGROUND: Stool is a potential sample for diagnosing Mycobacterium tuberculosis (Mtb) in patients with difficulty in expectorating. However, high mycobacterial culture contamination rates and Xpert MTB/RIF Ultra test error rates on stool samples have limited its use. OMNIgene SPUTUM (OM-S) is a sample transport reagent with characteristics of sputum decontamination while maintaining viable Mtb. We evaluated the impact of OM-S on Mtb diagnostic yield from stool using smear microscopy, Xpert MTB/RIF Ultra, and culture among presumptive TB patients. METHODS: Paired stool and expectorated sputum samples were collected from consecutive Ugandan adults undergoing diagnostic evaluation for pulmonary TB between June 2018 and June 2019. Stool was divided into 2 portions: one was homogenized in OM-S (OM-S stool) and the other in PBS (PBS stool) as control. Both sputum and processed stool were tested for Mtb using concentrated smear fluorescence microscopy (CFM), Xpert MTB/RIF Ultra (Xpert) and Mycobacteria Growth Indicator Tube (MGIT) culture. Sensitivity, specificity, and predictive values for each test were calculated against sputum MGIT culture as the reference standard. RESULTS: Of the 200 participants, 120 (60%) were male, 73 (37%) were HIV positive (median CD4 120 cells/uL (IQR 43–297)) and 128 (64%) had confirmed pulmonary TB by sputum MGIT culture. Seven (4%) OM-S stool Xpert samples reported errors while 47 (25%) and 103 (61%) were contaminated on OM-S stool MGIT and PBS stool MGIT, respectively. OM-S stool MGIT was able to accurately diagnose 56 of the contaminated PBS stool MGIT samples compared to only 5 of the contaminated OM-S stool MGIT samples diagnosed by PBS stool MGIT. Sensitivity (95% Confidence Interval, CI) 89% (83–94) for OM-S stool Xpert was higher compared to that of OM-S stool MGIT 60% (51–69) and PBS stool MGIT 42% (32–52). Specificity (95%CI) 91% (82–97) was also higher for OM-S stool Xpert compared to OM-S stool MGIT 64% (51–75) and PBS stool MGIT 26% (16–38). CONCLUSION: Stool processed with OM-S showed potential to improve Mtb diagnostic yield and reduce rates of indeterminate results when tested on Xpert and MGIT culture. The method may thus be of value in Mtb detection among patients with difficulty to expectorate. |
format | Online Article Text |
id | pubmed-10121033 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-101210332023-04-22 Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda Sessolo, Abdulwahab Musisi, Emmanuel Kaswabuli, Sylvia Zawedde, Josephine Byanyima, Patrick Sabiiti, Wilber Walimbwa, Stanley Ola, Joseph Sanyu, Ingvar Lalitha, Rejani Kamya, Moses Davis, Lucian Worodria, William Huang, Laurence PLoS One Research Article BACKGROUND: Stool is a potential sample for diagnosing Mycobacterium tuberculosis (Mtb) in patients with difficulty in expectorating. However, high mycobacterial culture contamination rates and Xpert MTB/RIF Ultra test error rates on stool samples have limited its use. OMNIgene SPUTUM (OM-S) is a sample transport reagent with characteristics of sputum decontamination while maintaining viable Mtb. We evaluated the impact of OM-S on Mtb diagnostic yield from stool using smear microscopy, Xpert MTB/RIF Ultra, and culture among presumptive TB patients. METHODS: Paired stool and expectorated sputum samples were collected from consecutive Ugandan adults undergoing diagnostic evaluation for pulmonary TB between June 2018 and June 2019. Stool was divided into 2 portions: one was homogenized in OM-S (OM-S stool) and the other in PBS (PBS stool) as control. Both sputum and processed stool were tested for Mtb using concentrated smear fluorescence microscopy (CFM), Xpert MTB/RIF Ultra (Xpert) and Mycobacteria Growth Indicator Tube (MGIT) culture. Sensitivity, specificity, and predictive values for each test were calculated against sputum MGIT culture as the reference standard. RESULTS: Of the 200 participants, 120 (60%) were male, 73 (37%) were HIV positive (median CD4 120 cells/uL (IQR 43–297)) and 128 (64%) had confirmed pulmonary TB by sputum MGIT culture. Seven (4%) OM-S stool Xpert samples reported errors while 47 (25%) and 103 (61%) were contaminated on OM-S stool MGIT and PBS stool MGIT, respectively. OM-S stool MGIT was able to accurately diagnose 56 of the contaminated PBS stool MGIT samples compared to only 5 of the contaminated OM-S stool MGIT samples diagnosed by PBS stool MGIT. Sensitivity (95% Confidence Interval, CI) 89% (83–94) for OM-S stool Xpert was higher compared to that of OM-S stool MGIT 60% (51–69) and PBS stool MGIT 42% (32–52). Specificity (95%CI) 91% (82–97) was also higher for OM-S stool Xpert compared to OM-S stool MGIT 64% (51–75) and PBS stool MGIT 26% (16–38). CONCLUSION: Stool processed with OM-S showed potential to improve Mtb diagnostic yield and reduce rates of indeterminate results when tested on Xpert and MGIT culture. The method may thus be of value in Mtb detection among patients with difficulty to expectorate. Public Library of Science 2023-04-21 /pmc/articles/PMC10121033/ /pubmed/37083706 http://dx.doi.org/10.1371/journal.pone.0284041 Text en © 2023 Sessolo 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 Sessolo, Abdulwahab Musisi, Emmanuel Kaswabuli, Sylvia Zawedde, Josephine Byanyima, Patrick Sabiiti, Wilber Walimbwa, Stanley Ola, Joseph Sanyu, Ingvar Lalitha, Rejani Kamya, Moses Davis, Lucian Worodria, William Huang, Laurence Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda |
title | Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda |
title_full | Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda |
title_fullStr | Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda |
title_full_unstemmed | Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda |
title_short | Diagnostic accuracy of Xpert MTB/RIF Ultra and culture assays to detect Mycobacterium Tuberculosis using OMNIgene-sputum processed stool among adult TB presumptive patients in Uganda |
title_sort | diagnostic accuracy of xpert mtb/rif ultra and culture assays to detect mycobacterium tuberculosis using omnigene-sputum processed stool among adult tb presumptive patients in uganda |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10121033/ https://www.ncbi.nlm.nih.gov/pubmed/37083706 http://dx.doi.org/10.1371/journal.pone.0284041 |
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