Sputum quality and diagnostic performance of GeneXpert MTB/RIF among smear-negative adults with presumed tuberculosis in Uganda
Introduction of GeneXpert MTB/RIF (Xpert) assay has constituted a major breakthrough for tuberculosis (TB) diagnostics. Several patient factors may influence diagnostic performance of Xpert including sputum quality. We carried out a prospective, observational, cross-sectional study to determine the...
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| creator | Meyer, Amanda J Atuheire, Collins Worodria, William Kizito, Samuel Katamba, Achilles Sanyu, Ingvar Andama, Alfred Ayakaka, Irene Cattamanchi, Adithya Bwanga, Freddie Huang, Laurence Davis, J Lucian |
| description | Introduction of GeneXpert MTB/RIF (Xpert) assay has constituted a major breakthrough for tuberculosis (TB) diagnostics. Several patient factors may influence diagnostic performance of Xpert including sputum quality.
We carried out a prospective, observational, cross-sectional study to determine the effect of sputum quality on diagnostic performance of Xpert among presumed TB patients in Uganda.
We collected clinical and demographic information and two sputum samples from participants. Staff recorded sputum quality and performed LED fluorescence microscopy and mycobacterial culture on each sample. If both smear examinations were negative, Xpert testing was performed. We calculated diagnostic yield, sensitivity, specificity, and other indicators for Xpert for each stratum of sputum quality in reference to a standard of mycobacterial culture.
Patients with salivary sputum showed a trend towards a substantially higher proportion of samples that were Xpert-positive (54/286, 19%, 95% CI 15-24) compared with those with all other sputum sample types (221/1496, 15%, 95% CI 13-17). Blood-stained sputum produced the lowest sensitivity (28%; 95% CI 12-49) and salivary sputum the highest (66%; 95% CI 53-77). Specificity didn't vary meaningfully by sample types. Salivary sputum was significantly more sensitive than mucoid sputum (+13%, 95% CI +1 to +26), while blood-stained sputum was significantly less sensitive (-24%, 95% CI -42 to -5).
Our findings demonstrate the need to exercise caution in collecting sputum for Xpert and in interpreting results because sputum quality may impact test yield and sensitivity. In particular, it may be wise to pursue additional testing should blood-stained sputum test negative while salivary sputum should be readily accepted for Xpert testing given its higher sensitivity and potentially higher yield than other sample types. These findings challenge conventional recommendations against collecting salivary sputum for TB diagnosis and could inform new standards for sputum quality. |
| doi_str_mv | 10.1371/journal.pone.0180572 |
| format | Article |
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We carried out a prospective, observational, cross-sectional study to determine the effect of sputum quality on diagnostic performance of Xpert among presumed TB patients in Uganda.
We collected clinical and demographic information and two sputum samples from participants. Staff recorded sputum quality and performed LED fluorescence microscopy and mycobacterial culture on each sample. If both smear examinations were negative, Xpert testing was performed. We calculated diagnostic yield, sensitivity, specificity, and other indicators for Xpert for each stratum of sputum quality in reference to a standard of mycobacterial culture.
Patients with salivary sputum showed a trend towards a substantially higher proportion of samples that were Xpert-positive (54/286, 19%, 95% CI 15-24) compared with those with all other sputum sample types (221/1496, 15%, 95% CI 13-17). Blood-stained sputum produced the lowest sensitivity (28%; 95% CI 12-49) and salivary sputum the highest (66%; 95% CI 53-77). Specificity didn't vary meaningfully by sample types. Salivary sputum was significantly more sensitive than mucoid sputum (+13%, 95% CI +1 to +26), while blood-stained sputum was significantly less sensitive (-24%, 95% CI -42 to -5).
Our findings demonstrate the need to exercise caution in collecting sputum for Xpert and in interpreting results because sputum quality may impact test yield and sensitivity. In particular, it may be wise to pursue additional testing should blood-stained sputum test negative while salivary sputum should be readily accepted for Xpert testing given its higher sensitivity and potentially higher yield than other sample types. These findings challenge conventional recommendations against collecting salivary sputum for TB diagnosis and could inform new standards for sputum quality.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0180572</identifier><identifier>PMID: 28686705</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Adults ; Biology and Life Sciences ; Blood ; Collaboration ; Critical care ; Cross-Sectional Studies ; Demographics ; Diagnosis ; Diagnostic systems ; Epidemiology ; Female ; Fluorescence ; Fluorescence microscopy ; Health sciences ; HIV ; Hospitals ; Human immunodeficiency virus ; Humans ; Infectious diseases ; Laboratories ; Lung diseases ; Male ; Medical diagnosis ; Medicine ; Medicine and Health Sciences ; Microscopy ; Molecular Diagnostic Techniques ; Multivariate analysis ; Mycobacterium tuberculosis - pathogenicity ; Patients ; People and Places ; Physical Sciences ; Pneumonia ; Prospective Studies ; Public health ; Quality ; Sensitivity ; Smear ; Sputum ; Sputum - microbiology ; Sputum culture ; Studies ; Tuberculosis ; Tuberculosis, Pulmonary - diagnosis ; Tuberculosis, Pulmonary - epidemiology ; Tuberculosis, Pulmonary - microbiology ; Tuberculosis, Pulmonary - pathology ; Uganda ; Young Adult</subject><ispartof>PloS one, 2017-07, Vol.12 (7), p.e0180572-e0180572</ispartof><rights>COPYRIGHT 2017 Public Library of Science</rights><rights>2017 Meyer et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2017 Meyer et al 2017 Meyer et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-49ef66c0a70b089bf315d50dc2f871d47cbcd1011ac3aa474b69c08479f920793</citedby><cites>FETCH-LOGICAL-c692t-49ef66c0a70b089bf315d50dc2f871d47cbcd1011ac3aa474b69c08479f920793</cites><orcidid>0000-0003-2318-1783</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5501569/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5501569/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2095,2914,23846,27903,27904,53770,53772,79347,79348</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28686705$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Cardona, Pere-Joan</contributor><creatorcontrib>Meyer, Amanda J</creatorcontrib><creatorcontrib>Atuheire, Collins</creatorcontrib><creatorcontrib>Worodria, William</creatorcontrib><creatorcontrib>Kizito, Samuel</creatorcontrib><creatorcontrib>Katamba, Achilles</creatorcontrib><creatorcontrib>Sanyu, Ingvar</creatorcontrib><creatorcontrib>Andama, Alfred</creatorcontrib><creatorcontrib>Ayakaka, Irene</creatorcontrib><creatorcontrib>Cattamanchi, Adithya</creatorcontrib><creatorcontrib>Bwanga, Freddie</creatorcontrib><creatorcontrib>Huang, Laurence</creatorcontrib><creatorcontrib>Davis, J Lucian</creatorcontrib><title>Sputum quality and diagnostic performance of GeneXpert MTB/RIF among smear-negative adults with presumed tuberculosis in Uganda</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Introduction of GeneXpert MTB/RIF (Xpert) assay has constituted a major breakthrough for tuberculosis (TB) diagnostics. Several patient factors may influence diagnostic performance of Xpert including sputum quality.
We carried out a prospective, observational, cross-sectional study to determine the effect of sputum quality on diagnostic performance of Xpert among presumed TB patients in Uganda.
We collected clinical and demographic information and two sputum samples from participants. Staff recorded sputum quality and performed LED fluorescence microscopy and mycobacterial culture on each sample. If both smear examinations were negative, Xpert testing was performed. We calculated diagnostic yield, sensitivity, specificity, and other indicators for Xpert for each stratum of sputum quality in reference to a standard of mycobacterial culture.
Patients with salivary sputum showed a trend towards a substantially higher proportion of samples that were Xpert-positive (54/286, 19%, 95% CI 15-24) compared with those with all other sputum sample types (221/1496, 15%, 95% CI 13-17). Blood-stained sputum produced the lowest sensitivity (28%; 95% CI 12-49) and salivary sputum the highest (66%; 95% CI 53-77). Specificity didn't vary meaningfully by sample types. Salivary sputum was significantly more sensitive than mucoid sputum (+13%, 95% CI +1 to +26), while blood-stained sputum was significantly less sensitive (-24%, 95% CI -42 to -5).
Our findings demonstrate the need to exercise caution in collecting sputum for Xpert and in interpreting results because sputum quality may impact test yield and sensitivity. In particular, it may be wise to pursue additional testing should blood-stained sputum test negative while salivary sputum should be readily accepted for Xpert testing given its higher sensitivity and potentially higher yield than other sample types. These findings challenge conventional recommendations against collecting salivary sputum for TB diagnosis and could inform new standards for sputum quality.</description><subject>Adult</subject><subject>Adults</subject><subject>Biology and Life Sciences</subject><subject>Blood</subject><subject>Collaboration</subject><subject>Critical care</subject><subject>Cross-Sectional Studies</subject><subject>Demographics</subject><subject>Diagnosis</subject><subject>Diagnostic systems</subject><subject>Epidemiology</subject><subject>Female</subject><subject>Fluorescence</subject><subject>Fluorescence microscopy</subject><subject>Health sciences</subject><subject>HIV</subject><subject>Hospitals</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Laboratories</subject><subject>Lung diseases</subject><subject>Male</subject><subject>Medical diagnosis</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Microscopy</subject><subject>Molecular Diagnostic Techniques</subject><subject>Multivariate analysis</subject><subject>Mycobacterium tuberculosis - pathogenicity</subject><subject>Patients</subject><subject>People and Places</subject><subject>Physical Sciences</subject><subject>Pneumonia</subject><subject>Prospective Studies</subject><subject>Public health</subject><subject>Quality</subject><subject>Sensitivity</subject><subject>Smear</subject><subject>Sputum</subject><subject>Sputum - microbiology</subject><subject>Sputum culture</subject><subject>Studies</subject><subject>Tuberculosis</subject><subject>Tuberculosis, Pulmonary - diagnosis</subject><subject>Tuberculosis, Pulmonary - epidemiology</subject><subject>Tuberculosis, Pulmonary - microbiology</subject><subject>Tuberculosis, Pulmonary - pathology</subject><subject>Uganda</subject><subject>Young 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quality and diagnostic performance of GeneXpert MTB/RIF among smear-negative adults with presumed tuberculosis in Uganda</title><author>Meyer, Amanda J ; Atuheire, Collins ; Worodria, William ; Kizito, Samuel ; Katamba, Achilles ; Sanyu, Ingvar ; Andama, Alfred ; Ayakaka, Irene ; Cattamanchi, Adithya ; Bwanga, Freddie ; Huang, Laurence ; Davis, J Lucian</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-49ef66c0a70b089bf315d50dc2f871d47cbcd1011ac3aa474b69c08479f920793</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Adults</topic><topic>Biology and Life Sciences</topic><topic>Blood</topic><topic>Collaboration</topic><topic>Critical care</topic><topic>Cross-Sectional Studies</topic><topic>Demographics</topic><topic>Diagnosis</topic><topic>Diagnostic 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Alfred</au><au>Ayakaka, Irene</au><au>Cattamanchi, Adithya</au><au>Bwanga, Freddie</au><au>Huang, Laurence</au><au>Davis, J Lucian</au><au>Cardona, Pere-Joan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sputum quality and diagnostic performance of GeneXpert MTB/RIF among smear-negative adults with presumed tuberculosis in Uganda</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2017-07-07</date><risdate>2017</risdate><volume>12</volume><issue>7</issue><spage>e0180572</spage><epage>e0180572</epage><pages>e0180572-e0180572</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Introduction of GeneXpert MTB/RIF (Xpert) assay has constituted a major breakthrough for tuberculosis (TB) diagnostics. Several patient factors may influence diagnostic performance of Xpert including sputum quality.
We carried out a prospective, observational, cross-sectional study to determine the effect of sputum quality on diagnostic performance of Xpert among presumed TB patients in Uganda.
We collected clinical and demographic information and two sputum samples from participants. Staff recorded sputum quality and performed LED fluorescence microscopy and mycobacterial culture on each sample. If both smear examinations were negative, Xpert testing was performed. We calculated diagnostic yield, sensitivity, specificity, and other indicators for Xpert for each stratum of sputum quality in reference to a standard of mycobacterial culture.
Patients with salivary sputum showed a trend towards a substantially higher proportion of samples that were Xpert-positive (54/286, 19%, 95% CI 15-24) compared with those with all other sputum sample types (221/1496, 15%, 95% CI 13-17). Blood-stained sputum produced the lowest sensitivity (28%; 95% CI 12-49) and salivary sputum the highest (66%; 95% CI 53-77). Specificity didn't vary meaningfully by sample types. Salivary sputum was significantly more sensitive than mucoid sputum (+13%, 95% CI +1 to +26), while blood-stained sputum was significantly less sensitive (-24%, 95% CI -42 to -5).
Our findings demonstrate the need to exercise caution in collecting sputum for Xpert and in interpreting results because sputum quality may impact test yield and sensitivity. In particular, it may be wise to pursue additional testing should blood-stained sputum test negative while salivary sputum should be readily accepted for Xpert testing given its higher sensitivity and potentially higher yield than other sample types. These findings challenge conventional recommendations against collecting salivary sputum for TB diagnosis and could inform new standards for sputum quality.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>28686705</pmid><doi>10.1371/journal.pone.0180572</doi><tpages>e0180572</tpages><orcidid>https://orcid.org/0000-0003-2318-1783</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2017-07, Vol.12 (7), p.e0180572-e0180572 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1916991371 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS); EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adult Adults Biology and Life Sciences Blood Collaboration Critical care Cross-Sectional Studies Demographics Diagnosis Diagnostic systems Epidemiology Female Fluorescence Fluorescence microscopy Health sciences HIV Hospitals Human immunodeficiency virus Humans Infectious diseases Laboratories Lung diseases Male Medical diagnosis Medicine Medicine and Health Sciences Microscopy Molecular Diagnostic Techniques Multivariate analysis Mycobacterium tuberculosis - pathogenicity Patients People and Places Physical Sciences Pneumonia Prospective Studies Public health Quality Sensitivity Smear Sputum Sputum - microbiology Sputum culture Studies Tuberculosis Tuberculosis, Pulmonary - diagnosis Tuberculosis, Pulmonary - epidemiology Tuberculosis, Pulmonary - microbiology Tuberculosis, Pulmonary - pathology Uganda Young Adult |
| title | Sputum quality and diagnostic performance of GeneXpert MTB/RIF among smear-negative adults with presumed tuberculosis in Uganda |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-22T08%3A56%3A05IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Sputum%20quality%20and%20diagnostic%20performance%20of%20GeneXpert%20MTB/RIF%20among%20smear-negative%20adults%20with%20presumed%20tuberculosis%20in%20Uganda&rft.jtitle=PloS%20one&rft.au=Meyer,%20Amanda%20J&rft.date=2017-07-07&rft.volume=12&rft.issue=7&rft.spage=e0180572&rft.epage=e0180572&rft.pages=e0180572-e0180572&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0180572&rft_dat=%3Cgale_plos_%3EA497893620%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1916991371&rft_id=info:pmid/28686705&rft_galeid=A497893620&rft_doaj_id=oai_doaj_org_article_e95435e9d82841f0bd51b8b6948658af&rfr_iscdi=true |