Use of a molecular diagnostic test in AFB smear positive tuberculosis suspects greatly reduces time to detection of multidrug resistant tuberculosis
The WHO has recommended the implementation of rapid diagnostic tests to detect and help combat M/XDR tuberculosis (TB). There are limited data on the performance and impact of these tests in field settings. The performance of the commercially available Genotype MTBDRplus molecular assay was compared...
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creator | Tukvadze, Nestani Kempker, Russell R Kalandadze, Iagor Kurbatova, Ekaterina Leonard, Michael K Apsindzelashvili, Rusudan Bablishvili, Nino Kipiani, Maia Blumberg, Henry M |
description | The WHO has recommended the implementation of rapid diagnostic tests to detect and help combat M/XDR tuberculosis (TB). There are limited data on the performance and impact of these tests in field settings.
The performance of the commercially available Genotype MTBDRplus molecular assay was compared to conventional methods including AFB smear, culture and drug susceptibility testing (DST) using both an absolute concentration method on Löwenstein-Jensen media and broth-based method using the MGIT 960 system. Sputum specimens were obtained from TB suspects in the country of Georgia who received care through the National TB Program.
Among 500 AFB smear-positive sputum specimens, 458 (91.6%) had both a positive sputum culture for Mycobacterium tuberculosis and a valid MTBDRplus assay result. The MTBDRplus assay detected isoniazid (INH) resistance directly from the sputum specimen in 159 (89.8%) of 177 specimens and MDR-TB in 109 (95.6%) of 114 specimens compared to conventional methods. There was high agreement between the MTBDRplus assay and conventional DST results in detecting MDR-TB (kappa = 0.95, p |
doi_str_mv | 10.1371/journal.pone.0031563 |
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The performance of the commercially available Genotype MTBDRplus molecular assay was compared to conventional methods including AFB smear, culture and drug susceptibility testing (DST) using both an absolute concentration method on Löwenstein-Jensen media and broth-based method using the MGIT 960 system. Sputum specimens were obtained from TB suspects in the country of Georgia who received care through the National TB Program.
Among 500 AFB smear-positive sputum specimens, 458 (91.6%) had both a positive sputum culture for Mycobacterium tuberculosis and a valid MTBDRplus assay result. The MTBDRplus assay detected isoniazid (INH) resistance directly from the sputum specimen in 159 (89.8%) of 177 specimens and MDR-TB in 109 (95.6%) of 114 specimens compared to conventional methods. There was high agreement between the MTBDRplus assay and conventional DST results in detecting MDR-TB (kappa = 0.95, p<0.01). The most prevalent INH resistance mutation was S315T (78%) in the katG codon and the most common rifampicin resistance mutation was S531L (68%) in the rpoB codon. Among 13 specimens from TB suspects with negative sputum cultures, 7 had a positive MTBDRplus assay (3 with MDR-TB). The time to detection of MDR-TB was significantly less using the MTBDRplus assay (4.2 days) compared to the use of standard phenotypic tests (67.3 days with solid media and 21.6 days with broth-based media).
Compared to conventional methods, the MTBDRplus assay had high accuracy and significantly reduced time to detection of MDR-TB in an area with high MDR-TB prevalence. The use of rapid molecular diagnostic tests for TB and drug resistance should increase the proportion of patients promptly placed on appropriate therapy.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0031563</identifier><identifier>PMID: 22347495</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Air bases ; Antitubercular agents ; Antitubercular Agents - pharmacology ; Assaying ; Biology ; Chemotherapy ; Clinical outcomes ; Codons ; Diagnostic systems ; Diagnostic tests ; Disease control ; Drug resistance ; Genotype & phenotype ; Georgia ; Hepatitis ; Humans ; Infectious diseases ; Isoniazid ; Isoniazid - pharmacology ; Laboratories ; Lung diseases ; Medical diagnosis ; Medical screening ; Medicine ; Microscopy ; Molecular Diagnostic Techniques - methods ; Multidrug resistance ; Multidrug resistant organisms ; Mutation ; Mycobacterium tuberculosis ; Reproducibility of Results ; Rifampin ; RpoB protein ; Smear ; Sputum ; Sputum - microbiology ; Tuberculosis ; Tuberculosis, Multidrug-Resistant - diagnosis ; Tuberculosis, Multidrug-Resistant - genetics</subject><ispartof>PloS one, 2012-02, Vol.7 (2), p.e31563-e31563</ispartof><rights>COPYRIGHT 2012 Public Library of Science</rights><rights>2012 Tukvadze et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://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>Tukvadze et al. 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c723t-2415f57bbb7ea2b9ff72757e63a0e113a3aea6d3dfc0a7ac23a2e4ba38c73fe3</citedby><cites>FETCH-LOGICAL-c723t-2415f57bbb7ea2b9ff72757e63a0e113a3aea6d3dfc0a7ac23a2e4ba38c73fe3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3276512/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3276512/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2095,2914,23846,27903,27904,53769,53771,79346,79347</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22347495$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Nicol, Mark Patrick</contributor><creatorcontrib>Tukvadze, Nestani</creatorcontrib><creatorcontrib>Kempker, Russell R</creatorcontrib><creatorcontrib>Kalandadze, Iagor</creatorcontrib><creatorcontrib>Kurbatova, Ekaterina</creatorcontrib><creatorcontrib>Leonard, Michael K</creatorcontrib><creatorcontrib>Apsindzelashvili, Rusudan</creatorcontrib><creatorcontrib>Bablishvili, Nino</creatorcontrib><creatorcontrib>Kipiani, Maia</creatorcontrib><creatorcontrib>Blumberg, Henry M</creatorcontrib><title>Use of a molecular diagnostic test in AFB smear positive tuberculosis suspects greatly reduces time to detection of multidrug resistant tuberculosis</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>The WHO has recommended the implementation of rapid diagnostic tests to detect and help combat M/XDR tuberculosis (TB). There are limited data on the performance and impact of these tests in field settings.
The performance of the commercially available Genotype MTBDRplus molecular assay was compared to conventional methods including AFB smear, culture and drug susceptibility testing (DST) using both an absolute concentration method on Löwenstein-Jensen media and broth-based method using the MGIT 960 system. Sputum specimens were obtained from TB suspects in the country of Georgia who received care through the National TB Program.
Among 500 AFB smear-positive sputum specimens, 458 (91.6%) had both a positive sputum culture for Mycobacterium tuberculosis and a valid MTBDRplus assay result. The MTBDRplus assay detected isoniazid (INH) resistance directly from the sputum specimen in 159 (89.8%) of 177 specimens and MDR-TB in 109 (95.6%) of 114 specimens compared to conventional methods. There was high agreement between the MTBDRplus assay and conventional DST results in detecting MDR-TB (kappa = 0.95, p<0.01). The most prevalent INH resistance mutation was S315T (78%) in the katG codon and the most common rifampicin resistance mutation was S531L (68%) in the rpoB codon. Among 13 specimens from TB suspects with negative sputum cultures, 7 had a positive MTBDRplus assay (3 with MDR-TB). The time to detection of MDR-TB was significantly less using the MTBDRplus assay (4.2 days) compared to the use of standard phenotypic tests (67.3 days with solid media and 21.6 days with broth-based media).
Compared to conventional methods, the MTBDRplus assay had high accuracy and significantly reduced time to detection of MDR-TB in an area with high MDR-TB prevalence. The use of rapid molecular diagnostic tests for TB and drug resistance should increase the proportion of patients promptly placed on appropriate therapy.</description><subject>Air bases</subject><subject>Antitubercular agents</subject><subject>Antitubercular Agents - pharmacology</subject><subject>Assaying</subject><subject>Biology</subject><subject>Chemotherapy</subject><subject>Clinical outcomes</subject><subject>Codons</subject><subject>Diagnostic systems</subject><subject>Diagnostic tests</subject><subject>Disease control</subject><subject>Drug resistance</subject><subject>Genotype & phenotype</subject><subject>Georgia</subject><subject>Hepatitis</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Isoniazid</subject><subject>Isoniazid - pharmacology</subject><subject>Laboratories</subject><subject>Lung diseases</subject><subject>Medical diagnosis</subject><subject>Medical screening</subject><subject>Medicine</subject><subject>Microscopy</subject><subject>Molecular Diagnostic Techniques - methods</subject><subject>Multidrug resistance</subject><subject>Multidrug resistant organisms</subject><subject>Mutation</subject><subject>Mycobacterium tuberculosis</subject><subject>Reproducibility of Results</subject><subject>Rifampin</subject><subject>RpoB protein</subject><subject>Smear</subject><subject>Sputum</subject><subject>Sputum - microbiology</subject><subject>Tuberculosis</subject><subject>Tuberculosis, Multidrug-Resistant - diagnosis</subject><subject>Tuberculosis, Multidrug-Resistant - genetics</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNqNk9-K1DAUxoso7jr6BqIBQfFixiZpm_ZGGBdXBxYWdPU2nKannQxtMybp4r6HD2zqdJepLCi9aJvz-77Tnj9R9JzGK8oFfbczg-2hXe1Nj6s45jTN-IPolBacLTMW84dHzyfRE-d2cZzyPMseRyeM8UQkRXoa_frmkJiaAOlMi2powZJKQ9Mb57UiHp0nuifr8w_EdRiCe-O019dI_FCiDYLw7ogb3B6Vd6SxCL69IRarQaEjXncBNaRCH-La9GOybmi9ruzQBCyoPfR-Zvc0elRD6_DZdF9EV-cfr84-Ly8uP23O1hdLJRj3S5bQtE5FWZYCgZVFXQsmUoEZhxgp5cABIat4VasYBCjGgWFSAs-V4DXyRfTyYLsPWeVUTycpZzxN8yLJA7E5EJWBndxb3YG9kQa0_HNgbCPBhjq1KGMKOc2hUAUTSZZkUJe8QoVFnhR5xdPg9X7KNpQdVgp7b6Gdmc4jvd7KxlxLzkSWUhYM3kwG1vwYQmNkp53CtoUezeBkkeVUxBnn_yZZqFPOwsAsold_kfeXYaIaCH-q-9qED1Sjp1wnQtCMFmLMurqHCleFnVZhSmsdzmeCtzNBYDz-9A0MzsnN1y__z15-n7Ovj9gtQuu3zrTDOH5uDiYHUFnjnMX6rhs0luOS3VZDjksmpyULshfHnbwT3W4V_w3_6CWp</recordid><startdate>20120209</startdate><enddate>20120209</enddate><creator>Tukvadze, Nestani</creator><creator>Kempker, Russell R</creator><creator>Kalandadze, Iagor</creator><creator>Kurbatova, Ekaterina</creator><creator>Leonard, Michael K</creator><creator>Apsindzelashvili, Rusudan</creator><creator>Bablishvili, Nino</creator><creator>Kipiani, Maia</creator><creator>Blumberg, Henry M</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20120209</creationdate><title>Use of a molecular diagnostic test in AFB smear positive tuberculosis suspects greatly reduces time to detection of multidrug resistant tuberculosis</title><author>Tukvadze, Nestani ; Kempker, Russell R ; Kalandadze, Iagor ; Kurbatova, Ekaterina ; Leonard, Michael K ; Apsindzelashvili, Rusudan ; Bablishvili, Nino ; Kipiani, Maia ; Blumberg, Henry M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c723t-2415f57bbb7ea2b9ff72757e63a0e113a3aea6d3dfc0a7ac23a2e4ba38c73fe3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Air bases</topic><topic>Antitubercular agents</topic><topic>Antitubercular Agents - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tukvadze, Nestani</au><au>Kempker, Russell R</au><au>Kalandadze, Iagor</au><au>Kurbatova, Ekaterina</au><au>Leonard, Michael K</au><au>Apsindzelashvili, Rusudan</au><au>Bablishvili, Nino</au><au>Kipiani, Maia</au><au>Blumberg, Henry M</au><au>Nicol, Mark Patrick</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Use of a molecular diagnostic test in AFB smear positive tuberculosis suspects greatly reduces time to detection of multidrug resistant tuberculosis</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2012-02-09</date><risdate>2012</risdate><volume>7</volume><issue>2</issue><spage>e31563</spage><epage>e31563</epage><pages>e31563-e31563</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>The WHO has recommended the implementation of rapid diagnostic tests to detect and help combat M/XDR tuberculosis (TB). There are limited data on the performance and impact of these tests in field settings.
The performance of the commercially available Genotype MTBDRplus molecular assay was compared to conventional methods including AFB smear, culture and drug susceptibility testing (DST) using both an absolute concentration method on Löwenstein-Jensen media and broth-based method using the MGIT 960 system. Sputum specimens were obtained from TB suspects in the country of Georgia who received care through the National TB Program.
Among 500 AFB smear-positive sputum specimens, 458 (91.6%) had both a positive sputum culture for Mycobacterium tuberculosis and a valid MTBDRplus assay result. The MTBDRplus assay detected isoniazid (INH) resistance directly from the sputum specimen in 159 (89.8%) of 177 specimens and MDR-TB in 109 (95.6%) of 114 specimens compared to conventional methods. There was high agreement between the MTBDRplus assay and conventional DST results in detecting MDR-TB (kappa = 0.95, p<0.01). The most prevalent INH resistance mutation was S315T (78%) in the katG codon and the most common rifampicin resistance mutation was S531L (68%) in the rpoB codon. Among 13 specimens from TB suspects with negative sputum cultures, 7 had a positive MTBDRplus assay (3 with MDR-TB). The time to detection of MDR-TB was significantly less using the MTBDRplus assay (4.2 days) compared to the use of standard phenotypic tests (67.3 days with solid media and 21.6 days with broth-based media).
Compared to conventional methods, the MTBDRplus assay had high accuracy and significantly reduced time to detection of MDR-TB in an area with high MDR-TB prevalence. The use of rapid molecular diagnostic tests for TB and drug resistance should increase the proportion of patients promptly placed on appropriate therapy.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>22347495</pmid><doi>10.1371/journal.pone.0031563</doi><tpages>e31563</tpages><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
subjects | Air bases Antitubercular agents Antitubercular Agents - pharmacology Assaying Biology Chemotherapy Clinical outcomes Codons Diagnostic systems Diagnostic tests Disease control Drug resistance Genotype & phenotype Georgia Hepatitis Humans Infectious diseases Isoniazid Isoniazid - pharmacology Laboratories Lung diseases Medical diagnosis Medical screening Medicine Microscopy Molecular Diagnostic Techniques - methods Multidrug resistance Multidrug resistant organisms Mutation Mycobacterium tuberculosis Reproducibility of Results Rifampin RpoB protein Smear Sputum Sputum - microbiology Tuberculosis Tuberculosis, Multidrug-Resistant - diagnosis Tuberculosis, Multidrug-Resistant - genetics |
title | Use of a molecular diagnostic test in AFB smear positive tuberculosis suspects greatly reduces time to detection of multidrug resistant tuberculosis |
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