Clinical value of IS6110-based loop-mediated isothermal amplification for detection of Mycobacterium tuberculosis complex in respiratory specimens
A fundamental to global tuberculosis (TB) control is timely and accurate diagnosis of infectious cases of the disease. Among various methods, techniques based on nucleic acid amplification are the ones with promising prospects. The present study evaluates the diagnostic value of the recently develop...
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description | A fundamental to global tuberculosis (TB) control is timely and accurate diagnosis of infectious cases of the disease. Among various methods, techniques based on nucleic acid amplification are the ones with promising prospects. The present study evaluates the diagnostic value of the recently developed IS6110-based loop-mediated isothermal amplification (LAMP) for detection of Mycobacterium tuberculosis complex (MTBC) in sputum specimens.
In this cross-sectional study (2008–2009), IS6110-LAMP was evaluated on 101 sputum specimens from 93 highly suspected TB patients and compared to Amplicor MTB test and in-house IS6110-PCR and -nested PCR assays. Culture results or clinical recovery following anti-TB therapy was considered as a reference to prove the TB cases.
The overall sensitivity of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 89.6% (69/77 specimens; 95% confidence interval [CI], 80.5–95.4%), 76.6% (59/77 specimens; CI, 65.6–85.5%), 79.2% (61/77 specimens; CI, 68.5–87.6%) and 59.7% (46/77 specimens; CI, 47.9–70.8%). The specificity and positive predictive value (PPV) were 100% for all the tests, and the negative predictive value (NPV) of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 75%, 57.1%, 60%, and 43.6%. There was an excellent overall agreement between LAMP and nPCR (k 0.828), and between LAMP and Amplicor (k 0.746), in addition to a better tolerance of IS6110-LAMP to inhibitors present in clinical specimens.
The better diagnostic performance of IS6110-LAMP compared to Amplicor (p = 0.009), nPCR (p = 0.013) and PCR (p |
doi_str_mv | 10.1016/j.jinf.2013.02.005 |
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In this cross-sectional study (2008–2009), IS6110-LAMP was evaluated on 101 sputum specimens from 93 highly suspected TB patients and compared to Amplicor MTB test and in-house IS6110-PCR and -nested PCR assays. Culture results or clinical recovery following anti-TB therapy was considered as a reference to prove the TB cases.
The overall sensitivity of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 89.6% (69/77 specimens; 95% confidence interval [CI], 80.5–95.4%), 76.6% (59/77 specimens; CI, 65.6–85.5%), 79.2% (61/77 specimens; CI, 68.5–87.6%) and 59.7% (46/77 specimens; CI, 47.9–70.8%). The specificity and positive predictive value (PPV) were 100% for all the tests, and the negative predictive value (NPV) of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 75%, 57.1%, 60%, and 43.6%. There was an excellent overall agreement between LAMP and nPCR (k 0.828), and between LAMP and Amplicor (k 0.746), in addition to a better tolerance of IS6110-LAMP to inhibitors present in clinical specimens.
The better diagnostic performance of IS6110-LAMP compared to Amplicor (p = 0.009), nPCR (p = 0.013) and PCR (p < 0.0001) besides its rapidity, simplicity, and cost-effectiveness makes it a valuable method for the detection of MTBC in clinical samples, particularly in resource-limited settings.</description><identifier>ISSN: 0163-4453</identifier><identifier>EISSN: 1532-2742</identifier><identifier>DOI: 10.1016/j.jinf.2013.02.005</identifier><identifier>PMID: 23466595</identifier><identifier>CODEN: JINFD2</identifier><language>eng</language><publisher>Amsterdam: Elsevier Ltd</publisher><subject>Biological and medical sciences ; Cross-Sectional Studies ; Diagnostic value ; General aspects ; Humans ; IS6110, sputum ; Loop-mediated isothermal amplification ; Medical sciences ; Molecular Typing - methods ; Mycobacterium tuberculosis ; Mycobacterium tuberculosis - genetics ; Mycobacterium tuberculosis - isolation & purification ; Mycobacterium tuberculosis complex ; Nucleic Acid Amplification Techniques - methods ; Reproducibility of Results ; Sensitivity and Specificity ; Sputum - microbiology ; Tuberculosis, Pulmonary - diagnosis ; Tuberculosis, Pulmonary - microbiology</subject><ispartof>The Journal of infection, 2013-06, Vol.66 (6), p.487-493</ispartof><rights>2013 The British Infection Association</rights><rights>2014 INIST-CNRS</rights><rights>Copyright © 2013 The British Infection Association. Published by Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c485t-950207fbd3f44ced2452761238afeabeff9519ae86337830bc035aa890a62ac23</citedby><cites>FETCH-LOGICAL-c485t-950207fbd3f44ced2452761238afeabeff9519ae86337830bc035aa890a62ac23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jinf.2013.02.005$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27307852$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23466595$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Aryan, Ehsan</creatorcontrib><creatorcontrib>Makvandi, Manoochehr</creatorcontrib><creatorcontrib>Farajzadeh, Ahmad</creatorcontrib><creatorcontrib>Huygen, Kris</creatorcontrib><creatorcontrib>Alvandi, Amir-Hooshang</creatorcontrib><creatorcontrib>Gouya, Mohammad-Mehdi</creatorcontrib><creatorcontrib>Sadrizadeh, Ali</creatorcontrib><creatorcontrib>Romano, Marta</creatorcontrib><title>Clinical value of IS6110-based loop-mediated isothermal amplification for detection of Mycobacterium tuberculosis complex in respiratory specimens</title><title>The Journal of infection</title><addtitle>J Infect</addtitle><description>A fundamental to global tuberculosis (TB) control is timely and accurate diagnosis of infectious cases of the disease. Among various methods, techniques based on nucleic acid amplification are the ones with promising prospects. The present study evaluates the diagnostic value of the recently developed IS6110-based loop-mediated isothermal amplification (LAMP) for detection of Mycobacterium tuberculosis complex (MTBC) in sputum specimens.
In this cross-sectional study (2008–2009), IS6110-LAMP was evaluated on 101 sputum specimens from 93 highly suspected TB patients and compared to Amplicor MTB test and in-house IS6110-PCR and -nested PCR assays. Culture results or clinical recovery following anti-TB therapy was considered as a reference to prove the TB cases.
The overall sensitivity of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 89.6% (69/77 specimens; 95% confidence interval [CI], 80.5–95.4%), 76.6% (59/77 specimens; CI, 65.6–85.5%), 79.2% (61/77 specimens; CI, 68.5–87.6%) and 59.7% (46/77 specimens; CI, 47.9–70.8%). The specificity and positive predictive value (PPV) were 100% for all the tests, and the negative predictive value (NPV) of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 75%, 57.1%, 60%, and 43.6%. There was an excellent overall agreement between LAMP and nPCR (k 0.828), and between LAMP and Amplicor (k 0.746), in addition to a better tolerance of IS6110-LAMP to inhibitors present in clinical specimens.
The better diagnostic performance of IS6110-LAMP compared to Amplicor (p = 0.009), nPCR (p = 0.013) and PCR (p < 0.0001) besides its rapidity, simplicity, and cost-effectiveness makes it a valuable method for the detection of MTBC in clinical samples, particularly in resource-limited settings.</description><subject>Biological and medical sciences</subject><subject>Cross-Sectional Studies</subject><subject>Diagnostic value</subject><subject>General aspects</subject><subject>Humans</subject><subject>IS6110, sputum</subject><subject>Loop-mediated isothermal amplification</subject><subject>Medical sciences</subject><subject>Molecular Typing - methods</subject><subject>Mycobacterium tuberculosis</subject><subject>Mycobacterium tuberculosis - genetics</subject><subject>Mycobacterium tuberculosis - isolation & purification</subject><subject>Mycobacterium tuberculosis complex</subject><subject>Nucleic Acid Amplification Techniques - methods</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>Sputum - microbiology</subject><subject>Tuberculosis, Pulmonary - diagnosis</subject><subject>Tuberculosis, Pulmonary - microbiology</subject><issn>0163-4453</issn><issn>1532-2742</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU2r1DAUhoMo3vHqH3Ah2QhuWk-SpmnBjQx-XLjiQl2HND3BDG1Tk_Ti_A1_sRln1J2uwoHnPZy8DyFPGdQMWPvyUB_84moOTNTAawB5j-yYFLziquH3ya5AomoaKa7Io5QOANCLvn1Irrho2lb2ckd-7Ce_eGsmememDWlw9OZTyxhUg0k40imEtZpx9CaXyaeQv2KcC27mdfKuJLMPC3Uh0hEz2l9TWfLhaMNgbMbot5nmbcBotykkn6gNJYrfqV9oxLT6aHKIR5pWtH7GJT0mD5yZEj65vNfky9s3n_fvq9uP7272r28r23QyV70EDsoNo3BNY3HkjeSqZVx0xqEZ0Llest5g1wqhOgGDBSGN6XowLTeWi2vy4rx3jeHbhinr2SeL02QWDFvSTLbAOOd9_39UNIpLpRQUlJ9RG0NKEZ1eo59NPGoG-qRNH_RJmz5p08B10VZCzy77t6GU_Sfy21MBnl8Ak4osF81iffrLKQGqk6c_vTpzWIq78xh1sh6XUo-PRY4eg__XHT8Btqa4Nw</recordid><startdate>20130601</startdate><enddate>20130601</enddate><creator>Aryan, Ehsan</creator><creator>Makvandi, Manoochehr</creator><creator>Farajzadeh, Ahmad</creator><creator>Huygen, Kris</creator><creator>Alvandi, Amir-Hooshang</creator><creator>Gouya, Mohammad-Mehdi</creator><creator>Sadrizadeh, Ali</creator><creator>Romano, Marta</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>IQODW</scope><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>7X8</scope><scope>7QL</scope><scope>C1K</scope></search><sort><creationdate>20130601</creationdate><title>Clinical value of IS6110-based loop-mediated isothermal amplification for detection of Mycobacterium tuberculosis complex in respiratory specimens</title><author>Aryan, Ehsan ; Makvandi, Manoochehr ; Farajzadeh, Ahmad ; Huygen, Kris ; Alvandi, Amir-Hooshang ; Gouya, Mohammad-Mehdi ; Sadrizadeh, Ali ; Romano, Marta</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c485t-950207fbd3f44ced2452761238afeabeff9519ae86337830bc035aa890a62ac23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Biological and medical sciences</topic><topic>Cross-Sectional Studies</topic><topic>Diagnostic value</topic><topic>General aspects</topic><topic>Humans</topic><topic>IS6110, sputum</topic><topic>Loop-mediated isothermal amplification</topic><topic>Medical sciences</topic><topic>Molecular Typing - methods</topic><topic>Mycobacterium tuberculosis</topic><topic>Mycobacterium tuberculosis - genetics</topic><topic>Mycobacterium tuberculosis - isolation & purification</topic><topic>Mycobacterium tuberculosis complex</topic><topic>Nucleic Acid Amplification Techniques - methods</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><topic>Sputum - microbiology</topic><topic>Tuberculosis, Pulmonary - diagnosis</topic><topic>Tuberculosis, Pulmonary - microbiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Aryan, Ehsan</creatorcontrib><creatorcontrib>Makvandi, Manoochehr</creatorcontrib><creatorcontrib>Farajzadeh, Ahmad</creatorcontrib><creatorcontrib>Huygen, Kris</creatorcontrib><creatorcontrib>Alvandi, Amir-Hooshang</creatorcontrib><creatorcontrib>Gouya, Mohammad-Mehdi</creatorcontrib><creatorcontrib>Sadrizadeh, Ali</creatorcontrib><creatorcontrib>Romano, Marta</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>The Journal of infection</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Aryan, Ehsan</au><au>Makvandi, Manoochehr</au><au>Farajzadeh, Ahmad</au><au>Huygen, Kris</au><au>Alvandi, Amir-Hooshang</au><au>Gouya, Mohammad-Mehdi</au><au>Sadrizadeh, Ali</au><au>Romano, Marta</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical value of IS6110-based loop-mediated isothermal amplification for detection of Mycobacterium tuberculosis complex in respiratory specimens</atitle><jtitle>The Journal of infection</jtitle><addtitle>J Infect</addtitle><date>2013-06-01</date><risdate>2013</risdate><volume>66</volume><issue>6</issue><spage>487</spage><epage>493</epage><pages>487-493</pages><issn>0163-4453</issn><eissn>1532-2742</eissn><coden>JINFD2</coden><abstract>A fundamental to global tuberculosis (TB) control is timely and accurate diagnosis of infectious cases of the disease. Among various methods, techniques based on nucleic acid amplification are the ones with promising prospects. The present study evaluates the diagnostic value of the recently developed IS6110-based loop-mediated isothermal amplification (LAMP) for detection of Mycobacterium tuberculosis complex (MTBC) in sputum specimens.
In this cross-sectional study (2008–2009), IS6110-LAMP was evaluated on 101 sputum specimens from 93 highly suspected TB patients and compared to Amplicor MTB test and in-house IS6110-PCR and -nested PCR assays. Culture results or clinical recovery following anti-TB therapy was considered as a reference to prove the TB cases.
The overall sensitivity of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 89.6% (69/77 specimens; 95% confidence interval [CI], 80.5–95.4%), 76.6% (59/77 specimens; CI, 65.6–85.5%), 79.2% (61/77 specimens; CI, 68.5–87.6%) and 59.7% (46/77 specimens; CI, 47.9–70.8%). The specificity and positive predictive value (PPV) were 100% for all the tests, and the negative predictive value (NPV) of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 75%, 57.1%, 60%, and 43.6%. There was an excellent overall agreement between LAMP and nPCR (k 0.828), and between LAMP and Amplicor (k 0.746), in addition to a better tolerance of IS6110-LAMP to inhibitors present in clinical specimens.
The better diagnostic performance of IS6110-LAMP compared to Amplicor (p = 0.009), nPCR (p = 0.013) and PCR (p < 0.0001) besides its rapidity, simplicity, and cost-effectiveness makes it a valuable method for the detection of MTBC in clinical samples, particularly in resource-limited settings.</abstract><cop>Amsterdam</cop><pub>Elsevier Ltd</pub><pmid>23466595</pmid><doi>10.1016/j.jinf.2013.02.005</doi><tpages>7</tpages></addata></record> |
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subjects | Biological and medical sciences Cross-Sectional Studies Diagnostic value General aspects Humans IS6110, sputum Loop-mediated isothermal amplification Medical sciences Molecular Typing - methods Mycobacterium tuberculosis Mycobacterium tuberculosis - genetics Mycobacterium tuberculosis - isolation & purification Mycobacterium tuberculosis complex Nucleic Acid Amplification Techniques - methods Reproducibility of Results Sensitivity and Specificity Sputum - microbiology Tuberculosis, Pulmonary - diagnosis Tuberculosis, Pulmonary - microbiology |
title | Clinical value of IS6110-based loop-mediated isothermal amplification for detection of Mycobacterium tuberculosis complex in respiratory specimens |
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