Evaluation of the Roche cobas® CT/NG Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Male Urine
Background: The Roche cobas® CT/NG test (c4800), performed on the cobas 4800 system, is a new diagnostic assay using an automated workstation to isolate nucleic acids from clinical specimens and a real-time instrument for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). Th...
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| Veröffentlicht in: | Sexually transmitted diseases 2012-07, Vol.39 (7), p.543-549 |
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| creator | Taylor, Stephanie N. Liesenfeld, Oliver Lillis, Rebecca A. Body, Barbara A. Nye, Melinda Williams, James Eisenhut, Carol Hook, Edward W. Van Der Pol, Barbara |
| description | Background: The Roche cobas® CT/NG test (c4800), performed on the cobas 4800 system, is a new diagnostic assay using an automated workstation to isolate nucleic acids from clinical specimens and a real-time instrument for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). This study compared the performance characteristics of the c4800 with the Becton Dickinson ProbeTec™ CT/GC Qx assay (Qx) and Gen-Probe® Aptima Combo 2 (AC2) assay for the detection of CT and NG in male urine using patient-infected-status (PIS). Methods: Urine and urethral swabs were obtained from men attending STD, family planning, or OB/GYN clinics from 11 geographically distinct locations. Aliquot order was randomized for urine specimens x between AC2, c4800, and Qx. Urethral swabs were randomized bex tween AC2 and Qx. Urethral swabs were only used to define PIS and were not tested on the c4800. A participant was considered infected if the 2 comparator assays with different molecular targets had positive results from either sample type. Results: A total of 790 men were screened, with 768 évaluable for CT and NG. Symptoms were reported in 296 (38.5%) participants. For urine, the overall sensitivity and specificity of the c4800 assay for CT were 97.6% and 99.5%, respectively, when compared with PIS. Sensitivity and specificity for NG were 100% and 99.7%, respectively. Conclusions: The c4800 has excellent sensitivity and specificity for male urine specimens when compared with PIS. Assay performance was similar in symptomatic and asymptomatic men and was equivalent to nucleic acid amplification tests that are currently on the market. |
| doi_str_mv | 10.1097/olq.0b013e31824e26ff |
| format | Article |
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This study compared the performance characteristics of the c4800 with the Becton Dickinson ProbeTec™ CT/GC Qx assay (Qx) and Gen-Probe® Aptima Combo 2 (AC2) assay for the detection of CT and NG in male urine using patient-infected-status (PIS). Methods: Urine and urethral swabs were obtained from men attending STD, family planning, or OB/GYN clinics from 11 geographically distinct locations. Aliquot order was randomized for urine specimens x between AC2, c4800, and Qx. Urethral swabs were randomized bex tween AC2 and Qx. Urethral swabs were only used to define PIS and were not tested on the c4800. A participant was considered infected if the 2 comparator assays with different molecular targets had positive results from either sample type. Results: A total of 790 men were screened, with 768 évaluable for CT and NG. Symptoms were reported in 296 (38.5%) participants. For urine, the overall sensitivity and specificity of the c4800 assay for CT were 97.6% and 99.5%, respectively, when compared with PIS. Sensitivity and specificity for NG were 100% and 99.7%, respectively. Conclusions: The c4800 has excellent sensitivity and specificity for male urine specimens when compared with PIS. Assay performance was similar in symptomatic and asymptomatic men and was equivalent to nucleic acid amplification tests that are currently on the market.</description><identifier>ISSN: 0148-5717</identifier><identifier>EISSN: 1537-4521</identifier><identifier>DOI: 10.1097/olq.0b013e31824e26ff</identifier><identifier>PMID: 22706217</identifier><identifier>CODEN: STRDDM</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins</publisher><subject>Adolescent ; Adult ; Bacterial diseases ; Bacterial diseases of the genital system ; Bioassays ; Biological and medical sciences ; Chlamydia ; Chlamydia Infections - diagnosis ; Chlamydia Infections - urine ; Chlamydia trachomatis ; Chlamydia trachomatis - genetics ; Chlamydia trachomatis - isolation & purification ; Detection ; DNA, Bacterial - isolation & purification ; Epidemiology. Vaccinations ; General aspects ; Gonorrhea - diagnosis ; Gonorrhea - urine ; Gonorrhoea ; Human bacterial diseases ; Human infectious diseases. Experimental studies and models ; Humans ; Infectious diseases ; Male ; Medical sciences ; Medical screening ; Men ; Middle Aged ; Neisseria gonorrhoeae - genetics ; Neisseria gonorrhoeae - isolation & purification ; Nucleic Acid Amplification Techniques - methods ; Original Study ; Sensitivity ; Sensitivity and Specificity ; Urethra - microbiology ; Urethra - pathology ; Urinalysis ; Urine ; Young Adult</subject><ispartof>Sexually transmitted diseases, 2012-07, Vol.39 (7), p.543-549</ispartof><rights>Copyright © 2012 American Sexually Transmitted Diseases Association</rights><rights>2015 INIST-CNRS</rights><rights>Copyright Lippincott Williams & Wilkins Jul 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c672t-45c364f863f6e33298fd7fe32c3c6f05e24663074020b6db7c5d6ce342229dcd3</citedby><cites>FETCH-LOGICAL-c672t-45c364f863f6e33298fd7fe32c3c6f05e24663074020b6db7c5d6ce342229dcd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/44981736$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/44981736$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,780,784,803,27924,27925,30999,31000,58017,58250</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26029936$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22706217$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Taylor, Stephanie N.</creatorcontrib><creatorcontrib>Liesenfeld, Oliver</creatorcontrib><creatorcontrib>Lillis, Rebecca A.</creatorcontrib><creatorcontrib>Body, Barbara A.</creatorcontrib><creatorcontrib>Nye, Melinda</creatorcontrib><creatorcontrib>Williams, James</creatorcontrib><creatorcontrib>Eisenhut, Carol</creatorcontrib><creatorcontrib>Hook, Edward W.</creatorcontrib><creatorcontrib>Van Der Pol, Barbara</creatorcontrib><title>Evaluation of the Roche cobas® CT/NG Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Male Urine</title><title>Sexually transmitted diseases</title><addtitle>Sex Transm Dis</addtitle><description>Background: The Roche cobas® CT/NG test (c4800), performed on the cobas 4800 system, is a new diagnostic assay using an automated workstation to isolate nucleic acids from clinical specimens and a real-time instrument for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). This study compared the performance characteristics of the c4800 with the Becton Dickinson ProbeTec™ CT/GC Qx assay (Qx) and Gen-Probe® Aptima Combo 2 (AC2) assay for the detection of CT and NG in male urine using patient-infected-status (PIS). Methods: Urine and urethral swabs were obtained from men attending STD, family planning, or OB/GYN clinics from 11 geographically distinct locations. Aliquot order was randomized for urine specimens x between AC2, c4800, and Qx. Urethral swabs were randomized bex tween AC2 and Qx. Urethral swabs were only used to define PIS and were not tested on the c4800. A participant was considered infected if the 2 comparator assays with different molecular targets had positive results from either sample type. Results: A total of 790 men were screened, with 768 évaluable for CT and NG. Symptoms were reported in 296 (38.5%) participants. For urine, the overall sensitivity and specificity of the c4800 assay for CT were 97.6% and 99.5%, respectively, when compared with PIS. Sensitivity and specificity for NG were 100% and 99.7%, respectively. Conclusions: The c4800 has excellent sensitivity and specificity for male urine specimens when compared with PIS. Assay performance was similar in symptomatic and asymptomatic men and was equivalent to nucleic acid amplification tests that are currently on the market.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Bacterial diseases</subject><subject>Bacterial diseases of the genital system</subject><subject>Bioassays</subject><subject>Biological and medical sciences</subject><subject>Chlamydia</subject><subject>Chlamydia Infections - diagnosis</subject><subject>Chlamydia Infections - urine</subject><subject>Chlamydia trachomatis</subject><subject>Chlamydia trachomatis - genetics</subject><subject>Chlamydia trachomatis - isolation & purification</subject><subject>Detection</subject><subject>DNA, Bacterial - isolation & purification</subject><subject>Epidemiology. Vaccinations</subject><subject>General aspects</subject><subject>Gonorrhea - diagnosis</subject><subject>Gonorrhea - urine</subject><subject>Gonorrhoea</subject><subject>Human bacterial diseases</subject><subject>Human infectious diseases. Experimental studies and models</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medical screening</subject><subject>Men</subject><subject>Middle Aged</subject><subject>Neisseria gonorrhoeae - genetics</subject><subject>Neisseria gonorrhoeae - isolation & purification</subject><subject>Nucleic Acid Amplification Techniques - methods</subject><subject>Original Study</subject><subject>Sensitivity</subject><subject>Sensitivity and Specificity</subject><subject>Urethra - microbiology</subject><subject>Urethra - pathology</subject><subject>Urinalysis</subject><subject>Urine</subject><subject>Young Adult</subject><issn>0148-5717</issn><issn>1537-4521</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>7QJ</sourceid><recordid>eNqF0VFLHDEQB_AgLfXUfgNbAkXw5TSZZJPdR7mqLZxKy_m8ZLOT3h67G012C_el-iH8ZOZ6pwVf-pIhzG_-MAwhx5ydcVboc98-nrGKcYGC5yARlHN7ZMIzoacyA_6OTBiX-TTTXO-TgxhXbPNn_APZB9BMAdcTsr78bdrRDI3vqXd0WCL96W16ra9MfPpDZ4vz22u6wDhQ5wP9igPaFz1btqZb142hQzB26buUE6npa3qLTYwYUueX730IS48GadPTG9MivQ9Nj0fkvTNtxI-7ekjury4Xs2_T-d3199nFfGqVhiGtYoWSLlfCKRQCitzV2qEAK6xyLEOQSgmmJQNWqbrSNquVRSEBoKhtLQ7J6Tb3IfjHMe1Rdk202LamRz_GkstCpQRd5P-nDDgHKaVI9MsbuvJj6NMif5WGTOuNkltlg48xoCsfQtOZsE6o3FyxvJv_KN9eMY193oWPVYf169DL2RI42QETrWldML1t4j-nGBSFUMl92rpVHHx47UtZ5ClFiWdgHq9r</recordid><startdate>20120701</startdate><enddate>20120701</enddate><creator>Taylor, Stephanie N.</creator><creator>Liesenfeld, Oliver</creator><creator>Lillis, Rebecca A.</creator><creator>Body, Barbara A.</creator><creator>Nye, Melinda</creator><creator>Williams, James</creator><creator>Eisenhut, Carol</creator><creator>Hook, Edward W.</creator><creator>Van Der Pol, Barbara</creator><general>Lippincott Williams & Wilkins</general><general>Lippincott Williams & Wilkins Ovid Technologies</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>7QJ</scope><scope>7QL</scope><scope>7T2</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20120701</creationdate><title>Evaluation of the Roche cobas® CT/NG Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Male Urine</title><author>Taylor, Stephanie N. ; Liesenfeld, Oliver ; Lillis, Rebecca A. ; Body, Barbara A. ; Nye, Melinda ; Williams, James ; Eisenhut, Carol ; Hook, Edward W. ; Van Der Pol, Barbara</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c672t-45c364f863f6e33298fd7fe32c3c6f05e24663074020b6db7c5d6ce342229dcd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Bacterial diseases</topic><topic>Bacterial diseases of the genital system</topic><topic>Bioassays</topic><topic>Biological and medical sciences</topic><topic>Chlamydia</topic><topic>Chlamydia Infections - diagnosis</topic><topic>Chlamydia Infections - urine</topic><topic>Chlamydia trachomatis</topic><topic>Chlamydia trachomatis - genetics</topic><topic>Chlamydia trachomatis - isolation & purification</topic><topic>Detection</topic><topic>DNA, Bacterial - isolation & purification</topic><topic>Epidemiology. Vaccinations</topic><topic>General aspects</topic><topic>Gonorrhea - diagnosis</topic><topic>Gonorrhea - urine</topic><topic>Gonorrhoea</topic><topic>Human bacterial diseases</topic><topic>Human infectious diseases. Experimental studies and models</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medical screening</topic><topic>Men</topic><topic>Middle Aged</topic><topic>Neisseria gonorrhoeae - genetics</topic><topic>Neisseria gonorrhoeae - isolation & purification</topic><topic>Nucleic Acid Amplification Techniques - methods</topic><topic>Original Study</topic><topic>Sensitivity</topic><topic>Sensitivity and Specificity</topic><topic>Urethra - microbiology</topic><topic>Urethra - pathology</topic><topic>Urinalysis</topic><topic>Urine</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Taylor, Stephanie N.</creatorcontrib><creatorcontrib>Liesenfeld, Oliver</creatorcontrib><creatorcontrib>Lillis, Rebecca A.</creatorcontrib><creatorcontrib>Body, Barbara A.</creatorcontrib><creatorcontrib>Nye, Melinda</creatorcontrib><creatorcontrib>Williams, James</creatorcontrib><creatorcontrib>Eisenhut, Carol</creatorcontrib><creatorcontrib>Hook, Edward W.</creatorcontrib><creatorcontrib>Van Der Pol, Barbara</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>Applied Social Sciences Index & Abstracts (ASSIA)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Sexually transmitted diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Taylor, Stephanie N.</au><au>Liesenfeld, Oliver</au><au>Lillis, Rebecca A.</au><au>Body, Barbara A.</au><au>Nye, Melinda</au><au>Williams, James</au><au>Eisenhut, Carol</au><au>Hook, Edward W.</au><au>Van Der Pol, Barbara</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of the Roche cobas® CT/NG Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Male Urine</atitle><jtitle>Sexually transmitted diseases</jtitle><addtitle>Sex Transm Dis</addtitle><date>2012-07-01</date><risdate>2012</risdate><volume>39</volume><issue>7</issue><spage>543</spage><epage>549</epage><pages>543-549</pages><issn>0148-5717</issn><eissn>1537-4521</eissn><coden>STRDDM</coden><abstract>Background: The Roche cobas® CT/NG test (c4800), performed on the cobas 4800 system, is a new diagnostic assay using an automated workstation to isolate nucleic acids from clinical specimens and a real-time instrument for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). This study compared the performance characteristics of the c4800 with the Becton Dickinson ProbeTec™ CT/GC Qx assay (Qx) and Gen-Probe® Aptima Combo 2 (AC2) assay for the detection of CT and NG in male urine using patient-infected-status (PIS). Methods: Urine and urethral swabs were obtained from men attending STD, family planning, or OB/GYN clinics from 11 geographically distinct locations. Aliquot order was randomized for urine specimens x between AC2, c4800, and Qx. Urethral swabs were randomized bex tween AC2 and Qx. Urethral swabs were only used to define PIS and were not tested on the c4800. A participant was considered infected if the 2 comparator assays with different molecular targets had positive results from either sample type. Results: A total of 790 men were screened, with 768 évaluable for CT and NG. Symptoms were reported in 296 (38.5%) participants. For urine, the overall sensitivity and specificity of the c4800 assay for CT were 97.6% and 99.5%, respectively, when compared with PIS. Sensitivity and specificity for NG were 100% and 99.7%, respectively. Conclusions: The c4800 has excellent sensitivity and specificity for male urine specimens when compared with PIS. Assay performance was similar in symptomatic and asymptomatic men and was equivalent to nucleic acid amplification tests that are currently on the market.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins</pub><pmid>22706217</pmid><doi>10.1097/olq.0b013e31824e26ff</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Sexually transmitted diseases, 2012-07, Vol.39 (7), p.543-549 |
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| source | MEDLINE; Applied Social Sciences Index & Abstracts (ASSIA); JSTOR Archive Collection A-Z Listing |
| subjects | Adolescent Adult Bacterial diseases Bacterial diseases of the genital system Bioassays Biological and medical sciences Chlamydia Chlamydia Infections - diagnosis Chlamydia Infections - urine Chlamydia trachomatis Chlamydia trachomatis - genetics Chlamydia trachomatis - isolation & purification Detection DNA, Bacterial - isolation & purification Epidemiology. Vaccinations General aspects Gonorrhea - diagnosis Gonorrhea - urine Gonorrhoea Human bacterial diseases Human infectious diseases. Experimental studies and models Humans Infectious diseases Male Medical sciences Medical screening Men Middle Aged Neisseria gonorrhoeae - genetics Neisseria gonorrhoeae - isolation & purification Nucleic Acid Amplification Techniques - methods Original Study Sensitivity Sensitivity and Specificity Urethra - microbiology Urethra - pathology Urinalysis Urine Young Adult |
| title | Evaluation of the Roche cobas® CT/NG Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Male Urine |
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