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Point-of-care test for detection of urogenital chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname
In general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity results. However, one study sponsored by the manufacturer (Diagnostics for the Real World) reported over 80% sensitivity with their Chlamydia Rapid Test (CRT...
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| Published in: | PloS one 2012-02, Vol.7 (2), p.e32122-e32122 |
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| creator | van der Helm, Jannie J Sabajo, Leslie O A Grunberg, Antoon W Morré, Servaas A Speksnijder, Arjen G C L de Vries, Henry J C |
| description | In general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity results. However, one study sponsored by the manufacturer (Diagnostics for the Real World) reported over 80% sensitivity with their Chlamydia Rapid Test (CRT). We evaluated the performance of this CRT in a non-manufacturer-sponsored trial.
Between July 2009 and February 2010, we included samples from 912 women in both high- and low-risk clinics for sexually transmitted infections (STIs) in Paramaribo, Suriname. Sensitivity, specificity, positive- and negative predictive values (PPV and NPV) for CRT compared to NAAT (Aptima, Gen-Probe) were determined. Quantitative Ct load and human cell load were determined in all CRT and/or NAAT positive samples.
CRT compared to NAAT showed a sensitivity and specificity of 41.2% (95% CI, 31.9%-50.9%) and 96.4% (95% CI, 95.0%-97.5%), respectively. PPV and NPV were 59.2% (95% CI, 47.5%-70.1%) and 92.9% (95% CI, 91.0%-94.5%), respectively. Quantitative Ct bacterial load was 73 times higher in NAAT-positive/CRT-positive samples compared to NAAT-positive/CRT-negative samples (p |
| doi_str_mv | 10.1371/journal.pone.0032122 |
| format | article |
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Between July 2009 and February 2010, we included samples from 912 women in both high- and low-risk clinics for sexually transmitted infections (STIs) in Paramaribo, Suriname. Sensitivity, specificity, positive- and negative predictive values (PPV and NPV) for CRT compared to NAAT (Aptima, Gen-Probe) were determined. Quantitative Ct load and human cell load were determined in all CRT and/or NAAT positive samples.
CRT compared to NAAT showed a sensitivity and specificity of 41.2% (95% CI, 31.9%-50.9%) and 96.4% (95% CI, 95.0%-97.5%), respectively. PPV and NPV were 59.2% (95% CI, 47.5%-70.1%) and 92.9% (95% CI, 91.0%-94.5%), respectively. Quantitative Ct bacterial load was 73 times higher in NAAT-positive/CRT-positive samples compared to NAAT-positive/CRT-negative samples (p<0.001). Human cell load did not differ between true-positive and false-negative CRT results (p = 0.835). Sensitivity of CRT in samples with low Ct load was 12.5% (95% CI, 5.2%-24.2%) and in samples with high Ct load 73.5% (95% CI, 59.9%-84.4%).
The sensitivity of CRT for detecting urogenital Ct in this non-manufacturer-sponsored study did not meet the expectations as described previously. The CRT missed samples with a low Ct load. Improved POC are needed as meaningful diagnostic to reduce the disease burden of Ct.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0032122</identifier><identifier>PMID: 22393383</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acids ; Adult ; Bacteria ; Biology ; Cells (Biology) ; Chlamydia ; Chlamydia infections ; Chlamydia Infections - diagnosis ; Chlamydia Infections - microbiology ; Chlamydia trachomatis ; Chlamydia trachomatis - genetics ; Clinics ; Computed tomography ; Corporate sponsorship ; Cost analysis ; Diagnostic systems ; Disease transmission ; Female ; Health aspects ; Health risks ; Health services ; Humans ; Infections ; Infectious diseases ; Laboratories ; Medical tests ; Medicine ; Neisseria gonorrhoeae ; Nucleic Acid Amplification Techniques - methods ; Pay-per-view television ; Performance evaluation ; Point-of-Care Systems - standards ; Predictive Value of Tests ; Public health ; Reagent Strips ; Sensitivity ; Sensitivity analysis ; Sensitivity and Specificity ; Sexually transmitted disease prevention ; Sexually transmitted diseases ; Sexually Transmitted Diseases - diagnosis ; Sexually Transmitted Diseases - microbiology ; STD ; Suriname ; Trends ; Vaginal Smears ; Womens health ; Young Adult</subject><ispartof>PloS one, 2012-02, Vol.7 (2), p.e32122-e32122</ispartof><rights>COPYRIGHT 2012 Public Library of Science</rights><rights>2012 van der Helm et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License (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>van der Helm et al. 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c691t-6dad96d25036cac34eccebdbc0b069e2dd852e99c415df1d38c47a81956000763</citedby><cites>FETCH-LOGICAL-c691t-6dad96d25036cac34eccebdbc0b069e2dd852e99c415df1d38c47a81956000763</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/1333199628/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/1333199628?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22393383$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Dean, Deborah</contributor><creatorcontrib>van der Helm, Jannie J</creatorcontrib><creatorcontrib>Sabajo, Leslie O A</creatorcontrib><creatorcontrib>Grunberg, Antoon W</creatorcontrib><creatorcontrib>Morré, Servaas A</creatorcontrib><creatorcontrib>Speksnijder, Arjen G C L</creatorcontrib><creatorcontrib>de Vries, Henry J C</creatorcontrib><title>Point-of-care test for detection of urogenital chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>In general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity results. However, one study sponsored by the manufacturer (Diagnostics for the Real World) reported over 80% sensitivity with their Chlamydia Rapid Test (CRT). We evaluated the performance of this CRT in a non-manufacturer-sponsored trial.
Between July 2009 and February 2010, we included samples from 912 women in both high- and low-risk clinics for sexually transmitted infections (STIs) in Paramaribo, Suriname. Sensitivity, specificity, positive- and negative predictive values (PPV and NPV) for CRT compared to NAAT (Aptima, Gen-Probe) were determined. Quantitative Ct load and human cell load were determined in all CRT and/or NAAT positive samples.
CRT compared to NAAT showed a sensitivity and specificity of 41.2% (95% CI, 31.9%-50.9%) and 96.4% (95% CI, 95.0%-97.5%), respectively. PPV and NPV were 59.2% (95% CI, 47.5%-70.1%) and 92.9% (95% CI, 91.0%-94.5%), respectively. Quantitative Ct bacterial load was 73 times higher in NAAT-positive/CRT-positive samples compared to NAAT-positive/CRT-negative samples (p<0.001). Human cell load did not differ between true-positive and false-negative CRT results (p = 0.835). Sensitivity of CRT in samples with low Ct load was 12.5% (95% CI, 5.2%-24.2%) and in samples with high Ct load 73.5% (95% CI, 59.9%-84.4%).
The sensitivity of CRT for detecting urogenital Ct in this non-manufacturer-sponsored study did not meet the expectations as described previously. The CRT missed samples with a low Ct load. Improved POC are needed as meaningful diagnostic to reduce the disease burden of Ct.</description><subject>Acids</subject><subject>Adult</subject><subject>Bacteria</subject><subject>Biology</subject><subject>Cells (Biology)</subject><subject>Chlamydia</subject><subject>Chlamydia infections</subject><subject>Chlamydia Infections - diagnosis</subject><subject>Chlamydia Infections - microbiology</subject><subject>Chlamydia trachomatis</subject><subject>Chlamydia trachomatis - genetics</subject><subject>Clinics</subject><subject>Computed tomography</subject><subject>Corporate sponsorship</subject><subject>Cost analysis</subject><subject>Diagnostic systems</subject><subject>Disease transmission</subject><subject>Female</subject><subject>Health aspects</subject><subject>Health risks</subject><subject>Health services</subject><subject>Humans</subject><subject>Infections</subject><subject>Infectious diseases</subject><subject>Laboratories</subject><subject>Medical tests</subject><subject>Medicine</subject><subject>Neisseria gonorrhoeae</subject><subject>Nucleic Acid Amplification Techniques - methods</subject><subject>Pay-per-view television</subject><subject>Performance evaluation</subject><subject>Point-of-Care Systems - standards</subject><subject>Predictive Value of Tests</subject><subject>Public health</subject><subject>Reagent Strips</subject><subject>Sensitivity</subject><subject>Sensitivity analysis</subject><subject>Sensitivity and Specificity</subject><subject>Sexually transmitted disease prevention</subject><subject>Sexually transmitted diseases</subject><subject>Sexually Transmitted Diseases - diagnosis</subject><subject>Sexually Transmitted Diseases - microbiology</subject><subject>STD</subject><subject>Suriname</subject><subject>Trends</subject><subject>Vaginal Smears</subject><subject>Womens health</subject><subject>Young Adult</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNqNk11rFDEUhgdRrFb_gWhAULzYNR8zmcmNUIofhULFqrchm5zZTckka5Lpun_DX2ym3Zau9EJyka_nfU9yklNVLwieE9aS9xdhjF65-Tp4mGPMKKH0QfWECEZnnGL28M74oHqa0gXGDes4f1wdUMoEYx17Uv35GqzPs9DPtIqAMqSM-hCRgQw62-BR6NEYwxK8zcohvXJq2BqrkPVoEwbwKK3CJiEXNiiBTzbbS5u3c3SE1hCL1aC8BgSXyo3qyjDl0Wwned4EpJ31Vqdpej5G69UAz6pHvXIJnu_6w-rHp4_fj7_MTs8-nxwfnc40FyTPuFFGcEMbzLhWmtWgNSzMQuMF5gKoMV1DQQhdk8b0xLBO163qiGg4xrjl7LB6de27diHJXTqTJIwxIgSnXSFOrgkT1IVcRzuouJVBWXm1EOJSqpitdiBZMa9ro1pCcAnYd5QLLUytcaNJp0Xx-rCLNi4GMBp8jsrtme7veLuSy3ApGRW4aVgxeLsziOHXWN5JDjZpcE55CGOSgnJe1y1pC_n6H_L-y-2opSrnt74PJayePOVR3bYY15xNSZrfQ5VmYLC6fL3elvU9wbs9QWEy_M5LNaYkT86__T979nOffXOHXYFyeZWCG6cvlfbB-hrUMaQUob_NMcFyqpybbMipcuSucors5d33uRXdlAr7C4I-FYA</recordid><startdate>20120229</startdate><enddate>20120229</enddate><creator>van der Helm, Jannie J</creator><creator>Sabajo, Leslie O A</creator><creator>Grunberg, Antoon W</creator><creator>Morré, Servaas A</creator><creator>Speksnijder, Arjen G C L</creator><creator>de Vries, Henry J C</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>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>20120229</creationdate><title>Point-of-care test for detection of urogenital chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname</title><author>van der Helm, Jannie J ; Sabajo, Leslie O A ; Grunberg, Antoon W ; Morré, Servaas A ; Speksnijder, Arjen G C L ; de Vries, Henry J C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c691t-6dad96d25036cac34eccebdbc0b069e2dd852e99c415df1d38c47a81956000763</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Acids</topic><topic>Adult</topic><topic>Bacteria</topic><topic>Biology</topic><topic>Cells (Biology)</topic><topic>Chlamydia</topic><topic>Chlamydia infections</topic><topic>Chlamydia Infections - diagnosis</topic><topic>Chlamydia Infections - microbiology</topic><topic>Chlamydia trachomatis</topic><topic>Chlamydia trachomatis - genetics</topic><topic>Clinics</topic><topic>Computed tomography</topic><topic>Corporate sponsorship</topic><topic>Cost analysis</topic><topic>Diagnostic systems</topic><topic>Disease transmission</topic><topic>Female</topic><topic>Health aspects</topic><topic>Health risks</topic><topic>Health services</topic><topic>Humans</topic><topic>Infections</topic><topic>Infectious diseases</topic><topic>Laboratories</topic><topic>Medical tests</topic><topic>Medicine</topic><topic>Neisseria gonorrhoeae</topic><topic>Nucleic Acid Amplification Techniques - 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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>van der Helm, Jannie J</au><au>Sabajo, Leslie O A</au><au>Grunberg, Antoon W</au><au>Morré, Servaas A</au><au>Speksnijder, Arjen G C L</au><au>de Vries, Henry J C</au><au>Dean, Deborah</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Point-of-care test for detection of urogenital chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2012-02-29</date><risdate>2012</risdate><volume>7</volume><issue>2</issue><spage>e32122</spage><epage>e32122</epage><pages>e32122-e32122</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>In general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity results. However, one study sponsored by the manufacturer (Diagnostics for the Real World) reported over 80% sensitivity with their Chlamydia Rapid Test (CRT). We evaluated the performance of this CRT in a non-manufacturer-sponsored trial.
Between July 2009 and February 2010, we included samples from 912 women in both high- and low-risk clinics for sexually transmitted infections (STIs) in Paramaribo, Suriname. Sensitivity, specificity, positive- and negative predictive values (PPV and NPV) for CRT compared to NAAT (Aptima, Gen-Probe) were determined. Quantitative Ct load and human cell load were determined in all CRT and/or NAAT positive samples.
CRT compared to NAAT showed a sensitivity and specificity of 41.2% (95% CI, 31.9%-50.9%) and 96.4% (95% CI, 95.0%-97.5%), respectively. PPV and NPV were 59.2% (95% CI, 47.5%-70.1%) and 92.9% (95% CI, 91.0%-94.5%), respectively. Quantitative Ct bacterial load was 73 times higher in NAAT-positive/CRT-positive samples compared to NAAT-positive/CRT-negative samples (p<0.001). Human cell load did not differ between true-positive and false-negative CRT results (p = 0.835). Sensitivity of CRT in samples with low Ct load was 12.5% (95% CI, 5.2%-24.2%) and in samples with high Ct load 73.5% (95% CI, 59.9%-84.4%).
The sensitivity of CRT for detecting urogenital Ct in this non-manufacturer-sponsored study did not meet the expectations as described previously. The CRT missed samples with a low Ct load. Improved POC are needed as meaningful diagnostic to reduce the disease burden of Ct.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>22393383</pmid><doi>10.1371/journal.pone.0032122</doi><tpages>e32122</tpages><oa>free_for_read</oa></addata></record> |
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| language | eng |
| recordid | cdi_plos_journals_1333199628 |
| source | Publicly Available Content Database (Proquest) (PQ_SDU_P3); PubMed Central |
| subjects | Acids Adult Bacteria Biology Cells (Biology) Chlamydia Chlamydia infections Chlamydia Infections - diagnosis Chlamydia Infections - microbiology Chlamydia trachomatis Chlamydia trachomatis - genetics Clinics Computed tomography Corporate sponsorship Cost analysis Diagnostic systems Disease transmission Female Health aspects Health risks Health services Humans Infections Infectious diseases Laboratories Medical tests Medicine Neisseria gonorrhoeae Nucleic Acid Amplification Techniques - methods Pay-per-view television Performance evaluation Point-of-Care Systems - standards Predictive Value of Tests Public health Reagent Strips Sensitivity Sensitivity analysis Sensitivity and Specificity Sexually transmitted disease prevention Sexually transmitted diseases Sexually Transmitted Diseases - diagnosis Sexually Transmitted Diseases - microbiology STD Suriname Trends Vaginal Smears Womens health Young Adult |
| title | Point-of-care test for detection of urogenital chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-25T15%3A15%3A13IST&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=Point-of-care%20test%20for%20detection%20of%20urogenital%20chlamydia%20in%20women%20shows%20low%20sensitivity.%20A%20performance%20evaluation%20study%20in%20two%20clinics%20in%20Suriname&rft.jtitle=PloS%20one&rft.au=van%20der%20Helm,%20Jannie%20J&rft.date=2012-02-29&rft.volume=7&rft.issue=2&rft.spage=e32122&rft.epage=e32122&rft.pages=e32122-e32122&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0032122&rft_dat=%3Cgale_plos_%3EA477004636%3C/gale_plos_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c691t-6dad96d25036cac34eccebdbc0b069e2dd852e99c415df1d38c47a81956000763%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=1333199628&rft_id=info:pmid/22393383&rft_galeid=A477004636&rfr_iscdi=true |