Abstract:
OBJECTIVES:We evaluated the performance of an enzymatic point-of-care rapid test for Chlamydia trachomatis (CT) (the BioChekSwab CT Rapid Test, EnZtek Diagnostics, Rio Vista, California, USA), which detects CT's Peptidase 123CBV enzyme and provides a result 15 min after specimen collection. METHODS:Two endocervical swabs, including one BioChekSwab, per person were obtained from 137 women who participated in a reproductive health study in Rwanda. The BioChekSwab was processed according to the manufacturer's instructions. A substrate was squirted over the swab by the study physician immediately after collection, and another reagent was released over the swab tip at arrival in the laboratory. The test was considered positive if a blue colour developed within 2 min. The other regular flocked endocervical swab was processed at the Institute of Tropical Medicine (ITM), Belgium, using a testing algorithm: Abbott RealTime CT/Neisseria gonorrhoeae (NG) assay with the confirmation of positive results by an in-house real-time PCR assay. RESULTS:Of the 137 women, nine were CT positive by the testing algorithm. All nine positive results were missed by the BioChekSwab assay and four false-positive results were obtained. The sensitivity was therefore 0% (95% CI 0% to 33.6%) and the specificity was 96.9% (95% CI 92.2% to 99.1%). CONCLUSIONS:The BioChekSwab Rapid Test, although ISO13485 certified and Conformitée Européenne (CE) labelled, lacked any sensitivity in our setting.
journal_name
Sex Transm Infectjournal_title
Sexually transmitted infectionsauthors
De Baetselier I,Mwambarangwe L,Cuylaerts V,Musengamana V,Agaba S,Kestelyn E,van de Wijgert J,Crucitti Tdoi
10.1136/sextrans-2015-052202subject
Has Abstractpub_date
2016-09-01 00:00:00pages
430-2issue
6eissn
1368-4973issn
1472-3263pii
sextrans-2015-052202journal_volume
92pub_type
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journal_title:Sexually transmitted infections
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journal_title:Sexually transmitted infections
pub_type: 杂志文章
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journal_title:Sexually transmitted infections
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doi:10.1136/sextrans-2015-052088
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pub_type: 杂志文章,随机对照试验
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journal_title:Sexually transmitted infections
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更新日期:2017-02-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章
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journal_title:Sexually transmitted infections
pub_type: 杂志文章
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更新日期:2016-03-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章
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更新日期:2006-04-01 00:00:00
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更新日期:2015-09-01 00:00:00
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更新日期:2020-05-01 00:00:00
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pub_type: 杂志文章
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更新日期:2004-02-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章
doi:10.1136/sti.76.5.395
更新日期:2000-10-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章,评审
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更新日期:2017-12-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 临床试验,杂志文章,多中心研究
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journal_title:Sexually transmitted infections
pub_type: 杂志文章,随机对照试验
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更新日期:2014-02-01 00:00:00
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journal_title:Sexually transmitted infections
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更新日期:2014-08-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章
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更新日期:2014-08-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章
doi:10.1136/sextrans-2016-053072
更新日期:2017-12-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章,多中心研究
doi:10.1136/sti.2008.033043
更新日期:2009-04-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章,多中心研究
doi:10.1136/sextrans-2015-052121
更新日期:2016-08-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章
doi:10.1136/sextrans-2015-052475
更新日期:2016-11-01 00:00:00
abstract:OBJECTIVE:To develop a risk assessment algorithm that will increase the identification and treatment of women with cervical infection in rural Haiti. METHODS:Study participants were randomly selected from new patients who accessed services at a women's health clinic in rural Haiti between June 1999 and December 2002. ...
journal_title:Sexually transmitted infections
pub_type: 杂志文章
doi:10.1136/sti.2005.016733
更新日期:2006-04-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章,多中心研究
doi:10.1136/sextrans-2013-051065
更新日期:2013-12-01 00:00:00
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journal_title:Sexually transmitted infections
pub_type: 杂志文章
doi:10.1136/sti.2009.037986
更新日期:2009-12-01 00:00:00