Abstract

In 2006, a new variant of Chlamydia trachomatis (nvCT) was reported in Sweden. The nvCT contains a deletion that includes the targets for the C. trachomatis genetic diagnostic single-target systems from Roche Diagnostics and Abbott Laboratories. Roche and Abbott have now developed certified dual-target assays that can detect the nvCT. This study examined the nucleic acid amplification tests (NAATs) currently used (in 2009) for C. trachomatis detection in laboratories from 17 European countries and five countries/regions outside Europe that are participating in the United Kingdom (UK) National External Quality Assessment Service (NEQAS). It further examined changes in these laboratories' testing strategy during the period from 2006 to 2009, and their performance regarding nvCT detection. A UK NEQAS blinded nvCT specimen was distributed to all 283 participating laboratories, which were asked to analyse the specimen according to their routine C. trachomatis diagnostic protocols for endocervical swabs. BD ProbeTec was the most commonly used NAAT, followed by Cobas Amplicor, Cobas TaqMan, and Aptima. From 2006 to 2009, the use of Cobas Amplicor, which does not detect the nvCT, decreased, but it was still used by 22% (n=57) of responding participants in 59% of the countries, 54 of these 57 used it as first assay. Virtually all of the other participants detected the nvCT correctly. Laboratories using commercial or in house NAATs that do not detect the nvCT are encouraged to carefully monitor their C. trachomatis incidence, participate in effective internal and external quality assurance and controls schemes, and to consider changing their testing system.

Highlights

  • In most middle- and high-resource settings nucleic acid amplification tests (NAATs) are the most commonly used tests for rapid, highly sensitive and specific detection of Chlamydia trachomatis.In 2006, a new variant of C. trachomatis, which contains a 377 bp deletion in the cryptic plasmid, was reported in Sweden [1,2]

  • The aims of this report were to describe the NAATs currently used for C. trachomatis detection in laboratories from European countries (n=17) and countries/regions outside Europe (n=5) that are participating in the United Kingdom (UK) National External Quality Assessment Service (NEQAS)

  • Nucleic acid amplification tests (NAATs) used in 2009 for C. trachomatis diagnostics and changes in testing strategy during 2006-2009 Of the 283 laboratories participating in the scheme, 261 (92.2%) returned results on the new variant of Chlamydia trachomatis (nvCT) specimen

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Summary

Introduction

In 2006, a new variant of C. trachomatis (nvCT), which contains a 377 bp deletion in the cryptic plasmid, was reported in Sweden [1,2]. This deletion includes the genetic targets for commercially available single-target systems that were at the time used worldwide, namely the Amplicor C. trachomatis/Neisseria gonorrhoeae (CT/NG) test, the Cobas Amplicor CT/NG test, and the Cobas TaqMan CT/NG test (Roche Diagnostics), as well as the RealTime CT/NG test (Abbott Laboratories). NvCT was identified in high proportions (10-65%) in most counties across Sweden. Q - PCR Alert Kit (Nanogen), were able to identify the nvCT; these NAATs target(s) are a) the cryptic plasmid (outside the deletion), b) specific 23S and 16S rRNA sequences, c) the ompA gene, d) both the ompA gene and the cryptic plasmid (outside the deletion), and e) the cryptic plasmid (outside the deletion), respectively

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