Roche chlamydia test approved in Europe

Jun 15 2008

Roche has announced that its new test for detection of Chlamydia trachomatis has received CE Mark certification, allowing it to be sold for clinical use in the European Union.

It is designed with a dual target approach to help ensure reliability of test results even when mutations occur in the bacteria's cryptic plasmid DNA. According to Eurosurveillance, a leading independent scientific journal, Chlamydia trachomatis is the most commonly reported sexually transmitted disease in Europe. Although it often causes no symptoms, Chlamydia can, if left untreated, lead to complications such as pelvic inflammatory disease or infertility in women.

"Unexpected mutations in the DNA of an infectious agent such as Chlamydia can disrupt laboratory testing and, by extension, proper treatment of patients," said Teresa L. Wright, M.D., O.B.E., Chief Medical Officer at Roche Molecular Diagnostics. "Because it is impossible to predict when these mutations will occur, we have designed this test to detect all Chlamydia strains that may cause a deletion in the cryptic plasmid, including the variant originally detected in Sweden in 2006."

Chlamydia trachomatis is often referred to as a "silent" sexually transmitted disease because approximately three quarters of infected women have no symptoms. Once detected, Chlamydia trachomatis can easily be treated with antibiotics. If left untreated, health risks can include chronic pelvic pain, pelvic inflammatory disease, potentially fatal ectopic pregnancy, increased risk of HIV infection if exposed, and infertility.

The highly sensitive and reliable COBAS TaqMan CT Test v2.0 simultaneously detects two targets within the C. trachomatis cryptic plasmid and genome target DNA. In contrast to earlier generation tests, the COBAS TaqMan CT Test v2.0 offers real-time PCR testing on the automated COBAS TaqMan 48 Analyzer. This automated platform can produce up to 48 tests per run and provide results in only 2.5 hours after sample preparation. Amplification and detection in a closed system combined with Roche's proprietary AmpErase enzyme and internal controls for each test help prevent cross contamination. This enhances test results integrity and quality control in laboratories.