New real-time PCR test for fast and reliable detection of Chlamydia trachomatis

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA), a leading provider of molecular diagnostics products, announces the development of the CE-marked artus® C. trachomatis Plus PCR Kit,* a highly sensitive, qualitative, 90-minute test for detection of Chlamydia trachomatis (C. trachomatis), even in the early stages of chlamydia infection.

Chlamydia, caused by C. trachomatis, is one of the most common sexually transmitted diseases (STD). In addition to urogenital disease, C. trachomatis can also cause trachoma — a chronic, recurrent infection of the conjunctiva and cornea, especially widespread in the tropics. According to the World Health Organization (WHO), 500 million people worldwide are in danger of infection, over 140 million are already infected, and more than 6 million have been blinded due to chlamydia infection, mostly in developing countries.

The C. trachomatis bacterium contains 5 to 10 copies of a conserved 7.5 kb cryptic plasmid. Using this plasmid as a target enables highly sensitive detection of C. trachomatis. However, since plasmid-free C. trachomatis bacteria have also been previously detected, conventional tests for C. trachomatis that are based solely on detection of the chlamydial cryptic plasmid do not always provide reliable testing. In order to detect plasmid-free variants of C. trachomatis, QIAGEN Hamburg GmbH has developed a detection system that detects a region of the ompA gene in addition to sequences on the cryptic plasmid.

“This highly sensitive, qualitative detection system enables early detection of chlamydia during routine testing, enabling diagnosis of chlamydia infection in the early stages of infection, even with plasmid-free variants of C. trachomatis. This is a significant step forward in chlamydia detection,” said Dr. Ulrich Spengler, managing director of QIAGEN Hamburg GmbH, “because serious consequences, such as sterility and blindness, can be prevented by early treatment. In contrast to traditional methods, the artus C. trachomatis Plus PCR Kit is the only system worldwide that detects both the chlamydial cryptic plasmid and the ompA gene in parallel.”

artus C. trachomatis Plus PCR Kits are ready-to-use reagent systems for detection of C. trachomatis DNA by real-time PCR (polymerase chain reaction). An internal control, supplied with the kits, serves as a control for DNA purification and to detect false negatives due to possible PCR inhibition. Excellent sensitivity and specificity has been demonstrated during validation of the kits using swab, urine, and sperm samples. artus C. trachomatis Plus PCR Kits are CE-marked and licensed for PCR. The kits are available for use with LightCycler® Instruments 1.1, 1.2, 1.5, or 2.0, with the Rotor-Gene™ 3000, or with the artus 3000™.

* artus C. trachomatis Plus PCR Kits are not available in the USA.