Abbott today announced that a highly sensitive new test for the simultaneous detection of the sexually transmitted pathogens Chlamydia trachomatis (CT) and Neissera gonorrhoeae (NG) has received CE Mark certification, allowing it to be marketed in the European Union.
The test is designed for use on the Abbott m2000, an automated instrument using magnetic particle and real-time PCR (polymerase chain reaction) technology.
"Chlamydia and gonorrhea are the two most common sexually transmitted diseases in the world, and accurate detection of these infections is extremely important in order to avoid serious illness," said Edward Michael, president, Abbott Molecular. "The Abbott RealTime CT/NG assay combined with the automated Abbott m2000 system gives European laboratories an important new option for delivering highly reliable test results to patients quickly and efficiently."
Amplified nucleic acid tests for detection of chlamydia and gonorrhea are accurate and, unlike conventional methods, can be performed non-invasively on urine samples.
The Abbott CT/NG test was developed for use on the Abbott m2000, which uses real-time PCR technology, sometimes referred to as "molecular photocopying." Real-time PCR enables the production of large quantities of DNA from very small samples in a short period of time, making it possible to detect extremely low levels of the bacteria's genetic material. The m2000 automates all critical steps of the process, from sample preparation to data analysis, allowing laboratories to process molecular tests efficiently and accurately.
According to the World Health Organization, more than 300 million cases of sexually transmitted diseases occur throughout the world every year, including more than 85 million new cases of chlamydia and more than 55 million new cases of gonorrhea. About 80 percent of women and 10 percent of men who are infected do not have symptoms. An infected person can transmit either chlamydia or gonorrhea anytime whether or not symptoms are present.
"If left untreated, sexually transmitted diseases like chlamydia and gonorrhea can lead to serious complications, including pelvic inflammatory disease, urethritis and sterility in both women and men," said Timothy Stenzel, M.D., Ph.D., medical director, Abbott Molecular. "Pregnant women can pass infections to their newborns during delivery, causing serious eye infections or blindness. The good news is that both chlamydia and gonorrhea, if detected, can be treated and cured with antibiotics."
The Abbott RealTime CT/NG test will be offered in Europe by Abbott as part of its alliance with Celera Diagnostics. To provide additional testing flexibility for laboratories, the companies will also offer the Abbott RealTime CT assay, a real-time PCR test for the sole detection of Chlamydia trachomatis. Offered along with the tests will be the Abbott multi-Collect Specimen Collection Kit, a unique laboratory tool for the collection and room-temperature transportation of urine specimens and endocervical, male urethral and vaginal swab specimens.
The new CE certification further expands the menu of tests available on the Abbott m2000 system, which also includes real-time PCR tests for HIV-1 and hepatitis C virus. Additional tests are in development for the system, including methods for detecting hepatitis B virus. Abbott plans to submit the CT/NG test for U.S. regulatory approval in 2006.