Roche has secured 510(k) clearance from the US Food and Drug Administration’s (FDA) for Treponema pallidum assay to assist clinicians in the diagnosis of syphilis infection.
The assay detects antibodies to Treponema pallidium for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments, including the cobas e 411, cobas e 601, cobas e 602 and MODULAR ANALYTICS E170 analyzers.
The Roche Syphilis treponemal antibody test has several advantages such as specific screening test giving an objective result, high thoroughput on automated analyzer and high specificity.
Syphilis is a sexually transmitted disease, but can also be transmitted from a mother to fetus during pregnancy and birth.
About 80% of syphilis infected pregnant women can experience adverse pregnancy outcomes which can result in more than 40% prenatal mortality rate.
The World Health Organization (WHO) recommends that all women should be tested at their first antenatal visit and again during the third trimester. It tested positive, WHO recommends to test their partners also.
In US, the Centers for Disease Control (CDC) recommends syphilis screening for all pregnant women and repeat testing as and when needed for protecting the health of mothers and their infants.
The FDA’s newly approved Treponema pallidum assay will compliment the toxoplasmosis, rubella, cytomegalovirus, herpes (TORCH) menu offerings of HSV-1 and 2 to diagnose and determine the immune status of the mother to prevent mother-to-child transmissions and provide in time treatments to prevent severe birth defects.
The CDC also recommends annual screening for all sexually active gay, bisexual and men who have sex with other men (MSM).
MSM who have multiple or anonymous partners should get screened more frequently for sexually transmitted diseases (STDs) between 3 to 6 month intervals. Syphilis infection can facilitate in HIV infection.
Roche Diagnostics chief medical officer Alan Wright said: "With the FDA approval of this fully automated assay, clinicians are now able to deliver clinically accurate, real-time results in as little as 18 minutes.
"Having a tool like this available ensures they're able to provide confident, appropriate and time-sensitive patient care in managing syphilis."