FDA clears first nucleic acid amplification test to detect Trichomonas Vaginalis
APTIMA assay will improve detection of a potentially serious sexually transmitted infection that is common in women of all ages
The US Food and Drug Administration (FDA) has cleared for marketing Gen-Probe’s APTIMA Trichomonas vaginalis assay on the fully automated TIGRIS system.
The APTIMA assay is the first amplified nucleic acid test specifically cleared to detect Trichomonas vaginalis, the most common curable sexually transmitted infection in the US. The assay may be used to test clinician-collected endocervical or vaginal swabs, urine and specimens collected in PreservCyt solution from symptomatic or asymptomatic women.
‘We believe our APTIMA Trichomonas assay will improve detection of a potentially serious sexually transmitted infection that is common in women of all ages,’ said Carl Hull, Gen-Probe's president and ceo. ‘Our assay will provide a convenient tool for physicians and laboratories because it employs the same technology as our market-leading tests for Chlamydia and gonorrhea, can be used with the same female samples, and runs on our unique, fully automated TIGRIS system.’
Trichomonas is a sexually transmitted parasite that causes vaginitis, urethritis and cervicitis in women. If left untreated, complications can include premature labour, low-birth-weight offspring and premature membrane rupture in pregnancy. The US Centers for Disease Control estimate that 7.4 million American men and women are infected with Trichomonas annually.
Screening for Trichomonas is limited today due in part to the shortfalls of current testing techniques. Most testing currently is done via culture methods, which are slow and less sensitive than molecular tests, or ‘wet mount’, which requires the microscopic examination of a sample shortly after it is collected and is even less sensitive than culture.