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Molecular Pathology Laboratory Network, Inc. (MPLN) was one of the first reference laboratories to offer the GEN-PROBE APTIMA® Trichomonas vaginalis Assay on the fully automated TIGRIS® system.
This test was approved by the FDA on April 20, and MPLN was one of the clinical trial site laboratories used by GEN-PROBE to support the FDA submission of the assay for IVD clearance. This assay may be used to test clinician-collected endocervical or vaginal swabs, urine, and samples collected in PreservCyt (ThinPrep) liquid based cytology media and can use the same samples submitted for CTNG testing.
Trichomonas is a sexually transmitted parasite that causes vaginitis, urethritis and cervicitis in women, and if left untreated can be associated with premature labor, low-birth-weight infants, and premature rupture of membranes. Trichomonas vaginalis is the most common curable sexually transmitted disease pathogen in the U.S., and the CDC estimates that more than 7 million Americans are infected with Trichomonas annually. A large percentage of these cases are in asymptomatic individuals.
The new GEN-PROBE APTIMA® Trichomonas vaginalis Assay is a nucleic acid amplification test (NAAT) that allows for the detection of T. vaginalis with much greater sensitivity and speed than conventional wet mount or culture methodologies allowing for more accurate and timely detection and improved patient management.
For more information about this new test, contact a client service specialist at 800.932.2943. |