Genzyme Corp has received clearance from the United States Food and Drug Administration to market a new rapid test that will aid in the diagnosis of Trichomonas infection, a frequent cause of vaginitis/vaginosis, and the most common, nonviral sexually transmitted disease in the world.
The OSOM® Trichomonas Rapid Test is an immunochromatographic assay that detects pathogen antigens directly from vaginal swabs. Results are provided within approximately 10 minutes. The test uses color immunochromatographic, capillary flow, dipstick technology that in Genzyme’s clinical study was found to be more sensitive than wet mount. The test procedure is performed by placing a vaginal swab specimen in a test tube containing the kit’s sample buffer and mixing the swab, which solubilizes specific Trichomonas antigens present in the sample. The OSOM Trichomonas Rapid Test stick is then placed in the sample mixture. If the Trichomonas antigens are present in the sample, they will react with the unique immunoassay reagents present in the test stick. The appearance of a visible blue test line along with the red control line indicates a positive result.
Genzyme plans to market its OSOM BVBLUE® Test along with the OSOM Trichomonas Rapid Test. The BVBLUE Test is an aid in the diagnosis of bacterial vaginosis (BV), the most common cause of vaginitis/vaginosis in women. It uses a vaginal swab sample, which is incubated in single-use testing vessels provided in the kit. A reagent in the testing vessels reacts with a specific enzyme secreted by pathogens that are associated with BV. The addition of a drop of developer solution into the testing vessel turns the sample blue or green to indicate a positive result. Results are obtained in about 10 minutes.
Genzyme Corp
(800) 905-4369; www.genzyme.com
