Genzyme Receives Waiver for OSOMR Trichomonas Rapid Test
Genzyme Corporation announced that it has received a Clinical Laboratory Improvement Act (CLIA) waiver from the U.S. food and Drug Administration for its OSOM® Trichomonas Rapid Test. This waiver significantly expands the number of clinics and doctors' offices that can use the test, which AIDS in the diagnosis of trichomonas infection.
The goal of the Clinical Laboratory Improvement Act is to ensure the accuracy of patient test results, regardless of the complexity of the tests and the location where they were performed. Some small labs and doctors' offices are not properly equipped to run certain complex tests. However, because some tests are simple to perform and do not require special training, the act provides a waived designation for these tests, enabling them to be run in smaller settings.
The OSOM® Trichomonas Rapid Test uses immunochromatographic "dipstick" technology that detects pathogenic antigens. Results are rapid, occurring in approximately 10 minutes. In a Genzyme clinical study at six investigational sites, the assay was found to be more sensitive than wet mount. 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.
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