FDA Approves First Point Of Care Test For Chlamydia And Gono
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
The U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings. This action is the result of the FDA granting a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for the Binx Health IO CT/NG Assay.

"The ability to diagnose at a point-of-care setting will help with more quickly and appropriately treating sexually-transmitted infections" According to the CDC, one in five Americans are diagnosed with sexually transmitted infections every year. More convenient testing with quicker results can help patients get access to the most appropriate treatment.

Following clearance for use by individuals trained in the test procedure and under the oversight of a CLIA certified laboratory that meets the requirements for high or moderate complexity testing, Binx Health applied for a CLIA Waiver by Application based on data demonstrating that the test meets the criteria for a CLIA waiver. The waiver granted today broadens its use to point-of-care settings operating under a CLIA Certificate of Waiver.

The test, which uses female vaginal swabs and male urine specimens, can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually transmitted infections chlamydia and gonorrhea, respectively.

The test is performed while the patient is present, providing an actionable result in approximately 30 minutes. The test’s performance was evaluated in females 16 years and older and in males 17 years and older and was demonstrated to be comparable to tests performed in a CLIA certified laboratory that meets the requirements for high or moderate complexity testing.

Source:
https://www.fda.gov/news-events/press-announcements/fda-allows-first-point-care-chlamydia-and-gonorrhea-test-be-used-more-near-patient-care-settings
Like
Comment
Share