FDA approves first Point-of-Care Test for Chlamydia and Gonorrhea
The US food and drug administration has cleared first Point-of-Care Test for Chlamydia and Gonorrhea. The use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. 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 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 ability to diagnose at a point-of-care setting will help with more quickly and appropriately treating sexually-transmitted infections, which is a major milestone in helping patients," said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "More convenient testing with quicker results can help patients get access to the most appropriate treatment. According to the CDC, one in five Americans are diagnosed with sexually transmitted infections every year, which is why access to faster diagnostic results and faster, more appropriate treatments will make significant strides in combatting these infections."
The Binx Health IO CT/NG Assay processes a single-use cartridge with samples collected using female vaginal swabs and male urine specimens. The test is performed while the patient waits, potentially allowing for faster diagnosis and treatment.
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