FDA Clears Home Urine Collection Kit for STI Testing - Takeaways - MDSpire

FDA Clears Home Urine Collection Kit for STI Testing

The clearance enables a validated mail-in workflow for self-collected urine specimens processed on Roche cobas systems.

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The FDA has cleared the Colli-Pee Dx Urine Collection Kit for at-home STI testing using Roche assays.
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The kit allows collection of first-void urine specimens for detecting Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma.
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It incorporates NucleoPrecision Technology to stabilize DNA and RNA in urine specimens at ambient temperatures.
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Health care providers can prescribe the kit, enabling direct mail-in specimen collection for laboratory testing.
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OraSure Technologies aims to enhance user-friendly testing options in decentralized settings with this innovation.