The US Food and Drug Administration has cleared OraSure Technologies' Colli-Pee Dx Urine Collection Kit for at-home collection of first-void urine specimens use with Roche assays that detect Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium, according to a press release from OraSure Technologies.

The collection kit is authorized for use with Roche molecular assays performed on the cobas 5800, 6800, and 8800 systems. According to OraSure, the clearance allows patients to collect first-void urine specimens at home or in another private setting.

OraSure said the Colli-Pee Dx Urine Collection Kit incorporates NucleoPrecision Technology, which is designed to stabilize DNA and RNA in urine specimens. The company stated that the technology maintains sample integrity at ambient temperatures.

According to the announcement, health care providers can prescribe the collection kit, and laboratories can receive self-collected urine specimens directly from patients' homes for processing on Roche cobas molecular diagnostic platforms. The cleared workflow supports mail-in specimen collection and high-volume laboratory testing.

The Colli-Pee Dx Urine Collection Kit is intended to collect a measured first-void urine specimen while achieving the specified specimen-to-preservative ratio used for testing, stated OraSure. The company identified that ratio as an important factor in the detection of sexually transmitted infections.

“We are committed to delivering user-friendly tests and collection devices that can be conveniently used in decentralized settings, and this clearance reflects meaningful progress on our innovation roadmap,” said Carrie Eglinton Manner, president and chief executive officer of OraSure Technologies.

OraSure said the Colli-Pee Dx Urine Collection Kit will be distributed through its subsidiary DNA Genotek.

Source: OraSure Technologies, Inc