Clinical Report: FDA Clears Home Urine Collection Kit for STI Testing

Overview

The FDA has cleared the Colli-Pee Dx Urine Collection Kit for at-home collection of first-void urine specimens for STI testing. This kit is designed for use with Roche assays to detect Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.

Background

The clearance of the Colli-Pee Dx Urine Collection Kit represents a significant advancement in the accessibility of STI testing. With rising rates of STIs, innovative solutions for early detection and treatment are crucial. This kit allows patients to collect specimens in a private setting, potentially increasing testing rates and reducing transmission.

Data Highlights

The Colli-Pee Dx Urine Collection Kit is authorized for use with Roche molecular assays on cobas 5800, 6800, and 8800 systems. It incorporates NucleoPrecision Technology to stabilize DNA and RNA in urine specimens, maintaining sample integrity at ambient temperatures.

Key Findings

• The Colli-Pee Dx Urine Collection Kit is cleared for at-home use, enhancing patient convenience.
• It is specifically designed for first-void urine specimens, which are crucial for accurate STI detection.
• The kit supports mail-in specimen collection, facilitating high-volume laboratory testing.
• It is authorized for use with assays that detect four STIs: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.
• The technology used in the kit ensures the preservation of specimen integrity during transport.

Clinical Implications

Healthcare providers can prescribe this kit to improve access to STI testing, particularly for populations that may face barriers to traditional testing methods. The ability to collect specimens at home may lead to increased testing rates and earlier diagnosis of STIs.

Conclusion

The FDA's clearance of the Colli-Pee Dx Urine Collection Kit marks a pivotal step in enhancing STI testing accessibility and may contribute to improved public health outcomes.

Related Resources & Content

1. OraSure Technologies, Inc., Street Insider, 2026 -- FDA Clearance that Expands Patient-Friendly Access to Testing for Sexually Transmitted Infections
2. Associated Press Health, AP News, 2023 -- FDA-approved at-home tests available for common sexually transmitted diseases
3. CDC, CDC Guidelines -- Chlamydial Infections - STI Treatment Guidelines
4. conexiant — FDA Clears At-Home HPV Screening Tool
5. Infection — Portable Isothermal Loop-Mediated Nucleic Acid Amplification for Quick Detection of Four Bacterial Sexually Transmitted Infections
6. the asco post — FDA Approves At-Home Self-Collection Device for Cervical Cancer Screening
7. FDA Clears At-Home HPV Screening Tool
8. Portable Isothermal Loop-Mediated Nucleic Acid Amplification for Quick Detection of Four Bacterial Sexually Transmitted Infections
9. OraSure Technologies, Inc. Announces FDA Clearance that Expands Patient‑Friendly Access to Testing for Sexually Transmitted Infections
10. Chlamydial Infections - STI Treatment Guidelines
11. At-home specimen self-collection as an additional testing strategy for chlamydia and gonorrhoea: a systematic literature review and meta-analysis - PMC