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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By
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Kathryn Wighton
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June 11, 2026
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Clinical Scorecard: FDA Clears Home Urine Collection Kit for STI Testing
At a Glance
| Category | Detail |
|---|
| Condition | Sexually Transmitted Infections (STIs) |
| Key Mechanisms | NucleoPrecision Technology stabilizes DNA and RNA in urine specimens. |
| Target Population | Patients requiring STI testing. |
| Care Setting | Home or private settings. |
Key Highlights
- Colli-Pee Dx Urine Collection Kit cleared by FDA for at-home use.
- Kit designed for first-void urine specimens with Roche assays.
- Supports mail-in specimen collection and high-volume laboratory testing.
- Maintains sample integrity at ambient temperatures.
- Intended for use with Roche cobas molecular diagnostic platforms.
Guideline-Based Recommendations
Diagnosis
- Use with Roche assays for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.
Management
- Health care providers can prescribe the collection kit.
Monitoring & Follow-up
- Laboratories can receive self-collected urine specimens directly from patients' homes.
Risks
- Proper specimen-to-preservative ratio is critical for accurate STI detection.
Patient & Prescribing Data
Individuals needing STI testing.
User-friendly collection device for decentralized testing.
Clinical Best Practices
- Ensure proper specimen collection to maintain integrity.
- Follow guidelines for specimen-to-preservative ratio.
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