FDA Clears Home Urine Collection Kit for STI Testing - Scorecard - MDSpire
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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.

  • By

  • Kathryn Wighton

  • June 11, 2026

  • 2 min

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

At a Glance

CategoryDetail
ConditionSexually Transmitted Infections (STIs)
Key MechanismsNucleoPrecision Technology stabilizes DNA and RNA in urine specimens.
Target PopulationPatients requiring STI testing.
Care SettingHome 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.

Related Resources & Content

Original Source(s)

FDA Clears Home Urine Collection Kit for STI Testing

  • by Kathryn Wighton

  • June 11, 2026

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