How it works
From urine cup to clinician decision in fifteen minutes.
Five steps, one specimen, no send-out lab. UroSure is designed so a medical assistant can run the workflow at the start of intake and the clinician sees the result before they walk into the room.
The workflow
The five-step workflow.
Designed to slot into the intake routine your clinical staff already runs. Hands-on time is minutes, not the better part of a visit.
- Step 01
Collect
- Patient provides a standard urine specimen in a clean-catch cup — the same collection your clinic already uses for UA and β-hCG.
- No clinician-collected swab required, no venipuncture, no separate collection-room setup.
- Workflow fits walk-in, scheduled, and adolescent-consent visits.
- Step 02
Prepare
- Specimen transfer follows the included instructions for use — no proprietary buffer mixing, no microscopy prep.
- Room-temperature handling at point of care; specific storage and run-window specs are detailed in the IFU.
- No refrigeration or centrifugation required during the run.
- Step 03
Run
- Prepared specimen is loaded into the UroSure cassette; the kit ships with a one-page workflow card for the bench.
- Hands-on time is measured in minutes — staff start the run and return to other intake tasks.
- Instrument requirements and final assay format are detailed in the spec sheet shipped with each case.
- Step 04
Read
- Result is available in approximately fifteen minutes.
- Six analytes are reported on a single readout — no separate panels to reconcile.
- Built-in control band confirms the run is valid before the result is read.
- Step 05
Read & refer
- Preliminary visual result is interpreted during the same visit by a qualified healthcare provider.
- Positive results require confirmatory testing by an alternative laboratory method per your clinic protocol; the visual result on the cassette must not be used alone to determine treatment.
- No result-disclosure phone tag for routine encounters; documentation guidance and a CPT coding reference are included.
Specifications
Product specifications.
The full spec sheet ships with every wholesale case; the table here is the at-a-glance reference.
- Product
- MobiLab 6-in-1 Rapid STI Screening Panel
- Manufacturer
- MobiLab
- Distributor
- UroSure
- Sample type
- Urine
- Read time
- ~15 minutes
- Sensitivity
- 88–97%
- Specificity
- 86–98%
- Storage
- Room temperature
- Regulatory
- FDA-listed IVD
- CLIA status
- Not CLIA-waived (moderate complexity)
What ships
What comes in a wholesale order.
- 01 Each kit contains a collection cup, transfer device, cassette, instructions for use, and lot documentation.
- 02 Case quantity and shelf life are documented on the spec sheet shipped with every order; contact sales for current case sizing.
- 03 Stored at room temperature — no refrigeration or cold-chain logistics.
- 04 Lot traceability documentation included with every case for your QA records.
- 05 Bulk packaging is designed for clinic-shelf storage, not warehouse pallet handling.
Onboarding
Onboarding and training.
- 01 Virtual training session for clinical staff is included with the first order — typically thirty minutes, scheduled at your convenience.
- 02 Laminated one-page workflow card ships in every case for the bench.
- 03 Recorded training video is accessible to all staff at any time.
- 04 Live phone and email support during business hours throughout the relationship.
- 05 Optional in-service visit available for qualifying volume — contact sales to scope.
Billing & coding
CPT reference.
Suggested reference codes for the six analytes UroSure detects. Reimbursement varies by payer; the codes below are reference only and should be confirmed with your billing partner before submission.
CPT code Analyte
87491 Chlamydia trachomatis (CT)
87591 Neisseria gonorrhoeae (NG)
87661 Trichomonas vaginalis (TV)
87563 Mycoplasma genitalium (MG)
87481 Candida (urogenital yeast)
87510 Gardnerella vaginalis (BV indicator)
- Codes are reference only; reimbursement varies by payer.
- Cash-pay practices receive a separate pricing and patient-receipt template.
Compliance & QA
Compliance and QA.
- 01 For In Vitro Diagnostic Use Only. FDA-listed IVD. Preliminary screening only — positive results require confirmatory testing by an alternative laboratory method.
- 02 Not CLIA-waived (moderate complexity). The kit must be run by clinical staff at a CLIA-certified site, not by patients.
- 03 QC log template included with every case for your QA records.
- 04 Proficiency testing guidance is available on request through your sales rep.
- 05 Lot deviation reporting and replacement process is documented in the kit insert and the procurement agreement.
Next step
Schedule a fifteen-minute demo.
We'll walk through the panel, the workflow, and pricing scoped to your practice — without a sales pitch.