Regulatory & intended use
Important medical disclaimer
For In Vitro Diagnostic Use Only. UroSure MobiLab is a screening tool, not a diagnostic device. This test is not a substitute for professional medical advice, diagnosis, or treatment. A positive result means you should consult with a qualified healthcare provider for confirmatory testing and treatment. A negative result does not rule out infection, especially if symptoms are present or if testing occurs during the window period after exposure.
Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or sexual health concern. Never disregard professional medical advice or delay in seeking it because of a test result. Use exactly as directed in the kit insert. Results are visual: a control (C) line must appear to confirm the test is valid.
Intended use
UroSure MobiLab is intended for in vitro diagnostic use only, as a screening aid for the qualitative detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), Candida species, and Gardnerella vaginalis (BV indicator) in urine specimens. UroSure MobiLab is not a stand-alone diagnostic device; positive results require confirmatory testing and clinical correlation by a qualified healthcare provider.
Use and result interpretation
- Use UroSure MobiLab exactly as directed in the kit insert. Deviations from the instructions for use may invalidate the result.
- Results are visual. A control (C) line must appear to confirm the test is valid. If the control line does not appear, the result is invalid and the test must be repeated.
- A negative result does not rule out infection, particularly when symptoms are present or when testing occurs during the window period after exposure.
- A positive result is a screening signal only. Confirmatory testing and clinical evaluation are required before treatment.