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Visby-STI-PCR-Test.png
Visby-sti-test-PCR.png
Visby-STI-PCR-Test.png

Visby Women's STI PCR Test

$0.00

  • Tests for Chlamydia, Gonorrhea, Trich

  • Results in 30 minutes

  • Vaginal swab (self or physician)

  • Chlamydia: 97.4% PPA, 97.8% NPA

  • Gonorrhea: 97.8% PPA, 99.1% NPA

  • Trich: 99.3% PPA, 96.7% NPA

Quantity:
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  • Tests for Chlamydia, Gonorrhea, Trich

  • Results in 30 minutes

  • Vaginal swab (self or physician)

  • Chlamydia: 97.4% PPA, 97.8% NPA

  • Gonorrhea: 97.8% PPA, 99.1% NPA

  • Trich: 99.3% PPA, 96.7% NPA

  • Tests for Chlamydia, Gonorrhea, Trich

  • Results in 30 minutes

  • Vaginal swab (self or physician)

  • Chlamydia: 97.4% PPA, 97.8% NPA

  • Gonorrhea: 97.8% PPA, 99.1% NPA

  • Trich: 99.3% PPA, 96.7% NPA

Specifications

  • CLIA Waived

  • Test type: PCR (integrated disposable PCR cassette)

  • Run time: 30 minutes

  • Collection type: Vaginal swab (self or physician-collected)

  • Chlamydia: 97.4% PPA, 97.8% NPA

  • Gonorrhea: 97.8% PPA, 99.1% NPA

  • Trichomoniasis: 99.3% PPA, 96.7% NPA

  • CPT Codes: 87801-QW for combined assay

  • CPT Codes: 87491 for CT-only, 87591 for NG-only, 87661 for TV-only

  • Manufacturer: Visby Medical

Storage & Expiration

  • Store at 2-30°C (35-86°F)

  • Do not freeze any contents of the kit.

  • Reagents and materials are stable until expiration date printed on outer packaging.

  • Test device must remain in the sealed pouch until use.

Box Components

  • Test Devices (20)

  • Sample Collection Kit (sold in separate kit)
    Vaginal self-collection swabs (50)
    Single-use pipettes (50)

Manuals & Documents

Intended use

The Visby Medical Sexual Health Test is a single-use, instrument-free molecular in vitro diagnostic test utilizing reverse transcription polymerase chain reaction (RT-PCR) technology for the qualitative detection and differentiation of nucleic acid from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). This test is designed for use with self-collected vaginal swab specimens, allowing healthcare providers to obtain accurate results in under 30 minutes. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The Visby Medical Sexual Health Test is authorized for use at the Point of Care (POC), in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.