Visby Sexual Health PCR STI Test

General Details

• CLIA Complexity: Waived

• Detectable Analytes: Chlamydia, Gonorrhea, Trichomoniasis

• Format: Integrated, instrument-free RT-PCR test

• Sample Type: Self-collected vaginal swab specimens

• Sensitivity: Approximately 97% accuracy. Please refer to the product’s instructions for use for detailed performance characteristics.

• For Use With (Application): RT-PCR for the detection of sexually transmitted infections (STIs) including Chlamydia, Gonorrhea, and Trichomoniasis.

• Test Time: ∽30 minutes

• Power Source: Requires Visby Power Adapter (9 V, 3.5 A DC)

• Quantity: Typically provided in individual test kits

• Shelf Life: Store between 36°F-86°F (2°C-30°C). Shelf life details are available in the product's instructions for use.

• Manufacturer: Visby Medical, Inc.

Box Components

• Visby Medical Sexual Health Test Device – Quantity: 20 devices per case (2 inner boxes of 10 devices each)

• Single-Use Pipette – Supplied in the kit for sample processing

• Sample Collection Kit – Includes 50 vaginal self-collection swabs (Visby Medical Sexual Health, Vaginal Specimen Collection Kit, 50 Pack)

Accessories Available Separately

• Power Adapter (SKU: PS-000288) – Required to power the test device (sold separately)

• External Controls – ZeptoMetrix external controls (NATCTNGTV-POS-IVD, NATCTNGTV-NEG-IVD) as referenced in the Instructions for Use for quality control purposes.

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.

The Visby Medical Sexual Health Test provides simultaneous detection of three critical sexually transmitted infections (STIs) that, if left untreated, can cause serious reproductive health issues, including infertility and ectopic pregnancy. Positive results indicate the presence of specific nucleic acids for CT, NG, and TV and should be interpreted in conjunction with patient history, clinical observations, and other diagnostic information to determine the infection status. Positive results do not exclude the possibility of co-infection with other pathogens. Testing facilities in the United States are required to report all results to the appropriate public health authorities.

Negative results do not preclude the presence of chlamydia, gonorrhea, or trichomoniasis and should not be the sole basis for patient management decisions. These results must be combined with clinical assessments, patient history, and epidemiological information.

The Visby Medical Sexual Health Test is intended for use by trained operators proficient in the test procedures. It is authorized for use under the Food and Drug Administration’s Emergency Use Authorization (EUA).