Visby Rapid Women’s At-Home STI Test Kit

The following devices and versions are compatible with this app:

• iPhone - iOS 16 and above
• Android - Android 12 and above

For the most up to date compatibility information, please visit Visby’s website: https://visby.com/pages/app

A multi-site clinical study was conducted from March 23, 2023, to April 1, 2024, at thirteen (13) geographically diverse locations across the US. In this study, the Visby Medical Women’s Sexual Health Test was used by 2293 women, with results compared to a combination of three FDA-cleared tests. The Visby Medical Women’s Sexual Health Test correctly identified:

• 97.2% of positive specimens (103 out of 106) and 98.8% of negative specimens (1815 out of 1837) for Chlamydia
• 100% of positive specimens (43 out of 43) and 99.1% of negative specimens (1885 out of 1902) for Gonorrhea
• 97.8% of positive specimens (174 out of 178) and 98.5% of negative specimens (1740 out of 1767) for Trichomoniasis

Visit home.visby.com for more information.

If you need help with making a purchase on questhealth.com, with shipping, or with the delivery of your kit, please contact Quest at 1.844.738.3787 Mon–Fri between 9 AM – 5 PM EST.

If you need help getting set up for your test, with sample collection, or with your test results, please contact Visby by visiting their website: home.visby.com, by emailing their support: AtHome@visby.com, or calling 1.833.GoVisby (1.833.468.4729).

No, you cannot cancel or return the Visby Rapid Women’s At-Home STI Test Kit. Tests are nonrefundable and nonreturnable.

Yes, there are limitations and warnings:

• The Visby Medical Women’s Sexual Health test is not a substitute for visits to a healthcare provider. The result obtained with this test should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider.
• The Visby Medical Women’s Sexual Health Test has only been validated with female vaginal specimens self-collected with Visby Medical Women’s Sexual Health Vaginal Specimen Collection Kit. The performance of this test has not been evaluated with other specimen types or other specimen collection devices.
• The Visby Medical Women’s Sexual Health test is not intended to detect oral or rectal chlamydia or gonorrhea.
• Careful compliance with the user instructions and the Visby Medical Application are necessary to avoid incorrect results. Accurate results are dependent on adequate product storage, and adherence to the specimen collection and testing procedures, and failure to follow test procedures can lead to incorrect results.
• A negative test result does not preclude the possibility of infection with other pathogens. If clinical symptoms persist, seek medical care.
• A positive test result does not preclude the possibility of co-infection with additional pathogens. • Avoid testing during heavy period flow. Taking this test during the heavy flow day(s) of your period slightly increases the chance the test will not work.
• Wait 48 hours to use the Visby Medical Women’s Sexual Health Test since last applying any of the following products in the genital area: douches, washes, lubricants, vaginal wipes, vaginal moisturizers, antiperspirants, deodorants, or feminine hygiene spray.
• Wait 48 hours to use the Visby Medical Women’s Sexual Health Test since taking the antibiotic doxycycline (also known as Vibramycin).
• Anyone with recent sexual contact with a person known to have a sexually transmitted infection, should visit a healthcare provider for treatment and evaluation as soon as possible (cdc.gov/std/ept).
• The Visby Medical Women’s Sexual Health Test is not intended to replace routine healthcare during pregnancy regardless of test results.
• The performance characteristics of the Visby Medical Women’s Sexual Health Test have not been evaluated in women less than 14 years of age.
• As with other assays of this type, there is a risk of false negative or invalid results (“Test did not work”) due to the presence of sequence variants (mutations) in the amplification targets.
• This test has been evaluated with human specimen material only.
• Assay interference was observed in the presence of the following substances: RepHresh Odor Eliminating pH Balancing Gel at a concentration greater than 2.5% w/v; Replens Long Lasting Vaginal Moisturizer at a concentration greater than 1.25% w/v; Dove 0% alcohol antiperspirant spray at concentration greater than 0.2% w/v; Menstrual blood at a concentration greater than 1.25% v/v; Bleach-based cleaner at a concentration greater than 2.5% v/v; and Biotin at concentration greater than 1.75 μg/mL.
• The Visby Women’s Sexual Health Test is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.
• Failure to follow the instructions may cause the test to not work or lead to incorrect results.
• Do not use any other swab. Use of another swab (Q-Tip, Covid Swab) can lead to inaccurate results.
• Do not use any other tube or liquid. Use of another tube or liquid can lead to incorrect results. • Infections can be spread from private parts (genital area) to other parts of body.
• Wash hands with soap and water for at least 20 seconds or use hand sanitizer with at least 60% alcohol.
• Use of any of the following within the last 48 hours can lead to incorrect results:
  • Vaginal products (douches, washes, lubricants, vaginal wipes, vaginal
  • moisturizers, antiperspirants, deodorants, or feminine hygiene spray)
  • The antibiotic doxycycline (also known as Vibramycin) 
• Do not ingest. Keep out of reach of children. Avoid contact with skin and eyes. If contact with the body occurs, rinse with water. If irritation persists, seek medical advice.
• Consult with your healthcare provider prior to collecting your vaginal sample if you are in the third trimester of pregnancy.
• If you have ongoing abdominal pain, fever, and/or vomiting, inform your healthcare provider as these symptoms can be due to pelvic inflammatory disease (PID).
• Prompt diagnosis and treatment of PID can help prevent infertility and ectopic pregnancy associated with PID. Avoid testing during heavy period flow.
• For additional information, refer to the Visby Medical Women’s Sexually Health test instructions for use available at home.visby.com.

You may be able to use your FSA or HSA funds to purchase lab tests at questhealth.com. Please review your FSA/HSA plan or check with a tax professional to confirm specific requirements for individual eligibility.