• Gonorrhea is a bacteria that can infect the genital tract and cause permanent damage to the reproductive system.
• Gonorrhea is very common: it affects more than half a million people per year in the US.

Yes, gonorrhea is treatable. The US Centers for Disease Control (CDC) recommends a single injection of an antibiotic called ceftriaxone for treating gonorrhea.

• Trichomoniasis, commonly referred to as “trich,” is caused by a parasite that can infect the vagina, and it can increase your risk of becoming infected with HIV, the virus that causes AIDS. If you are pregnant, it could cause your child to be born too early.
• Trich is very common: it affects about 3.7 million people in the US.
• Yes, trich is treatable. The US Centers for Disease Control (CDC) recommends the antibiotic metronidazole for treating trich.

Take this test if you think you have a sexually transmitted infection (STI) because:

• You are experiencing symptoms (new vaginal discharge or a change in your vaginal discharge; painful or burning urination; painful sexual intercourse/bleeding after having sex; bleeding between your periods; other symptoms or concerns with your vaginal or urinary health).
• You have had a new sexual partner.
• A sexual partner told you they have symptoms, were tested for, or have been diagnosed with an STI, or they recommended you get tested.
• You have multiple sexual partners.
• Your sexual partner has other partners, or you suspect that they have other sexual partners.
• You think you may have been exposed to an STI, even if you do not have any symptoms.

Anyone who is sexually active and has sex without a condom is at risk if their partner has an STI.

• Chances are, if you are taking this test, you are experiencing symptoms, have had sexual activity that may have put you at risk for a sexually transmitted infection (even if you don’t have symptoms), or have been informed that you may have been exposed to an STI.
• This test is NOT a sexual assault evidence collection kit (SAEK, also known as a “rape kit”). If you believe you are the victim of sexual assault or sexual violence, go to your local emergency room or call the National Sexual Assault Hotline at (800) 656-HOPE or visit hotline.rainn.org/online for directions on how to get help.

• Wait to take this test until it has been at least 48 hours since you have taken the antibiotic doxycycline (also known as Vibramycin) or used any of the following in your genital area: douches, washes, lubricants, vaginal wipes, vaginal moisturizers, antiperspirants, deodorants, or feminine hygiene spray.
• You can take this test at any point in your menstrual cycle. However, it is best to avoid testing during the heavy flow day(s) of your period.

• To ensure that your sample does not have other possible contaminants that would change your test results.
• To avoid spreading any possible infections to yourself or others.
• To avoid possible spread of infection to your eyes, which can lead to serious eye infections, and even blindness.

• Yes. Performing a vaginal swab is a safe and reliable procedure. Follow the provided collection instructions.
• If you are in the 3rd trimester of pregnancy, consult your healthcare provider prior to collecting a vaginal swab.

• Call Visby Medical at 1-833-GoVisby (1-833-468-4729) for assistance.
• Do not use any swab other than a vaginal collection swab provided by Visby Medical. Use of another swab will lead to inaccurate results.

• You may need to push hard to slide the switch.
• You will know it’s closed when you can no longer see the opening.

• The device is ready to use once you have plugged it into an electrical outlet and the white power light is on. Leave the device plugged in the whole time you are using it.
• The device will make a noise while running the test. This is normal.
• It will take 30 minutes for the device to process your sample, and the green “ready” light will come on at that time. Test results should not be read beyond 2 hours after the test is complete.

Yes.

No, the device does not need to charge. It is ready to use as soon as you plug it in, and it will only work while plugged into an electrical outlet.

• Don’t worry—this is normal.
• Noise and vibration are expected while the device is running. Do not disturb the device. Allow the test to complete. The noise and vibration will stop once the test is complete.

If you have questions or concerns, please call Visby Medical at 1-833-GoVisby (1-833-468-4729) for assistance.

• There is extra liquid in the tube. If you can still fill the syringe to the black line, proceed as normal.
• If you cannot fill the syringe to the black line, call Visby Medical at 1-833-GoVisby (1-833-468-4729). Do not run the test if you cannot fill the syringe to the black line. Do not use any other liquid (e.g., water). Running the test without enough liquid or use of another liquid will lead to incorrect results.

No. Any sample other than a vaginal swab will not produce a valid test result.

• No. The test kit and device are single-use only and cannot be used again.
• Dispose of the device in your regular trash.

No. Throw it away.

• If you have symptoms or concerns about an STI after a negative result, contact your healthcare provider or local sexual health clinic for additional testing.
• You may have a different STI or vaginal or urinary tract infection.
• You may have tested too soon after the sexual activity of concern and may need to repeat the test at a later time.
• You can also use the Visby Medical App to access a healthcare provider through a telemedicine appointment.

• A positive result means an STI was found in your sample. Read on for more information about positive results for each of the infections.

• Get treatment from your healthcare provider or a local sexual health clinic rightaway. You can also access a telemedicine provider in the Visby Medical App to find a healthcare provider who treats sexually transmitted infections.
• Speak to the healthcare provider openly. These infections are common. Healthcare providers know how to treat them.
• Take action right away. It’s important to get treated quickly so that you don’t develop serious health issues or risk spreading infection to other people or other parts of your body.
• It is important to let anyone you’ve had sexual contact with know about your infection so that they can also be tested. If your sexual partner(s) are not treated, they may reinfect you or others.
• Refrain from having sex until 7 days after treatment and the symptoms are gone.

• It is possible that you could have more than one STI that was detected by this test. Please contact your healthcare provider and share all the results so that you can get treated properly for all infections that you may have.

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 your test did not work, the device malfunctioned. If this happens to you, please call Visby Medical at 1-833-GoVisby (1-833-468-4729) for next steps.

• No. Chlamydia does not go away by itself. You will need medical treatment because untreated chlamydia can lead to serious health issues, such as infertility, ectopic pregnancy (a life-threatening and pregnancy-ending condition), and long-term pelvic pain.
• Chlamydia is easily spread. Getting treated quickly helps you protect your sexual partner(s).

• No. Gonorrhea does not go away by itself. You will need medical treatment because untreated gonorrhea can lead to serious health issues, such as infertility, ectopic pregnancy (a life-threatening and pregnancy-ending condition), and long-term pelvic pain.
• Gonorrhea is easily spread. Getting treated quickly helps you protect your sexual partner(s).

• Symptoms due to a trich infection can come and go without treatment, but trich can become a chronic infection that, if untreated, can lead to serious health issues such as increased risk of HIV infection, or if untreated during pregnancy, low birth weight and/or preterm delivery.
• Trich is easily spread. Getting treated quickly helps you protect your sexual partner(s).

• Call Visby Medical at 1-833-GoVisby (1-833-468-4729) for assistance or use the Visby Medical App to access a healthcare provider through a telemedicine appointment.
• For comprehensive public health information about sexually transmitted infections (STIs), including information on prevention, testing, and treatment, visit cdc.gov/std.

Potential Risks include:

• Possible incorrect test results. Although infrequent, this can include missed infection or incorrect diagnosis. This is why you should see a healthcare provider if you still have symptoms after treatment.

Potential Benefits include:

• The test results, along with other information, can help healthcare providers make informed decisions about your care. Including avoiding the use of unnecessary antibiotics.
• Obtaining timely and appropriate treatment for chlamydia, gonorrhea or trichomoniasis may prevent long term health consequences and reduce the spread of these infections.

• You will be able to interact with a healthcare provider through your phone.
• The results of this test will be shared with the provider. In order to best treat your symptoms and address your concerns, the provider may ask additional questions about your sexual activity.
• The provider might discuss treatment options with you, and if the healthcare provider decides you need medication they will write you a prescription and give you information about clinics where you can receive treatment.
• Additional fees may apply for the telemedicine visit and any prescribed medication.