What is Chlamydia? Is it treatable?

Chlamydia is a bacteria that can infect the genital tract and cause permanent damage to the reproductive system

Chlamydia is very common: it affects nearly 2 million people per year in the US.

Yes, chlamydia is treatable. The US Centers for Disease Control (CDC) recommends the antibiotic doxycycline for treating chlamydia.

What is Gonorrhea? Is it treatable?

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.

What is Trichomoniasis? Is it treatable?

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.

How do I know whether I should test for these infections?

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.

This test CAN

tell you if you have any of the following common sexually transmitted infections (STIs):

  • Chlamydia
  • Gonorrhea
  • Trichomoniasis (also known as "trich")

This test CANNOT

tell you if you have other kinds of STIs, such as:

  • HIV (the virus that causes AIDS)
  • Syphilis
  • Herpes
  • Human papillomavirus (HPV) (genital warts and cervical infection)

However, if you are at risk or have symptoms of these or other STIs, contact a healthcare provider or local sexual health clinic to be tested.

This test CANNOT

tell you if you have other infections of the vagina or urinary tract, some of which may be more likely to occur after sexual activity. These infections include:

  • Bacterial vaginosis (BV)
  • Candida vulvovaginitis (yeast infection)
  • Urinary tract/bladder infections (UTIs)

If you have symptoms of these or other infections, contact a healthcare provider or local sexual health clinic to be tested.

General

How are these sexually transmitted infections (STIs) spread?

  • You can be infected with chlamydia, gonorrhea, or trich by having sex without a condom with a partner who has an infection.
  • A baby can be infected with chlamydia or gonorrhea during childbirth if the mother is infected and untreated.

Who is at risk?

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

What can this test tell me?

  • 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.

When can I take this test?

  • 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.

Taking the Test

What is the Visby Medical App for? Do I have to use the Visby Medical App?

  • The Visby Medical App is necessary to use the test.
  • The Visby Medical App will guide you through the test with video instructions.
  • Paper instructions for use are provided in the box as additional support.
  • After the test is completed, the Visby Medical App will also help you capture a photo of the device, and the App will analyze the photo to interpret your result.
  • The Visby Medical App can be used to generate a PDF report of your results that can be used by your healthcare provider.

Why should I wash my hands?

  • 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.

Are vaginal swabs safe?

  • 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.

I dropped my sample collection swab. What should I do?

  • 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.

I am having trouble closing the device port. What should I do?

  • You may need to push hard to slide the switch.

You will know it’s closed when you can no longer see the opening.

How do I know if the test is working?

  • 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.

Do I need to plug the device into an electrical outlet?

Yes.

Do I need to charge the device?

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.

My device is making noise and/or is vibrating. What should I do?

  • 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.

I think something went wrong while I was using the device. What should I do?

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

I spilled the liquid in the tube. What should I do?

  • 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.

Can I test urine or a different sample type?

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

Device Disposal and Clean Up

How do I dispose of the device?

Throw the device and all test components away in a trash can. Clean your work area and wash your hands to prevent possible spread of infection.

Can I use these supplies to test again?

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

What should I do with my leftover sample? Can I save it for other tests?

No. Throw it away.

Understanding Your Results

My test result is negative for all 3 sexually transmitted infections (STIs). What does this mean?

This means the device did not find the 3 STIs in your sample. If you are not experiencing symptoms, and it has been at least 3 days since the sexual activity that made you decide to take this test, it is unlikely that you have chlamydia, gonorrhea, or trichomoniasis.

If my test result is negative for all 3 STIs and I am still worried, what should I do?

  • 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.

What does a positive result mean?

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

What should I do if I test positive?

  • Get treatment from your healthcare provider or a local sexual health clinic right away. 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.

Can I have more than one positive result?

  • 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.

How accurate is this test?

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

My test did not work. Now what do I do?

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.

Chlamydia

My test result is positive for chlamydia. What does this mean and what do I do now?

  • A positive result means that chlamydia was found in your sample. You should seek medical care.
  • If you are pregnant, this infection could be transmitted to your child or could lead to preterm delivery if not properly treated.

Does chlamydia go away on its own? I don’t want to get treatment. Can I wait and see if my body heals chlamydia on its own?

  • 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).

Gonorrhea

My test result is positive for gonorrhea. What does this mean and what do I do now?

  • A positive result means that gonorrhea was found in your sample. You should seek medical care.
  •  If you are pregnant, this infection could be transmitted to your child or could lead to preterm delivery if not properly treated.

Does gonorrhea go away on its own? I don’t want to get treatment. Can I wait and see if my body heals gonorrhea on its own?

  • 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).

Trichomoniasis (“Trich”)

My test result is positive for trich. What does this mean and what do I do now?

  • A positive result means that trich was found in your sample. You should seek medical care.
  • If you are pregnant, this infection could lead to preterm delivery if not properly treated.

Does trich go away on its own? I don’t want to get treatment. Can I wait and see if my body heals trich on its own?

  • 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).

After reading this information, I still have questions about my result. What should I do?

  • 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.

What Happens Next?

Besides my healthcare provider, who else should I tell when I have a sexually transmitted infection (STI)?

If you have an STI, it’s very likely any sexual partner(s) you have had since contracting it have become infected. So, if you know or suspect you have an STI, you should let anyone you’ve had recent sexual contact with know about your infection and recommend that they also be tested for these treatable infections.

  • Your partner(s) should visit a healthcare provider for treatment and evaluation as soon as possible (cdc.gov/std/ept).
  • You might say or write something like this: “I wanted to let you know that I tested positive for gonorrhea, so you probably have it, too. It spreads easily and you might not have symptoms. You should get tested.”
  • Tell your current sexual partner(s) that you cannot have any sexual activity (even using condoms) until you and they have been completely treated for the infection.

This is because infections can be passed back and forth over and over again.

What are the known and potential risks and benefits of this test?

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.

I need more help. Where else can I get it?

  • For questions or help with the Visby Medical Women’s Sexual Health test, call Visby Medical at 1-833-GoVisby (1-833-468-4729) for assistance.
  • For comprehensive public health information about sexually transmitted infections (STIs), including information on prevention, testing, and treatment, visit cdc.gov/std.
  • For help finding a healthcare provider and other medical support, access a telemedicine provider in the Visby Medical App.
  • For detailed information about the Visby Medical Women’s Sexual Health Test, see the instructions for use at home.visby.com or by calling Visby Medical at 1-833-GoVisby. The information will be provided at no additional cost.

Need Support?

If you have any questions with your product, please contact the Visby Medical Support Team for assistance a AtHome@visby.com or 1-833-468-4729 (1-833-GoVisby).