Intended Use

The Visby Medical Flu and COVID-19 Test is a single-use (disposable), fully integrated, fast, automated RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of influenza A, influenza B, and SARS-CoV-2 viral RNA in anterior nasal (AN) swab samples from individuals 14 years or older (self-collected) or 6 months to 13 years of age (collected by an adult) with signs and symptoms of viral respiratory infection.

Influenza A, influenza B, and SARS-CoV-2, viral RNA identified by this test are generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. Correlation with past medical history and other diagnostic information is necessary to determine infection status. The agent detected may not be the definite cause of disease. Individuals who test positive with the Visby Medical Flu and COVID-19 Test should seek follow up care with their physician or healthcare provider as additional testing may be necessary. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have a respiratory infection and should seek follow-up care with their healthcare provider.

Individuals should report all SARS-CoV-2 results obtained with this product to their healthcare provider for public health reporting and to receive appropriate medical care. Healthcare providers will report all test results they receive to relevant public health authorities in accordance with local, state, and federal requirements.

How do I know whether I should test for a respiratory tract infection?

  • Take this test if you have a runny nose, sore throat, cough, fever, headache, body aches and pains.

How can this test help me?

This test CAN help you if:

  • SARS-CoV-2 (the virus that causes COVID-19), Influenza A virus, Influenza B virus was detected in your sample.
  • If viruses are detected in your sample, your healthcare provider may recommend treatment with an antiviral medication and/or other medicines and supportive care. Early treatment, guided by results from this test, may help you recover more rapidly.
  • If any of these viruses are detected in your sample, your healthcare provider may recommend that you isolate yourself from others until your infection clears.

This test CANNOT help you if:

You have other kinds of respiratory tract infections, such as:

  • The common cold virus
  • Group A streptococcus (the cause of “strep throat”)
  • If you have concerns about these infections, contact your healthcare provider to be checked and properly treated.

When can I take this test?

  • You may want to take this test if you have a runny nose, sore throat, cough, fever, headache, fatigue, or muscle pains and body aches, especially if COVID-19 infections or influenza (flu) infections are occurring in your community.
  • WARNING: If you have trouble breathing, chest pain, confusion, weakness, or any loss of consciousness, seek emergency care immediately by calling 911 or going directly to a hospital emergency room.

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

  • Use of the Visby Medical app is required.
  • The Visby Medical app will help guide you through the test with video instructions.
  • 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 determine your test results.
  • The Visby Medical app also links to an optional telemedicine consultation with a healthcare provider.
  • The Visby Medical app can generate a PDF report of your results that your healthcare provider can use.

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 infection to others.

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.

My device is making noise and/or 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.

Are nasal swabs safe?

  • When used as demonstrated in the video instructions (accessible via the Visby Medical app), self-collection of a nasal swab sample is safe. You may experience a little discomfort or a tickling sensation, but use of the swab as directed will not cause any injury.
  • The provided swab is safe for both self-collection and adult collection on a child.
  • Adult collection of a swab in children aged 6 months and older is also safe when performed as described in the instructions. You may not need to insert the swab as deep into the nostril with children.

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 the swab provided by Visby Medical. Use of another swab will lead to inaccurate results.

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

  • If there is enough liquid in the tube to fill the syringe to the black line, continue to run the test following the instructions.
  • 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.

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.
  • After 30 minutes, you have a 2-hour window to read the results. After that, the test results may fade or be unreliable.

Are there any power requirements to properly plug in the device?

  • You will find a USB-C power cable included in the box.
  • You will need to provide a USB-C power adaptor with 5 volts, 3 amps minimum.

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

  • Yes (do not plug the device into a laptop or other device).