myLAB Box At Home Coronavirus (COVID-19) Test – Saliva

At Home Testing for Coronavirus (COVID-19)

The myLAB Box P23 COVID-19 At-Home Test was developed by a CLIA-certified high complexity clinical laboratory capable of large volume testing. All testing follows the FDA Emergency Use Authorization (EUA) for conducting COVID-19 testing.

The test collection kit uses a non-invasive self-collected saliva sample. This type of sample collection is much simpler to perform than the current nasopharyngeal (NP) swab which requires passing a swab through the nostril into the back of the nose and throat. Self-collection of saliva is painless and reduces the risk of spreading COVID-19 to the public and to healthcare providers compared to collecting NP swabs in the office or hospital.

The sample is sent by overnight mail directly to the laboratory for processing. The laboratory uses a combination of viral RNA extraction and amplification along with PCR to detect the COVID-19 virus if present. The accuracy of this test has been validated and is authorized by the FDA under an EUA.

Test results will be available in as little as 24 hours after your specimen arrives at the laboratory. Results will be posted on the myLAB Box HIPAA-compliant confidential customer portal. From the time you place your order, it should take 3-4 days to receive your results, allowing time for shipping your sample overnight to the clinical laboratory.

As required by law, COVID-19 tests must be ordered by a physician licensed in your state. myLAB Box utilizes the services of a 50 state physician-affiliate who orders the test following revised CDC testing recommendations (CDC Testing Recommendations for COVID-19). In the event that you test positive for COVID-19 infection, you will be offered a post-test counseling consultation within 24 hours.

For more details on the testing process and detailed instructions, please refer to the myLAB Box P23 At-Home COVID-19 Test Collection Kit Saliva – Unsupervised – Instructions for Patients

• This test uses the P23 Labs TaqPath SARS-CoV-2 Assay
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Product features:

• Screen for coronavirus (COVID-19)
• Mail-in kit for home use
• Viral detection test using saliva sample
• Gold standard PCR technology
• Simple collection in 5 minutes or less
• Results in as little as 24 hours
• Free physician consult for positives
• Free overnight shipping included
• FDA authorized

Who should be tested and why?
To limit the spread of the COVID-19 epidemic in the United States, it is important to test at-risk individuals in the community. Infected individuals can then isolate at home, reducing the likelihood that they will infect others. In addition, contacts of infected individuals can themselves be tested, and if infected, stay home as well.

There are many reasons for ordering a test for COVID-19:

• Symptoms of possible COVID-19 infection (see *** below)
• Exposure to a lab-confirmed COVID-19 infected individual
• Travel overseas in places with large numbers of COVID-19 infected individuals
• Employment in industries such as grocery stores, pharmacies, nursing homes, transportation, delivery services, warehouse/distribution, and banking
• Have a chronic condition such as chronic lung disease (asthma/emphysema/COPD), diabetes mellitus, heart disease, chronic kidney or liver disease, cancer, immunocompromised conditions, or receiving immunosuppressive drugs

If you have any of the following emergency warning signs and symptoms of a serious COVID-19 infection (difficulty breathing or shortness of breath, persistent pain or pressure in the chest, new confusion or inability to arouse, bluish lips or face), please do NOT order a test for COVID-19. Please instead call your health care provider immediately, and failing to reach them, go to the nearest emergency room or dial 911.

Extended Product Information:

COVID-19 Saliva PCR Test Kit DISCLAIMER:
- IVD
- For use by people 18 years of age or older. This test kit requires access to the Internet and email account. Not for resale. Intended for sale and use in the U.S. only. Store kit at room temperature.
- This home collection kit has been authorized by FDA under an EUA. This home collection kit has been authorized only for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
- This home collection kit in combination with the authorized test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic, Act 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.