At Home Coronavirus (COVID-19) Viral Detection Test

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.

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.

Background on the COVID-19 virus

Human coronaviruses are common and are typically associated with mild illness, similar to the common cold. COVID-19 is an illness caused by a new (novel) form of the human coronavirus called Severe Acute Respiratory Coronavirus, also known as SAR-CoV-2. For simplicity, we refer to this new virus as the COVID-19 virus or COVID-19 for short.

What we now know is that COVID-19 is a contagious disease that is spread from an infected to an uninfected person through:

• Respiratory droplets and aerosols when you cough, sneeze, sing or talk
• Close personal contact such as touching, hugging or shaking hands, and
• Touching something with the virus on it and then touching your eyes, nose or mouth before washing your hands.

Infection with COVID-19 can cause:

• No symptoms (individual is asymptomatically infected)
• Mild symptoms such as cough, mild fever, sore throat, headache, body ache, and fatigue
• Severe symptoms including moderate to severe difficulty breathing or shortness of breath, persistent pain or pressure in the chest, new confusion or inability to arouse, and bluish lips or face.

About 80% of infected individuals have mild symptoms or often no symptoms at all. Symptoms usually develop 2-14 days after exposure to an infected person, on average about 5 days later. Symptoms may progress from mild to severe in a short period of time, from a few hours to a few days.

Infected individuals may shed virus for a few days before they become symptomatic. Viral shedding can last up to two weeks afterwards. Viral shedding in asymptomatic individuals contributes to transmission of the COVID-19 virus, resulting in new infections. Recent estimates suggest that many new infections are the result of infection by individuals with no or unrecognized symptoms.

It is recommended that persons with COVID-19 infection who are symptomatic should have home isolation for 10 days from when symptoms first appeared. And persons with COVID-19 infection who are asymptomatic should have home isolation for 10 days from the date of the first positive test.

In the interest of caution, individuals who are home isolating should have at least two consecutive COVID-19 viral tests collected 24 or more hours apart. Prior to ending home isolation, individuals should have two negative test results.

Additional information can be found at https://www.cdc.gov/coronavirus/2019-ncov/index.html