Testing for Coronavirus (COVID-19)
The Coronavirus (COVID-19) test collection kit distributed by myLAB Box 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 coronavirus test collection kit uses a non-invasive self-collected saliva/sputum sample from your mouth and throat. 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 middle and back of the nose and throat. Self-collection of saliva/sputum samples 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.
To collect a saliva/sputum sample, you will be asked to collect an oral fluid sample and place it in a sterile vial or cup. 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.
Your COVID-19 test results will be available 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. Under recent guidance from the US Department of Health and Human Services, licensed pharmacists can also order and administer COVID-19 tests. myLAB Box utilizes the services of a 50 state physician-affiliate and a network of pharmacists who order the test following 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 using telemedicine within 24 hours.
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 stay 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.
The reasons for ordering a Coronavirus (COVID-19) test are listed below:
- You have symptoms of possible COVID-19 infection (see Background on the COVID-19 virus for a symptom list) ***
- You have been exposed to a COVID-19 lab-confirmed infected individual:
- In your household
- In your community
- As a healthcare contact by workers and visitors
- You have been traveling overseas in places such as China and Europe with large numbers of COVID-19 infected individuals.
- You work in industries such as grocery, transportation, delivery services, warehouse/distribution, banking, and other services where you may have been exposed to COVID-19 by customers and co-workers with limited personal protective equipment (PPE)
- You are at increased risk of becoming infected with COVID-19 because you have one of the following chronic conditions: chronic lung disease (asthma/emphysema/COPD), diabetes mellitus, heart disease, chronic kidney or liver disease, other chronic medical or immunocompromised conditions, are receiving treatment for cancer or receiving immunosuppressive drugs, as well as those 65 years of age or older.
- You are a family member or caretaker of an individual with a condition listed above in order to reduce the likelihood of transmitting COVID-19 to a loved one.
*** 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 COVID-19 test. Please instead call your health care provider immediately, and failing to reach them, go to the nearest emergency room or dial 911.
Please note, a brief medical questionnaire must be completed by you and then reviewed by our physician-affiliate or pharmacist prior to receiving a myLAB Box COVID-19 test kit. Please also note that State and Federal law requires that positive test results be confidentially shared with the CDC and your State or County Health Department.
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 or sneeze
- 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 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 (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 8 days afterwards. It is currently not known the full extent to which viral shedding in asymptomatic individuals can contribute to transmission of the COVID-19 virus to others, resulting in new infections. Recent estimates suggest that about one quarter of new infections are the result of infection by individuals with no symptoms.
Additional information can be found at https://www.cdc.gov/coronavirus/2019-ncov/index.html
If you are diagnosed with COVID-19, it is best to self isolate and to speak with a healthcare provider for further instructions. If you think you have a medical emergency, call 911 or proceed to the closest emergency room.
Tests for COVID-19 have been authorized by the FDA under an EUA for use by authorized laboratories.
These tests are 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.