Testing for COVID-19

The 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 for conducting COVID-19 testing.

The test collection kit uses a non-invasive self-collected saliva (oral fluid) sample from your mouth. This type of specimen collection is much simpler to perform than the current nasopharyngeal (NP) swab which requires passing a swab approximately 3-4 inches long through the nostril into the back of the nose and throat. Self-collection of specimens at home also reduces the risk of spreading COVID-19 to the public and to healthcare providers performing NP swabs in the office or at the hospital.

To collect a saliva (oral fluid) sample, you will be asked to rub the swab for at least 20 seconds on the left inside cheek, right cheek, roof of the mouth, and along the top and bottom of the tongue. The swab is then placed in the sterile tube provided in the kit and sent by overnight mail directly to the laboratory for processing. The laboratory uses a combination of viral RNA extraction and amplification along with RT-PCR to detect the COVID-19 virus if present. The accuracy of this test has been validated, and the test can detect as few as 12.5 viral RNA copies/microliter.

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 overnight shipping the test kit to you and then overnight shipping your specimen to the laboratory in San Dimas, California.

As required by law, COVID-19 tests must be ordered by a physician. myLAB Box works with Kulbersh Health Screening Services (KHSS). The KHSS network has physicians in every state who order the test following CDC recommendations (CDC Testing Recommendations for COVID-19). A physician or designated staff member will be available and will call within 24 hours and provide post-test counseling for those who are infected with COVID-19.

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 COVID-19 test are listed below in approximate order of importance:

• 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.

*** 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.

In addition, some experts have recommended testing for individuals who are at increased risk of becoming infected with COVID-19. This group includes individuals with chronic lung disease (asthma/emphysema/COPD), diabetes mellitus, heart disease, chronic kidney or liver disease, immunocompromised conditions, are receiving treatment for cancer or receiving immunosuppressive drugs, as well as those 65 years of age or older. Family members and other caretakers of these individuals should consider testing to reduce the likelihood of transmitting COVID-19 to their loved ones.

Please note, a brief symptom questionnaire must be completed and reviewed by a KHSS physician or their delegate prior to receiving a myLAB Box COVID-19 test kit. Please also note that Sate 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 will 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 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.

Infected individuals may shed virus for a few days before they become symptomatic and 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 virus resulting in new infections.

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