MDL now offers testing for SARS-CoV-2 [COVID-19]
Coronavirus Disease 2019 (COVID-19) is an acute respiratory disease caused by a viral infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus, which has infected and caused deaths of over 4 million people worldwide, has rapidly escalated to pandemic status since it first appeared in Wuhan, China in December 2019. Additional cases have now been reported in the United States. An infection with coronavirus 229E, NL63, OC43, or HKU1 is not the same as a COVID-19. Patients with COVID-19 are evaluated and cared for differently than patients with common coronavirus diagnosis.
- Nasopharyngeal swab OR Oropharyngeal swab specimen collection submitted in a COVID-OneSwab™ transport media vial
- NasoSwab® specimen collection for adult patients ONLY (may be self-collected on-site)
- Specimens should be refrigerated until ready for transport and shipped within 72 hours of collection
What are the symptoms of COVID-19?
Common signs of infection may appear 2-14 days after exposure and include:
- Shortness of breath & breathing difficulties
In severe cases, infection can cause:
- Severe acute respiratory syndrome
- Kidney failure
People with heart and lung disease, weakened immune systems, and older adults are at higher risk for lower respiratory tract illness.
How is COVID-19 spread?
This virus is spread person-to-person by someone who is currently sick with COVID-19 through:
- Respiratory droplets produced while coughing and sneezing
- Close personal contact (i.e., within about 6 feet)
- Touching or shaking hands
It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this is not reported to be the primary way the virus spreads.
How is COVID-19 diagnosed?
Due to symptom overlap with other common viral infections, diagnosis on the basis of clinical symptoms alone is highly inaccurate. Patients who meet the testing criteria described by the Centers for Disease Control and Prevention (CDC) should undergo testing for SARS-CoV-2.
What types of tests are available from MDL for COVID-19?
MDL offers two types of testing for SARS-CoV-2 (COVID-19). Direct detection of SARS-CoV-2 viral genetic material using a highly sensitive molecular assay is available from MDL for nasopharyngeal, oropharyngeal, and mid-turbinate area swabs.
Test 1131 SARS-CoV-2 [COVID-19] by Reverse Transcription Real-Time PCR (CDC N1, N2, RP Targets)
- This test has been approved by the New Jersey Department of Health in accordance with FDA EUA policy;
- This test has not been FDA cleared or approved; and
- This test has been submitted for authorization by the FDA under an EUA for use by authorized laboratories.
Testing for IgM and IgG antibodies, produced by a patient’s immune system in response to the presence of SARS-CoV-2 virus, is available from MDL on serum specimens by ELISA. The presence of certain antibodies can indicate an immune response to SARS-CoV-2, whether symptoms developed from infection or the infection was asymptomatic.
Test 1132 SARS-CoV-2 [COVID-19] IgG/IgM by ELISA (serum required)
This test is not “FDA Approved”. However, it is being run under the following FDA guidelines:
The FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to the FDA, and information along the lines of the following is included in the test reports:
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, LN63, OC43, or 229E.