Coronavirus | Medical Diagnostic Laboratories

Combined Testing for SARS-CoV-2 and Influenza Viruses* from a Single Specimen!

Test No. 1134

CombiVid® Panel by Real-Time PCR

SARS-CoV-2 virus (COVID-19) by Real-Time Reverse Transcription PCR (CDC N1, N2, RP targets)£*
Influenza A virus
Influenza B virus*

Available on Nasopharyngeal swab specimen collection submitted in a COVID-OneSwab^™ transport media vial specimen collection

Detect multiple respiratory pathogens from a single sample
Assists in guiding triage, patient care, and treatment decisions to prevent further transmission
Less discomfort for the patient compared to collecting a separate sample for each test
Reduce the risk of exposure to healthcare workers gathering multiple specimens
Conserves precious sampling & testing resources by reducing the demand for important materials which may be in short supply
Allows for ongoing flu surveillance while also testing for SARS-CoV-2
High precision robotic accuracy
High diagnostic sensitivity & specificity
24 – 48 hour turnaround time

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.

Test No. 1131

SARS-CoV-2 [COVID-19] by Reverse Transcription Real-Time PCR (CDC N1, N2, RP Targets) This assay has been authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA)*

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

*Not available in NY

What are the symptoms of COVID-19?

Common signs of infection may appear 2-14 days after exposure and include:

In severe cases, infection can cause:

Fever
Cough
Shortness of breath & breathing difficulties

Pneumonia
Severe acute respiratory syndrome
Kidney failure
Death

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.