Novel Coronavirus Disease: COVID-19

The novel coronavirus disease (COVID-19) is a new virus of global health significance caused by infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On March 11, 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic.

Transmission and Symptoms

According to the U.S. Centers for Disease Control and Prevention (CDC), COVID-19 is thought to spread from person to person in close contact through respiratory droplets. It is also possible that a person can catch COVID-19 by touching a surface or object that has the virus on it.

The CDC reports that the following symptoms may appear 2-14 days after exposure: Fever, Cough, and Shortness of breath.

Diagnostic Testing for COVID-19

BioReference offers a real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay, giving healthcare providers accurate and timely test results to ensure greater access to testing, promote earlier diagnosis and help limit the subsequent spread of infection. The test detects the presence of SARS-CoV-2 and is for use with patients who meet current guidance for evaluation of infection with COVID-19.

The test has been made available pursuant to the US Food and Drug Administration (FDA) emergency Use Authorization (EUA) for diagnostic testing in CLIA Certified high-complexity laboratories. The Novel Coronavirus COVID-19 test has been validated and is being performed by BioReference.

Guidance for Testing

The CDC has released criteria for healthcare providers for the evaluation of patients under investigation (PUI) of COVID-19. As of March 4, 2020 recommendations include testing for a wider group of symptomatic patients. Providers should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Decisions on which patients receive testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness.

Please refer to the most current CDC guidelines for further information on appropriate testing of patients, based on exposure history and the presence or absence of symptoms. Click Here to access the CDC guidelines.

Healthcare providers should notify their local or state health department immediately in the event of a patient under investigation for COVID-19.

Collection Instructions

Patients under investigation of COVID-19 and seeking evaluation of the disease will not be collected at BioReference Patient Service Centers. Specimen should be collected at physician offices, hospitals or other clinic settings. As of March 24, 2020, the FDA and CDC recommend collecting and testing an upper respiratory specimen with a nasopharyngeal collection (NP), as the preferred choice for swabbased SARS-CoV-2 testing. If a NP specimen cannot be collected, alternate collection sites are acceptable and detailed below. Refrigerate specimen at 2-8° C. Label with patient name. Place in specimen bag and label with “COVID-19” and submit to laboratory.

Flocked plastic NP swabs in universal or viral transport media (UTM/VTM) at 3 mL volume are preferred. The FDA has made alternative recommendations in the context of limited quantities of testing supplies during this public health crisis, based on the best available evidence and in consultation with outside experts. When considering alternate swab types, use only synthetic fiber swabs with plastic shafts. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit PCR testing.

Please refer to the most current CDC guidelines for further information on collecting, handling, and testing clinical specimens here and the FDA FAQs on Diagnostic Testing for SARS-CoV-2 “What If I Do Not Have…?” here

Standard Procedures for Nasopharyngeal Collection

  1. Tilt patients head so nasal passages are parallel to the palate.
  2. Insert a swab into nostril. Leave the swab in place for several seconds to absorb secretions.
  3. Slowly remove swab while rotating it.
Nasopharyngeal collection

Self-Pay Pricing

Along with many of our other clinical tests, COVID-19 is available with a self-pay patient price to increase access to comprehensive testing for patients who do not have health insurance or for those who intentionally choose not to submit a claim to their insurance company. The COVID-19 self-pay price is $55.

 

The COVID-19 assay provides you with accurate and timely test results to provide proper care and reduce subsequent spread of infection. Please speak with your sales representative or call our Customer Service team for ordering information.

Click here to download the physician resource, click here to download ICD-10 Coding Guidelines, and click here to access a list of frequently asked questions.

 

Full test information can also be found using the Test Directory.

CLICK HERE