COVID-19: Information for Healthcare Providers

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. At BioReference, our priority remains in the health and safety of the physicians, patients and communities we serve, and we are doing our part to deliver answers during these uncertain times.

Transmission and Symptoms

According to the U.S. Centers for Disease Control and Prevention (CDC), COVID-19 is thought to spread mainly 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 some or all of the following symptoms may appear up to 14 days after exposure:

  • Fever
  • Cough
  • Fatigue
  • Anorexia
  • Shortness of breath
  • Sputum production
  • Myalgias

Fall/Winter Testing for COVID-19 and Influenza A and B

Differentiate Between COVID-19 and Flu Infection with One Collection

Differentiating COVID-19 patients from those with Influenza A or B (flu) will be especially important during the fall and winter months. Both types of infections can have very similar symptoms, and it may not be possible in many cases to differentiate based on clinical history alone.

BioReference Laboratories is now offering a multiplex test for flu and COVID-19 at the same time, using a single sample. This allows for more rapid diagnosis, conserves critical testing supplies, and provides surveillance for flu and COVID-19. Identifying the correct infectious agent, especially in high risk populations, will allow for early treatment and appropriate management.

Increased Risk for Pregnant Women: Some Key Facts

  • Pregnant women may be at an increased risk for severe illness from COVID-19
  • Flu infection is more likely to cause severe illness in pregnant women than in non-pregnant women of reproductive age
  • Flu infection may also be harmful to the developing fetus
  • Only half of pregnant women are vaccinated for flu

Advantages of Multiplex Testing for COVID-19 and Flu A/B

  • Multiplex testing only requires one sample collection, conserving valuable supplies
  • Allows for rapid diagnosis
  • Identifies the correct infectious agent for early and appropriate management
  • Provides simultaneous testing for COVID-19 and flu viruses

COVID-19 Testing

COVID-19 testing is imperative in helping healthcare providers identify infected and exposed patients more quickly. BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure

Molecular Test For COVID-19 Diagnosis
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COVID-19 RT-PCR Assay

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.

Who should be tested

The molecular RT-PCR test is for patients under investigation of COVID-19 and seeking evaluation of active disease infection. Please refer to the most current CDC guidelines for further information.

Test Code

TH68 Novel Coronavirus COVID-19 Nasopharynx

TH69 Novel Coronavirus COVID-19 Oropharynx

TH71 Novel Coronavirus COVID-19 Pooled N/NP/OP

Sample Type

Upper respiratory specimen via nasopharyngeal collection (NP) placed in 3 mL of transport media

Specimen Collection

Specimens of patients under investigation of COVID-19 and seeking evaluation of the disease will not be collected at BioReference Patient Service Centers. Specimens 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 swab based SARS-CoV-2 testing. If a NP specimen cannot be collected, alternate collection sites are acceptable. 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, and transport in 3 mL of media. 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.

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.

Utilization with Antibody Testing

Many patients with COVID-19 will be asymptomatic or have mild symptoms, and will not have been diagnosed with PCR. Antibody testing can be used to identify these past infections.

Patients with symptoms who test negative with molecular tests may still be suspected of having COVID-19. If antibodies are detectable in these patients, they are likely to have been infected and had a false negative PCR result.

Stability

3 Days (Refrigerated) 30 Days (Frozen)

Turnaround Time

Molecular test results will typically be available within 3 days after the sample is received at our facility in New Jersey.

Results
  • Positive 2019-nCoV – Critical.

  • Presumptive Positive 2019-nCoV – Critical. The viral concentration is likely to be near or below the limit of detection. Re-collection of a new sample is suggested, if clinically indicated.

  • Inconclusive – Please consider re-collection of a new specimen, as clinically indicated. • Invalid – Please consider re-collection of a new specimen, as clinically indicated.

  • Not Detected – Please consider re-collection of a new specimen, as clinically indicated

Result Availability

Test results for clients will be available electronically via InsightDx or other EMR, and can also be faxed. COVID-19 test results can be viewed by patients in the BioReference Patient Portal once final.

COVID-19 Self-Pay Pricing

Along with many of our other clinical tests, COVID-19 molecular and serology testing 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 $100 for RT-PCR.

CDC Guidance for Testing

The CDC has released criteria for healthcare providers for the evaluation of patients under investigation (PUI) of COVID-19. Please refer to the most current CDC guidelines for further information. Please refer to the most current CDC guidelines for further information. www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html

Serology Test For COVID-19 Exposure
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COVID-19 Antibody Test

BioReference offers an immunoassay which measures SARS-CoV-2 specific antibodies, correlating with the patient’s adaptive immune response after COVID-19 infection.  Antibodies are expected to be detectable in the majority of patients by 14 days after the onset of symptoms, and are presumed to remain elevated for some time after recovery.

This test plays a critical role in the fight against COVID-19 by assessing the antibody response in individuals and populations.  It identifies patients who have been exposed to COVID-19 in the past, allowing for detection after the infection has resolved.  This is especially important for asymptomatic or mildly symptomatic COVID-19 patients, who may not have been diagnosed with molecular testing.  It can also help providers and health authorities understand the prevalence of COVID-19 in their area, and the change in prevalence over time.

For many pathogens, testing positive for antibodies after infection usually indicates some level of immunity from re-infection.  However, whether antibodies to COVID-19 indicate a lower risk of infection is still unclear, and ongoing studies will further detail COVID-19 specific immunity.

Who should be tested

The Antibody test is for patients that may have been exposed to COVID-19 and seeking to measure immune response after COVID-19 infection.

Test Code

TH99 – COVID-19 Antibody

Sample Type

Blood sample in 2 mL Serum (SST)

Specimen Collection

Serology (antibody) testing via blood sample for COVID-19 exposure is now available at all BioReference PSC locations. Please find a location nearest you by visiting our Locations page.

For those collecting in-house: Fill SST tube, invert gently 5 times, label with patient name, let stand for minimum of30 minutes, maximum of 1 hr,spin for 10-15 minutes. Place in specimen bag and label with “COVID-19 ANTIBODY” and submit to laboratory. Please Note: COVID-19 antibody specimensmust be collected in a separate SST tube, and the specimen bag should be labeled with “COVID-19 ANTIBODY”. Orders for serology antibody testing cannot be combined with other tests, and add-ons will not be accepted.

Technology

BioReference offers an immunoassay for antibody testing with high sensitivity and specificity. Each COVID-19 antibody test is performed utilizing the Roche Elecsys Anti-Sars CoV-2 assay or the DiaSorin Liaison Sars CoV-2 S1/S2 assay.  The performance of these high-volume instruments were tested against large sets of positive and negative clinical samples by the manufacturers. The data showing high sensitivity and specificity were submitted to the FDA, and both platforms have a FDA Emergency Use Authorization (EUA).

Utilization With Molecular Testing

Many patients with COVID-19 will be asymptomatic or have mild symptoms, and will not have been diagnosed with PCR. Antibody testing can be used to identify these past infections.

Patients with symptoms who test negative with molecular tests may still be suspected of having COVID-19. If antibodies are detectable in these patients, they are likely to have been infected and had a false negative PCR result.

Stability

3 Days (Refrigerated or Room Temperature) 30 Days (Frozen)

Turnaround Time

Antibody test results will typically be available within 3 days after the blood sample is received at our facility in New Jersey.

Results
  • Not Detected
  • Detected
Result Availability

Test results for clients will be available electronically via InsightDx or other EMR, and can also be faxed. COVID-19 test results can be viewed by patients in the BioReference Patient Portal once final.

COVID-19 Self-Pay Pricing

Along with many of our other clinical tests, COVID-19 molecular and serology testing 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 for antibody testing.

Other Important Notes

BioReference uses antibody tests with demonstrated high accuracy and lack of cross reactivity with other common coronaviruses.

Antibody testing should not be used alone to diagnose acute COVID-19 infections, and antibodies are unlikely to be detected in the first few days of infection.

COVID-19 patients with detectable antibody levels may still be infectious during the acute phase of infection.

CDC Guidance for Testing

Healthcare providers should notify their local or state health department immediately in the event of a patient under investigation for COVID-19. Please refer to the most current CDC guidelines for further information. www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html


The COVID-19 Molecular Test provides physicians with accurate and timely test results to guide proper care and reduce subsequent spread of infection.
Click here to download the RT-PCR physician resource.

The COVID-19 Antibody Test is an integral part of the public health response when assessing individual and population exposure to the virus, and informs decisions about easing social distancing in the general population. Click here to download the Antibody physician resource.

Please speak with your sales representative or call our Customer Service team for ordering information.

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

CLICK HERE