COVID-19: Information for Healthcare Providers

COVID-19 is reported to affect different people in different ways – from mild symptoms to severe illness. At BioReference®, our priority lies in the health and safety of the healthcare providers, patients and communities we serve, and we are doing our part to deliver testing, service and technology solutions 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 or chills
Cough
Shortness of breath or difficulty breathing
Fatigue

Muscle or body aches
Headache
New loss of taste or smell
Sore throat

Congestion or runny nose
Nausea or vomiting
Diarrhea

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

MULTIPLEX TEST FOR COVID-19/FLU
PCR TEST FOR DIAGNOSIS
ANTIBODY TEST FOR EXPOSURE

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® Health, LLC offers 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.

Download the Multiplex test for Covid-19/Flu physician resource here

Multiplex Testing Advantages +

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

Who should be tested +

According to the U.S. Centers for Disease Control and Prevention (CDC), both COVID-19 and flu can have varying degrees of signs and symptoms, ranging from no symptoms (asymptomatic) to severe symptom. The multiplex test for flu and COVID-19 test is for patients under investigation of COVID-19 or flu and seeking evaluation of active disease infection. Please refer to the most current CDC guidelines for further information.

Test Codes +

M123 – COVID-19 + Influenza A/B

Specimen Collection +

Nasal Swab

Specimens of patients under investigation of COVID-19 and seeking evaluation of the disease will not be collected at BioReference® Health Collection Centers. Specimens should be collected at physician offices, hospitals or other clinic settings.

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.

Stability +

5 days at 2–8˚ C

2 days at 2–25˚ C followed by 3 days at 2–8˚ C

Frozen 30 days

Results +

Positive 2019-nCoV
Presumptive Positive 2019-nCoV
Inconclusive
Not Detected
Flu A/B Detected

Self-Pay Pricing +

Click here to download the physician resource.

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.

Download the RT-PCR physician resource here.

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

RT-PCR Specimen Collection +

Specimens of patients under investigation of COVID-19 and seeking evaluation of the disease will not be collected at BioReference® Laboratory Collection 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.

Standard Procedures for Nasopharyngeal Collection +

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

Stability +

3 Days (Refrigerated) 30 Days (Frozen)

Turnaround Time +

Molecular test results will typically be available within 3 days after the blood 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.

Antibody testing for COVID-19 plays a critical role in the fight against the disease by assessing the antibody response in individuals or populations. Testing identifies patients who have been successfully vaccinated or have been previously exposed to COVID-19 in the past.

BioReference® offers immunoassays which measures SARS-CoV-2 specific antibodies, correlating with the patient’s adaptive immune response after COVID-19 infection or successful COVID-19 vaccination. Most patients will have detectable antibody levels by 14 days after vaccination or onset of symptoms and levels are presumed to remain elevated for some time. At this time, it is not known how long antibodies will persist following vaccination or infection.

Download the Antibody physician resource here.

Who should be tested +

Testing is to identify patients who have been successfully vaccinated or have been previously exposed to COVID-19 in the past.

Test Code +

BioReference® offers Roche Elecsys Anti-SARS-CoV-2 S immunoassay technology (Test Code M160).

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® Health Collection Centers. 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 of 30 minutes, maximum of 1 hr, spin for 10-15 minutes.

Test Benefits +

This test can play an important part in characterizing a vaccine-induced immune response. Many current candidate vaccines aim to induce an antibody response against the SARS-CoV- 2 spike protein. Tests that quantify antibodies to the spike protein could be used to measure the level of that response and track that measurement over time.

This test can help in the determination of seroprevalence (i.e. the frequency of individuals with antibody to the virus), in a given population. Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions.

This test can complement diagnostic tests of SARS-CoV-2 infection. Many patients with COVID-19 will be asymptomatic or have mild symptoms, and may not have been diagnosed with PCR. Antibody testing can be used to identify these past infections.

Testing Antibodies In Combination With Molecular Testing +

Patients who are asymptomatic or have recovered from COVID-19 may have immunity from re-infection if IgG is positive, based on past behavior with other types of infections. Ongoing studies will further detail COVID-19 specific immunity to re-infection.

During infection, PCR results are more likely to be positive during the acute phase, with IgG rising later as part of the body’s immune response.

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

Stability +

7 Days Room Temperature or Refrigerated

Technology +

This test can measure the quantity of antibodies to the receptor-binding domain (RBD) of the spike protein of the SARS-CoV2 virus, which is the causative agent of COVID-19. The RBD-spike protein complex is the part of the virus that binds to human cells, which is required for the virus to enter the host cells and replicate.

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 +

Qualitative results are provided as Detected (Positive) or Not Detected (Negative), and semi-quantitative results are provided as a numerical value ranging from 0.80 to 2,500 U/mL

Result Availability +

COVID-19 Self-Pay Pricing +

FDA/CDC +

This test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

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