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 coronavirus testing, service and technology solutions.

Woman with mask for covid 19

 

 

Information for Patients

Get tested to find out if you’ve been exposed or are actively infected with COVID-19.

Learn More

Test solutions that yield high quality and accurate test results

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® 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.

Click here to download the Multiplex test for COVID-19/Flu physician resource.

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 Laboratory 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

Test 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 help 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.

Click here to download the RT-PCR physician resource.

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 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.

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.

Test 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

Antibody testing plays a critical role in the fight against COVID-19 by assessing the antibody response in individuals and 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.

Click here to download the Antibody physician resource.

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 Laboratory Collection Center 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 of 30 minutes, maximum of 1 hour, 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.

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).

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.

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 +

7 Days Room Temperature or Refrigerated.

Turnaround Time +

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

Test Results +

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

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.

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

Safe, convenient and scalable

Collection Sites

BioReference® offers the scalability to provide organizations with on-site phlebotomy services to help ensure proper specimen collection and handling.

Drive Thru Collection

Through government collaborations, BioReference® supports safe and convenient drive-thru options to expand patients’ testing collection options.

A digital suite with flexibility to meet organizational needs

Digital Registration

BioReference® provides a unique digital platform for online registration and test scheduling.

Check-In

Digital appointment retrieval via QR codes allows for easy arrival and low-contact check-in.

Patient Portal

Test results are provided in a patient-friendly report form via BioReference®’s secure online Patient Portal.

Digital Integrations

BioReference® offers FHIR API solutions to maintain flexible connectivity standards .

Dashboard

BioReference® offers a COVID-19 Dashboard to present detailed reports of an organization’s COVID-19 test results.

Local and National Collaborations

Schools and Districts

BioReference® is proud to collaborate with schools, districts and camps to provide laboratory testing services to help ensure safe learning environments for students and staff.

Sport Leagues 

BioReference® is proud to collaborate with sport leagues to provide comprehensive, turn-key testing strategies that help create healthy environments for athletes and assist in performance improvement.

Employers and Governments

BioReference® is proud to collaborate with employers, governments and host organizations to provide laboratory testing services that help identify infection and promote safe environments.

Click here to submit a collaboration inquiry and be contacted by a BioReference® representative about opportunities for laboratory services within your organization.