COVID-19

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.

TH68 Novel Coronavirus COVID-19 Nasopharynx

TH69 Novel Coronavirus COVID-19 Oropharynx

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

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

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.

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.

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.

3 Days (Refrigerated) 30 Days (Frozen)

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

• 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

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.

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.

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

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

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

Blood sample in 2 mL Serum (SST).

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.

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.

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.

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.

7 Days Room Temperature or Refrigerated.

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

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.

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.

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.

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.

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