Information for Hospitals

Quest Diagnostics

Print

COVID-19

Quest Diagnostics

COVID-19: Information for hospitals and health systems

More than half of US hospitals and health systems trust Quest Diagnostics to deliver accurate and timely test results every day. During the COVID-19 pandemic, you can continue to rely on our fast action and clear insights in the face of uncertainty.

Just as we have during other health emergencies, the entire Quest team is rising above the challenge at hand. We’re here to empower your hospital and the communities you serve.

Quest employees

Quest helps strengthen your connection to the patients and healthcare workers who put their trust in you.

This page is updated frequently as new information becomes available and we continue increasing testing capacity to meet your needs.

Quest Diagnostics is receiving COVID-19 specimens and performing testing nationwide.

A molecular test (test code 39448) is available to test symptomatic patients for COVID-19. Through qualitative multi-target molecular diagnostics, this testing option helps to detect the presence of SARS-CoV-2.

Quest processes four different molecular tests—the FDA Emergency Use Authorized Quest Diagnostics lab-developed test (LDT), the FDA Emergency Use Authorized Roche Diagnostics test, the FDA Emergency Use Authorized Hologic Panther Fusion test, and the FDA Emergency Use Authorized Hologic Panther Covid-19 molecular assay.

To simplify the test ordering process and further increase capacity, Quest has implemented a one code ordering system (test code 39448) that applies to all molecular tests.

GET MOLECULAR TEST DETAILS & RESOURCES

 

The following co-testing options can help differentially detect or evaluate the pathogen(s) responsible for a patient’s respiratory infection. These co-testing options include many clinical advantages including, but not limited to, collecting a single specimen, potentially minimizing patient discomfort, and expediting time to diagnosis.

These tests include:

 

  • The SARS-CoV-2 Serology (COVID-19) Antibody (IgG), Immunoassay (test code 39504) is a specific test used to detect IgG antibodies to the SARS-CoV-2 virus in your blood. The IgG antibody test can help identify recent or prior infection to SARS-CoV-2 (which may be resolved or is still resolving), versus the molecular test which is used to help identify an active infection

  • The SARS-CoV-2 Serology (COVID-19) Antibodies (IgG, IgM), Immunoassay (test code 31672) provides qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in serum (blood) samples and offers additional insights into a patient’s infection and/or recovery status. Separate results are provided for IgG and IgM

  • These tests have specificity values of 99.6% to 100% which minimizes false positives, and sensitivity values of approximately 90% to 100%1-4

  • The antibody tests currently offered by Quest Diagnostics were granted Emergency Use Authorizations (EUA) by the FDA for public health and clinical use—Abbott ARCHITECT, Ortho Clinical Diagnostics, and EUROIMMUN5

  • IgG and IgG/IgM antibody testing must be ordered by a physician. Patients may make an appointment at a Quest Patient Service Center for these tests

GET ANTIBODY TEST DETAILS & RESOURCES

 

References

  1. Anti-SARS-CoV-2 ELISA (IgG). Instruction for use. EUROIMMUN. Updated May 4, 2020. Accessed November 9, 2020. https://www.fda.gov/media/137609/download
  2. Abbott Architect SARS-CoV-2 IgG [package insert]. Abbott; 2020.
  3. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG. Instructions for use. Ortho-Clinical Diagnostics. Updated April 2020. Accessed November 9, 2020. https://www.fda.gov/media/137363/download
  4. AdviseDx SARS-CoV-2 IgM [package insert]. Abbott. Published October 2020. Accessed October 23, 2020. https://www.fda.gov/media/142940/download
  5. Emergency Use Authorization (EUA) information, and list of all current EUAs. Food and Drug Administration. Updated November 2,2020. Accessed November 4, 2020. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization

Quest Diagnostics patient service centers are not accepting patients with suspected or confirmed COVID-19 and are not collecting respiratory specimens for COVID-19 molecular testing.

Blood specimens for SARS-CoV-2 antibody testing can be collected by a hospital or health system or in any healthcare setting where a licensed phlebotomist can draw blood. Quest will be collecting serology specimens at patient service centers (PSCs) by appointment across the country.

The personnel at our PSCs are trained in collecting a range of specimens, including blood and urine, for various medical health conditions, but not respiratory specimens for COVID-19 or other respiratory illnesses such as influenza.

Quest recommends individuals who suspect they have COVID-19 contact their healthcare provider directly about COVID-19 testing. Quest laboratories are accepting and performing testing on COVID-19 specimens submitted by healthcare providers across the United States.

Important information about SARS-CoV-2 (COVID-19) antibody testing

The IgG and IgM antibody tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Results are for the detection of SARS-CoV-2 antibodies.1-4

IgG and IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized.

Compared to IgG antibodies, IgM antibodies are typically detected earlier, during the acute phase of an infection but generally are not detected later in the infection. In the typical infection cycle, the presence of IgM would suggest a more recent or possibly unresolved infection, while the IgG antibody would suggest a prior infection.

The use of an IgG/IgM panel can help identify and differentiate those individuals with a recent infection from those who have encountered SARS-CoV-2 and recovered, thus helping to further evaluate disease course.

  • Presence of IgG/IgM with symptoms suggests recent infection even if RNA/antigen is not detected5

  • Presence of IgG alone, absent symptoms, suggests recovery6-8

  • The sensitivity of the IgM test early after infection is unknown

  • Due to the risk of false positive results, confirmation of positive results should be considered using a second, different IgM assay or an IgG assay

  • Samples should only be tested for IgM from individuals with 15 days to 30 days post symptom onset

  • SARS-CoV-2 antibody negative samples collected 15 days or more post symptom onset should be reflexed to a test that detects and reports SARS-CoV-2 IgG

At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.1-4 Individuals may have detectable virus present for several weeks following seroconversion.5-8 Negative results do not preclude acute SARS-CoV-2 infection.5-8 If acute infection is suspected, molecular testing for SARS-CoV-2 is necessary.

The tests should not be used to diagnose acute SARS-CoV-2 infection. False positive results for the tests may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

  • The antibody tests have not been FDA cleared or approved

  • The antibody tests have been authorized by FDA under an EUA for use by authorized laboratories

  • The antibody tests have been authorized only for the detection of IgG and IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens; and

  • The antibody tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

COVID-19 testing statements

  • The cobas® SARS-CoV-2 and Influenza A/B Test and the Quest SARS-CoV-2 RT-PCR test and other molecular tests (“Tests”) have not been FDA cleared or approved

  • The SARS-CoV-2 Serology (COVID-19) Antibody (IgG), Immunoassay test and SARS-CoV-2 Serology (COVID-19) Antibodies (IgG, IgM), Immunoassay from Quest have not been FDA cleared or approved

  • The Tests have been authorized by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform moderate and high complexity tests. The Roche test has been authorized only for the detection of RNA from SARS-CoV-2 virus, influenza A virus, and influenza B virus and not any other viruses or pathogens

  • The Roche test is only authorized for the duration of the declaration that circumstances exist justifying the authorized emergency use of in vitro diagnostics for detection and differentiation of SARS-CoV-2 virus, influenza A, and influenza B under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorized is terminated or revoked sooner

  • The Quest test and other molecular tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens

  • The Quest test and other molecular tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

References

  1. Anti-SARS-CoV-2 ELISA (IgG). Instruction for use. EUROIMMUN. Updated May 4, 2020. Accessed November 9, 2020. https://www.fda.gov/media/137609/download
  2. Abbott Architect SARS-CoV-2 IgG [package insert]. Abbott; 2020.
  3. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG. Instructions for use. Ortho-Clinical Diagnostics. Updated April 2020. Accessed November 9, 2020. https://www.fda.gov/media/137363/download
  4. AdviseDx SARS-CoV-2 IgM [package insert]. Abbott. Published October 2020. Accessed October 23, 2020. https://www.fda.gov/media/142940/download
  5. Espejo AP, Akgun Y, Al Mana AF, et al. Review of current advances in serologic testing for COVID-19. Am J Clin Pathol. 2020;154(3):293-304. doi:10.1093/ajcp.aqaa112
  6. Important information on the use of serological (antibody) tests for COVID-19 – letter to health care providers. Food and Drug Administration. Updated April 17, 2020. Accessed October 25, 2020. https://www.fda.gov/medical-devices/letters-health-careproviders/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers
  7. Interim guidelines for COVID-19 antibody testing. Centers for Disease Control and Prevention. Updated August 1, 2020. Accessed October 25, 2020. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html#anchor_1590264293982
  8. IDSA COVID-19 antibody testing primer. Infectious Diseases of America. Updated April 22, 2020. Accessed April 23, 2020. https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf