COVID-19: Information for healthcare professionals

Last updated May 9, 2022

As the COVID-19 health crisis evolves, healthcare professionals rely on insights from Quest Diagnostics to make the best choices for their patients. Find COVID-19 testing options, patient care tools, support for your practice, clinical resources, and more. 

POWERING AFFORDABLE CARE through better SARS-CoV-2 (COVID-19) testing 

Quest receives SARS-CoV-2 (COVID-19) specimens and performs testing nationwide with precision and reliability. Learn more about the test options available to your patients.

Antibody tests are intended as aids in identifying individuals with an adaptive immune response to COVID-19, indicating recent or prior infection. It can be useful in providing evidence of an immune response over time and may benefit people at high-risk for being infected or for severe outcomes. Results are for the detection of SARS-CoV-2 antibodies.

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.

At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Individuals may have detectable virus present for several weeks following seroconversion. Negative results do not preclude acute SARS-CoV-2 infection. 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 test may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

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.

• The antibody tests have not been FDA cleared or approved
• The antibody tests have been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories
• The antibody tests have been authorized only for detecting antibodies against SARS-CoV-2, not for any other viruses or pathogens
• The SARS-CoV-2 Total Antibody, Spike, Semi-Quantitative test has been authorized by FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform high complexity tests
• The IgM serology test component has been authorized only for the detection of IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens
• These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

• The Cepheid SARS-CoV-2, Influenza A/B and RSV test, the cobas® SARS-CoV-2 & 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 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 Cepheid SARS-CoV-2, Influenza A/B and RSV test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), and not for any other viruses or pathogens;
• The Cepheid SARS-CoV-2, Influenza A/B and RSV test is 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• The Roche test is only authorized for the duration of the declaration that circumstances exist justifying the authorized of the 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 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 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.

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