COVID-19
COVID-19: Information for healthcare professionals
During the COVID-19 health crisis, fast action and trusted information matter more than ever. At Quest Diagnostics, we’re committed to serving our communities and connecting our customers to answers quickly and reliably every day. Stepping up to meet the ever-evolving demands of the pandemic is what we're here for.
We work to empower the healthcare heroes like you on the front lines.
You’ve always trusted Quest labs to deliver the crucial insights you need to make the best decisions for your patients. And we know you’re relying on us to continue that same level of accuracy with an even greater sense of urgency today.
This page is updated frequently as new information becomes available and we continue increasing testing capacity to meet your needs.
Quest Diagnostics is receiving SARS-CoV-2 (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
SARS-CoV-2 antibody testing is a major part of managing the spread of COVID-19,1 and Quest Diagnostics offers a full complement of antibody serology testing to provide additional insights into a patient’s recent or prior infection.
NEW! SARS-CoV-2 Antibody (IgG), Spike, Semi-Quantitative (test code 34499):
A SARS-CoV-2 semi-quantitative IgG test result is reported as positive at an index2 of ≥1.00. This positive result indicates that an individual has developed an immune response to a SARS-CoV-2 infection or a SARS-CoV-2 spike vaccine within the limits of the assay.2
Conversely, a negative result is reported at an index3 of <1.00. A negative semi-quantitative antibody result means that the patient serum specimen had no SARS-CoV-2 spike IgG antibodies, or that the relative level of antibodies in the patient specimen was below the index cutoff.2,3
- Estimated assay sensitivity is >99.9%3 for specimens collected at least 15 days post–symptom onset,3 based on positive percent agreement (PPA)4 of SARS-CoV-2 IgG serology results among SARS-CoV-2 RNA−positive patients3
- Estimated assay specificity is approximately 99.9%3 based on negative percent agreement (NPA)4 assessed by performing cross-reactivity studies utilizing serum specimens positive for antibodies to other respiratory viruses pre– and post–COVID-19 time periods3
SARS-CoV-2 Antibody (IgG), Nucleocapsid, Qualitative (a component of the IgM/IgG panel [test code 31672) (test code 39749):
This test is used to detect IgG antibodies in serum (blood) samples, and aids in identifying an immune response to recent or prior natural infection with SARS-CoV-2.
- Estimated assay sensitivity is >99.6%5 for specimens collected at least 15 days post–symptom onset,5 based on PPA4 of SARS-CoV-2 IgG serology results among SARS-CoV-2 RNA−positive patients5
- Estimated assay specificity is >99.9%,5 based on NPA4 assessed by performing cross-reactivity studies utilizing serum specimens positive for antibodies to other respiratory viruses pre– and post–COVID-19 time periods5
SARS-CoV-2 Serology (COVID-19) Antibodies (IgG, IgM), Immunoassay (test code 31672):
Quest only offers SARS-CoV-2 IgM in a panel that includes a separate IgG determination. The results from this qualitative test for SARS-CoV-2 IgM can be positive (reactive) or negative (non-reactive).6 Separate results are provided for IgG and IgM.
- Estimated assay sensitivity is 95%7 for specimens collected at least 15 days post–symptom onset,7 based on PPA4 of SARS-CoV-2 IgM serology results on patients who are SARS-CoV-2 RNA−positive7
- Estimated specificity is >99%7 based on NPA4 assessed by performing SARS-CoV-2 IgM tests on serum specimens positive for antibodies to other respiratory viruses pre– and post–COVID-19 time periods7
- The antibody response to SARS-CoV-2 usually starts with IgM being detectable first, followed by the longer-lasting and more specific IgG. Data suggest that IgM antibodies can be detected within a few days and IgG antibodies will be detectable from 10 days after SARS-CoV-2 exposure or symptom onset3-5,8
The antibody tests currently offered by Quest Diagnostics were granted Emergency Use Authorization (EUA) by the FDA for public health and clinical use—Abbott AdviseDx and Abbott ARCHITECT, Ortho Clinical Diagnostics VITROS, Siemens Centaur® and Siemens Atellica,® and Ortho Clinical Diagnostics.9
All 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
- FDA. Important information on the use of serological (antibody) tests for COVID-19 – letter to health care providers. Updated April 17, 2020. Accessed February 11, 2021. https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers
- FDA. Fact sheet for healthcare providers: Siemens Healthcare Diagnostics Inc. Atellica® IM SARS-CoV-2 IgG (COV2G). SARS-CoV-2 IgG semi-quantitative and ADVIA Centaur® SARS-CoV-2 IgG (COV2G). Updated July 31, 2020. Accessed January 22, 2021. https://www.fda.gov/media/140698/download; https://www.fda.gov/media/140702/download
- FDA. Atellica® IM SARS-CoV-2 IgG (COV2G) and ADVIA Centaur® SARS-CoV-2 IgG (COV2G). Instructions for use. Siemens Healthcare Diagnostics Inc; 2020. Accessed February 14, 2021. https://www.fda.gov/media/140699/download; https://www.fda.gov/media/140704/download
- FDA. EUA authorized serology test performance. Updated January 8, 2021. Accessed February 11, 2021. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance
- SARS-CoV-2 IgG [package insert]. Abbott Laboratories; 2020. Accessed January 21, 2021. https://www.fda.gov/media/137383/download
- FDA. Fact sheet for healthcare providers: Abbott Laboratories AdviseDx SARS-CoV-2 IgM. Updated October 9, 2020. Accessed January 22, 2021. https://www.fda.gov/media/142938/download
- AdviseDx SARS-CoV-2 IgM [package insert]. Abbott Laboratories; 2020. Accessed January 21, 2021. https://www.fda.gov/media/142940/download
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG. Instructions for use. Ortho-Clinical Diagnostics; 2020. Accessed January 21, 2021. https://www.fda.gov/media/137363/download
- FDA. Emergency Use Authorization (EUA) information, and list of all current EUAs. Updated February 5, 2021. Accessed February 5, 2021. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
It’s flu season, but we’re also still in the midst of the COVID-19 pandemic. SARS-CoV-2 (COVID-19), influenza (flu), and other respiratory infections can present with similar symptoms such as fever, cough, and shortness of breath.
That’s why it’s important to consider testing for each of these contagious illnesses at the same time—especially for older adults, pregnant women, and people with underlying conditions or compromised immune systems.
New tests from Quest use a single specimen to co-test for SARS-CoV-2 and other respiratory pathogens, which helps expedite diagnosis so you can develop an appropriate treatment/care plan.
New tests include:
- SARS-CoV-2 RNA (COVID-19) and Influenza A and B, Qualitative NAAT (test code 31688)
- SARS-CoV-2 RNA (COVID-19) and Respiratory Pathogen Panel, Qualitative NAAT (test code 31687)
- SARS-CoV-2 RNA (COVID-19) and Respiratory Viral Panel, Qualitative NAAT (test code 31686)
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.
Quest Diagnostics has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) to use pooled specimens in connection with molecular diagnostic testing for COVID-19. Pooling is an efficient way to evaluate patients in regions or populations with low prevalence of disease (less than 10% positivity). Specimen pooling is a proven laboratory technique that can expand COVID-19 molecular diagnostic testing capacity, which is critical to our COVID-19 public health response in the United States. Pooled testing has long been used by the American Red Cross to test donated blood for hepatitis B and C, Zika virus, and HIV. Priority specimens will not be pooled.
GET SPECIMEN POOLING DETAILS & RESOURCES
A national emergency doesn’t change the fact that your patients may need healthcare and lab services for issues not related to COVID-19. At Quest, we’re carefully enhancing services in our Patient Service Centers (PSCs) to ensure standard patient care can continue.
Support for telemedicine services
Because Quest Diagnostics is committed to doing everything we can to better serve our communities, we’re working with CompuGroup Medical to provide telemedicine offerings to enable engagement with your patients via web, phone, or mobile app.
Learn more about our solutions for telemedicine >
COVID-19 has caused many patients to defer their regular course of care which includes important routine testing. That’s why Quest has introduced a new Back to Patient Care program which provides guidance that can help you:
 Make informed decisions about your practice |  Minimize risk of exposure in your work environment |
 Get patients back to routine care |  Treat patients in-office, as appropriate |
Quest can conduct drug monitoring services for your patients in our PSCs to help maintain regular testing routines during the pandemic.
Contact your Quest representative to help put this system in place for your patients.
Your patients can always access their results directly through their secure MyQuest™ account.
The online portal is free to set up and can be used on any desktop, tablet, or smartphone device.
Quest Diagnostics provides key insights about COVID-19 status to help people who are thinking about resuming daily routines—such as work, care, school, dining out, sports, etc. Our testing protocols and solutions can help you make clear, actionable suggestions for your patients' return to work and daily routines.
LEARN MOREAs the pandemic evolves and new data accumulates daily, we’re committed to providing you with the most up-to-date testing information and important resources for your practice.
|
| ||||
|
| ||||
|
|
Important information about SARS-CoV-2 (COVID-19) antibody testing
Antibody tests are intended for use as an aid in identifying individuals with a recent or prior infection of SARS-CoV-2 (which may be resolved or is still resolving), or an immune response to a COVID-19 spike-targeted vaccine. 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 EUA for use by authorized laboratories;
- The antibody tests have been authorized only for the detection of 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 antibody tests 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 authorization 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.