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COVID-19 Testing: Provider Update

Tuesday, May 19, 2020   (0 Comments)
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Written by: Quest Diagnostics 



Overview

 

COVID-19 testing is critical to overcoming the current healthcare crisis. Quest Diagnostics is receiving COVID-19 specimens and performing testing nationwide, and has performed and reported results of approximately 2.15 million COVID-19 diagnostic tests and 975,000 antibody tests to date (as of May 18th). Read further for quick facts on active infection and antibody testing, information on additional safety measures at Quest Patient Service Centers (PSCs), and key resources and tools to help you navigate through the crisis and protect the health of your patients and employees.

 

Centers for Disease Control (CDC) testing guidelines1:

  • Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested.
  • Decisions on which patients receive testing should be based on priority guidelines as outlined by the CDC
  • Per CDC guidelines, clinicians should consider testing for other causes of respiratory illness, including infections such as influenza.

For detailed information visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html

 

SARS-CoV-2 (COVID-19) test offerings from Quest Diagnostics

 

MOLECULAR (ACTIVE INFECTION) QUICK FACTS

 

Molecular testing emergency use authorization (EUA)

  • The Quest Diagnostics, Roche, and Hologic Panther Fusion tests have not been FDA cleared or approved;
  •  These tests have been authorized by the FDA under an EUA for use by authorized laboratories;
  • These tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
  • 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

 

 

Test name: SARS-CoV-2 RNA (COVID-19), Qualitative NAAT

Test code 39448: As of mid-April, Quest has implemented a one code ordering system for all molecular tests. Healthcare professionals can now order SARS-CoV-2 (COVID-19) molecular testing using a single code. This allows Quest to more efficiently distribute testing to whichever platform offers the best capacity, either at the ordering site or across our network of laboratories, This helps improve turnaround time and result reporting.

Primary use: The molecular test is a qualitative, multi-target molecular diagnostic test that aids in the detection of COVID-19. This test is intended to be performed on respiratory specimens collected from people who meet the CDC clinical and/or epidemiological criteria for COVID-19 testing.

Sample collection: Samples must be collected and testing must be ordered by a physician or authorized healthcare provider and sent to Quest Diagnostics. Find our most up-to-date collection and transportation guidance here, by choosing resources and guides > specimen collection. Please note: Quest Diagnostics personnel are not able to collect respiratory specimens in Patient Service Centers.

 

 

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Key specimen submission note: Nasopharyngeal (NP) and/or oropharyngeal (OP) swabs can be collected and transported in individual vials or combined in a single vial for testing. Each COVID-19 specimen transport vial that is submitted should be accompanied by its own separate requisition and transported in its own sealed bag.

Turnaround time: Quest continues to scale up capacity for SARS-CoV-2 (COVID-19) molecular testing to help meet demand. Turnaround time is typically less than 2 days from the time the specimen is received in our laboratory, but can vary due to high demand and regional location. Local Quest representatives are the best resource for location-specific turnaround time information. 

 

SEROLOGY (ANTIBODY) QUICK FACTS:

 

 IgG antibody serology testing statement

 

The test is 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. IgG 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 test 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.

  •  This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an EUA for use by authorized laboratories;·
  • This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and,
  • This 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

 

Test name: SARS-CoV-2 Serology (COVID-19) Antibody (IgG), Immunoassay

Test code 39504

Primary use: The serology immunoassay test is a qualitative test to detect IgG antibodies to the SARS-CoV-2 virus in the blood. IgG antibody testing may be performed to help identify people who may have been previously exposed to SARS-CoV-2 and may indicate prior an immune response. We don’t know yet whether having antibodies to SARS-CoV-2 will prevent against getting the infection again.

  • IgG testing provides insights into an individual’s prior exposure to the virus that causes COVID-19 help to identify people who may be lower risk to resume work and other daily activities in society. While the role of antibodies in preventing COVID-19 disease has yet to be established, experience from other respiratory illnesses (SARS, flu) suggests they may have some immunity.
  • IgG antibody testing should not be used to diagnose active infection, and symptomatic patients should always be diagnosed using a molecular SARS-CoV-2 (COVID-19) test (Test Code 39448).

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Sample collection: Blood specimens for SARS-CoV-2 antibody testing can be collected in any healthcare setting where a licensed phlebotomist can draw blood. Quest is collecting serology specimens by appointment at PSCs across the country.

Key specimen submission note: The antibody testing does not need to be on its own requisition, and can be submitted with other testing, but it is preferred that the serology specimen be in its own SST tube. Molecular testing should continue to be submitted on its own requisition. In the case where a physician orders a molecular/PCR and an antibody test for the same patient, it is still preferred that the molecular test continue to be in its own bag, on its own requisition.

Turnaround time: Turnaround time for the antibody test is typically around 2 days from the time the specimen is received in our laboratory, but can vary due to high demand and regional location.

Safeguarding patients

Quest’s Peace of Mind program reserves the first hour of each day for patients who are 60 years of age or older, pregnant, or have underlying medical conditions that make them more vulnerable to COVID-19. The program also includes additional safety measures, such as more frequent cleaning, mask/face covering requirements, and social distancing. With our Wait by Text program, patients can wait where they are most comfortable and receive a text message when it’s their turn.

Healthcare provider resources

Quest now offers a Back to Care Program that can help guide you in making informed decisions about managing your clinic amid the crisis—helping your patients and staff take steps towards managing their COVID exposure, and continuing care and treatment.

 

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Looking for more information? Visit the Quest Diagnostics COVID-19 webpage for up-to-date information, specimen collection and transport guidance, email alerts, FAQs, and a dedicated client support inbox. For more tailored support or guidance, contact your local Quest representative or call 1.866.MYQUEST (1.866.697.8378).

 

 

Footnotes:

1. Centers for Disease Control and Prevention. Recommendations for viral testing, specimen collection, and reporting. Updated May 3, 2020. Accessed May 15, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fclinical-criteria.htm

 

 

 

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