Molecular testing to help diagnose COVID-19
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.
Quest Diagnostics is receiving COVID-19 specimens and performing testing nationwide.
An unforeseen increase in testing demand has had an inevitable impact on COVID-19 turnaround time (TAT) overall. We continue to target TAT for Priority 1 (hospitalized) patients at 1 day. For all other patients, TAT is now 4-6 days, on average nationally.
However, as we anticipate demand for COVID-19 testing to continue to rise, TAT for patients may exceed these current levels over the coming weeks.
Please contact your Quest representative to obtain the turnaround time at your specific laboratory location or for more information around COVID-19 testing.
To increase testing capacity and make the ordering process more convenient for healthcare professionals and hospitals, Quest has implemented a one code ordering system for all molecular tests.
Healthcare professionals can now order COVID-19 molecular testing using a single code—39448. Ordering COVID-19 molecular testing with a single code 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 delivery.
Video update on PCR molecular testing
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, but not during the hours designated for the Peace of Mind program reserved for patients at greatest risk for COVID-19.
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 or find a testing location through national partnerships with Walmart, CVS Health or find local testing options through Google. Quest laboratories are accepting and performing testing on COVID-19 specimens submitted by healthcare providers across the United States.
The US Department of Health and Human Services (HHS) offers clear recommendations for prioritizing COVID-19 testing for individuals. As the need for COVID-19 testing continues to escalate across the country, this uniform guidance is important to ensure testing is prioritized for those patients whose circumstances require more immediate results.
To align our COVID-19 response effort with HHS recommendations, Quest implemented a COVID-19 Priority Testing Program. Healthcare professionals should submit test processing orders using color-coded cards according to the following priority levels:
COVID-19 Priority Testing Program
Priority 1 Testing
- Hospitalized patients
- Healthcare facility workers with symptoms
Priority 1 testing helps ensure optimal care options for all hospitalized patients, lessens the risk of healthcare-associated infections, and maintains the integrity of the US healthcare system.
Priority 2 Testing
- Patients in long-term care facilities with symptoms
- Patients over age 65 years with symptoms
- Patients with underlying conditions with symptoms
- First responders with symptoms
Priority 2 testing helps ensure those at highest risk for complications of infection are rapidly identified and appropriately triaged.
Priority 3 Testing
- Critical infrastructure workers with symptoms
- Individuals who do not meet any of the above categories with symptoms
- Healthcare facility workers and first responders
- Individuals with mild symptoms in communities experiencing high numbers of COVID-19 hospitalizations
As resources allow, the testing of Priority 3 individuals involves those in the surrounding community of rapidly increasing hospital cases to decrease community spread and ensure the health of essential workers.
- Individuals without symptoms
How to order Priority Handling Cards
For hospital customers: Using Quanum™ supplies ordering, order your Priority Handling Cards using part numbers FM18 (P1), FM121 (P2), and FM122 (P3).
For physician customers: For P2 and P3 Priority Handling Cards, use Quanum™ supplies ordering using part numbers FM121 (P2) and FM122 (P3). Given strict limitations for P1 Priority Handling Card use in non-hospital environments, physicians should contact their Regional Client Supply Call Center to order P1 Priority Handling Cards.
What is the test name and test code?
What facilities can collect specimens?
Specimens are to be collected by hospitals, physician offices, and clinics. Quest Diagnostics patient service centers and Quest’s in-office phlebotomists do not collect respiratory specimens, including those from patients suspected of having COVID-19.
How can I order the Quest Diagnostics test for COVID-19?
Physicians may order the test using one test code — 39448. The test must be ordered on a separate requisition from other tests.
Specimens submitted will be evaluated upon receipt by Quest and routed to the appropriate COVID-19 testing platform (LDT, Roche, Hologic) after evaluating the specific specimen type received, collection vial (medium/swab, etc) submitted, patient type priority status, and testing capacity available. This helps optimize test turnaround time.
How does having one test code improve flexibility and testing capacity?
A single test code will allow Quest to better manage the capacity within each lab and across labs performing the molecular PCR COVID-19 tests. As tests are submitted, Quest will route the incoming specimens to a molecular PCR test (LDT, Roche, Hologic, or others) to optimize capacity and minimize the possibility of a backlog on a given platform. Being able to direct the specimen across numerous different, but equivalent, platforms allows Quest to optimize testing capacity across all options and across the Quest laboratory network. The single test code system helps maximize throughput and ability to manage demand.
When is the single test code available to use?
The new, flexible test code, 39448, should be used immediately after April 13. Previous codes 39433 (Quest LDT) and 39444 (Roche) will be discontinued and will not be orderable after May 4.
What is Quest’s capacity for testing?
Quest Diagnostics has rapidly expanded testing capacity with the addition of multiple test types running simultaneously in many of our laboratories across the country.
Is saline an acceptable transport medium?
Saline has been indicated by the FDA as an acceptable transport medium that can be used in situations where commercial viral transport media are unavailable for molecular RT-PCR SARS-CoV-2 assays (such as those in use for the Quest COVID-19 tests). Note: The FDA believes that for saline, a sterile plastic vial containing between 1mL and 3mL of phosphate-buffered saline is appropriate. The FDA believes that sample collection with a flocked swab is preferred. When options are limited, collection by a foam swab or spun synthetic swab is also acceptable, but may not be sufficient to rule out infection. Collection should be conducted with a sterile swab.
Quest PBS (Phosphate-Buffered Saline) NP Swab convenience kits for nasopharyngeal specimen collection are available. Client orders will be facilitated via the existing order fulfillment process for COVID-19 specific collection supplies.
How do I order appropriate supplies for COVID-19 testing?
We are still accepting orders for COVID-19 testing. As a reminder, Quest does not manufacture the collection supplies used in testing. Due to extraordinary demand, we are temporarily unable to accept orders for upper respiratory specimen collection and transport supplies online. You do not have to use supplies from Quest to send us testing. Please refer to the Specimen Device Collection Guide to help you identify acceptable supplies for COVID-19 specimen collection.
How do healthcare providers and patients get results?
Providers will receive a phone call if the test result is positive or inconclusive. Patients will be notified through MyQuest if they signed up for it.
The antibody tests (sometimes known as the serology tests or IgG 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. 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 antibody test should not be used to diagnose acute SARS-CoV-2 infection. False positive results for the antibody test may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
- The antibody tests and the molecular tests (together “All tests”) have not been FDA cleared or approved;
- All tests have been authorized by FDA under EUAs for use by authorized laboratories;
- The antibody tests have been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;
- The molecular tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and,
- All 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.