Roche IVD Test for COVID-19

Quest Diagnostics

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Roche IVD Test for COVID-19 Offered by Quest Diagnostics

Quest Diagnostics is receiving COVID-19 specimens and performing testing. Testing is available nationally.

To meet the growing demand of our healthcare providers and patients, Quest Diagnostics has been rapidly expanding testing capacity by adding a high-throughput, FDA-authorized Roche Diagnostics test for COVID-19, which is now available.

With the Roche test (test code 39444) now available broadly, customers should be ordering the Roche test when submitting upper respiratory specimens. The Roche platform provides high-throughput automation, which will enable us to provide more testing capacity. For lower respiratory specimens, including bronchial lavage/wash (BAL), nasopharyngeal aspirate/wash, tracheal aspirate, or sputum, customers must order the Quest Diagnsotics LDT (test code 39433) for those specimen types.

For other respiratory specimens (eg, bronchial lavage/wash (BAL), nasopharyngeal aspirate/wash, tracheal aspirate, or sputum) the test code 39433 (Quest Diagnostics LDT test) should be used.

 
 
 
 
 
 
 

The SARS Coronavirus with CoV-2 RNA, Qualitative Real-Time RT-PCR test is a qualitative multi-target molecular diagnostics test that aids in the detection of COVID-19. This test is intended to be performed on respiratory specimens collected from individuals who meet the Centers for Disease Control and Prevention (CDC) clinical and/or epidemiological criteria for COVID-19 testing

Quest Diagnostics patient service centers are not accepting patients with suspected or confirmed COVID-19 and are not collecting specimens for COVID-19 testing. The personnel at these centers 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 concerned individuals contact their healthcare provider directly about COVID-19 testing. Quest is accepting and performing testing on COVID-19 specimens submitted by healthcare providers across the United States.

FAQs

What is the test name and test code?
The test name in the Test Directory is SARS Coronavirus with CoV-2 RNA, Qualitative Real-Time RT-PCR and the test code is 39444.

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 the appropriate test code. The test must be ordered on a separate requisition from other tests. With the Roche test (test code 39444) now available broadly, customers should be ordering the Roche test when submitting upper respiratory specimens. The Roche platform provides high-throughput automation, which will enable us to provide more testing capacity. For lower respiratory specimens, including bronchial lavage/wash (BAL), nasopharyngeal aspirate/wash, tracheal aspirate, or sputum, customers must order the LDT (test code 39433) for those specimen types.

Is saline an acceptable transport media?
Saline has been indicated by the FDA as an acceptable transport media that can be used in situations where commercial viral transport media is unavailable for molecular RT-PCR SARS-CoV-2 assays (such as those in use for the Quest LDT and Roche tests). Note: FDA believes that for saline, a sterile glass or plastic vial containing between 1mL and 3mL of phosphate buffered saline is appropriate. 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.

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. 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 I get my 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.

What is Quest’s capacity for testing?
Quest Diagnostics has rapidly expanded testing capacity with the addition of both the Roche Diagnostics high-throughput test and the Quest Diagnostics lab-developed test (LDT) running simultaneously in many of our laboratories across the country. This expansion in testing capacity will allow us to perform approximately 30,000 tests a day by the end of March furthering our ability to meet the growing demand of our healthcare providers and patients.

  • 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 nucleic acid from 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 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

Please direct any questions regarding coding to the payer being billed.

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