What To Know
- This means that while Quest Diagnostics has validated the test and has the data to believe the test and the collection kit are accurate, this test has not been FDA-cleared or -approved.
- The new test uses the gold standard of COVID-19 diagnostic testing – highly sensitive molecular diagnostic technologies that have received emergency use authorization from the FDA to aid the detection of the RNA of SARS-COV-2, the virus that causes COVID-19.
September 17, 2020
Individuals can now purchase a test to diagnose COVID-19 online, without visiting a doctor’s office, through QuestDirect, the consumer-initiated testing business of Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services. The QuestDirect COVID-19 Active Infection test* can be purchased online with specimen collection available in two ways: at-home or at one of more than 500 Walmart Neighborhood Market drive-thru pharmacy locations across the United States.
The test to diagnose COVID-19 online (QuestDirect COVID-19 Active Infection test*) is available online at QuestCOVID19.com.
“Accessible, high-quality COVID-19 diagnostic testing is essential to containing the spread of COVID-19,” said Jay Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer for Quest Diagnostics. “With our new QuestDirect COVID-19 Active Infection self-collection kit, anyone can access a high-quality COVID-19 test with access to interpretation and referral into care from a physician. Additionally, individuals can receive a self-collection kit either at home or at a nearby Walmart drive-thru location, for the ultimate in speed, safety, and convenience.”
The new test uses the gold standard of COVID-19 diagnostic testing – highly sensitive molecular diagnostic technologies that have received emergency use authorization from the FDA to aid the detection of the RNA of SARS-COV-2, the virus that causes COVID-19. The test is appropriate for individuals who seek access to COVID-19 diagnostic testing, due to COVID-19-like symptoms or exposure to someone with COVID-19.
The kit includes a device for anterior nares (nasal) swab collection, a comparatively noninvasive specimen collection technique that involves inserting a swab into one nostril in the front of the nose.
Easy-to-Order Process with Two Access Options
After an individual purchase the test online, a licensed physician with an independent national network of physicians providing clinical oversight for QuestDirect services, will promptly review the order and, if deemed appropriate, order the test.
Unlike other consumer-initiated COVID-19 diagnostic tests, Quest provides two options for specimen collection:
A specimen collection kit is mailed to the individual’s home. The individual may then submit the specimen in the kit via FedEx overnight to a Quest Diagnostics laboratory for testing.
An individual may also opt to purchase the kit online and take it to one of more than 500 Walmart drive-thru pharmacy window locations in the United States for observed collection. At these Walmart locations, a trained pharmacist will observe the collection process and the specimen will be picked-up from a secure dropbox and delivered to a Quest laboratory for testing.
Test results are available in an easy-to-read report on MyQuest, the company’s secure patient portal accessible on a smartphone, tablet, or desktop.
Physicians are available post-test via telehealth to help consumers with the interpretation of the result and referral into appropriate care.
The new service complements the QuestDirect™ COVID-19 Antibody Test, which was launched in April 2020.
MyQuest™ Patient Portal Makes it Easy to Share Test Results
As areas of the country continue to reopen, and people are spending more time together in person, consumers are looking to learn that the people they spend time with pose a reduced risk for spreading COVID. Like all QuestDirect test results, the QuestDirect COVID-19 Active Infection test results are sent directly to Quest’s patient portal, MyQuest, where they can be downloaded and/or shared with friends, or directly imported into a consumer’s MyCircle – an online platform that securely links the results across authorized individuals, such as caregivers and dependents.**
Additionally, through MyQuest, patients can share their QuestDirect COVID-19 Active Infection test results in combination with other test results performed by Quest with their physician, in order to provide a more comprehensive view of their state of health.
*This test has been authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA). This means that while Quest Diagnostics has validated the test and has the data to believe the test and the collection kit are accurate, this test has not been FDA-cleared or -approved; This test has been authorized by FDA under a 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 on in-vitro diagnostics for the 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. Additional studies need to be conducted for this test and others like it to be FDA cleared or approved.
**Consumers may only purchase the COVID-19 Active Infection Test on behalf of themselves.
