Two commercial labs testing now for COVID-19
Two commercial lab companies have announced they are moving into testing for COVID-19. LabCorp. said Thursday it was immediately offering testing for COVID-19 and Quest Diagnostics has announced it will start testing this week. The LabCorp 2019 Novel Coronavirus (COVID-19), NAA test is available for ordering by physicians or other authorized healthcare providers anywhere in the U.S. The test detects the presence of the underlying virus that causes COVID-19 and is for use with patients who meet current guidance for evaluation of infection with COVID-19. “We have been intensely focused on making testing for COVID-19 available as soon as possible, working with the government and others to address this public health crisis,” said Adam H. Schechter, president and CEO of LabCorp. “By expanding access to testing in the U.S., and preparing to support the development of vaccines and treatments for COVID-19 through our Covance Drug Development business, we are delivering on LabCorp’s mission to improve health and improve lives.” The LabCorp 2019 Novel Coronavirus (COVID-19), NAA test was developed internally by LabCorp and is being made available pursuant to guidance issued by the U.S. Food and Drug Administration (FDA). LabCorp’s test has been validated for use with respiratory samples, including nasopharyngeal (NP) or […]
Two commercial lab companies have announced they are moving into testing for COVID-19.
LabCorp. said Thursday it was immediately offering testing for COVID-19 and Quest Diagnostics has announced it will start testing this week.
The LabCorp 2019 Novel Coronavirus (COVID-19), NAA test is available for ordering by physicians or other authorized healthcare providers anywhere in the U.S. The test detects the presence of the underlying virus that causes COVID-19 and is for use with patients who meet current guidance for evaluation of infection with COVID-19.
“We have been intensely focused on making testing for COVID-19 available as soon as possible, working with the government and others to address this public health crisis,” said Adam H. Schechter, president and CEO of LabCorp. “By expanding access to testing in the U.S., and preparing to support the development of vaccines and treatments for COVID-19 through our Covance Drug Development business, we are delivering on LabCorp’s mission to improve health and improve lives.”
The LabCorp 2019 Novel Coronavirus (COVID-19), NAA test was developed internally by LabCorp and is being made available pursuant to guidance issued by the U.S. Food and Drug Administration (FDA). LabCorp’s test has been validated for use with respiratory samples, including nasopharyngeal (NP) or oropharyngeal (OP) aspirates or washes, NP or OP swabs, and broncheoalveolar lavage (BAL). The test is a qualitative assay using PCR technology, which LabCorp played a central role in commercializing when PCR was introduced nearly 30 years ago, according to a press release.
LabCorp does not currently collect specimens for the test. Patients for whom testing has been ordered should not be sent to a LabCorp location to have a specimen collected. Instead, an appropriate specimen should be collected at the healthcare facility where the patient was seen and the test was ordered. The specimen should be sent to LabCorp using standard procedures. Test results will be available in 3-4 days. More information about the test, including specimen collection and packaging requirements, is available here: https://www.labcorp.com/tests/139900/2019-novel-coronavirus-covid-19-naa.
“As COVID-19 continues to spread in the U.S., having high-quality, reliable, scalable laboratory tests available is a critically important part of the response,” said Marcia Eisenberg, Ph.D., chief scientific officer for LabCorp Diagnostics. “Identifying people who are infected is necessary to make sure that patients receive the appropriate care, to better manage the use of healthcare resources, and to help contain the spread of the virus. We will continue to stay closely involved in the ongoing response, and we are prepared to expand our testing capacity to help meet demand.”
Quest starts today
Meanwhile, Quest Diagnostics expected to begin testing today. The new test service aids the presumptive detection of nucleic acid in respiratory specimens of patients meeting CDC’s clinical criteria for COVID-19 testing.
Quest said it would be in position to receive specimens for testing, and begin to provide testing on Monday, March 9, 2020. With the new service, Quest Diagnostics will provide access to a COVID-19 test service for patients in the United States.
The new test service will be provided as a laboratory developed test, pending review by the FDA under emergency use authorization (EUA) which the company will submit per FDA guidance within 15 days of clinical testing. The test is a molecular based assay which detects viral RNA in respiratory specimens.
“In times of national health crises, quality laboratory testing is absolutely critical to mobilizing effective public health response,” said Steve Rusckowski Chairman, CEO and President, Quest Diagnostics. “Quest’s national scale, diagnostic expertise and innovation, and relationships with half the country’s physicians and health systems is a vital complement to the efforts of the CDC and other public health labs to contend with a growing number of suspected COVID-19 cases in the United States. We applaud the FDA for providing the flexibility for innovative, quality lab developed tests to be brought to patients and providers quickly to advance effective response to the coronavirus outbreak.”
The new service is expected to employ respiratory specimens collected in appropriate health care settings, such as hospitals and physician offices. Quest Diagnostics patient service centers and phlebotomy sites do not collect respiratory specimens on suspected COVID-19 cases. Patients suspected of, or confirmed to have, COVID-19 should consult with a physician regarding the best way to provide a specimen for testing by Quest.
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