Labcorp has been regularly tracking mutations of the coronavirus throughout the pandemic, including a new variant strain of SARS-CoV-2 (VOC 202012/01 or B.1.1.7) in the UK and more recently in the US, to determine the impact it would have on our PCR test sensitivity. To date, we have not seen any impact. The B.1.1.7 strain is detectable by our current molecular testing. The only way to identify the strain is by sequencing, and we have research support underway that includes sequencing of the virus.
It is not yet determined what level of antibodies (to the SARS-CoV-2 spike protein) correlate to immunity against developing symptomatic SARS-CoV-2 disease. Studies are underway to measure the quantitative levels of specific SARS-CoV-2 antibodies following vaccination. Such studies will provide valuable insights into the correlation between protection from vaccination and antibody levels.
Physicians and other healthcare providers anywhere in the United States can order COVID-19 PCR testing (Test Code 139900) from Labcorp. 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.
Serology testing is available to check for different types of antibodies developed after exposure to the SARS-CoV-2 virus that causes COVID-19. This type of COVID-19 test is for individuals who think they may have previously had COVID-19 and do not currently have symptoms. Note: antibody testing should not be used as the sole basis to diagnose or exclude infection (Test Code 164055 or Test Code 164068).
Select Labcorp patient service centers are collecting specimens for COVID-19 PCR testing. This option is only for patients without symptoms and who have not been exposed to COVID-19.
COVID-19 antibody test collections (blood draw) are available through Labcorp patient service centers, including Labcorp at Walgreens locations. This type of COVID-19 test is for individuals who think they may have had COVID-19 and do not have symptoms.
Note: Antibody testing should not be used as the sole basis to diagnose or exclude infection.
The COVID-19 PCR tests performed by Labcorp are qualitative assays using PCR technology, which Labcorp played a central role in commercializing when PCR was introduced nearly 30 years ago.
As of August 26, 2020, the current average time to deliver results for the COVID-19 swab test is 1-2 days from the date of specimen pickup.
For the COVID-19 antibody test, the average delivery of test results is 1-3 days from the date of specimen pickup.
Labcorp is reporting COVID-19 results to the appropriate public health agency in accordance with applicable requirements; however, healthcare providers may also be required to report positive patients to the appropriate public health agency.
Labcorp’s molecular COVID-19 testing is not impacted by the FDA alert issued on August 17, 2020, regarding Thermo Fisher Scientific and the risk of false results. The FDA alert is based on two issues related to the test kit and its associated Applied Biosystems COVID-19 Interpretive Software. Neither issue is applicable to Labcorp’s test.
While Labcorp uses some Thermo Fisher Scientific instruments and reagents in its testing – including in its Pixel by Labcorp at-home collection kits – the way in which we are using them in our test is not the subject of the FDA alert and, therefore, is not affected by the alert. Moreover, we have internally validated the Thermo Fisher Scientific instruments and reagents that are used in the Labcorp COVID-19 PCR test to confirm that they meet our high standards.