Coronavirus Disease (COVID-19)
LabCorp currently offers several options of COVID-19 tests that identify if individuals are infected or may have been infected with coronavirus. The infographic below was developed to help you determine which test is right for you.
LabCorp offers COVID-19 PCR testing (COVID-19 swab test) through a hospital or healthcare provider, or through an at-home kit on our Pixel by LabCorp™ website. This type of COVID-19 test is for individuals who have COVID-19 symptoms or meet the testing criteria established by the CDC. LabCorp launched a COVID-19 test on March 5, 2020, for ordering by authorized healthcare providers anywhere in the U.S.
The COVID-19 test home collection kit to detect an active COVID-19 infection is available through Pixel by LabCorp, a platform where patients can request many routine lab tests, and the required physician order, online. The COVID-19 test home collection kit is available to individuals who complete an online eligibility screening questionnaire. Visit Pixel by LabCorp™ to learn more.
Serology testing, also known as coronavirus antibody testing, can 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.
On May 5, 2020, LabCorp announced expanded access to COVID-19 antibody test through LabCorp’s wide network of doctors, healthcare providers, and online. Individuals have the ability to receive the COVID-19 IgG antibody test from their doctor, in person or through a telemedicine program, and now directly using www.LabCorp.com/antibody-testing.
There are also several telehealth providers that offer access to COVID-19 antibody testing without having to go into a doctor’s office or visiting another healthcare provider. LabCorp has provided more information about telemedicine providers that can order tests from LabCorp.
LabCorp’s COVID-19 PCR test has not been FDA cleared or approved, has been authorized by FDA under an Emergency Use Authorization (EUA), and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The 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 sooner.
LabCorp is providing serology testing based on tests from various manufacturers. Such tests have either received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) or were released for use under FDA guidance, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers and Food and Drug Administration Staff” that was updated on May 4, 2020. Tests being performed under an EUA have not been FDA cleared or approved and LabCorp has completed independent validation of these tests. In addition, various manufacturers have submitted or will seek EUA for their tests.