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No Charge Program Uses High-Affinity Test to Detect SARS-CoV-2 Antibodies
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Beginning today for the next three months,
Patients will be able to access their results through the LabCorp Patient™ portal and through their doctor. Result data from the antibody testing program will also be reported to the
Individuals who have tested positive for COVID-19 and have not experienced symptoms for at least two weeks, or who have been confirmed to have antibodies to the virus are likely candidates for plasma donation. Many people who have had COVID-19 do not experience symptoms and may be unaware they have antibodies that can help other patients. The antibody test performed by
Patients who test positive for COVID-19 antibodies are encouraged to donate their blood plasma. Donating plasma does not affect the donor’s immunity, as their body will continue to produce antibodies. More information can be found about plasma donation at TheFightIsInUs.org.
For more information on antibody tests and LabCorp’s diagnostic COVID-19 testing options, as well as information on how to get involved, go to our website. Patients interested in donating plasma should visit TheFightIsInUs.org. The website can help check eligibility criteria and connect patients directly to plasma and blood donation centers nearby.
For Healthcare Providers
Under this program, providers can order the high-affinity antibody test that is based on an in-solution double-antigen sandwich format and can detect antibodies to SARS-CoV-2, the virus that causes COVID-19. The test will be performed at no charge for the next three months. Antibodies could signal whether a person has already been infected and potentially developed immunity to the virus. LabCorp’s antibody test uses the Roche Elecsys® Anti-SARS-CoV-2 platform, has 99.8 percent specificity and shows no cross-reactivity to the common cold, HIV and other coronaviruses. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual. The Anti-SARS-CoV-2 test detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. Please note, the no-charge antibody testing program includes the Roche Elecsys® Anti-SARS-CoV-2 and does not apply to specific antibody tests, such as the IgG test.
Emergency Use Authorization (EUA) Status
The Elecsys Anti-SARS-CoV-2 test has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. It is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements, including but not limited to statements with respect to clinical laboratory testing, the potential benefits of COVID-19 serological testing, our responses to and the expected future impacts of the COVID-19 pandemic, and the opportunities for future growth. Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the Company’s control, including without limitation, whether our response to the COVID-19 pandemic will prove effective, the impact of the COVID-19 pandemic on our business and financial condition, as well as on general economic, business, and market conditions, competitive actions and other unforeseen changes and general uncertainties in the marketplace, changes in government regulations, including healthcare reform, customer purchasing decisions, including changes in payer regulations or policies, other adverse actions of governmental and third-party payers, the Company’s satisfaction of regulatory and other requirements, patient safety issues, changes in testing guidelines or recommendations, federal, state, and local governmental responses to the COVID-19 pandemic, adverse results in material litigation matters, failure to maintain or develop customer relationships, our ability to develop or acquire new products and adapt to technological changes, failure in information technology, systems or data security, and employee relations. These factors, in some cases, have affected and in the future (together with other factors) could affect the Company’s ability to implement the Company’s business strategy and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the Company’s most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the Company’s other filings with the
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