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There are two terms being used when discussing the coronavirus. COVID-19 is the coronavirus disease; SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) is the virus that causes the disease. They are often used interchangeably when we are talking about the pandemic or lab testing methods.
There are three types of lab testing methods/platforms available. They detect the virus or the patient’s response to the virus in different ways:
Note: Illustrative course of markers in SARS-CoV-2 infection. Image sourced from Roche Diagnostics, North America. Source/citations found here.
During the rise of viral RNA and viral antigen levels, a molecular (PCR or isothermal nucleic acid amplification based) or viral antigen test detects the presence of the virus. Often times, these molecular and viral antigen tests can be used as the primary basis for diagnosing your patient’s condition. Rather than going through the normal approval process, the U.S. Food and Drug Administration (FDA) is permitting all COVID-19 molecular and viral antigen tests to be cleared through its emergency use authorization (EUA) process during the pandemic. COVID-19 tests that go through the EUA process can request and secure a CLIA categorization.
Serology antibody tests detect the IgM and IgG antibodies that indicate your patient has developed an immune response to the virus but does not provide definitive evidence of a current infection. While experts say these tests will be important in the future, we have not seen widespread guidance on how these tests should be used. Serology antibody tests continue to be a focus in healthcare with the U.S. Food and Drug Administration (FDA) releasing very specific updates on these tests. The FDA has issued emergency use authorization (EUA) for some serology antibody tests. However, some serology antibody tests are being marketed without EUA. COVID-19 antibody serology tests without EUA currently default to a high complexity status. In addition, the accuracy and quality of those tests may vary greatly.
For more information visit FDA.gov and review the FDA’s Revised Policy on Antibody Tests and the FDA’s EUA Authorized Serology Test Performance page.
Which molecular tests are currently available?
A large number of manufacturers have received EUA for their molecular tests; three are of potential importance to McKesson customers:
Abbott is starting production and getting tests to caregivers as fast as possible. Early distribution is focused on “hot zones” with the highest levels of infection. They are speeding up production but are not currently installing new instruments.
QIAGEN has received EUA on the QIAstat-DX. This is produced in Germany. Global demand is many times higher than maximum product capacity. QIAGEN will have limited allocation of COVID-19 tests for existing customers. You can order new analyzers, but it may take several months before they can be installed.
Mesa Biotech (Sekisui) has received EUA for their Accula SARS-CoV-2 test. U.S. distribution is under discussion.
We will update you once access to these tests become available.
Which viral antigen tests are currently available?
Quidel has received EUA authorization to market its Sofia® SARS Antigen FIA, a rapid point-of-care antigen test to be used on the Sofia® Fluorescent Immunoassay Analyzer (“Sofia 1”) and the Sofia 2 Fluorescent Immunoassay Analyzer for SARS-CoV-2 in nasal or nasopharyngeal specimen. This is a “reader-style” test that identifies an active infection. Quidel is producing and getting tests to caregivers as fast as possible.
Continue to have discussions with your McKesson Account Manager for the latest updates on product availability.
Which serology antibody tests are available?
The FDA provided guidance for this type of testing, stating that these antibody serology tests should not be used as the sole basis for diagnosis of SARS-CoV-2. Antibody serology testing identifies IgM and IgG antibodies in the bloodstream but does not provide definitive evidence of a current infection. Further, according to the CDC, we don’t have enough information yet to say whether someone will definitely be immune and protected from reinfection if they have antibodies to the virus.
Rapid serology testing
As it relates to rapid antibody serology testing, our approach at this time will be to offer only rapid antibody serology tests receiving an EUA. We believe that reliance on the FDA’s EUA process is the best approach to supporting better patient care at this time. Currently, there are limited rapid serology tests on the market that have received an EUA (as in the Policy for Diagnostic Tests for Coronavirus Disease-2019).
McKesson is now offering a rapid serology antibody test from Healgen Scientific. Healgen Scientific’s COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device, which recently received EUA for use in high and moderate complexity labs; the test requires a venous blood draw. Download the product flier and information for use (IFU) document for more information.
Contact your McKesson Account Manager to understand how to order.
High throughput serology testing
Regarding high throughput testing, McKesson is currently offering tests from Abbott that are EUA authorized for IgG tests on Architect and Alinity platforms; Siemens is EUA authorized for Atellica platform serology, Dimension EXL and Vista serology and for ADVIA Centaur XPT/XP analyzer serology. Both Siemens assays are IgG/IgM total assays. Beckman Coulter is EUA authorized for their Access SARS-CoV-2 IgG reagent for several of their Access and Dx platforms. McKesson is selling the Abbott, Ortho, Beckman Coulter, and Siemens reagents, calibrators and controls to customers that are CLIA certified to perform moderate or high complexity testing. Additional high-throughput manufacturers have or will be announcing serology tests. They will be seeking EUA approval.
Your McKesson account manager will update you once these tests become EUA approved and product is available.
Many lab supplies related to COVID-19 and respiratory testing are in high demand. For the latest on McKesson product availability, contact your McKesson Medical-Surgical Account Manager.
Page updated July 1, 2020
Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.