COVID 19 May 21

The COVID-19 tests, they are coming

How viral and antibody testing may help us get back to a new normal

The COVID-19 pandemic is all consuming—both personally and professionally. As a healthcare company, we understand your challenges and we’re continuously developing solutions to help meet your immediate needs. Right now, one of the many areas we’re focused on is testing and providing you with frequent updates on when tests for COVID-19 will be available.

From the early days—when schools and businesses temporarily closed, and communities and states implemented “shelter-in-place” orders—the common thread in the question of when we might return to “normal” is the prevalence of testing. The song “Should I stay or should I go” has never felt more relevant. Until more testing is widely available and local governments start lifting some of the restrictions, “I should stay,” must be the current refrain wherever and whenever possible.

What the tests can tell us

The symptoms of COVID-19 are similar to symptoms of other diseases, which is why testing is critical to identifying patients infected with the virus and helping to stop the spread. The types of tests available are molecular and antibody tests. One (molecular) can test for the presence of the virus. The second (antibody) can test whether your body has developed antibodies that show you have been exposed to COVID-19. Antibody tests usually detect two types of antibodies. One, IgM, is typically produced about a week after infection and indicates an ongoing infection. As levels of IgM begin to fall, another antibody, IgG, starts to rise and typically indicates a resolved infection.1 A third option, antigen testing, is also becoming available. This will be addressed in subsequent articles.

“… the question of when we can return to work and resume our normal activities is one of the most critical issues facing our nation. Antibody tests — also known as serological tests — may have the potential to play a role in this complex calculation.”2

One important note about antibody testing. Many believe that this test can verify immunity. That is a question that has not yet been answered. As Tim Herrera writes for The New York Times: “The antibody test does not test for immunity to COVID-19. There is no test yet that can tell if you are immune. It is simply too early to know if the presence of antibodies confers immunity, as this is a new virus… But experts generally agree that, based on experiences with other viruses, including SARS, the presence of antibodies most likely does confer some level of protection, though we don’t know to what extent or for how long.”3

More about the differences:

Molecular testing
A diagnostic test for viral RNA
Antibody testing
A serology test for anti-viral antibodies
Purpose:
Tests for the presence of the SARS-CoV-2 virus RNA. If the test comes back positive, it can be an indicator that the patient has an active COVID-19 infection.
Purpose:
Tests for a patient’s immune response (antibodies) to the SARS-CoV-2 virus. If the test comes back positive, it can be an indicator that that the patient has been exposed to the SARS-CoV-2 virus.
How it works:
Analyzes a sample taken via swab from deep inside the nose or the nostrils (depending on the test)
How it works:
Identifies antibodies in venous blood, serum, or plasma samples
When to administer:
Taken at the early stages of infection or between 5-10 days after appearance of symptoms, depending on test
When to administer:
Recommendation is to wait at least 2 weeks after symptoms resolve for best results4
Outcome:
Can determine whether a person currently has the virus but not whether a resolved patient previously had the condition
Outcome:
Can help providers determine if a patient can proceed with normal, daily life— when combined with other patient information
Identifies the virus after symptoms have started (or should have started, if the patient is asymptomatic) Does not identify the presence of the virus itself and should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection
Where it’s performed:
Point-of-care (POC) setting or in a laboratory—depending on the analyzer being used
Where it’s performed:
Moderate- to high-complexity lab settings —so far, no antibody test has been cleared for POC settings
Time to run the test:
Minutes to hours depending on the manufacturer
Time to run the test:
5 – 20 minutes

NOTE: Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E

For more insight into the differences between these tests and their advantages and limitations, please see our infographic.

This is all great, but how does it apply to you?

Medline is sourcing a serological based antibody test (IgG/IgM differentiating) in response to COVID-19. As this is an antibody test, it is not meant to conclusively diagnose the novel COVID-19 virus. Instead, the antibody test is meant to be a tool in a diagnostic arsenal that includes molecular tests. Our role as a lab distributor is to provide options that allow our customers to make their own informed decisions on a facility-by-facility basis, and we understand this may not be a fit for everyone.

Is it ready? Please contact your Medline sales representative regarding availability.

Many of our large, national brand vendor partners who provide molecular point-of-care devices for respiratory testing are now beginning to roll out COVID-19 testing. These platforms include Cepheid GeneXpert Xpress, Sekisui Silaris®, and Abbott ID NOW™, amongst others that will roll out in the near future. We look forward to supporting our partners as solutions develop and as products become more widely available.

Is it ready? At this point these manufacturers are managing their own allocations due to limited supply. As their distribution partner, they are notifying us when we are able to support customers on their platform.  We are able to start taking orders for the Cepheid GeneXpert/GeneXpert Xpress systems. Please contact your Medline sales representative regarding availability.

Who is it for? We’re confident that many hospitals and non-acute facilities will gravitate towards this testing methodology in the long-term.

We’re also partnering with ELITechGroup to provide a RT-PCR COVID-19 test that can be run on an open system. This particular assay has been given EUA by the FDA—and has been validated on both the Applied Biosystems™7500 Fast and Bio-Rad CFX96 instrument platforms. The ELITech assay can be used on other open systems but must be validated before being fully integrated into testing procedures. We offer third-party consulting services to assist with COVID-19 specific validations for RT-PCR if needed.

Is it ready? These tests are currently available through our Lab distribution channel.

Our commitment

We understand that having access to essential products and relevant information is top of mind for you and all our healthcare partners. We share that sense of urgency and continue to work in tandem with industry and government organizations to help keep you informed. You and your team are on frontlines of this crisis. That’s why our commitment to innovation and supply chain improvements is stronger than ever.

Beyond this article, we’ll continue to keep you informed with updates and more relevant content on what our Lab team and other teams are doing to assist and support you across the continuum of care. For further information and technical questions please contact your Medline representative or call 1 800 Medline.