Healthcare News & Insights

Coronavirus: Antibody testing, development of treatments & vaccines underway

The next wave of coronavirus testing involves serology tests to identify antibodies that help fight off the infection. 

Typically, the presence of the antibodies indicates that someone has been exposed to the virus and developed some level of immune response.

Roche’s Elecsys Anti-SARS-CoV-2 antibody test, which was approved under the Food and Drug Administration’s (FDA’s) emergency use authorization, is live at more than 20 hospital and commercial lab sites throughout the U.S.

In the coming weeks, that’s expected to increase to more than 200 sites that would be capable of performing millions of tests per week.

A full list of tests authorized by the FDA can be found here.

Physician guidance

But tell your clinicians to be careful. The American Medical Association (AMA) cautioned in a statement that physicians should avoid using antibody test results as the sole basis for determining:

  • a patient’s COVID-19 immunity
  • whether they should return to work
  • if they can discontinue social distancing, or
  • as the basis for “immunity certificates.”

AMA President Patrice Harris said: “We encourage physicians to only use antibody tests authorized by the Food and Drug Administration and only for the purposes of population-level studies, evaluating recovered individuals for convalescent plasma donations or along with other clinical information as part of a well-defined testing plan for groups or individuals.”

According to the AMA, some tests on the market may return false positives or identify antibodies for other coronaviruses, such as those that cause the common cold.

“The vast majority of more than 120 tests on the market have not been authorized by the FDA, despite marketing claims to the contrary,” the organization said.

So it’s a good idea to ensure that your doctors are aware of the limitations of antibody tests and understand their potential results.

The AMA said that’s especially crucial for doctors serving communities where access to testing services may be limited, or where housing or employment status of patients may make it difficult to adhere to physical distancing and other precautions.

Vaccine update

Solutions for managing COVID-19 may also come from the Accelerating COVID-19 Therapeutic Interventions and Vaccines partnership between the federal government and private companies.

National Institutes of Health Director Dr. Francis Collins said there are at least four vaccine candidates that could be ready for production as soon as this fall.

Pfizer reported that its BNT162 vaccine was showing promise, and it echoed Collins’ remarks that an effective vaccine could arrive in October because of plans to expand human clinical trials to thousands of people by September.

Also, several pharmaceutical manufacturers are reportedly close to obtaining FDA approval for therapies that use monoclonal antibodies from patients that have recovered from COVID-19.

We’ll keep you posted on any developments.

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