U.S. Food and Drug Administration has approved Roche, the Swiss drugmaker, for antibody tests that will determine whether COVID-19 has ever infected people according to a recently published article.

What is an Antibody Test?

According to the Centers for Disease Control and Prevention, this test is done to check the blood for antibodies that show if a person had a previous infection with the virus.

Moreover, antibodies are proteins that help fight off infections. There are instances, however, where antibodies may not be found to someone who has a current COVID-19. The CDC also recommends that the antibody test should not only be used to diagnose if someone has COVID-19 but is recommended to determine the number of infected persons in a certain place or region in the country.

FDA Approves the Swiss Drugmaker for Antibody Tests 

Roche has won the emergency approval of the U.S. Food and Drug Administration for an antibody test. This will help to determine the number of infected persons in the United States.

Following this, Roche's head of diagnostics Thomas Schinecker said that the company aims to double its tests from 50 million to 100 million every month at the end of this year. This will help the country on how to open its economy again for Phase 3 strategically.

Today, the number of COVID-19 cases in the U.S. has reached more than 1.1 million and has claimed 68,000 lives. However, the number of infected persons is expected to be more than the reported cases because many remained not tested for the virus.

With the help of Roche's antibody test, it will help not only to determine the real number of infected persons from individuals, businesses, to government officials but to help as well on how to craft strategies to end the national lockdown.

How accurate is the test?

Accuracy of the diagnostic test should always be the topmost priority before FDA approved a company to conduct antibody tests. Roche, who also makes molecular tests to identify COVID-19 infections, said that its antibody test has a specificity rating of 99.9 percent and 100 percent sensitivity.

This means that their tests will show very few false positives and no false negatives. They also added that their test is done through intravenous blood, which has higher accuracy compared to a finger prick test. 

Schinecker said: "If you take blood from a finger prick, you will never be able to achieve the same level of specificity that you will achieve ... when you take blood from the vein. You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference."

Other Companies Who Applied for Antibody Test

Aside from Roche, other companies applied for the U.S. FDA to conduct antibody tests. That includes the U.S.-based Abbott Laboratories, Becton Dickinson, and Italy's DiaSorin.

The Abbott Laboratories has said that the specificity of its test is 99.5 percent, while its sensitivity is 100 percent, while DiaSorin has a specificity of 98.5 percent and a sensitivity of 97.4 percent. 

Moreover, Roche was asked as to how much the test cost but declined to answer the question. The company said instead that it would be identical worldwide. Schinecker noted that there would be a high demand for antibody tests for healthcare workers, their families for exposure, and individuals who have developed the symptoms.

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