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Covid-19 tests emergency authorized by FDA 17th March 2020, by turnaround time

The U.S. Food and Drug Administration (FDA) had issued emergency use authorizations for around ten COVID-19 diagnostic tests as of March 17, 2020. Health care diagnostics company LabCorp has developed RT-PCR test kits that have a turnaround time of 24 hours.

What are RT-PCR tests?

Reverse transcription-polymerase chain reaction (RT-PCR) tests are available for the detection of the SARS-CoV-2 virus, which causes the COVID-19 disease. Any presence of the virus can be identified by taking a swab of the nose or back of the throat. Once the specimen is collected, the RNA of the sample is extracted and reverse transcribed to complementary DNA (cDNA). Finally, the RT-PCR test kit analyzes the mixture with very high sensitivity to determine whether or not the patient is infected.

Are other tests available for COVID-19?

Other companies are developing serology tests, which are also known as antibody tests. These tests are important in detecting infections in persons who are asymptomatic, i.e., showing few or no symptoms. The test checks for the presence of antibodies in the blood sample of a patient. Antibodies are proteins made by some immune cells that are used to fight viral pathogens. The presence of antibodies means the person has been exposed to the virus and may have developed some immunity to it.

FDA emergency use authorizations for Covid-19 tests as of 17 March, 2020, by turnaround time*

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Sources

Release date

March 2020

Region

United States

Survey time period

March 17, 2020

Supplementary notes

* Excludes academic-developed tests.
FDA = (U.S.) Food and Drug Administration.

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