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FDA approves first non-prescription SARS-CoV-2 test to detect RSV and flu

multi-analyte test multi-analyte test
multi-analyte test multi-analyte test

What's new?

For detection of respiratory syncytial virus, flu, and SARS-CoV-2, the FDA has authorized direct-to-consumer multi-analyte test for use without a prescription.

On 16 May 2022, the Food and Drug Administration (FDA) granted authorization for the first COVID-19 test (Labcorp Seasonal Respiratory Virus RT-PCR DTC Test) that is indicated for use without a prescription by people with respiratory viral infection symptoms consistent with SARS-CoV-2 infection.  Using this test, a person can self-identify their requirement for a test, order it, collect their sample and send it to lab for testing, without consulting a medical care professional.

This non-prescription multi-analyte COVID-19 test exhibits certain remarkable features as depicted below:

  • It enables a person to self-collect nasal swab sample at their own place and then forward it to Labcorp for further assessment.
  • It helps in identification and differentiation of various respiratory viruses at one time. It can detect SARS-CoV-2, respiratory syncytial virus (RSV), and influenza A and B (flu).
  • It delivers the outcomes via an online platform followed by an examination from a medical-care provider for invalid or positive test results.

Labcorp Seasonal Respiratory Virus RT-PCR DTC Test may be obtained from a store or online with no requirement of a prescription. People aged 18 years and older can self collect their samples. People 14 years and older require adult supervision and people 2 years and older need adult assistance for sample collection.

This COVID-19 test aids the customers to identify if they are infected with RSV, flu, or COVID-19. It further helps to determine whether getting self-isolated (quarantine) is suitable and to get assistance with medical-care decisions after discussing with the doctor.  Hence, the advancements being made in consumer access to diagnostic tests have brought us an additional step closer to conduct viral tests solely at home.

Source:

US-FDA

Article:

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV

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