Frequently Asked Questions

Q.

Can the Wytcote Superbio SARS CoV-2 IgM/IgG antibody fast detection kit be sold in the USA

A.

Yes. The product is commercially available.

Q.

What is the regulatory status of the antibody test?

A.

Wytcote has submitted the test for Emergency Use Authorization and received a PEUA 200809 on April 28th. This means the FDA is reviewing the data. It also means that manufactures can distribute serology tests to identify antibodies to the SARS-CoV-2 for a reasonable period of time, where the test has been validated and while the manufacturer is preparing the EUA request.

Q.

Are there limitations on distribution of tests before receiving an Emergency Use Authorization by the FDA?

A.

Yes there are. The FDA wants to help users and patients understand the test results and requires the following information to be included:

  • This test has not been reviewed by the FDA.
  • Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • 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.

We have this information in our Instructions for Use in each box of product

Q.

Where can I see this information on the FDA website?

A.

Here is the link:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2

Scroll down to the section: What commercial manufacturers are distributing serology test kits under the policy outline in section IV.D of the policy for coronavirus disease-2019 tests. Scroll down the list to the manufacture name Jiangsu Superbio.

Q.

Who developed the test?

A.

The test was developed by Jiangsu Superbio. Wytcote Inc is the US importer.

Q.

What is the test kit?

A.

It is a lateral flow assay kit. Everything needed to carry out an antibody test is in the kit. It uses only fingerprick blood.

Q.

What size is the Wytcote antibody test kit?

A.

The Wytcote antibody test kit comes in boxes of 20 individual test kits with full instructions.

Q.

What performance studies are there that shows that your kit works?

A.

The Wytcote antibody test kit has been tested and validated including two independent tests in the USA at Children's Hospital of Orange County who used it in a study and National Institutes for Health (NIH). The FDA worked to assess the performance of serological tests for the detection of SARS-CoV-2 antibodies, and they developed performance assessment protocols using a well-characterized sample panel. Wytcote sent 140 tests so that the NIH/NCI could independently validate tests that are on the market that have not completed the EUA process.

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