COVID-19 Update

In response to the current situation, we’ve implemented our business continuity plan which examines all areas of business operations.  During these challenging times, we have taken precautionary measures to limit the potential spread of the virus, to support our employees, and to ensure we maintain the ability to serve our customers.

On PPE (Personal Protective Equipment) 

Although we can source medical-grade PPE, we only do that for front line health care workers and hospitals involved in fighting COVID-19.  Medical grade products are reserved for licensed health care facilities.

 

Other PPE, such as protective masks, gloves, face shields, gowns, and goggles are available for everyone.  These we offer to non-healthcare related entities in order to comply with government health directives and to re-open for business.

On COVID-19 Serology Tests

COVID-19 Tests (Serology tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens).

 

The policy described in this subsection applies to developers of serology tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens. This policy is limited to such testing in laboratories or by healthcare workers at the point-of-care. This policy does not apply to at-home testing.

 

Considering that serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

 

  • This test has not been reviewed by the FDA.

  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

  • Results from antibody testing should not be used as the sole basis to diagnose or exclude

  • SARS-CoV-2 infection or to inform infection status.

  • 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.

©2020 by Rossler Group.