Description
The purpose of this document is to provide guidance to manufacturers of serological assays intended for the detection of antibodies to SARS-CoV-2, the virus that causes COVID-19 disease. The guidance outlines recommendations regarding the minimum testing that should be performed for SARS-CoV-2 diagnostics.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Requirements for serological antibody tests submitted under the COVID-19 Interim Order: guidance | HTML | Open resource | |
| Requirements for serological antibody tests submitted under the COVID-19 Interim Order: guidance | HTML | Open resource |