; and (B) the standards used by States and territories when deciding when to authorize laboratories to develop or perform diagnostic tests; (6) an assessment of the steps taken by laboratories and diagnostic test manufacturers to validate diagnostic tests, as well as the evidence collected by such entities to support validation; and (7) based on available reports, an assessment of the accuracy and sensitivity of a representative sample of available diagnostic tests. (d) Definition In this section, the term diagnostic test means an in vitro diagnostic product (as defined in section 809.3(a) of title 21, Code of Federal Regulations) for— (1) the detection of SARS–CoV–2; (2) the diagnosis of the virus that causes COVID–19; or (3) the detection of antibodies specific to SARS–CoV–2, such as a serological test.