Question: Are tests for SARS-CoV-2 without an EUA authorized by FDA?

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Accessing Laboratory Testing
Under what circumstances should laboratories use either a SARS-CoV-2 viral or serology (antibody) test that has received EUA from FDA?
section_content: FDA has authorized EUAs for both viral and antibody tests for COVID-19. Viral
(nucleic acid and antigen) tests are used to diagnose the presence of SARS-
CoV-2 infections. In contrast, antibody tests can detect IgG, IgA, and IgM
antibodies from an immune response to SARS-CoV-2.
Whenever possible, laboratories should rely on viral tests to diagnose the
presence of SARS-CoV-2 infections. However, a negative result from viral
testing does not rule out COVID-19.
Most of the PCR-based tests that use two or more targets are likely to have
high specificity (few false positives). However, there is some variation in
the stated sensitivity of the different assays, and sensitivity is highly
dependent on the stage of the disease. For this reason, negative results
should always be interpreted in the context of the exposure history and
symptoms of the patient.
Results from antibody testing should not be used to diagnose or exclude SARS-
CoV-2 infections or to inform infection status. Negative results from antibody
testing do not rule out SARS-CoV-2 infections, particularly for those
individuals who have been exposed to the virus and are still within the
estimated incubation period. Until the performance characteristics of antibody
tests have been evaluated, it is possible that positive results from such
testing may be due to past or present infections with a coronavirus other than
SARS-CoV-2.
If a laboratory initially uses antibody testing for diagnostic purposes,
follow-up testing using a viral test should be performed.
Read: Important Information on the Use of Serological (Antibody) Tests for
COVID-19: FDA Letter to Healthcare Providersexternal
icon
More: FDA EUA Authorized Serology Test Performanceexternal
icon

Reviewer feedback on this answer:
Specifies which tests are approved by the FDA, including discussing EUAs specifically.
The answer does mention EUA's and the FDA but it doesn't really answer the question about if tests don't have a EUA  are not authorized by the FDA.

Reviewer ratings:
Excellent
Could be Improved

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Serology
Will CDC submit its antibody test for an EUA?
section_content: Not at this time. CDC is using its antibody test as part of a multi-agency
study to evaluate current commercially marketed antibody tests for specificity
and sensitivity and to help determine how results from antibody tests could
support policymaking. CDC will share information publicly on the recommended
use of antibody testing as soon as enough data becomes available.

Reviewer feedback on this answer:
Is fairly short, but makes it clear that antibody tests, as opposed to EUA tests, aren't approved yet.
It doesn't mention anything about EUA's at all and if they are required by the FDA for a test.

Reviewer ratings:
Acceptable
Bad

Answer passage (source: CDC):
page_title: Frequently Asked Questions about Laboratory Testing and COVID-19
section_headers: For All Laboratories: Accessing Laboratory Testing
What is the CLIA test complexity categorization of SARS-CoV-2 tests that do not have an EUA?
section_content: Tests for SARS-CoV-2 that are offered prior to or without an EUA have not been
reviewed by FDA, are not FDA-authorized, and have not received a CLIA
categorizationexternal icon. Thus, those tests are
considered high complexity by default until they receive an EUA or other FDA
review that indicates they may be performed as moderate complexity or waived
tests. For more information, visit FDA COVID-19 Resourcesexternal
icon, and navigate to the section titled “General
FAQs.”

Reviewer feedback on this answer:
Clearly says that any test without a EUA hasn't been approved by the FDA.
This answers the question directly.a test that does not have a EUA is notn authorized by the FDA in the first sentence.

Reviewer ratings:
Excellent
Excellent