Based on the policies outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised), Section IV.B Puerto Rico has chosen to authorize laboratories in the Archipelago to develop and perform testing for COVID-19. This opportunity enacted the formation of the Puerto Rico Diagnostics Testing Commission, PRoDTEC. Now, laboratories within the jurisdiction of Puerto Rico must submit their emergency use authorizations (EUA) directly to PRoDTEC for evaluation and authorization of molecular, antigen, and serological SARS-CoV-2 testing.
PRoDTEC, as part of their oversight process, will require laboratories developing SARS-CoV-2 tests to validate those tests before use. As stated by the FDA, in vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.
The PRDoTEC will locally authorize the emergency use of laboratory-developed tests of the following types:
- Diagnostic Tests – Tests that detect parts of the SARS-CoV-2 virus can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
- Serology/Antibody Tests – Tests that detect antibodies (e.g., IgM, IgG) to the SARS-CoV-2 virus. Serology/antibody tests cannot be used to diagnose a current infection.
- Tests for Management of COVID-19 Patients – Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in managing patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can inform patient management decisions.