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The President of the United States, released on March 13, 2020, a “Memorandum of Expanding State-Approved Diagnostic Tests” (Memorandum) . This Memorandum allowed the Department of Health and Human Services to promulgate policies that enable other states to authorize testing for COVID-19. Under this policy, other States have oversight responsibility, “notification of SARS-CoV-2 test validation is not submitted to the FDA, and the laboratory does not submit a EUA request to FDA”. However, the states or territories must notify the FDA if they decide to choose this pathway for enabling test access.

Accordingly, the FDA issued a “Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices” with emphasis on in vitro diagnostics. In line with the “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency, Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff” issued on the web on March 16, 2020, and the Memorandum issued by the President of the United States, States were allowed to authorized laboratories within the State to develop and perform tests used to detect COVID-19.

[1] https://www.whitehouse.gov/presidential-actions/memorandum-expanding-state-approved-diagnostic-tests/
[2] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019

About the Commission

The ​Puerto Rico Diagnostic Test Evaluation Commission (PRoDTEC) is a panel of experts coordinated by the Puerto Rico Department of Health to expedite the revision and approval of the use of in vitro diagnostic testing to detect the SARS-CoV-2 virus, responsible for the COVID-19 illness.

Members of the Committee

Marcos López Casillas, PhD

Federico Goodsaid, Ph.D.

Lcda. Agnes A. Rodríguez Soto,MT,MS,ASQ/CMQ/OE/CFSQA

Guidelines

Currently, we are enduring a public health emergency in the Commonwealth of Puerto Rico due to the novel coronavirus SARS-Cov-2. Accordingly, it is imperative to take proactive measures to prepare and act to the public health threat involving COVID-19. Diagnostic tests are critical for the prompt clinical management of affected individuals and the epidemiologic monitoring, control, and prevention of the pandemic. Accordingly, a diagnostic test must be robustly validated to safeguard that results obtained from the test meet the expected performance criteria. Then, the reliability of the diagnostic test is essential, as its results will have significant implications in clinical care and public health practice.

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.

Commercial manufacturers looking to distribute their SARS-CoV-2 diagnostic tests in other states of the US should follow the traditional EUA submission to the FDA route as these policies only applied to Laboratory Developed Tests.

PRoDTEC will follow the same established guidelines described by the FDA described in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) – Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff. PRoDTEC has adapted the following templates, that are part of the policy established by the FDA.

Laboratories wishing to obtain an emergency use authorization for their LBTs should use the following templates to help facilitate the preparation, submission, and authorization of a EUA:

Laboratories are encouraged to contact PRoDTEC to discuss the use of alternative approaches to any specific concerns and questions at approvals@prodtec.org. The formal EUA should be submitted through approvals@prodtec.org.