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NY State Labs Get FDA Emergency Use Authorization for SARS-CoV-2 Test

NEW YORK – Two public health labs in New York state have been granted emergency use authorization to run an assay to detect SARS-CoV-2, the pathogen that causes coronavirus disease, or COVID-19. The test was approved according to new emergency diagnostic regulations.

The new US Food and Drug Administration guidance issued on Saturday allows high-complexity commercial, academic, and government labs to develop and use SARS-CoV-2 tests. The guidance requires labs to validate their tests, and then to notify FDA. They may then begin using the test, but must also submit a completed EUA request to FDA within 15 days.

Under these new guidelines, on Saturday a test in New York State was granted EUA.

The New York test, called the Wadsworth Center, New York State Department of Public Health's New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel, has now been authorized for emergency use on nasopharyngeal and oropharyngeal swabs and sputum samples collected from people who meet the clinical or epidemiological criteria.

These criteria include clinical signs and symptoms of COVID-19, contact with a possible or confirmed COVID-19 case, history of travel to a location where COVID-19 cases were detected, or other epidemiologic links for which COVID-19 testing may be indicated as part of a public health investigation.

Testing is limited to two labs: the New York State Department of Public Health Wadsworth Center, and the Public Health Laboratories of the New York City Department of Health and Mental Hygiene. Both are certified under the Clinical Laboratory Improvement Amendments to perform high complexity tests and are also permitted under the New York State Clinical Laboratory Evaluation Program to perform clinical diagnostic molecular virology testing.

In a letter issuing the authorization, FDA noted that "based on the totality of scientific evidence available to FDA, it is reasonable to believe that the New York SARS-CoV-2 Real-time RT-PCR Diagnostic Panel may be effective in diagnosing COVID-19, and that the known and potential benefits of [the test], when used for diagnosing COVID-19, outweigh the known and potential risks of such product."

Furthermore, the agency highlighted that there is "no adequate, approved, and available alternative to the emergency use of the New York SARS-CoV-2 Real-time RT-PCR Diagnostic Panel for diagnosing COVID-19."

According to the letter, the test uses commercially sourced materials and other authorized materials and ancillary reagents that are commonly used in clinical labs. It is performed on the FDA cleared Applied Biosystems 7500 Fast Dx Real-Time PCR instrument with SDS 1.4 software.

As authorized, the quality control of the test in the lab includes a human cell culture preparation used as an extraction control as well as a positive control for the RNase P primer and probe set and that is extracted and tested concurrently with each extraction run. The SARS-CoV-2 positive control is run with each batch of specimens, although the letter does not specify what specifically is used for this step.

The authorization also stipulates that Wadsworth must report spurious results, and may request the addition of other instruments, extraction methods, specimen types, and changes in reagents and control material.

The New York test is the second test to be authorized following the assay from the Centers for Disease Control and Prevention, which was authorized in early February. That test subsequently proved problematic to validate when it was distributed to state and local labs. Revised CDC test kits have been now distributed and the agency said last week that it is now on track to begin a surveillance program for the virus. COVID-19 has now caused two deaths and 86 infections in the US, as well as more than 89,000 confirmed infections and more than 3,000 deaths globally.