What you need to know
Hackensack Meridian Health’s Center for Discovery and Innovation (CDI) has created a test to dramatically reduce the time it takes for diagnosing COVID-19.
This is a major advance that will benefit patients, create a more effective triage system in our hospitals and potentially better control the spread of disease.
The new diagnostic tool will reduce the current process of testing for COVID-19 from days to hours.
The test permits the network to quarantine and treat patients suspected of having COVID-19 more rapidly or in the case of a negative result, spare the patient unnecessary time in the hospital.
The Center for Discovery and Innovation received preliminary Emergency Use Authorization from the Food and Drug Administration to start using the test today. Additionally, the state Department of Health has also approved the test.
“The Department of Health commends Hackensack Meridian Health’s effort in bringing online their laboratory to test for SARS-COV-2 and adding more testing capacity in New Jersey,’’ said Chris Neuwirth, assistant commissioner of the New Jersey Department of Health. “As more hospital and commercial laboratories begin testing, New Jersey residents will have greater access to SARS-COV-2 diagnostic testing and public health officials will have a greater ability to monitor, track, and respond to new cases.”
“We believe our test could make the difference in stemming outbreaks,” said David S. Perlin, Ph.D., the chief scientific officer and senior vice president of the CDI. “It’s fast and it’s accurate, and crucial hours could mean the difference in stopping the spread of this virus.”
FAQ and more details about the test
The CDI test combines elements of the U.S. Centers for Disease Control and Prevention (CDC) diagnostic, and a test developed in Germany and adopted by the World Health Organization (WHO). CDI experts began work on the test in mid-January, following the outbreak of the virus first identified in China in December 2019
Last week, the center received live virus and viral RNA, a crucial step toward bringing the test to use in clinical settings, said Dr. Perlin, a global infectious diseases expert who helped develop diagnostics for SARS and other infectious diseases. The CDI validated the results and completed FDA requirements to administer the test. Initially, the network will be able to test 24 patients every eight hours. Our goal is to capitalize on the technology and find ways to expand its use in the region.
The network will continue to follow strict protocols on which patients will be tested. Patients cannot simply request the test if they believe they have been exposed to the virus or are experiencing respiratory symptoms. Patients should first consult with their primary care physician to determine if they are a candidate for testing.
A key scientist analyzing and developing the diagnostic is Yanan Zhao, M.D., Ph.D., who is an assistant member of the CDI and leads research at the Perlin laboratory. She is expert in rapid molecular diagnostics for pathogens.