Northwell Health Labs has been given the green light by state and federal authorities to begin manual testing for novel coronavirus.
According to Northwell, “beyond the manual testing authorized today, Northwell Labs is seeking the US Food & Drug Administration’s approval to use semi-automated testing within the next week.
This would give the laboratory the capability to process hundreds of tests daily, with a plan to ramp up to thousands daily in the near future.”
Doctors believe they could manually process upwards of 100 tests daily. Once the labs are automated, health officials said they could potentially conduct hundreds of tests each day.
“Once the process is fully automated, we will have the ability to conduct tests within three-to-four hours of receiving samples at the lab, and report the results immediately,” Dwayne Breining, the executive director of laboratory services at Northwell stated. If the virus continues to spread, the ability to have local lab-testing capability is vitally important."
Breining said that over the course of the next month, the lab is working with test manufacturers to make this testing available within Northwell’s hospitals throughout New York City, Long Island and Westchester County, further expanding the health system’s ability to respond to an epidemic.
Those facilities will be doing "rapid molecular testing for the seasonal flu using similar technology."
“With local labs, you can test quicker and get the results quicker,” the doctor added.
Northwell noted that over the past six weeks, they have already invested more than $5 million on coronavirus preparation, including more than $2 million for lab testing and supplies.
“Over the past week, we’ve been developing the test for COVID-19, thanks to the assistance we‘ve received from New York State’s DOH Laboratory,” Breining said. “Now that the accuracy of our testing process has been validated, we can begin notifying providers and patients of their lab results and start gearing up for an automated testing process that would enable us to significantly expand the number of samples we can process.”
New York Gov. Andrew Cuomo visited the facility on Sunday, March 8 prior to the official approval being announced. (See photo and video above.)
"After days of advocating the FDA and the federal government to expand testing capacity for the novel coronavirus in New York State and working with Northwell and Wadsworth to expedite the process, we just received word that Northwell Laboratories has been authorized to test under Wadsworth's emergency use authorization," he said. "Manual testing of 75 to 80 samples per day will begin at Northwell immediately, but we still need automated testing approved so we can perform thousands per day.
"While this approval is a good first step, the FDA must increase the testing capacity for the State and private labs, because the more tests we run, the more positive people we will find and the better we can control and contain the virus. It's one thing for the federal government not to have the testing capacity in place themselves - that was bad enough - but there's no excuse for them not to be authorizing existing labs to do the work."
As of March 9, there are now 142 positive coronavirus cases in New York:
- Westchester: 98 (16 new);
- New York City: 19 (seven new);
- Nassau: 17 (12 new);
- Rockland: Four (two new);
- Saratoga: Two;
- Ulster: One;
- Suffolk: One.
Globally, there have been 111,758 confirmed COVID-19 cases, which led to 3,889 deaths. Of those cases, 566 were reported in the United States, including 22 deaths.
“Every effort to contain the virus and slow the spread saves lives. These efforts give health systems and all of society much needed time to prepare, and researchers more time to identify effective treatments and develop vaccines, the World Health Organization said. “We must stop, contain, control, delay and reduce the impact of this virus at every opportunity. Every person has the capacity to contribute, to protect themselves, to protect others, whether in the home, the community, the healthcare system, the workplace or the transport system.”
According to Northwell Health officials, the "expanded ability to test patients for COVID-19 will greatly enhance Northwell’s ability to manage patients with potential infection.
However, given the limited testing capacity and the CDC’s current recommendations, patients with milder symptoms who do not require hospitalization will not be tested. Such testing is currently reserved for patients who have had contact with someone infected with the virus, or those who are very sick and will require hospitalization."
“Only people who meet that criteria will be tested – and that testing is currently being performed at hospital emergency departments and urgent care centers,” John D’Angelo, the chair of emergency medicine at Northwell, said. “Even as our testing capacity increases, we will continue to screen people judiciously so we can focus our attention on those most at risk for severe COVID-19 infection who require more-immediate and intensive medical attention. All others who are concerned about exposure but who have mild or no symptoms should recuperate at home.”
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