|This is an excerpt of a 2,375-word article in the March 9, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group.
CEO SUMMARY: Clinical labs are working with haste to develop a novel coronavirus test. In this rare behind-the scenes look, laboratorians can learn about Northwell Health’s efforts to prepare for high capacity testing for viral respiratory illness include validating molecular tests for the newly-identified virus and making those tests available for testing patients who may have the COVID-19 illness. At Northwell, the lab team has been validating the CDC’s manual test and a multi-test panel for respiratory diseases that will include the novel coronavirus.
Following the outbreak of a novel coronavirus in China at the end of December, clinical laboratories have faced multiple significant challenges.
Among the challenges they face are validating a diagnostic novel coronavirus test that has the sensitivity and specificity to make it useful for physicians treating patients and working with public health officials to manage a rapidly evolving epidemic.
Another of these challenges is to develop the ability to perform these novel coronavirus tests at high volume levels and with a fast turnaround time for results. While seeking to meet all of these challenges, clinical labs also must comply with federal and state regulations that govern the use of these assays.
In mid-January, scientists in China released the genetic information for this novel virus. At that time, the leaders and staff in the clinical laboratories of Northwell Health in Lake Success, N.Y., recognized the need to be able to validate a novel coronavirus test that the federal Centers for Disease Control and Prevention (CDC) would release, and then be able to run that test in enough numbers to meet an unknown level of demand.
As one of the nation’s biggest health systems, Northwell has 23 hospitals and a central reference laboratory serving both Northwell and other hospitals in the greater New York metropolitan area, making Northwell’s lab one of the largest in-system clinical laboratories in the United States, according to Stefan Juretschko, PhD, D(ABMM), Northwell’s Senior Director of the Division of Infectious Disease Diagnostics. Juretschko is leading the systemwide efforts to increase the labs’ capacity for testing for the novel coronavirus that causes the coronavirus disease (COVID-19).
As soon as the test kits arrived from the CDC and from the New York State Department of Health (NYSDOH), Juretschko, other lab directors, and the lab staff began the steps required to validate and run the novel coronavirus test in Northwell’s labs. Also, the lab began acquiring new analyzers, testing supplies, and reagents from vendors nationwide to support their efforts to run large volumes of tests for patients and their physicians.
Working Day and Night