New York’s Wadsworth Center, the state’s public health research lab, received the CDC test kits on Saturday, February 8. Upon examining the kits, the Wadsworth lab technicians realized they would not be able to rely on the CDC test kits. First, as the press later reported nationwide, the kits produced false positives—inaccurately reporting that someone was infected when in fact they were not. Second, the reagent chemicals needed to run the CDC test were in limited supply, available only from the CDC.
New York immediately mobilized to create our own COVID test, using different chemical reagents that were both more reliable to accurately find positive COVID cases and more commercially available than the reagents provided by the CDC—a potential “win-win-win” where New York State would have its own test with results reported within a day, a more reliable test than the CDC’s, and the ability to scale up quickly by purchasing the chemical reagents from commercial suppliers. By the third week of February, Wadsworth had developed a test that passed the validation process—where known positive specimens are run and successfully detected on the new test. On February 29 the FDA sent over the official documents approving Wadsworth’s test—the first non-CDC test to be approved by the FDA.
It is critical during a viral outbreak on the scale of COVID-19 that public health laboratories have the expertise, supplies, and equipment necessary to quickly develop in-state testing capabilities, helping ensure states are able to perform widespread testing in case the federal government fails to establish a national testing program.
Mobilizing a Network of Local Labs
The moment the FDA approved New York’s test, the state mobilized to activate a network of hundreds of labs licensed by New York State to test. Within the first two weeks of March, New York State had helped eight top-quality labs in the state get the equipment, supplies, and necessary FDA approval to test for COVID. Finally, on March 13, the FDA gave New York’s Department of Health the authority to approve all labs within New York State.
To mobilize the labs, the state issued an executive order directing all public and private labs in New York to coordinate with the Department of Health to prioritize coronavirus diagnostic testing. In addition, the state issued executive orders waiving regulatory burdens that constrained labs from reaching greater capacity. Together with a team of logistics and laboratory experts who coordinated with each lab in the state to help on issues including securing equipment, supplies, regulatory guidance, and staff, these measures helped activate more than 250 laboratories that now do COVID testing for New York State.
In addition, New York invested in manufacturers to help develop lab equipment and supplies, including $750,000 for Rheonix, an Ithaca-based manufacturer of lab instruments and reagent kits, that have been deployed throughout New York State and now are relied upon for thousands of daily tests.
It is critical during a pandemic that states’ public and private clinical laboratories are ready to direct their resources and priorities toward testing for whatever contagious disease is part of a global viral outbreak. Further, to avoid the problems with relying on national supply chains, U.S. manufacturers should be prepared, with assistance from the government, to retool operations to build lab equipment and supplies to help meet demand.
Building a Massive Sample Collection Network
As of this writing, the most popular way to test for COVID-19 is a nasal swab, where a health-care professional inserts a cotton swab into a patient’s nose and then puts the swab in a glass vial that holds a liquid transport medium, similar to saline solution. This sample is then put on ice and transported to a laboratory to test.
New York State built a network of more than 850 collection sites located across the entire state and launched a website where New Yorkers could put in their address and find a site near them to get tested. This network of testing sites included walk-in locations in dense, urban communities and drive-through locations in rural and suburban communities. Further, New York State set up testing sites at dozens of churches in minority communities primarily in New York City. To support all these testing sites, the state provided PPE, test kits, and other resources to ensure all New Yorkers had access to testing.
In a public health crisis like COVID, states need the capacity to quickly mobilize hundreds of locations to give residents convenient locations to get tested, as well as be able to build and launch the IT systems needed for finding sites, scheduling appointments, and reporting results.
Setting Testing Criteria Based on Lab Capacity
As testing capacity expands or restricts, likewise the criteria of who is eligible for a test must be adjusted. On Friday, March 6, while New York still had very limited capacity, New York’s eligibility included New Yorkers with symptoms who had traveled from hot-spot parts of the globe, contacts of known positives, individuals in quarantine, and individuals who had symptoms and tested negative for other influenzas. In June, when New York was doing more than sixty-five thousand tests a day, the state expanded testing criteria to all New Yorkers.
Since reopening on May 15, New York successfully capitalized on our expanded testing capacity to conduct widespread community surveillance testing—random testing of asymptomatic individuals without known exposure. Because 40 percent of infected people do not develop symptoms but may still be contagious, this approach helps identify where the virus may be spreading undetected. Community surveillance testing has been critical in identifying the virus early and controlling the spread through contact tracing before it reaches those who may become sick and require hospitalization—and is a testing approach that must be supported by the government in a widespread viral outbreak such as COVID.
Requiring Prompt Reporting of Results
New York State requires every laboratory in the nation that tests a New York resident for a communicable disease to report the results four times daily to the Department of Health. Known as the Electronic Clinical Laboratory Reporting System, this provides real-time insight into new cases throughout the entire
