Northwell Health Labs has announced that it has begun using LabGold, a low-cost, highly-reliable polymerase chain reaction (PCR) test with a self-collected specimen to screen employees for coronavirus disease 2019 (COVID-19) with plans to expand its use through a $2.5 million grant from the Bill & Melinda Gates Foundation.
The nasal swab, which looks like a Q-tip and screws into a tube the size of a pen cap, was developed through funding from the Gates Foundation in conjunction with Corteva Agriscience, Quantigen and SteriPack.
Northwell and United Kingdom-based LGC received authorization for LabGold at the Northwell Health Labs through the U.S. Food and Drug Administration on August 20 after validating the test internally.
“Diagnostic testing has been a crucial step in combating the virus. This affordable, self-administered swab is a game-changer in the fight against COVID-19,” said Dr. Dwayne Breining, executive director of Northwell Health Labs. “We can process LabGold specimens quickly and cheaply, helping to stop the spread of COVID-19 in its tracks.”
After extended use by employees as part of routine workforce infection surveillance, LabGold will be rolled out to the public. The goal is to support employee and school screening programs, as well as underserved communities. The nasal specimen can be self-collected in the privacy of the home for personal use or at work as part of routine company-wide screening. If self-administered at home, the specimen can be dropped off at any Northwell Health Labs patient service center for processing.
Unlike nasopharyngeal swabs, which require a health care worker to administer and collect a specimen deep inside the nasal cavity, LabGold swabs can be inserted just inside the nose by the individual. The collection process is painless and – most importantly – safe because it limits exposure for others.
“The ability to initiate testing untethers COVID-19 screening from the hassles and frustrations of going to a health care facility or testing site, and puts the power of health and wellness in the hands of the public,” said Dr. James Crawford, senior vice president of laboratory services at Northwell. “Importantly, this convenient test is still the high-sensitivity PCR assay that has been the bedrock of COVID-19 testing throughout the pandemic. This maximizes our ability to detect COVID, and thus reduce the chance of COVID exposure and workplace or community spread.”
Northwell’s ultra-high throughput PCR test costs a fraction of current tests. Using a portal accessed from any smartphone or computer, the person being tested self-registers and use the phone’s camera to scan a barcoded tube containing the swab. This links that individual to that specimen tube. LGC’s Nexar automated, high throughput platform can process up to 100,000 LabGold specimens per day on a single testing line.
Northwell has processed more than 300,000 PCR tests for employees alone since the start of the year and – as a leader in health system-based lab testing since the beginning of the pandemic – delivered COVID-19 test results on over 3 million samples overall dating back to March 2020.
For more information about Northwell Health Labs, go to: https://www.northwell.edu/northwell-health-labs