Hundreds of thousands of 15-minute COVID-19 test kits will be ready to distribute in the United States by Monday, a Long Island company said Thursday.
The announcement by Melville-based Henry Schein Inc. comes as health and government officials have reported desperate shortages of coronavirus tests, along with ventilators and personal protection equipment.
The rapid blood tests, made by South Korea-based SD Biosensor Inc., were cleared for suspected COVID-19 cases under emergency guidance by the Food and Drug Administration.
"I am really excited about these tests," said Dr. Tylis Chang, vice chairman, pathology informatics, at Northwell Health Labs.
He said the tests could be used, for example, to identify health care workers who had been infected with the virus previously but not fallen seriously ill.
"One of the biggest concerns is that our health care system collapses," he said. Medical professionals who contracted the virus and developed immunity could take care of patients without "fearing for their lives."
Unlike the polymerase chain reaction (PCR) tests, which identify the COVID-19 RNA but must be processed through a laboratory, the near-instant blood test finds antibodies, indicating that a patient has been fighting an infection.
For that reason, the FDA suggests that the blood test not be used as the sole basis to diagnose COVID-19 and that follow-up testing be used as confirmation.
Another limitation is that the body of a coronavirus victim may not generate detectable antibodies until more than a week after the virus was contracted.
Chang said manufacturers around the world as well as the Mount Sinai Health System in Manhattan are working on similar rapid blood tests, which he likens to the pregnancy tests available at drugstores.
Henry Schein said the pinprick blood tests initially would be marketed in United States through several channels.
"This pandemic is an unprecedented situation, and making rapid diagnostic tools available to health care professionals is critical," Stanley M. Bergman, chairman and chief executive of Henry Schein said in a statement.
In a research note, Evercore ISI analyst Elizabeth Anderson said even if the blood test can't be used as a sole basis of diagnosis, it will help patients more quickly receive care and enter quarantine.
Henry Schein, which has operations or affiliates in 31 countries, said it plans to distribute additional tests for COVID-19 from other suppliers.
Shares of Henry Schein, Long Island's largest company by revenue, climbed 7.1% to close at $53.56 on Thursday.