A rapid-result screening test that will help health-care workers determine the need for coronavirus testing in symptomatic patients now is available to labs from a Santa Maria microbiology product company.
Hardy Diagnostics has opened supply chains for delivery throughout the United States in partnership with Chinese company Autobio Diagnostics, which developed the test and has seen success among Chinese patients, company officials said.
The Anti-SARS-CoV-2 Rapid Test is a one-step lateral flow assay that detects SARS-CoV-2 virus-fighting antibodies in patients via finger prick, producing results in 15 minutes that show whether the symptoms could be connected to the coronavirus, according to the company.
Negative results indicate the person is suffering from a respiratory condition other than COVID-19, while positive results indicate the potential for the virus and the need for further confirmatory testing, which has been in short supply locally and nationwide.
"Because of the nature of this test, it's going to help to make sure we are getting [coronavirus] tests for the people who need it most," said Joel Tefft, Hardy Diagnostics spokesman.
In Santa Barbara County, low availability has caused the tests to be reserved mostly for high-risk or elderly patients with severe symptoms and first responders such as doctors, with other potential cases being advised to ride out their symptoms at home.
Through an emergency use authorization issued by the FDA, the test was able to be deployed rapidly on the market while still being under review, Tefft said.
Due to the test's high-complexity classification, its use only will be allowed by certain medical professionals and will not be available as an in-home kit, he said.
"Private labs and public labs are our targets," Tefft said, adding that the test also could be administered by emergency room personnel.
The Anti-SARS-CoV-2 Rapid Tests became available Wednesday, with several thousand initial orders prepared for distribution, Tefft said.
"They’ve had great success with this product in the Chinese domestic department," Tefft said. "It’s cool for a hometown company to now be involved, and for our workers to know they’re making a difference."
Hardy Diagnostics is also preparing to ramp up its production of viral transport media at its Santa Maria and Ohio facilities.
Earlier this month, the company was inundated with orders for the vessels, as well as specimen collection kits and sanitation supplies.
The viral transport media store the swabs after they are used to collect specimens from patients and ensure the survival of the virus specimen on the swab until it reaches the lab.
"We have made this product for years but never sold much of it," Tefft said. "With the pandemic, we’ve been rapidly increasing manufacturing because the demand is now greater than our supply."
The company is currently able to manufacture 75,000 of the vessels per week and hopes to produce hundreds of thousands as production is increased, Tefft said.
Laura Place covers city government for the Santa Maria Times.
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