A Santa Maria medical-device manufacturer has started accepting orders from licensed laboratories for a new rapid blood test developed by a firm in China to help diagnose patients with COVID-19.
Hardy Diagnostics announced the new service on Wednesday for the Anti-SARS-CoV-2 Rapid Test developed by Autobio Diagnostics Co., Ltd, a publicly traded microbiology medical-device manufacturer, based in Zhengzhou, China.
That’s one of two roles Hardy Diagnostics is performing during the coronavirus pandemic.
“As a locally based company, it’s pretty exciting to be able to make a difference for our neighbors, and to make a difference in this global pandemic,” said Joel Tefft, Hardy’s marketing manager. “It’s kind of strange to be part of it in little Santa Maria, but we’re pretty proud of it.”
So far, customers have ordered several thousand tests in the first wave, with expectations the interest will continue in the future. The first deliveries likely will occur in early to mid-April.
By using a patient’s finger-prick blood, serum or plasma specimen, the new test offers a fast turnaround time, according to Hardy representatives.
“Basically, the main advantage to this product is that if somebody is showing symptoms and is concerned they may be infected, this quick 15-minute test will indicate to the clinician whether or not the symptoms are backed by an immune response that indicates COVID-19 infection,” Tefft said. “At that point, they need to do further testing.”
A negative test provides a fairly clear result someone isn’t infected and doesn’t need to undergo molecular testing, avoiding using the limited supply for patients who need them most, he said.
While the new test uses blood samples, the molecular tests involve nasopharyngeal swabs
“As you know, there’s a severe shortage of that testing so this prevents people who are otherwise healthy from getting a test unnecessarily and keeping them for somebody who could really use the test,” he said.
People who receive a positive result should still get a molecular test for final confirmation.
“But it’s a clear indication that you should probably begin the treatment cascade immediately and not wait for an additional test to come back with an additional positive,” he said. “It would just be better to say we’re going to start point of care, immediately triage, and then also run this (molecular) test.”
Hardy representatives said that while the test is simple to use, it is limited to certified laboratories with clinical personnel trained in procedures and is not for home use.
Through their partnership, Hardy Diagnostics and Autobio received permission for a quick deployment of the new test in the United States thanks to the Food and Drug Administration’s Emergency Use Authorization (EUA) program.
After Hardy received clearance to ship the tests, the firm leveraged existing teams to add the new product to its offerings in two days, instead of several months.
“Once we got the green light from Autobio, we were able to launch it within a matter of days, which is kind of unprecedented even for us,” Tefft said.
The FDA program, designed for use during a crisis, allows for selling the device while regulators continue reviewing the Anti-SARS-CoV-2 Rapid Test.
“We are incredibly proud of the work our partners in China have accomplished,” said Andre Hsiung, Hardy’s director of technical services. “Because Autobio quickly developed this technology and because the FDA allowed emergency use authorization, we will be able to more effectively leverage our sales network to get this product out to where it is needed the most.”
Hardy Diagnostics also has ramped up production of its viral media, key for conducting molecular tests in COVID-19 patients. Clinics use the product after nasopharyngeal or oropharyngeal swabs to make sure the virus survives on its way to the lab for testing.
Weekly production will be at the 75,000 level and soon even higher, likely hundreds of thousands, he added.
“These tests are in high demand, as you can imagine,” Tefft said. “We have made this product for years, but never sold much of it. With the pandemic, we’ve been rapidly increasing manufacturing because the demand is now greater than our supply.
“This will help to reduce the shortages we’re seeing all across America,” he added.
Hardy Diagnostics is an FDA-licensed manufacturer of medical devices for microbiological testing located on West McCoy Lane in Santa Maria.
In addition to 280 employees at that site, Hardy has a second manufacturing facility in Ohio, plus distribution centers across the country.
The now-employee-owned company was founded in 1980 by Jay Hardy, a clinical laboratory scientist from Santa Barbara.