Santa Maria medical device manufacturer taking orders for new COVID-19 rapid test kits
SANTA MARIA, Calif. - Hardy Diagnostics, a Santa Maria based medical device manufacturer is taking orders for new rapid test kits to be used here in the US.
These specific tests for COVID-19 were developed and made in China.
To take the test, a doctor just takes a blood sample. The lab inputs the blood into the device and results come in just 15 minutes.
The tests many doctors have been using involve nose and throat swabs, with results taking one to three days.
Hardy Diagnostics said the device is very easy to use.
"When a person is having symptoms, the antibodies will start to rise," said Andre Hsiung, head of research at the company. "So basically this is a serum or plasma or finger prick, you put a drop of blood in this well, and if you have an antibody, you should see one band on the test."
If someone tests positive for coronavirus with the rapid test, a second swab test may be ordered to confirm the results.
CEO Jay Hardy said they have 3,000 rapid test kits coming soon. Each kit tests 50 patients. They will arrive in the next two weeks.
They are not yet FDA approved, but the FDA has given permission to sell and use them because of the emergency situation.
The test is currently in the process of being reviewed by the FDA.
Hardy diagnostics is working as fast as it can, but there's a massive need right now.
The company says it just had its busiest sales day in 40 years because demand for coronavirus testing supplies is so high.
"The demand for our products far exceeds what we can produce and supply," said Christopher Catani, sales and marketing director. "We have backlogs of over $5 million worth of orders of a variety of products for COVID-19."
Hardy said they are allocating product based on need, and also giving first priority to American orders.
They are also ramping up production of a viral transport medium, a tube used by clinics for the nose and throat swab tests for COVID-19.
This product ensures the virus survives on its way to the lab for testing.
Hardy Diagnostics is currently able to produce about 75,000 of those a week and plan to increase production soon.
The Santa Maria based company is 100 percent employee owned.
