A new coronavirus antibody test being used by American armed forces can tell if people have been previously infected in a matter of minutes.
The test, made by California-based Global WholeHealth Partners Corp (GWHP), was developed by Dr Shujie Cui, who is known as the ‘father’ of the Strep A test and worked with the Chinese government on SARS testing and vaccine development.
It looks for both IgM antibodies, which are first found after infection, and IgG antibodies, which are most commonly produced in the blood.
Officials say the test can deliver a positive result in just 15 minutes with nearly 99 percent accuracy, and is currently being used by the US Navy.
The company expects to ramp up production so that, in two weeks, 500,000 tests are made per day and, in 30 days, one million tests are produced each day.
A new coronavirus antibody blood test (pictured) has been made by California-based Global WholeHealth Partners Corp, which produces pharmaceutical products
It was developed Dr Shujie Cui, who is known as the ‘father’ of the Strep A test and worked with the Chinese government on SARS testing and vaccine development. Pictured: Hospital Corpsman 1st Class Kossi Fandoumi tests plasma samples on the hospital ship USNS Comfort in New York City, April 19
Peter Santeusanio, product manager for distributor COVIDSignals, told DailyMail.com that testing – both for active infections and antibodies – ‘has been the biggest failure’ of America’s response to the pandemic.
‘Testing is absolutely critical’ to slowing down infections and getting the economy going again, he added.
GWHP’s test is different from other tests currently on the market because both the materials and reagents are made in Santa Barbara, California.
Many of the others are made abroad, such as in China.
‘There is a flood of antibody tests in the marketplace. A lot of tests were made in China and did not have good quality control,’ Santeusanio said.
The test (pictured) can reportedly deliver a positive result in just 15 minutes with nearly 99% accuracy
‘When the source of the supply chain isn in the US – not from China, not from Italy, not from India – you don’t have to do source inspections abroad.’
This part of the reason why the US Food and Drug Administration (FDA) rolled back a decision on Monday that allowed scores of coronavirus blood tests to hit the US market without first providing proof that they worked.
Some tests turned out to be inaccurate or frauds while other companies claimed they could be used at home, which the FDA doesn’t allow.
Companies with tests that don’t have FDA authorization will be required to submit formal applications to regulators within 10 business days
Additionally, Santeusanio said that GWHP has a history of making tests for many years, such as Ebola, Zika, malaria and influenza.
Several tests are currently being developed by manufacturers that normally produce products such as shoes.
Santeusanio said the Navy began using GWHP’s test because one of the workers was friendly with someone a few levels across the supply chain.
After the Navy tested the company’s samples, they ordered 1,000 tests. About 100,000 are expected to be shipped over the next few days.
Several Navy ships are using the test, including the USS Theodore Roosevelt (pictured), whose captain was fired after he sounded the alarm of a coronavirus outbreak
According to Santeusanio, GWHP’s tests are being used on a number of Navy ships, including the USS Theodore Roosevelt.
This is the ship on which Captain Brett Crozier was fired after he sounded the alarm of a coronavirus outbreak aboard the aircraft carrier.
‘We expect that [Navy] order to be bumped up to one million in the next 30 days,’ Santeusanio said.
He added that he wants to stress the importance of widespread testing.
‘The economy will eventually recover; people who’ve died will not come back to us,’ said Santeusanio.
‘The bottom line is antibody testing is fast, relatively inexpensive, much safer for those administering it, and states should be deploying antibody testing because reopening without testing is suicide.’
Source: Daily Mail | Health News