- China's new rules for coronavirus tests are causing delays for US medical-supply distributors.
- The companies are waiting on tens of thousands of antibody kits that detect past exposure to the virus.
- Once received, one company hopes to send them to providers in New York and New Jersey.
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China's new rules for coronavirus tests are causing delays for US distributors hoping to supply them to providers or launch studies for at-home use.
The Chinese government is cracking down on test kits, requiring manufacturers with unapproved products to go through more rounds of verification, Reuters first reported.
Authorities are also instructing at least one major manufacturer of approved coronavirus antibody tests to fulfill orders in certain countries before those in the US, the startup Scanwell Health told Business Insider.
The antibody tests are highly sought after because they can detect past exposure and potential immunity to the virus. Positive results could send people back to work, including frontline healthcare workers currently in quarantine. The tests work by looking for the antibodies that your body generates to fight off the virus in a blood sample.
'They can't give us a timeline right now'
Ideal Rehab Care is waiting on at least 50,000 antibody tests from Healgen Scientific, a global device manufacturer with operations in China, according to Margaret Davino, one of the company's lawyers.
Once received, they'll be distributed to providers in New York and New Jersey, Davino said in a statement.
"My client has unfortunately had delays in getting shipments" due to "new requirements for anything manufactured in China," Davino said.
Ideal Rehab "expects to obtain another shipment next week (of hopefully 50,000 tests) but we are still waiting to get confirmation that the tests will be shipped at the time expected," she said in the statement.
Healgen Scientific did not respond to requests for comment.
Scanwell Health, a startup that offers at-home medical tests, hopes to sell a serology kit paired with a mobile app that you can use at home to see if you have coronavirus antibodies. But the company needs testing components from China that it's having difficulty acquiring, according to Jack Jeng, Scanwell's chief medical officer.
One of its manufacturers said it was instructed to fill orders for other countries before getting around to Scanwell's, Jeng said in an interview. The first order was for 10,000 parts for antibody tests, Jeng said.
Scanwell asked that the manufacturer not be named for fear of inviting scrutiny from the Chinese government, but Business Insider verified its name and relationship with the company. The manufacturer did not respond to a request for comment.
"They can't give us a timeline right now," Jeng said. "But it's a good reminder that the pandemic is a global problem. It's not just affecting us."
Scanwell needs the parts in order to perform a clinical trial, demonstrating to the US Food and Drug Administration that the kits are safe without in-person supervision by a clinician.
The FDA loosened regulations for antibodies tests for professional use on March 16, but companies seeking to ship the tests directly to consumers still have to run expedited trials.
Over 70 companies are offering antibody tests, with little oversight
Scanwell and Ideal Rehab are just two of more than 70 companies trying to make their mark on the market for antibody tests, which are also called serology tests, according to the FDA. Only one firm has obtained official authorization, while the rest are selling their tests to providers after validating them internally, according to the agency.
The scramble has caused some confusion, as some developers make false claims about unverified tests. Many sell kits with less than 90 percent sensitivity, the ability of the test to detect antibodies accurately, according to research produced earlier this month by Evercore.
"This policy has given laboratories and other healthcare professionals early access to these tests to conduct their own validation and determine if they warranted being used by that laboratory or healthcare facility," a spokesperson for the FDA told Business Insider in a statement.
"At the same time, FDA has continued to review serology tests through its Emergency Use Authorization (EUA) process and has already authorized a test with others currently under review," she said.
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