Photo Credit: KUOW Photo/Ann Dornfeld
This article first appeared on the KUOW website.
Across Seattle, blue yard signs along busy streets advertise walk-in “FDA approved” antibody tests at COVID-19 Test Center.
The location, on 12th Avenue in Capitol Hill, looks less than clinical: It’s a gray AirBnB hotel with cardboard hung in the windows. An industrial-size laundry detergent bucket next to the front door has “PCR SWAB COVID test” scrawled on the lid in black marker.
That a budget hotel has become a makeshift medical facility offering unproven antibody tests highlights the gaps in regulatory oversight at the local, state and federal levels during this pandemic.
“It’s a little bit of the Wild West,” said Cyndee Jones, the director of System Blood and Lab Services at Swedish Medical Center.
Jones said the race to identify cases of Covid-19 has led to tests, drugs and medical devices of dubious validity, and “definitely when it comes to these antibody tests, because there are so many people that are desperate to have access to a test, and they’re so scared.”
The FDA has allowed manufacturers to rush tests to market and bypass its usual approval process, which takes years and thousands of trials “to prove that the test really does meet a certain manufacturer’s claims,” Jones said. No antibody tests on the market are yet FDA-approved.