Congressional committee investigating private lab doing COVID-19 antibody testing in Wisconsin, other states
A subcommittee of the Congressional committee for Oversight and Reform is investigating ARCpoint Labs, a third-party lab that has conducted antibody testing for COVID-19 across the nation and in Wisconsin, including a
conducted in Oneida County last week. In total, ARCpoint Labs tells 7 Investigates their Milwaukee North location has conducted about 1,500 tests.
ARCpoint Labs has locations in thirty states according to its website, and has been conducting antibody testing around the country. When reached for comment, ARCpoint Labs CEO John Constantine told 7 Investigates that "we received Rep. Krishnamoorthi's letter, and we are working diligently to address all of the House Oversight subcommittee’s concerns and ensure we are in compliance with current FDA guidelines.”
sent from the subcommittee on Economic and Consumer Policy, said they had received reports of ARCpoint Labs conducting point-of-care testing outside of certified labs, which violates FDA policy.
“There are reports that ARCpoint Labs offered point-of-care fingerprick tests, despite FDA’s requirement that antibody tests be performed at labs certified for high complexity,” the letter states. ARCpoint Labs told 7 Investigates that the statement was a reference to the
on which labs can offer these tests, which the lab said their Milwaukee location is in compliance with.
The letter also said the lab's documentation for results interpretation (a copy of which was attached to the letter) said a positive test suggested functional immunity and social distancing could be discontinued.
The undated document attached to the Congressional letter provides directions which read "Suggests functional immunity. Discontinue social distancing," under positive IgG results for antibodies.
“At this time, scientists do not yet know whether a person with antibodies has immunity, and studies from South Korea and China suggest that antibodies may not offer protection from another infection,” the Congressional letter states. In a fact sheet on serology (antibody) testing,
it is unknown how long COVID-19 antibodies remain present in the body after infection and whether they provide immunity to future infection.
The FDA has provided emergency approvals for
but has allowed labs to use un-reviewed tests under specific circumstances. According to ARCpoint Lab's website, their test is not FDA-reviewed. Medical experts have
about the accuracy of current serology tests on the market, but they are also widely considered to be a major step towards reopening the country.
7 Investigates has reached out for more information to Representative Raja Krishnamoorthi’s office, the congressman who chairs the subcommittee, as well as Wisconsin Rep. Glenn Grothman, who represents the 6th District and also sits on the subcommittee.
The subcommittee has provided ARCpoint Labs with a list of questions regarding their testing, and given them until Friday, May 1st to respond. The Committee on Oversight and Reform is the main investigative committee for the House of Representatives and has broad authority to investigate matters related to legislative and executive policy. Additionally,
that the same subcommittee is investigating FDA policy flaws that led to unproven Covid-19 antibody tests being sold in the United States.