Goal of his foundation is to provide access to COVID-19 medical laboratory tests for first responders, as well as low-cost tests to the general public
Early in April, when many of the nation’s clinical laboratories were facing numerous challenges in their attempts to obtain adequate supplies for collecting, transporting, and testing for COVID-19, a Hollywood actor was funding his foundation and obtaining enough supplies for his foundation to offer access to COVID-19 testing to residents in his community of Malibu—as well as in other areas.
In many ways, local medical laboratories that offer COVID-19 tests are competing with actor/philanthropist Sean Penn’s Community Organized Relief Effort (CORE) foundation for the supplies they need to provide COVID-19 testing to the patients in their own communities. The non-profit organization says it is working with various healthcare providers to provide free coronavirus testing to first responders, and low-cost testing to the general public, in eleven cities and counties in California, Georgia, North Carolina, and Illinois.
In fact, the volume of COVID-19 testing CORE currently provides is large enough that The Hollywood Report published a story on June 3, titled, “How Sean Penn Made the Biggest COVID-19 Testing Site in U.S.” The article stated that, “In late May, Mayor Eric Garcetti announced the opening of a new COVID-19 testing site at Dodger Stadium in partnership with CORE, the Los Angeles Dodgers, Live Nation Entertainment, Red Rock Entertainment, and the Los Angeles Fire Department. Operated by CORE and LAFD, this site has capacity to test 6,000 residents a day free of charge––making it three times the size of any other location in L.A. County and said to be the largest testing site in the U.S.”
The Reporter did not make the distinction that the Dodger Stadium site is only collecting specimens. And, no news accounts of the CORE COVID-19 testing program names the clinical laboratories that CORE currently uses to perform the coronavirus tests for the specimens it collects.
CORE Partnered with Private Healthcare Provider Elevated Health
CORE first got underway in 2010 providing disaster relief following the catastrophic magnitude 7.0 earthquake in Haiti. It was known then as the Jenkins-Penn Haitian Relief Organization (J/P HRO). The foundation initiated its support of COVID-19 testing efforts in California in April, reported the Orange County Register (OCR). At that time, testing was much more limited than it is today and drive-thru testing in most areas in America was not available.
Elevated Health’s COVID Clinic website enables consumers to complete pre-test enrollment and payment before arriving at the drive-up testing site at the Westminster Mall.
“Right now, hospitals have very strict guidelines on who can be tested. Public health departments are overwhelmed and possibly underfunded. That’s where I’m trying to bridge the gap,” Matthew Abinante, DO, a doctor of osteopathy and Elevated Health’s founder and CEO, told the OCR.
The coronavirus test kits Elevated Health uses are made in China and were purchased from Georgia-based HealthTrackRx. According to Abinante, they are “FDA authorized, but not FDA approved,” reported the OCR.
Clinical laboratory leaders may be intrigued to see consumers waiting their turn at drive-through testing lines as they take COVID-19 diagnosis into their own hands. Sites like the one above run by Elevated Health at the Westminster Mall demonstrate that people are willing to patronize providers that serve their needs directly. (Photo copyright: Orange County Register.)
CORE Aims to Be a Model for Partnering in Testing
Though CORE’s COVID-19 testing relief efforts are no longer limited to Los Angeles County, that is where it all began. Specimen collection at drive-through sites for COVID-19 tests initially prioritized first responders and essential workers. CORE funds provided for a staff of 70 people at four of the 35 drive-thru specimen collection sites in LA, reported CBS Los Angeles(CBSLA).
CORE-funded services also made it possible for Los Angeles city employees—who were running the drive-thru specimen collection sites—to return to their primary jobs as emergency first responders, reported the Associated Press (AP).
“It’s something that we can adapt to very quickly with the training of the Los Angeles Fire Department initially. And we’re able to take all those firemen and put them back in to serve the people in the way that we need them to,” said Penn in the AP article.
At that time, city officials planned to perform 10,000 tests a day, Deputy Mayor Jeff Gorell, JD, told the LA Times. The City of Los Angeles purchased the tests and CORE covered the cost of staff, volunteers, and personal protective equipment (PPE), reported the LA Times.
“We have servers and people from the Peace Corps, actresses—a lot of people from the communities where the test site is. We’re trying to hire as much locally as possible,” Ann Lee, CORE’s Chief Executive Officer, told Business Insider.
CORE also partnered with the City of Malibu in western Los Angeles County to provide mobile COVID-19 testing services for the city’s 3,000 residents, first responders, and essential workers from April 6 to 17 at a testing site at Malibu City Hall.
“This is what I hope will be a model in terms of the government and community foundation partnerships that can be replicated not only in the city of Los Angeles and throughout California, but throughout the country,” Sean Penn (above at the COVID-19 drive-thru testing site in Malibu, Calif.), founder of CORE, told CBSLA. Since making that statement, CORE has gone on to partner with healthcare providers in three other states to provide coronavirus drive-thru specimen collection. (Photo copyright: Associated Press/ABC News.)
Should Drive-Through Testing Continue Post-Pandemic?
An April Dark Daily e-briefing reported on drive-thru COVID-19 specimen collection operations across 30 states. The e-briefing also noted that drive-thru collections protects medical laboratory professionals and emergency department staff from possible exposure to infectious agents.
It’s likely many industries—from education and retail to travel and restaurants—will be revamped as a result of the pandemic. Clinical laboratory leaders and pathologists will want to study the different approaches used to develop drive-through COVID-19 specimen collection; how some providers that ran them partnered with charitable organizations such as CORE; why drive-thru specimen collection appeals to consumers; and how it may improve phlebotomists’ safety and increase clinical laboratory business.
Schwan’s concerns about inaccurate or unreliable COVID-19 serology tests were supported when the FDA issued more restrictive rules for these medical laboratory tests on May 4
During a conference call with investors about the company’s first-quarter results, Schwan said of the recently-launched COVID-19 antibody assays, “These tests are not worth anything, or have very little use,” according to reporting from Reuters and other publications. “Some of these companies, I tell you, this is ethically very questionable to get out with this stuff.”
On May 3, Roche announced that its own Elecsys Anti-SARS-CoV-2 antibody test for SARS-CoV-2, the coronavirus that causes the COVID-19 illness, had obtained an emergency use authorization (EUA) from the federal Food and Drug Administration (FDA). In its news release, Roche stated that “the serology test has a specificity greater than 99.8% and sensitivity of 100% (14 days post-PCR confirmation).”
In a separate interview with Bloomberg, Schwan said about antibody testing, “It is very important to pick the right test and then to validate those tests with enough patients.” He then returned to the issue of poor quality in some antibody tests for the SARS-CoV-2 virus, saying, “Unfortunately, there are a number of tests already out there in the market which are not reliable simply because they haven’t been tested sufficiently.”
In reference to the initial release of serological COVID-19 antibody tests, CEO Severin Schwan (above) said during Roche Holding’s first quarter earnings call that, “It’s a disaster. These tests are not worth anything, or have very little use,” reported CNBC. He added, “This is really what matters. Every kind of amateur could produce an antibody test. The two of us could do it overnight in the garage. That’s not the problem. The question is, does it really work? And for that, you have to do testing and validation.” (Photo copyright: Reuters/Arnd Wiegmann.)
A ‘Wild West’ of Unregulated Assays
Prior to issuing tougher rules for how a manufacturer can market a COVID-19 serological test, the FDA had listed about 200 serological tests designed to identify antibodies produced by the human immune system in response to a SARS-CoV-2 infection. This is the process of seroconversion, which is the development of detectable antibodies in a patient’s blood against a pathogen. Detection of IgG antibodies indicates exposure to SARS-CoV-2, according to ARUP Laboratories.
Public health experts have raised questions about the proliferation of such tests for the new coronavirus. Under the FDA’s previous March 16 rules—which were more relaxed than those FDA applied when granting EUAs—the agency was swamped with requests to review more than 200 COVID-19 antibody tests. The looser regulations resulted in nearly no oversight of those tests, reported the Associated Press (AP).
In comments to the AP, Eric Blank, DrPH, Senior Director of Public Health Systems and Programs for the Association for Public Health Laboratories (APHL), said, “Right now it’s a wild west show out there. It really has created a mess that’s going to take a while to clean up.”
“In the meantime,” Blank added, “you’ve got a lot of companies marketing a lot of stuff and nobody has any idea of how good it is.” Blank confirmed to Dark Daily that he made these comments and stands by them.
Calls for Closer Scrutiny of Serological Antibody Tests
In response to the FDA’s March 16 rules for COVID-19 serology tests, APHL requested the federal agency to review its looser approach to reviewing these tests. The impact of the FDA’s much tougher COVID-19 serological testing rules released on May 4 was immediate.
In a press release issued on May 2, the FDA said, “to date, the FDA has authorized 105 tests under EUAs, which include 92 molecular tests, 12 antibody tests, and one antigen test.”
Clinical laboratories in the United States still face difficult challenges if they plan to launch their own COVID-19 serology testing programs. They must select one or more tests from among the antibody and antigen tests that have an FDA EUA. However, data for each of these tests is not as comprehensive as is the data for diagnostic test kits reviewed by the FDA and cleared for market under the pre-market approval process.
This webinar was conducted by James O. Westgard, PhD, and Sten Westgard of Westgard QC, Inc., and the full program is available for free download by clicking here, or by placing this URL in your web browser: https://www.darkdaily.com/webinar/quality-issues-your-clinical-laboratory-should-know-before-you-buy-or-select-covid-19-serology-tests/.
In the webinar recording, the Westgards provide a detailed overview of what elements are required for a clinical lab to have confidence that its COVID-19 serology testing program is producing accurate, reliable results. They explain that labs must understand the unique aspects of the populations they are testing in their communities. All of these factors can then be used by labs to evaluate the different COVID-19 serology tests available for them to purchase, and to select the test that best fits their lab’s capabilities and the characteristics of the patient population that will be tested.
Another important requirement for clinical laboratories to understand is the list of steps necessary to bring up a COVID-19 serological testing program. That starts with validating the test, then bringing it into daily production. As that happens, issues associated with quality control (QC), proficiency testing (PT), and regulatory compliance take center stage, so that the clinical lab has high confidence in the accuracy and reproducibility of the COVID-19 serology test results they are using in patient care or in support of employers who are screening employees for COVID-19.
To register for the June 11 webinar, click here, or place this URL in your web browser: https://www.darkdaily.com/webinar/achieving-high-confidence-levels-in-the-quality-and-accuracy-of-your-clinical-labs-chosen-covid-19-serology-tests/.
New COVID-19 Intelligence from Dark Daily
Announcing Dark Daily’s new COVID-19 STAT Intelligence Briefings! This free service for clinical laboratories, anatomic pathology groups, and diagnostics companies features:
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One popular feature is the COVID-19 Live! conference calls that happen every Tuesday and Thursday for 30 minutes at 1 PM, EDT. Visit the COVID-19 STAT Intelligence Briefings website and join us for the live calls.
