Since Covid-19 at-home tests suddenly became more available to the general public during the winter of 2021, more and more adjusters and administrators have been faced with the question about whether antigen tests are sufficient to meet the criteria under Senate Bill 1159’s first responder and outbreak presumptions.
The short answer is simple – the antigen tests are not accurate enough to meet the criteria set forth by SB 1159’s presumptions.
Why not? They aren’t accurate enough.
WHAT THE STATUTE SAYS
To begin our analysis, let’s take a look at what types of tests the first responder and outbreak presumptions call for. They call for:
Unless otherwise indicated, “test” or “testing” means a PCR (Polymerase Chain Reaction) test approved for use or approved for emergency use by the United States Food and Drug Administration to detect the presence of viral RNA. “Test” or “testing” does not include serologic testing, also known as antibody testing. “Test” or “testing” may include any other viral culture test approved for use or approved for emergency use by the United States Food and Drug Administration to detect the presence of viral RNA which has the same or higher sensitivity and specificity as the PCR Test.
In summary, if you are evaluating whether a claim meets SB 1159’s first responder and outbreak presumptions, and the applicant is not going to use a PCR test, then the applicant needs a:
- Viral culture test
- That is FDA approved
- And has the same or higher sensitivity and specificity as a PCR test
Let’s jump into that third bullet point, which is the most important part – antigen tests, as they stand today, fail to meet that third criterion. As documented in this great article from National Public Radio which features quotes from epidemiologists, microbiologists and departmental chairs, antigen tests are just not as reliable as PCR tests.
That finding prompted the Food and Drug Administration to update its online guidance in late December to note that, while rapid antigen tests do detect the omicron variant, “they may have reduced sensitivity.”
A week later, a small preprint study found that in 30 people infected with the omicron variant, rapid antigen tests only detected a positive case two or three days after a PCR test caught it — and “sometimes even longer,” says Anne Wyllie, a microbiologist at Yale School of Public Health and one of the authors of that study.
The internet is currently full of anecodotal stories like this one, where symptomatic people are still registering as “negative” for Covid-19.
Earlier this month, Dr. Robert Wachter, chair of the Department of Medicine at the University of California, San Francisco, tweeted about his son’s brush with COVID-19. Roughly 36 hours after hanging out with a friend who later turned out to be positive, his son woke up feeling terrible – with a sore throat, “dry cough, muscle aches, chills,” Wachter wrote. The son tested negative on a rapid antigen test that day, but came up positive on a second rapid test the next day.
Still skeptical? Okay, I’ll just defer to Dr. Sheldon Campbell, a Yale medicine pathologist and microbiologist.
But limiting false negatives might be extremely important, especially with the rise of more transmissible variants.
“It’s actually true for those who have—and who don’t have—symptoms, but if you do have symptoms, a PCR test is more likely than an antigen test to pick up an infection accurately,” says Dr. Campbell.
THE OTHER STATUTORY CRITERIA
Regarding the other criteria, we do know that many tests are FDA-approved.
As for the first criteria, it’s arguable that an antigen test is a test that detects “viral RNA.” Why? Antigen tests detect proteins created by the viral RNA, but not necessarily the viral RNA itself. I’ve noticed that some literature refers to detection of viral RNA as a term of art, which means that the test must detect the viral RNA itself which infects cells. This is different than detection of a protein created by the viral RNA.
Also, focus on the words “viral culture test.” This article about STDs refers to a viral culture test literally obtaining viral RNA to literally infect new cells. On its face, that sounds different than simply detecting proteins created by the viral RNA.
Still at the end of the day, I could see a non-doctor arguing that by definition, an antigen test still detects viral RNA by detecting the proteins created by that viral RNA. That makes sense on its face. But is it a true viral culture test? Good question.
So when evaluating whether an antigen test can meet the three statutory criteria – even though the first two criteria are arguable, even if they could be met, antigen tests just do not have the same accuracy as PCR tests. Will antigen tests eventually reach the same accuracy and specificity of PCR tests? Possibly.
That sure would be nice to not have to wait 2-3 days for a lab result.
But right now, the antigen tests just are not equal to the “gold standard” of PCR tests. And when evaluating whether a claim for work-related Covid-19 benefits meets one of the statutory presumption, if it isn’t a PCR test, it isn’t good enough.
- CDC Study: Covid-19 Unlikely to Spread by Touching Surfaces
- Covid-19 Sick Pay Could Be Back Sooner Than You Think
Got a question about workers’ compensation defense issues involving the coronavirus? Feel free to contact Bradford and Barthel’s Covid Response Team at firstname.lastname@example.org. John P. Kamin, the author of this article, is a member of the team. Mr. Kamin is a workers’ compensation defense attorney and partner at Bradford & Barthel’s Woodland Hills location, where he monitors the recent legislative affairs as the firm’s Director of the Editorial Board. Mr. Kamin previously worked as a journalist for WorkCompCentral, where he reported on work-related injuries in all 50 states. Please feel free to contact John at email@example.com or at (818) 654-0411.
Viewing this website does not form an attorney/client relationship between you and Bradford & Barthel, LLP or any of its attorneys. This website is for informational purposes only and does not contain legal advice. Please do not act or refrain from acting based on anything you read on this site. This document is not a substitute for legal advice and may not address every factual scenario. If you have a legal question, we encourage you to contact your favorite Bradford & Barthel, LLP attorney to discuss the legal issues applicable to your unique case. No website is entirely secure, so please be cautious with information provided through the contact form or email. Do not assume confidentiality exists in anything you send through this website or email, until an attorney/client relationship is formed.