Outpatient Practice

Physicians Should Promote Over-The-Counter Influenza Testing

When the COVID history books are written, one of the good things to come out of the pandemic is the public’s successful use of home antigen testing for viruses. Forty years ago, if you wanted any kind of diagnostic medical test, you had to go to a doctor. The U.S. Food and Drug Administration (FDA) took the position that the general public was just not sophisticated enough to perform any kind of home testing. Then, in 1976, the FDA made a ground-breaking approval of e.p.t. – the Early Pregnancy Test which became the first over-the-counter pregnancy test that anyone could do. By 1988, 33% women of child-bearing potential had used a home pregnancy test. Today, global annual sales of home pregnancy tests are $705 million and they are well-accepted for their ability to accurately identify pregnancy as early as a week after conception.

Home glucose testing followed a similar timeline. The first glucose test strip, Dextrostix, was developed in 1965 and for the next fifteen years, the use of test strips was limited to physician offices. In 1980, the Dextrometer was launched and home glucose testing rapidly became the standard of care.

But it wasn’t until the COVID pandemic that home testing for an infection became available. Indeed, the home tests for COVID became one of public health’s most valuable tools to identify infections early in order to isolate contagious persons and slow the infection rate in communities. I can remember the earliest COVID home tests that required a person to use a camera on a phone or computer to link with a person trained in proctoring the steps in testing and in interpretation of the results. Those test kits gave way to tests that anyone could do on their own, without telemedicine proctoring. It turned out that the general public was more sophisticated than the health community had thought and were able to correctly perform and interpret these tests without proctoring.

Labcorp’s Pixel test can diagnose RSV and influenza infection in addition to COVID. Anyone can buy an over-the-counter Pixel test and do the nasal swab themself at home; however, it must be mailed to Labcorp for analysis and the results can take 2 days to come back. This delay of 2 days to make a diagnosis renders Pixel of limited use since rapid influenza tests can be performed in a doctor’s office in a matter of minutes. Thus, if a person is worried that they have influenza, it is far more expedient to go to their doctor, an urgent care center, or an emergency department for a rapid flu test.

Last year, in February 2023, the FDA approved Lucira, a home test for both COVID and influenza. This test, produced by Pfizer, correctly identified 90% of positive influenza A samples and 99.3% of negative influenza A samples. Lucira also detects influenza B but there were few cases of influenza B circulating at the time that Lucira was tested for accuracy. Unlike Pixel, Lucira tests are done by having the person do their own nasal swab and then perform testing and test interpretation themselves. The test requires a battery-powered device to analyze the specimens (the device and batteries are included in the Lucira kit). The total amount of time to perform the nasal swab and run the test through the device is about 35 minutes. Lucira is available through Amazon and costs $50 for one test kit. You can read the full kit instructions here, at the FDA’s website.

Why aren’t more people using Lucira tests?

Lucira has been a major breakthrough – a home influenza test that anyone can do and get immediate results. Diagnosing influenza early is crucial for infection control and treatment efficacy. You get influenza by being exposed to an infected person’s respiratory droplets. Thus, early diagnosis permits isolation of an infected person so as to reduce the chance of spreading influenza to family members, co-workers, or classmates. We have a very effective treatment for influenza – oseltamivir (Tamiflu), made by Genentech. However, for oseltamivir to be effective, it should be started within 2 days of the onset of influenza symptoms. This limits the usefulness of the Pixel tests since by the time the results get back, it is often too late to start Tamiflu. For these reasons, you would think that Lucira would be flying off the shelves but the reality is that few Americans (including doctors) have even heard of it. So why is it being so woefully underutilized?

  • It is only available through Amazon. In larger communities, Amazon can deliver a Lucira test kit the same day it is ordered. But in some areas of the country, it can take longer. Most people would prefer to stop by their local pharmacy to buy a test kit on-demand when they first develop flu symptoms but you can’t buy Lucira at a CVS or Walgreens. By limiting sales through Amazon, there is an access and time barrier to obtaining a test kit.
  • It is expensive. Personally, I would be more than willing to pay $50 to find out as early as possible if my fever and cough are due to influenza or not. But $50 can be a cost barrier to many people, especially since a COVID-only test kit costs less than $20 (for 2 tests in a kit) at your local pharmacy.
  • It is not being marketed. The American public is inundated with TV commercials for drugs. That’s because there is money to be made when pharmaceutical companies sell more of those drugs. Pfizer has relatively little to gain by selling its Lucira test kits. If Genentech produced an influenza home test kit, it would have an enormous financial incentive in the form of greater sales of Tamiflu from all of those early influenza diagnoses. Pfizer lacks an incentive to put money into advertising Lucira or to reduce the price of Lucira.
  • The public has COVID fatigue. Let’s face it, we’re all tired of COVID and just want it to go away. And the truth is that COVID hospitalizations were lower last week than any week since June 2023. We are also at the end of influenza season and flu cases are dwindling. If you get flu-like symptoms today, it is statistically more likely to be some other respiratory virus that there is no treatment for, anyway. COVID and influenza are out-of-sight, out-of-mind in the American public’s consciousness.

So, what can we do?

I’ve seen many people die from influenza during my career. As a pulmonologist, I know that the best way to reduce the chance that my patients will die from influenza is to diagnose it as early as possible. But I also know that it can be difficult for patients to get in to see a doctor within 48 hours of onset of flu-like symptoms. Patients will often call their doctor or message their doctor through their electronic medical record patient portal when they have flu-like symptoms but most doctors will not prescribe Tamiflu unless they have confidence that the patient actually has influenza as opposed to some other respiratory virus. So, what can we do to improve the use of home influenza testing?

  1. Make it more widely available. Don’t get me wrong, I buy a lot of stuff through Amazon. I’m surprised that Jeff Bezos doesn’t send me a fruit basket every Christmas in gratitude. But by limiting distribution to Amazon, the test kits are just not readily available to many (or most) Americans. Physicians should ask Pfizer to sell Lucira at brick and mortar pharmacies.
  2. Increase competition. Adam Smith, the father of supply and demand economics, identified that the best way to improve the quality and availability of a good or service as well as reduce the price of that good or service is through competition. Right now, Pfizer has a monopoly on the home influenza test kit market and is not incentivized to reduce the cost of test kits or to improve those kits. The FDA needs to authorize home influenza test kits from other manufacturers. It’s industrial competition that makes America great.
  3. Physicians need to educate themselves. We are influenced the greatest when a trusted peer advocates a new test or treatment. This can be through formal educational programs, such as grand rounds, or through informal settings such as department meetings or medical staff meetings. We need to spread the word about the availability of home influenza testing – not only among ourselves but also among our patients.
  4. A perfect opportunity for telemedicine. My inbasket in our electronic medical record was always the bane of my existence. I would tediously clear out all of the test results and patient messages every evening but by the next day, that inbasket would be full again. Physicians don’t like providing health advice or treatment via a patient portal or phone call because it takes up a lot of time and they don’t get paid (or if they do, they get paid very little). But with the expansion of telemedicine reimbursement during the COVID pandemic, a doctor can get paid for their time and expertise while improving the health of their patient expediently. Home influenza testing creates an ideal opportunity to utilize telemedicine – the doctor can observe the patient’s general condition and look at the test result via the video link. If the test is positive, a prescription for Tamiflu can be sent to the pharmacy without the patient having to come to the doctor’s office (and potentially infect patients in the waiting room, the office staff, or the doctor him/herself). Ideally, medical practices should make same-day telemedicine encounters available for any patient with a positive home influenza test. Every hour faster that we can prescribe Tamiflu is better for our patients.

At age 65-years-old, I recognize that I am at higher risk of death or serious illness from either COVID or influenza. Even if the infection doesn’t make me sick enough to be admitted to the hospital, those infections will still make me feel pretty crappy for several days and I don’t particularly like to feel crappy. I’m financially secure enough (and value my health enough) that next fall, when influenza season starts, I’ll spend the $50 and buy a Lucira kit through Amazon and leave it in my medicine cabinet for a year in case I develop symptoms. But I think that we can do better – and by we, I mean doctors, the FDA, and kit manufacturers. I’m hoping that like e.p.t. paved the way for other home pregnancy tests, Lucira will pave the way for other home influenza test kits that are easier to use, more accurate, more available, and less expensive.

April 25, 2024

By James Allen, MD

I am a Professor Emeritus of Internal Medicine at the Ohio State University and former Medical Director of Ohio State University East Hospital