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Clinical Laboratories and Pathology Groups

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Healthcare Experts Say Consumers Are Ready for Self-Test Flu Kits, But Are Physicians and Clinical Laboratories Ready to Let That Cat Out of the Bag?     

Clinical laboratories could play a key role in helping users collect their samples correctly, interpret results, and transfer flu test data to their health records

Clinical laboratories may have another opportunity to provide service to their clients and the physicians who treat them. With the success of at-home COVID-19 testing, consumer demand for self-tests is changing and advances in diagnostic technology now make it feasible to make more influenza (flu) tests available for consumers to buy and use at home.

At-home tests for SARS-CoV-2 can be found at pharmacies all across America. But that’s not the case with tests for influenza.

Should self-test flu kits eventually become available and common, clinical laboratories could offer the service of helping consumers understand:

  • that the test was conducted correctly (specimen collection and analysis),
  • that the result is accurate and reproducible, and
  • how to understand the results.

Clinical laboratories also could collect and input the results into their laboratory information system (LIS), then send those results to the patients’ electronic health record (EHR) at their physician’s clinic.

Christina Yen, MD

“Home flu testing would ensure that those who do need and receive antiviral medication for influenza are the ones who need it the most,” and that “we are making our treatment decisions based on data,” infectious disease specialist Christina Yen, MD (above), University of Texas Southwestern Medical Center, told STAT News. At-home flu self-tests could also bring opportunities for clinical laboratories to provide service to healthcare consumers and the physicians who treat them. (Photo copyright: UT Southwestern Medical Center.)

Pros and Cons of Consumers Doing At-home Influenza Testing

According to the federal Centers for Disease Control and Prevention (CDC), COVID-19 and influenza are both upper respiratory illnesses with similar symptoms. So, why don’t we have more at-home flu tests available? Partly because at-home testing is a relatively new phenomenon in modern healthcare.

“It’s really rare, and it’s really new that people are allowed to know about what’s happening inside their body without a physician in the middle,” Harvard epidemiologist Michael Mina, MD, PhD, told STAT News. The article uses the example of at-home pregnancy tests. Despite a prototype for an at-home pregnancy test being created in 1967, it took another decade before an over-the-counter pregnancy test became available to the public.

“The general thinking was, ‘How could a woman possibly know what to do if she found out she was pregnant on her own without a doctor in the room?’ That is a ridiculous concern because women have been doing that for millions of years,” Mina added.

So, why be cautious when it comes to giving patients the option of at-home flu testing?

There are some cons to at-home influenza tests. Average citizens are not clinical laboratory professionals. They might obtain too little sample for an accurate reading or read the results incorrectly. Then, there is the possibility for false-negatives or false-positives.

An at-home test user is not likely to consider the possibility of a false result, however clinicians look at the situation with more nuance. If the patient was still symptomatic or in a high-risk community, the provider could administer a more sensitive medical laboratory test to confirm the previous test results.

There are other concerns about at-home testing as well. Another STAT News article titled, “Growing Use of Home COVID-19 Tests Leaves Health Agencies in the Dark about Unreported Cases,” reported on a superspreading event that health officials did not know about: a Phish concert on Halloween.

“In a Facebook post from mid-November with hundreds of responses, concertgoers compared symptoms and positive test results, many of those from tests taken at home. But those data weren’t added to state public health tallies of COVID’s spread,” STAT News noted.

The larger concern is that samples obtained by at-home self-test users are not submitted for genomic sequencing. This could lead to incomplete data and delay identifying new variants of the coronavirus in communities.

“If nobody’s reporting the tests, are we really getting the information we need?” Atul Grover, MD, PhD, Executive Director of the Association of American Medical Colleges Research and Action Institute, told STAT News. “We have no idea what the true positivity rate is.”

Another barrier to at-home flu testing is that rapid influenza diagnostic testing can be unreliable. In 2009, the rapid influenza tests could only detect the H1N1 influenza virus in a mere 11% of samples, STAT News reported. Because of this, the FDA now requires manufacturers to test their rapid tests against eight different strains that change every year depending upon which strains are prevalent. This could present a problem if individuals use leftover tests from the previous flu season.

Do Pros of At-home Testing Outweigh the Cons?

At-home testing is convenient and makes testing more accessible to patients who may not be able to get to a clinic. Being able to test at home also encourages individuals to take precautions necessary to stop the spread of whichever illness they may have. Given the similarities in symptoms between influenza and COVID-19, people could benefit from having tools at home that correctly identify their illness.

At-home COVID-19 tests are here to stay, and at-home influenza tests may be on the way soon. Clinical laboratories could play an important role in educating the public on the correct handling of these tests.

Ashley Croce

Related Information:

Why Doesn’t the U.S. Have At-Home Flu Tests?

What Is the Difference between Influenza (Flu) and COVID-19?

We Still Don’t Have At-Home Testing for the Flu—But COVID-19 Has Changed the Stakes

Growing Use of Home COVID-19 Tests Leaves Health Agencies in the Dark about Unreported Cases

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