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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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As clinical laboratory self-testing expands, sharing of test results with healthcare providers becomes even more essential to optimize health outcomes

Survey data collected by the University of Michigan’s Institute for Healthcare Policy and Innovation (IHPI) indicates that consumer interest in direct-to-consumer (DTC) medical self-testing is growing. In fact, DTC testing appears to be more popular ever, even among older adults who were asked how they feel about performing clinical laboratory self-testing and specimen collecting for certain illnesses.

With support from AARP and the Michigan Medicine Department of Communications, more than 2,000 older adults between the ages of 50 and 80 responded to the IHPI’s National Poll on Healthy Aging (NPHA) either online or by telephone.

According Michigan Medicine’s MHealth Lab, “82% of older adults say that in the future, they would be somewhat or very interested in taking a medical test at home.”

Dark Daily has written regularly about this trend and how leaders need a strategy to serve this class of consumer. That strategy could include collecting the self-test results from consumers and keeping a complete record of consumers’ clinical laboratory test results from inpatient, outpatient, and self-test settings.

Jeffrey Kullgren, MD

“As more companies bring these direct-to-consumer [medical] tests to market and buy ads promoting them, it’s important for healthcare providers and policymakers to understand what patients might be purchasing, what they’re doing with the results, and how that fits into the broader clinical and regulatory picture,” said research scientist Jeffrey Kullgren, MD (above), Associate Professor of Internal Medicine and Health Management and Policy at the University of Michigan in a press release. Clinical laboratories may find opportunities to support patients’ self-testing in tandem with the physicians who treat them. (Photo copyright: University of Michigan.)

Importance of Sharing Clinical Laboratory Self-Test Results

Individuals responding to the poll were asked only about medical laboratory self-tests they had purchased themselves either online or at a retail store. Tests provided to respondents by a healthcare provider or given to them for free were not part of the survey.

The researchers discovered that 48% of respondents had purchased at least one variety of at-home health tests in the past. The types of tests bought included:

  • COVID-19 (32%),
  • DNA/genetic kits (17%),
  • Cancer tests, such as colon or prostate (6%),
  • Tests for infections other than COVID-19, such as urinary tract infections or HIV (4%), and
  • Other types of at-home tests, including those for allergies and food sensitivities (10%).

Approximately 82% of the respondents said they would be somewhat or very interested in taking at-home medical tests and nine out of 10 believed the test results should be shared with their doctors. But only 55% of respondents who had taken an at-home medical test and received positive results for infection other than COVID-19 had shared those results with their primary care physician.

However, 90% of respondents who had purchased a self-test for cancer screening did provide their doctors with the results.

“As we have seen in COVID-19, it’s important to share results from a home test with a provider so that it can be used to guide your care and be counted in official statistics,” said Jeffrey Kullgren, MD, Associate Professor of Internal Medicine and Health Management and Policy at the University of Michigan in an IHPI press release. Kullgren, a primary care physician and healthcare researcher at Michigan Medicine and the VA Ann Arbor Healthcare System, directed the IHPI poll.

Not All Medical Self-Tests Are Regulated by the FDA

The most prominent reason for wanting to use at-home tests was convenience and 59% of those surveyed felt that the results could be trusted. 

The poll also found that 53% of older adults believe at-home medical tests are regulated by the federal government, which isn’t always the case. Many at-home medical tests are reviewed by the federal US Food and Drug Administration (FDA), but not all such tests receive full FDA review.

The FDA, however, offers an online, searchable database consumers can use to determine if a certain over-the-counter test is regulated by the FDA.  

“Home tests can be a convenient way for older adults to check if they have an illness, such as COVID-19” stated Indira Venkat, Senior Vice President, AARP Research in the press release. “But consumers should make sure they know whether the test they are taking is FDA-approved, and how their health or genetic information might be shared.”

Other interesting outcomes of the research include:

  • The purchasing of at-home COVID-19 tests was highest among those between the ages of 50 and 64 when compared to the 65 to 80 age group, but there were no age differences for other types of at-home tests.
  • Respondents who are married or have who more education and/or higher household incomes were more likely to have purchased at-home tests.
  • Blacks were less likely to buy at-home medical tests than Whites or Hispanics.
  • Interest for at-home tests was higher among women than men.
  • Advertising swayed 44% of purchasing respondents to buy a DNA test and 11% to buy a cancer screening test.

Are DTC Home Tests as Accurate as Clinical Laboratory Testing?

At-home medical self-testing and sample collection is becoming accepted and established with consumers and the medical community, which is drawing attention to the accuracy of these tests and how clinical laboratories are being affected by the trend.

In “Patient Safety Organization Releases Report Rating COVID-19 Home Tests for Ease of Use,” we covered the Emergency Care Research Institute’s investigation into certain COVID-19 rapid antigen tests to find out how easy—or not—they are to use and what that means for the accuracy of the tests’ results.

And in “‘Femtech’ Diagnostic Start-up Firms Want to Provide Women with At-Home Tests for Health Conditions That Currently Require Tests Done by Clinical Laboratories,” we reported how growth in this segment could lead to new diagnostic tests that could boost a medical laboratory’s bottom line or, conversely, reduce its revenue as patients self-diagnose urinary tract infections (UTIs), yeast infections, and other conditions through at-home DTC testing.

The findings of this recent survey of older consumers is just the latest evidence that at-home self-testing for everything from COVID to cancer is here to stay. Clinical laboratories should be looking for ways to serve this patient population and the physicians who treat them.

JP Schlingman

Related Information:

Medical Tests at Home: Poll Shows High Interest, Uneven Use

The National Poll on Healthy Aging at Five Years

Medical Tests in the Comfort of Your Own Home: Poll Shows High Interest, Uneven Use by Older Adults

At-Home Medical Tests

Self-Testing at Home or Anywhere: For Doing Rapid COVID-19 Tests Anywhere

Patient Safety Organization Releases Report Rating COVID-19 Home Tests for Ease of Use

‘Femtech’ Diagnostic Start-up Firms Want to Provide Women with At-Home Tests for Health Conditions That Currently Require Tests Done by Clinical Laboratories

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