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The Pathologist / Issues / 2025 / Jan / Health Checks While the Kettle Boils
Point of care testing Quality assurance and quality control Regulation and standards

Health Checks While the Kettle Boils

What is the Association for Diagnostics & Laboratory Medicine’s position on the at-home testing market?

By Helen Bristow 01/24/2025 Interview 4 min read

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Credit: ADLM

From gonorrhea to gluten intolerance and from colorectal cancer to iron deficiency, patients are opting to check their health in the comfort of their own home rather than at the clinic. Is this a good thing?

Here, we present the answer to this question and more from Anthony Killeen, President of the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), Professor and vice-chair for clinical affairs, department of laboratory medicine and pathology, University of Minnesota, Minneapolis.

What are the drivers for the increased demand for at-home tests for medical conditions?
 

In the last few years, one of the biggest drivers of this increased demand has been the COVID-19 pandemic. At-home testing was integral to managing the pandemic, and it led people to become much more comfortable performing self-collection of samples and using kits to test themselves and others for COVID. 

Before this, such widespread use of at-home sample collection and testing was unprecedented. Now, the public’s expectations for medical testing are clearly being shaped by the convenience, privacy, and speed of obtaining COVID results at home. 

More than that, the public and healthcare providers came to really trust results from at-home COVID tests, using them to make critical decisions about travel, personal/social interactions, and other behaviors. This, in turn, has increased trust in at-home testing across the board.

What are the advantages of at-home testing to patients?
 

A major goal of the ADLM – and the laboratory medicine community at large – is to improve patient access to testing, something that at-home testing is definitely helping us to accomplish. 

Another positive is that at-home testing empowers people to take a more active role in their own medical care and may help reduce the burden on the healthcare system when used appropriately.

What about the disadvantages?
 

As with all new healthcare paradigms, we must be aware of and mitigate the downsides of at-home testing in addition to embracing its benefits. One of these is that at-home tests may not be as reliable as testing that is performed in clinical laboratories. 

It is also important to help patients understand that results of at-home tests cannot be used in isolation to provide a diagnosis. The test result counts of course, but clinical context must be carefully considered when acting on that result. The ADLM advises patients who are using at-home tests to consult with their healthcare providers and use evidence-based guidance when interpreting the test results.

We must also consider that the unnecessary use of single-use at-home tests is wasteful on resources. We experienced this at several points throughout the pandemic as the demand for at-home tests surged – sometimes without clear necessity or supporting proof of the value of testing – resulting in inadequate supply.

Finally, the potential of increasing health anxiety in patients is another issue that at-home testing raises. For instance, if an individual were to get a false-positive result on an at-home test saying that they have an infection or condition that they don’t actually have, that could certainly cause undue stress. 

To reiterate what I’ve said above, this is yet another reason why it’s so important that people consult with their healthcare providers when interpreting home test results and deciding what action to take in response to them.

How do pathology labs benefit from patients performing their own testing?
 

One of the biggest operational challenges that clinical labs in the US are facing is that they have been chronically short-staffed for many years. This shortage has led to increased workloads and stress for current staff, raising risks of errors and delays in test results. Since the pandemic, we have also been dealing with ongoing shortages of some essential supplies. 

Increasing the use of at-home tests could help with both of these issues by alleviating the burden on clinical labs – and, in fact, this is exactly what we saw happen during the height of the pandemic. At-home tests played an integral role in helping clinical labs keep up with the demand for COVID testing in the midst of staffing and supply chain shortages. 

Are pathology labs generally supportive of at-home testing?
 

The laboratory medicine community as a whole is very supportive of expanding patient access to testing through the advancement of home tests. At the same time, we do believe that it’s important to balance innovation in this area with the need to ensure that home tests are accurate and used appropriately. We want patients who use these tests to access the care they need, and also to ensure that we are not overutilizing testing and healthcare resources. 

ADLM, therefore, continues to recommend that patients and consumers consult with their healthcare providers and evidence-based guidelines for when to test and how to interpret home test results. This advice also applies to determining the best course of medical care based on these results.

How can patients ensure they are purchasing a validated/approved product?
 

In the US at least, all at-home diagnostic tests must be approved by the Food and Drug Administration (FDA) before they are sold. Any home test that you can buy from a reputable store will have gone through the FDA’s validation process. 

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About the Author(s)

Helen Bristow

Combining my dual backgrounds in science and communications to bring you compelling content in your speciality.

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