Inaccurate results from medical lab tests can result in unnecessary treatments or under-treatment of deadly diseases. Tests are usually advertised as highly-accurate, but the FDA warns that some are very unreliable.
Overview
Between 7 and 10 billion laboratory tests are performed every year in the United States for a wide variety of medical and non-medical purposes, including:
- Employment drug screening
- Blood work for life insurance
- Paternity testing
- Prenatal testing for genetic abnormalities
- Breast cancer gene mutation (HER2)
- And more
What is the problem?
Most people assume the tests are accurate, and in most cases they are. However, even with error rates below 0.1%, millions of inaccuracies occur. Because inaccurate results can have devastating consequences, it is a good idea to double-check the results.
Many factors contribute to the problem. In some cases, the test itself is unreliable. In other cases, human error is to blame — samples get mixed up, equipment is used improperly, results are misinterpreted, or the technician uses the wrong protocol.
FDA Warning: Lab Test Errors Harm Patients
In November 2015, the FDA released a report (PDF) analyzing adverse events that occurred due to inaccurate results from 20 different laboratory tests. According to the FDA:
“Due to false-positive tests, patients were told they have conditions they do not really have, causing unnecessary distress and resulting in unneeded treatment. In other cases, the LDTs were prone to false-negative results, in which patients’ life-threatening disease went undetected.”
The FDA concluded that lab test errors are harming patients, and they listed many serious health consequences:
- Unnecessary medical treatment
- Diagnosis of actual condition is delayed
- Expensive treatments
- Surgery to remove healthy organs (ovaries, for example)
- Appropriate treatment is delayed
- Healthy pregnancy is aborted, or a child is born with birth defects
- Cancer treatment is inappropriate, harmful, or ineffective
- And more
Prenatal Lab Tests Have High Rate of Failure
Inaccurate results from prenatal laboratory tests can lead women to abort healthy fetuses, or give birth to babies with severe genetic birth defects. The unregulated tests claim to detect defects with near-perfect accuracy, but in reality they can lead to false-alarms in nearly 50% of cases, according to a warning by the New England Center for Investigative Reporting.
20% False-Negative for HER2 Breast Cancer Gene
Women with the HER2 gene are more likely to develop aggressive breast cancer. If they do, special drugs that target HER2 receptors can improve survival. This is why all women with breast cancer should be tested. Inaccurate results can results in less-than-optimal treatment. According to the FDA:
“At least in the past, 20% of tests may have been inaccurate, creating concern that some invasive breast cancer patients may have been exposed to treatments that are less than optimal.”
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