By Kayla Matthews
When 70 percent of the medical decisions in the United Sates are influenced by laboratory tests, it’s critical for those tests to be reliable. Inaccurate medical tests can be wasteful or even dangerous. Forgetting to calibrate a testing machine may seem like a minor offense, but it can lead to deadly miscalculations in how much medication a patient needs.
Unfortunately, current medical testing practices are woefully insufficient. Like any business, labs are always looking for ways to save a little time and money. But are the time and money saved worth the cost to patients’ well-being?
The tests that fall under this category pose minimal risk to patients and are cleared for home use. Some well-known examples include finger pricks to measure blood glucose and cheek swabs to detect HIV.
Even waived tests are not foolproof, though. Botched paternity tests can tear families apart, and a false negative on an HIV test can leave a patient without life-sustaining treatment.
Unfortunately, many healthcare professionals are lured into a false sense of security by the simple nature of these tests. With the lack of regulation, it’s easy to make careless mistakes when administering waived tests.
Proficiency testing (PT) is a form of external quality control required for all non-waived tests, but waived tests are exempt. However, enrolling in an optional PT program is a good way for labs to improve the integrity of their waived testing procedures.
As technology advances, LDTs are becoming more complex and widespread. Without consistent FDA evaluation, it’s virtually impossible to ensure the accuracy and usefulness of these individually-developed tests.
Tests with poor sensitivity may leave serious conditions undetected and untreated. For example, the lab-developed SurePath Collection Medium test for Human Papillomavirus (HPV) is prone to false negatives, allowing the virus to advance into full-blown cervical cancer without early detection.
Other LDTs are prone to false positives, indicating a condition that isn’t actually present. This is common in ovarian cancer screenings, leading to the invasive and pricey removal of perfectly healthy ovaries.
In other cases, LDTs are irrelevant or are based on bad research. These unnecessary tests can be costly to patients, society and the environment. For instance, the CARE Clinics Autism Biomarkers Test was based on disproven research. A total of 2,027 children were misdiagnosed over a four-year period, leading to an estimated $66.1 million in inappropriate services.
Image by University of Exeter