What We Should Address About Medical Testing Technology

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?

Simple doesn’t mean foolproof

Labs that perform only waived tests can obtain a Certificate of Waiver (COW) under the Clinical Laboratory Improvement Amendments (CLIA), exempting them from routine inspections. To be waived, tests must be simple and accurate, requiring little-to-no technical knowledge to perform.

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.

Accept no exceptions to regulation

Laboratory-developed tests (LDTs) occupy another regulatory loophole. Commercial test kits must be reviewed by the Food and Drug Administration (FDA) before hitting the market, but no such requirement exists for tests created and used within individual labs.

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.

A two-pronged solution

Increased federal oversight of medical testing technology is an obvious solution to these quality control problems, but it’s only part of the picture. Labs can expedite the process by taking responsibility into their own hands. Here are four ways labs can demonstrate their commitment to scientific integrity and quality patient care:

• Research tests carefully: It’s essential to meticulously research tests before implementing them. This is the best way to avoid tests that are poor quality or based on obsolete research.


• Practice equipment maintenance: Equipment repairs and calibration are a vital part of running a lab. Worn-down equipment can significantly impact test results.


• Train staff thoroughly: When training staff, emphasize the importance of following procedures. Be explicit about why each step is important, and provide clear and frequent feedback so mistakes can be corrected early.


• Harvest outside feedback: Enrolling in proficiency testing or other external quality control programs helps ensure no corners are being cut.

We’re a long way from perfecting the art of medical testing, but increased federal regulation and a commitment to quality from individual labs are definite steps in the right direction.

Image by University of Exeter