Imagine learning the news that you have cancer. Stage Four, metastasized to multiple areas, roughly six to eight months to live — if you’re lucky. Then, imagine finding out your diagnosis was incorrect.

Accuracy of results is highly dependent on the functionality of testing instruments and components; without the right materials as a foundation, analysis and the subsequent diagnosis may be unreliable. (Credit: Porex)

According to a study published in BMJ Quality & Safety, 12 million people in the United States each year receive the wrong diagnosis from outpatient clinics.1 Nearly half of these errors are potentially harmful, causing untold stress and costs and jeopardizing the reputation of healthcare facilities and clinical laboratories. Typically, these misdiagnoses are attributed to human or instrument error, with healthcare practitioners analyzing reports incorrectly, making assumptions or possibly lacking enough information about certain conditions. Other theories claim that rushed procedures and testing are to blame. After all, clinics are busy, and fast turnover allows for more patients to be seen and provide greater economies of scale. Alternatively, some find fault in clinical laboratories, imagining images of thousands of samples in disarray with labels addressed or swapped haphazardly.

While these are possible causes of unreliable or incorrect diagnostic outcomes, a core threat continues to fly under the radar: device materials. Even though they compose the finished piece of equipment or test device, materials are often overlooked as potential factors in diagnostic testing quality. There is an inherent level of trust in testing devices that, if operated correctly, they will yield accurate results, but optimized procedures can only guarantee accuracy to an extent. The same goes with assessing condition — if the test information is reviewed correctly, the subsequent diagnosis goes uncontested, but is there certainty that samples were kept safe and uncontaminated throughout analysis? No matter how seasoned a medical or laboratory professional is or how carefully they handle equipment, if the materials are ineffective, the test results are unreliable.

Sample purity is critical at every level of testing in order to receive a reliable diagnosis and maintain patient trust. (Credit: Porex)

This is where new start-to-finish diagnostics solutions come into play. With the ability to seamlessly collect, transport, prepare, and analyze samples without risking integrity, the right technologies can help prevent sample interference and deliver a result with unquestionable accuracy. These solutions can properly wick, vent, filter, separate, and meet other functional needs to preserve sample quality through unique material composition customizable to diverse diagnostics applications. For an industry responsible for finding and disseminating information and that relies heavily on trust between provider and patient, this sample security and the resulting quality of diagnosis are paramount.

What Does It Cost to Be Wrong?

More than 7.5 billion lab tests are performed in the United States annually, and 80 percent of clinical decisions are taken after laboratory testing, according to the American Clinical Laboratory Association.2 For practitioners and patients in the position of deciding following test results, a diagnosis can be life-changing. If a false positive is the result, patients may believe they are ill and undergo treatments they do not need. This means the patient can incur tremendous out-of-pocket costs, funding unnecessary procedures and medications or traveling to various health care centers — all for a condition they do not have. In some cases, these treatments also place patients under enormous duress, potentially targeting and damaging areas of the body that were actually functioning correctly.

Even when unreliable results are for something more benign, like mistaking a sinus infection with a cold, the patient will spend additional time and money at subsequent appointments to try to reach the correct diagnosis. Additional research by Mayo Clinic confirms the value of a second opinion due to the chances of initial misdiagnosis. In 21 percent of cases studied, final diagnoses were distinctly different than referral diagnoses.3

On the other side of the coin, if a patient does not know they are ill, they do not receive the treatment they may desperately need. Being left in the dark can cause conditions to go untreated and become worse, or in the most severe cases, reduce a patient’s viability and/or time greatly.

In either situation, whether they are told they are sick, not sick, or are given the wrong diagnosis, the patient and their loved ones suffer. Deep emotional stress and lifestyle changes happen quickly in response to a diagnosis. This type of news has the power to point people in the right or wrong direction, and healthcare providers and clinical laboratories are tasked with getting that trajectory right — the first time.

For medical and laboratory professionals, an incorrect diagnosis also carries enormous weight. When patients visit a healthcare center, they trust they are using valid and trusted sources with the proper tools to deliver insight. Once a sample is in the hands of the person conducting the analysis, the patient has no other choice but to rely on the information. Relaying incorrect results — especially repeatedly — can cost a healthcare center or clinical laboratory not just a patient, but credibility as a whole.

Highly specialized, pure materials and media are engineered to enhance functionalities and provide accurate results in a range of diagnostics tests. (Credit: Porex)

For laboratories, receiving an unreliable diagnosis causes greater costs on an operational level. If a professional is forced to redo a test because accuracy was questionable on the first try, the lab incurs the cost of additional materials and time, in addition to having to recollect patient samples for repeat testing.

Finding Greater Accuracy through New Technologies

To maintain credibility, minimize extra costs, and provide superior patient outcomes, healthcare centers and clinical laboratories must examine the quality of their instrumentation and ensure that they are using the best possible materials and technologies to ensure performance, purity, and accuracy. Results are only as reliable as the tools used to provide them, making it critical to use solutions best suited to carefully handle and process samples throughout testing.

New innovative components that can preserve sample quality from beginning to end help to address concerns of inadequate results and improve clinical outcomes in in vitro diagnostic applications. At the first stage of the process, advanced porous collection media containing capillary structures with customizable properties for wicking, absorption, and flow enables controlled delivery of a sample. Critical color-changing and sufficiency-indicator technologies add visual assurance for professionals conducting tests. The media is also designed to reduce potential contamination by enhancing surface energy, increasing recovery of analytes, reducing viscosity, and minimizing nonspecific binding that can compromise results.

From collection, to transport, to preparation, to analysis, new technologies help to preserve sample quality and streamline the diagnostic testing process. (Credit: Porex)

As the sample moves to the next phase, patented porous matrix technology contains unique material structures that can collect, transport, store, and release the sample in one single system that can be tailored to low- or high-throughput formats. Liquid-tight components with interlocking screw cap closures contain and protect samples and avoid leakage during inter- and intra-laboratory transport. The technologies can also eliminate higher costs associated with transportation and biohazard shipping.

To further streamline testing steps, additional all-in-one material solutions can help to prepare samples quickly and with precision. Designed to reduce instrument downtime and provide reliable results, disposable laboratory products assist in readying samples for analysis. Blood serum filters separate serum or plasma from centrifuged whole blood samples, eliminate gel separation particulates and fibrin and allow direct access to a sample instead of through a secondary pour-off or container. Other technologies provide collection, filtration, transfer, and storage of buffers, serum, plasma, urine, stool, blood, saliva, and other liquids or viscous bodily fluids and tissues in self-contained, positive closure preparation systems. Using cutting-edge solutions like these can make the difference in a process that is often complex and time consuming.

Finally, advancements in components for analysis can aid goals for reliable diagnosis and reproducibility for applications such as microfluidics, lab-on-a-chip, molecular diagnostics, and point-of-care (POC) testing. Highly specialized, pure materials and media enhance functionalities including particulate capture, debubbling, fluid metering, filtration, absorption, venting, separation, and more. Smart, enabling materials provide essential performance for micro device applications, while also offering robust, certified nonleachable and extractable design that is easy to use and can be device inserted through press fitting, heat staking and ultrasonic welding.

At any individual stage of the testing process, and most powerfully when used in conjunction with one another, these advanced solutions can yield more accurate results to support a confident diagnosis. Designed as a platform and conduit of critical functionalities, porous components can protect the integrity of valuable samples and maintain quality at every level.

When paired with the right tools and applications, these new technologies allow healthcare facilities and labs to have greater reassurance in the accuracy of results. Patients depend on providers for accurate information; using dependable materials is the first step in delivering against that promise.

References

  1. H. Singh, et al., “The frequency of diagnostic errors in outpatient care: estimations from three large observational studies involving US adult populations,” BMJ Quality & Safety, Sept. 23, 2014
  2. “In Vitro Diagnostics (IVD) Quality Control Market Analysis Report By Applications (Clinical Chemistry, Immunochemistry, Hematology, Molecular Diagnostics, Coagulation, Microbiology), By End-use, And Segment Forecasts, 2018–2024,” 2018: Grandview Research
  3. Monica Van Such et al., “Extent of diagnostic agreement among medical referrals,” International Journal of Forecasting, April 4, 2017

This article was written by Maria De Capua, MT (ASCP), Vice President at Porex, a Filtration Group company, Fairburn, GA. For more information, visit here.