In the world of diagnostic testing, accuracy reigns supreme. A single erroneous result can lead to misdiagnosis, delayed treatment, and could potentially endanger a patient's health.  Quality Control (QC) steps are a key part of the procedures designed to guarantee the reliability and accuracy of test outcomes. 

Incorporating independent, third-party external controls offers significant safeguards to your testing protocols. Let us delve into why these controls are indispensable for any laboratory performing diagnostic tests. 

The Limitations of Internal Controls 

Regulatory bodies such as CLIA (Clinical Laboratory Improvement Amendments) establish minimum QC requirements, typically based on adherence to the manufacturer's instructions for waived testing. While some tests incorporate internal controls, these controls have limitations and should not be the sole standard for quality control. 

The Necessity of External Controls in Professional Settings 

Some tests with both Over-The-Counter (OTC) and Point-of-Care (POC) indications may not explicitly require external quality controls. If the tests are used in laboratories or healthcare settings, however, the reliance on the internal control is not adequate. For these tests, implementing a robust QC program that incorporates external controls is paramount for guaranteeing patient safety and accurate diagnoses.  External controls provide an independent assessment of test performance, helping to identify potential errors and validate the reliability of test results. External controls provide confirmation that the test was operating correctly and that the test preparation was free of contamination. 

Why Choose a Test Provider that Emphasizes External QC? 

A test provider that prioritizes external quality control demonstrates a firm commitment to the accuracy and reliability of their products. Here is why choosing such a provider is crucial: 

•  Enhanced Confidence in Results: By incorporating external controls, you gain an independent verification of your test system's performance, leading to a greater sense of confidence in the accuracy of your diagnoses. 

• Reduced Error Risk: External controls help identify potential issues before they can impact patient results, significantly minimizing the risk of errors and misdiagnoses. 

• Improved Patient Care: Accurate diagnoses are the cornerstone of effective patient care. Utilizing tests with robust QC programs ensures you are providing the best possible care for your patients. 

• Regulatory Compliance: In some cases, professional-use tests may have specific regulatory requirements for external quality controls. Choosing a provider that emphasizes quality control helps you stay compliant with relevant state and local regulatory and accreditation requirements. 

By integrating external controls into your QC routine, you gain a powerful tool to ensure the accuracy and reliability of your diagnostic tests. Your commitment to a high-quality control procedure translates to superior patient care, improved outcomes, and peace of mind knowing your results are trustworthy. 

The investment you make in robust QC testing will have some associated costs and may require some adjustments to existing workflows, but these considerations pale in comparison to the significant benefits they offer in terms of patient safety and accurate diagnoses. 

Anavasi Diagnostics is a leading manufacturer of point-of-care diagnostic solutions, dedicated to advancing healthcare through a continuum of rapid testing technologies. 

Our flagship product, the AscencioDx® testing platform, is a Nucleic Acid Amplification Test (NAAT) that offers sensitivity and specificity comparable to laboratory-based PCR assays. This innovative technology is miniaturized to run on a palm-sized device, delivering COVID-19 test results in as little as 20 minutes. 

We are continually expanding our product pipeline with additional molecular tests currently in development or clinical trials. 

Anavasi Diagnostics is headquartered in Redmond, Washington. For more information, please visit www.anavasidx.com, contact us directly at (888) 262-8274, or email us at sales@anavasidx.com.