Analyzing the Accuracy of Antibody Tests

Getting it right the first time: Optimizing Accuracy and Precision for Point-of-Care Testing

November 9, 2020

When everyone else is focused on moving fast, sometimes it’s best to take your time.

Obtaining a quick and actionable point-of-care (POC) test result is critical in providing patients with clarity about their health and enabling prudent action (or peace of mind, in the case of a negative result). But in the haste to develop rapid POC testing, too often accuracy and precision are left behind in diagnosing diseases and other health concerns. This can be very problematic, as trading precision and accuracy for faster results brings its own set of challenges. Most notably, it can create misinformed consumers – the very people these tests are designed to benefit in the first place. So how can we optimize accuracy and precision for POC testing, while delivering results to consumers more quickly than traditional laboratory-developed testing? The answer is nuanced, but much of it focuses on creating more reliable and scientifically-backed precision tests.

Accuracy vs. Precision

Before getting into POC precision and accuracy, it’s essential to understand the difference. Accuracy is the closeness of the result to the standard. Precision is how close the results are to one another or the consistency of the results. Accuracy and precision both play a crucial role in laboratory testing and POC testing.

Quality & Precise POC Testing: Why It Matters

The conversation around the need for quality, precise and rapid testing options for clinicians is more necessary than ever. At Truvian, our mission is to make routine health testing more accessible for patients. With that comes the need for an innovative approach to testing and getting results to the patient sooner. This means a streamlined and convenient process with easy-to-use testing hardware, long-lasting reagents in testing centers, and quick results at an affordable price point for consumers. With POC testing on the rise, there is more data to evaluate for precision and accuracy. The more tests that are run, the more data points there are to continually improve the testing platforms. Ultimately, with a solution that is simple to administer and use, it’s quite possible to lose sight of the importance of the accuracy and precision of the test results.

POC Testing for Clinicians and Patients

There are many reasons why precision and accuracy are important for clinicians and patients. The reliability of test results can either give peace of mind or raise questions for consumers regarding the quality and accuracy of such tests. That’s why we are developing a platform that prioritizes accuracy and reliability. Our automated blood testing solutions undergo independent evaluations in clinical labs to ensure robustness, reproducibility, and accuracy of assay results in real-world situations.

For clinicians, accurate and rapid test results ensure that they can partner with the patient to develop the plan of care in real-time. For patients, the quality of the POC test matters because they can discuss their results with their providers without waiting a week or more for their results to come back from the lab. Lab-accurate POC test results ensure that patients can focus on the treatment and recovery process, rather than worrying about whether or not the results were precise.

How Truvian Aims for Quality & Precision

Sound and thorough science is part of Truvian’s DNA. We’ve strived to meet the industry’s skepticism with rigorous scientific vetting and oversight. Many companies want to be the first to go to market with benchtop blood diagnostics, but we want to get it right the first time. The process must be balanced in order to provide a much-improved process for consumers — convenient, fast (results in 20 minutes or less), and affordable — while ensuring ease-of-use for clinicians and laboratory-accurate results. Jerry Yeo, PhD, DABCC, FAACC, Professor of Pathology at the University of Chicago, recently published a landmark clinical study in The American Journal of Clinical Pathology that validates the performance and accuracy of the Easy Check COVID-19 IgM/IgG™ Antibody Test – revealing one of the highest overall accuracy rates for SARS-CoV-2 antibody detection via lateral flow technology. During this independent analytical and clinical validation, Easy Check demonstrated excellent clinical performance with 96.6% sensitivity, 98.2% specificity, and 98.1% overall accuracy – achieving comparable performance to large lab-based serology analyzers. To fully optimize accuracy, speed, and precision testing, we took our time to get it right so we could go fast.

Sources:
Truvian Sciences Receives FDA Emergency Use Authorization for Easy Check COVID-19 IgM/IgG™ Test

New Research Study Validates Performance and Accuracy of Truvian Sciences’ Easy Check COVID-19 IgM/IgG™ Test