Tapping the expertise of a third-party expert who’ll challenge your assays’ performance across its Analytical Measuring Range (AMR) is a good practice. A best practice. That’s especially true when that partner’s expertise includes developing products specifically for a myriad of analyzers on the market today.
While not all validation characteristics are applicable for every type of test being performed in the laboratory, two standard validation characteristics are linearity and accuracy. Linearity is achieved when the tested assay recovers values that are directly proportional to the analyte’s concentration in the sample. Accuracy is when the values recovered and the accepted reference value agree. The slightest variations in tested recoveries can affect linearity accuracy. So, your values may be linear, but not accurate.
Since both are required to ensure assay performance, what’s the solution? Know the values you should obtain and accept that you won’t be on the mean all the time. This will increase your confidence in the assay and the results you report to your providers.
Benefit from shared expertise
Many labs use a third-party manufacturer for their quality controls so they can compare themselves to their peers; however, these levels may not cover the full AMR. Knowing the Typical Recovered Values (TRV) of your specific lot of a third-party control is vital to knowing where your results should fall. TRVs are provided in each VALIDATE® product insert.
LGC Clinical Diagnostic, Inc., the manufacturer of VALIDATE, employs a quality control (QC) lab with multiple vendor platforms, with highly skilled technologists maintaining optimal analyzer operation to ensure excellence in QC and to validate product performance. Monthly quality control statistics, in comparison with our peer groups, demonstrate excellence in performance across all analyzer platforms.
Our team sees reagent lot-to-lot variability sooner than most clinical labs because of the scheduling and release of our manufactured products. We regularly incorporate that variability into our VALIDATE target ranges throughout the shelf-life of our products. We also continuously monitor customer feedback on product performance to ensure they’re operating accurately. We make adjustments, as needed, and our staff is focused on providing the highest quality calibration/validation products to our customers.
Leverage data reduction services
Our data reduction services are always included with the purchase of VALIDATE products, at no additional charge. Data can be sent to LGC Maine Standards as often as you need, from six-month checks to retesting and troubleshooting or after instrument maintenance. Reports are returned within five business days.
MSDRx®, our user-friendly data reduction software program, is also available for download so that the laboratory can instantly analyze the linearity results recovered using the VALIDATE product lines. Simply enter your results into the stand-alone program to view, print, and save your linearity reports from your own computer. For peer data, send in your MSDRx file and we’ll provide your peer report with available peers, at that time. The algorithm reports are identical to the data reduction services provided by LGC Maine Standards.
Try it! Download MSDRx, our free data reduction software.