All CLIA certified laboratories are required to “demonstrate that prior to reporting patient tests results, it can obtain the performance specifications for accuracy, precision, and reportable range of patient test results, comparable to those established by the manufacturer. The laboratory must also verify that the manufacturer’s reference range is appropriate for the laboratory’s patient population.”

Many laboratories perform a series of experiments designed to estimate certain types of analytical errors, e.g., a linearity experiment to determine reportable range, a replication experiment to estimate imprecision or random error, a comparison of methods experiment to estimate inaccuracy or systematic error, or interference and recovery experiments to specifically estimate constant and proportional systematic errors (analytical specificity), and a detection limit experiment to characterize analytical sensitivity.

PAML assists hospital clients with their validation studies by providing:

• routine, special and rare samples for testing
• advice and remote troubleshooting, when possible.

“No matter how well a product, process or method performs elsewhere, hospital laboratories need to confirm that the equipment, test or methodology is valid when applied in their laboratory,“ said Dawn Goertz, PAML R&D technologist. “PAML is committed to helping our clients with their method validation studies by providing them with samples and technical support.”

To order validation samples online, you can access the request form at http://www.paml.com/. Once on PAML’s website, click on Hospital Services and then click on Correlation Sample Request under Technical Resources. There is a nominal fee to cover retrieval, shipping and handling. If you have further questions, please contact your marketing representative.