Validation of Amylase2 (AMY2) Assay Integration for Alinity Ci-Series Analyzers
Faculty Mentor Information
Kirsten Blanchette, North Idaho College; Melissa Ryskamp, Kootenai Health; and Sandra Hess, Kootenai Health
Presentation Date
7-15-2026
Abstract
Test assays used by clinical laboratories must undergo frequent analytical performance verifications to ensure the resulting values are reliable for use in patient treatment. Abbott Diagnostics is discontinuing its first-generation Alinity c Amylase assay and replacing it with Amylase2 (AMY2), a second-generation variant designed to improve the test’s analytical precision and calibration stability through Six Sigma quality metrics. This transition requires Kootenai Health Laboratory to verify Abbott’s reported analytical measuring range (AMR) and the performance of AMY2 before its integration into the Alinity ci-series analyzers. The assay measures the presence of amylase and is primarily used in tandem with lipase to identify signs of acute pancreatitis. The validation study began with precision assessment using quality control materials, followed by serum and urine linearity testing to establish accuracy. Next, samples from 20 healthy adults were compared to Abbott’s AMY2 reference range to verify its applicability to Kootenai’s patient population, and method comparison tests between Alinity c Amylase and AMY2 using 40 blood and 40 urine samples checked for systematic bias and value consensus. Finally, a fluid matrix study was conducted to determine whether peritoneal and pleural fluid specimens would perform similarly to the serum/plasma matrix and not impede analyte recovery. All raw data was then processed by EP Evaluator, a quality assurance program. AMY2 successfully met the performance criteria and passed the validation testing, confirming the assay’s reliability and accuracy. Based on these findings, Kootenai Health Laboratory will soon be able to take AMY2 online for clinical implementation.
Validation of Amylase2 (AMY2) Assay Integration for Alinity Ci-Series Analyzers
Test assays used by clinical laboratories must undergo frequent analytical performance verifications to ensure the resulting values are reliable for use in patient treatment. Abbott Diagnostics is discontinuing its first-generation Alinity c Amylase assay and replacing it with Amylase2 (AMY2), a second-generation variant designed to improve the test’s analytical precision and calibration stability through Six Sigma quality metrics. This transition requires Kootenai Health Laboratory to verify Abbott’s reported analytical measuring range (AMR) and the performance of AMY2 before its integration into the Alinity ci-series analyzers. The assay measures the presence of amylase and is primarily used in tandem with lipase to identify signs of acute pancreatitis. The validation study began with precision assessment using quality control materials, followed by serum and urine linearity testing to establish accuracy. Next, samples from 20 healthy adults were compared to Abbott’s AMY2 reference range to verify its applicability to Kootenai’s patient population, and method comparison tests between Alinity c Amylase and AMY2 using 40 blood and 40 urine samples checked for systematic bias and value consensus. Finally, a fluid matrix study was conducted to determine whether peritoneal and pleural fluid specimens would perform similarly to the serum/plasma matrix and not impede analyte recovery. All raw data was then processed by EP Evaluator, a quality assurance program. AMY2 successfully met the performance criteria and passed the validation testing, confirming the assay’s reliability and accuracy. Based on these findings, Kootenai Health Laboratory will soon be able to take AMY2 online for clinical implementation.