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In order to ensure the accuracy of the product, we established 1st model of metrological traceability hierarchy for light‐initiated chemiluminescent assay (LICA) of 17β‐estradiol (E2) at the manufacturer, based on… Click to show full abstract
In order to ensure the accuracy of the product, we established 1st model of metrological traceability hierarchy for light‐initiated chemiluminescent assay (LICA) of 17β‐estradiol (E2) at the manufacturer, based on International Organization for Standardization (ISO) 17511:2020. Moreover, we verified/validated the basic performance (such as matrix effect and long‐term stability of end‐user IVD MD calibrator, precision, linearity interval, accuracy/ trueness, and detection capability) at the clinical end‐user.
Journal Title: Journal of Clinical Laboratory Analysis
Year Published: 2022
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