Comparison of Method Validation for Test and Inspections

Abstract

One of the most important purposes of a validation method is to verify whether a test method is suitable for the purpose of the test. In this study, validation parameters that are used by national and international institutes for test and inspection bodies are classified. As a result of classifying these general factors, method validation parameters were performed, including the following cases: ① the confirmation of a new test method, ② comparison between a non-standardized test method and standardized method, ③confirmation of a test method needing such extensions as a test method verification, verification of the test method applied between other test institutes or analysts, ④ verification of the required similarity between test methods, and ⑤ revalidation of the previously verified test methods. The general parameters applied in the validation processes were classified as follows; specificity, selectivity, linearity, sensitivity, accuracy, precision, detection limit uncertainty, quantitative limit, and range. By a comparison of the validation guidelines or guideline parameters applied by the test and inspection bodies, the survey results were considered to be useful in preparing validation guidelines for environmental testing and inspection methods.

Development of fluorometric detection for saxitoxin with its specific binding peptide

“…All experiments used certified reference material (CRM) samples, and reproducibility and reliability can be confirmed by applying homogeneous and stable CRM samples to the system several times. 18,19 STX-specific binding peptide (SABP1) was tagged with 5-carboxyfluorescein (FAM) as the fluorophore. Peptides as receptors show promise for usage outside of the laboratory due to their high thermal stability and high affinity with the target.…”