WARNING: We do not support Internet Explorer. It is not secure and will not work correctly. Please come back using a newer web browser.
CLSI’s Method Evaluation standards provide concise explanations and step-by-step instructions for evaluation of test method performance characteristics such as precision and accuracy. We provide your lab with the information needed to comply and keep up-to-date with the latest best practice guidelines and laboratory accreditation requirements.
This implementation guide describes the minimum procedures necessary for a medical laboratory to verify the performance of qualitative, binary output (yes or no, positive or negative, target condition present or absent) examinations.
This guideline provides recommendations based on risk management for laboratories to develop quality control plans tailored to the combination of measuring system, laboratory setting, and clinical application of the test.
This guideline provides approaches for selecting measurands for which delta checks are useful, establishing delta check limits and rules for comparing current clinical reported results with previously reported results for a given patient, initiating delta check alerts in the laboratory information system, investigating patient samples with delta check alerts, and evaluating the effectiveness of the laboratory’s delta check program.
This guideline provides recommendations for establishing and verifying shelf-life and in-use stability claims for in vitro diagnostic medical laboratory test reagents such as reagent kits, calibrators, and control products.
