Basic Method Validation focuses on the essentials for validating the performance of laboratory methods for moderate or high complexity tests. These methods comprise the majority of tests performed in most healthcare laboratories. The knowledge and skills required for basic method validation are the minimum training and education needed to validate method performance in any healthcare laboratory.
This course covers all the basic studies, from replication, linearity (reportable range), and comparison of methods, to the more advanced studies required for more complex methods, including interference, recovery, detection limit, and transference of reference intervals.
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Precision and accuracy are fundamental performance characteristics of an analytical method and must be properly managed to assure the quality of any laboratory test. Related characteristics that are always important are the reportable range and the reference intervals for patient test results. Proper management of any testing process requires that these characteristics be validated to assure that laboratory performance is acceptable for the intended clinical applications.
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