Validating high complexity lab test methods the dating game video


14-Jul-2020 01:49

The strategies described are meant to serve as a guide and should not replace the laboratory’s specific accrediting agency’s regulations.It is the responsibility of the laboratory director to determine the extent of validation or verification required.Strategies for Validation The approach to validation of body fluid specimen testing for chemistry analysis is similar to that of other validations performed in the laboratory.outlines an example of a typical workflow required to validate a series of body fluid tests.Off-Label Use of FDA-Approved Assays For most chemistry assays, manufacturers have defined acceptable specimen types as serum, plasma, whole blood, and urine.With the exception of glucose, lactate, immunoglobulin G (Ig G), and total protein for CSF, alternative fluid specimens likely are not evaluated or included in FDA-510k submissions.Once a sufficient number of specimens are collected for each fluid type, the recommendation is to analyze all fluid specimens for every test being validated.

validating high complexity lab test methods-49

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Further analysis may include albumin, p H, lactate dehydrogenase (LDH), and total protein, whereas additional applications include identifying bacterial infection, diagnosing chylous ascites, and distinguishing the origins of peritonitis.The assay then becomes an LDT, which requires validation.



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