Validating high complexity lab test methods

12-Jun-2020 05:29

validating high complexity lab test methods-48

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A retrospective analysis of data from the laboratory information system (LIS) can identify frequently ordered tests involving body fluids.At our institution, we identified five major fluid types and a total of 28 analytes as routinely ordered (see ).

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.

n health care, the analysis of body fluids plays an important role in the diagnosis and management of a wide variety of conditions.