Validating laboratory tests

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Common reference intervals for numerical pathology tests have been proposed for many years as an improvement over the common situation where individual laboratories establish or select and validate their own intervals.

However it is important that any intervals that are developed for common use are themselves validated for use in individual laboratories.

There are three main aspects to consider, the appropriateness of the interval, methodological factors and population factors.

Techniques for assessing method biases are reasonably straightforward with the use of shared samples and appropriate external quality assurance schemes.

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The tests available from commercial sources may not fit the exact needs of a laboratory, or the tests may not be FDA approved for patient testing.These factors have led many laboratories to develop and validate new molecular assays for their current patient testing needs.The task of developing and validating these tests is considerable, and the laboratory must learn to navigate the field of molecular testing.This article describes the process of assay development and validation of real-time PCR and nucleic acid sequencing assays; included are descriptions of important considerations, such as the PCR workflow, inhibition testing, proper use of controls, and multiplexing.Your access to the NCBI website at gov has been temporarily blocked due to a possible misuse/abuse situation involving your site.This is not an indication of a security issue such as a virus or attack.

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