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What analytical performance is needed for a laboratory test?

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What analytical performance is needed for a laboratory test?

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In the US, CLIA defines minimum standards of analytical quality in the form of the criteria for acceptability in proficiency testing surveys. These criteria define the allowable total error around a target value (TV). For example, acceptable test results for cholesterol are described as TV plus/minus 10%, which means that test results should be within 10% of the correct value. Most countries have proficiency testing or external quality assessment schemes that define standards for analytical quality in a similar manner. Note that use of an allowable total error does not provide a specification for an individual characteristic, such as imprecision, inaccuracy, interference, recovery, etc., but provides a requirement of the total amount of error when all sources are combined.

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