ERP Micro December 2019

Summary of the GENE-UP LMO Collaborative Study Statistics

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Interpretation of data

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A summary of results for each level evaluated in the study are presented in Table 8.

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Table 8 – Summary of Results

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For an unpaired study, the difference between (ND – PD) is calculated for the level(s) where fractional

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recovery is obtained. The observed value found for (ND – PD) shall not be higher than the AL. The AL is

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defined as [(ND – PD) max ] and calculated per level where fractional recovery is obtained as described

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below using the following three parameters:

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( ) ref x x P p N + =

0

where

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P x = number of samples with a positive result obtained with the reference method at level x ( L 1 or L 2 ) for

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all the collaborators

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