Evaluating Second Instrument Performance

An abbreviated evaluation can be done when introducing an instrument that is of like make and model to one that has already been evaluated and found acceptable. The abbreviated evaluation can also be done after updating an instrument or moving it from one room or building to another. The abbreviated protocol consists of:

  1. Running 20 replicates of a sample within the same run and comparing the standard deviation with that of the original evaluation data. Analyte concentration should be near the mid point of the reference, or therapeutic range. The standard deviation on the second instrument should not vary by more than 10% from the standard deviation on the original instrument.
  2. Running 20 samples with analyte concentration spread over the usual analytical range on both instruments. The results are compared by linear regressionr should be >0.92.
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