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  • Stephen Biss

Change at One Point but Not at Another Point that is Equivalent


Purpose:

To suggest that there is empirical evidence in the matter before the Court of change in response by the approved instrument at the lower end of the measuring interval (reading much lower) and at the upper end of the measuring interval (reading slightly higher) without corresponding change in response at the single data point control test level.

To suggest that linearity has therefore changed, and in other words, the calibration curve programmed into the instrument, at the factory or on the last re-calibration, is no longer reliable.

To lay the foundation for the O'Connor order.

To connect the lack of multi-point calibration of an approved breath instrument with the lack of adequate multi-point calibration of the Elisa screening system (lack of multiple (5) calibrators) - the confusion of quantitative and qualitative analysis - criticized in the Motherisk Inquiry report.

To challenge the evidence of the government expert as to the adequacy of single point control tests to establish linearity in an instrument, that has not recently been re-calibrated across the measuring interval.

To suggest that the empirical evidence in the facts of this case - the annual inspections - supports the inference that the calibration curve has shifted, rotated, or stretched (or more correctly that although the learned calibration curve was fixed at time of last calibration, it is now different -shifted, rotated, or stretched, over time - from what the correct calibration curve would be if the instrument was properly re-calibrated) i.e. accuracy and precision have drifted over time.

#calibrationcurve #autocalibration #linearity #accuracy #precision #reliability #learned

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