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Division 7.3 Determination of cut-off values

United Kingdom

Original text. Later amendments are not shown.

The relationship between bioanalytical results in BEQ and results from confirmatory methods in TEQ shall be established (e.g. by matrix-matched calibration experiments, involving reference samples spiked at 0, 0,5×, 1× and 2× the maximum level (ML), with six repetitions on each level (n = 24)). Correction factors (blank and recovery) may be estimated from this relationship but shall be checked in each test series by including procedure/matrix blanks and recovery samples (see point 7.2).

Cut-off values shall be established for decision over sample compliance with maximum levels or for control of action levels, if of interest, with the respective maximum or action levels set for either PCDD/Fs and dioxin-like PCBs alone, or for the sum of PCDD/Fs and dioxin-like PCBs. They are represented by the lower endpoint of the distribution of bioanalytical results (corrected for blank and recovery) corresponding to the decision limit of the confirmatory method based on a 95 % level of confidence, implying a false-compliant rate < 5 %, and on a RSDR < 25 %. The decision limit of the confirmatory method is the maximum level, taking into account the expanded measurement uncertainty.

In practice, the cut-off value (in BEQ) may be calculated from the following approaches (see Figure 1):

  1. 7.3.1Use of the lower band of the 95 % prediction interval at the decision limit of the confirmatory method
  2. 7.3.2Division 7.3.2
  3. 7.3.3Division 7.3.3
  4. 7.3.4Restrictions to cut-off values