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PSA Standardization



WHO Calibration/Concordance at 3.1 ng/mL Cutoff5

Slide 23

October 2009

Going back to the original screening study that led to FDA approval of the 4.0 ng/mL cutoff with the Hybritech assay, using concordance calculations alone it can be shown that a 4.0 translates to a 3.1 ng/mL cutoff if the WHO standardized assay is used. Use of this different cutoff yields a clinically equivalent patient distribution with the Hybritech cutoff.

WHO Calibration

 


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