Assay Precision

Tim Holzer (holzert@centocor.com)
Thu, 21 Aug 1997 09:59:11 -0400

Can someone direct me to any published documents by regulatory or QA organizations or
committees that specify or recommend Intra and Inter-assay precision for Flow Cytometry
assays?

Specifically, I would like to know CVs for Intra-assay (same sample multiple times), and
Inter-assay for: Run to Run, Instrument to Instrument, Lab to Lab, Reagent Lot to Reagent
Lot, Technician to Technician.

Do they differ for analytes that detect cells that are more rare in a population versus more
frequent? Do they differ for dim cells (few epitope) versus bright.

Thanks ! Tim Holzer Centocor, Inc. holzert@centocor.com

Telephone: 610-889-4492 FAX 610-889-4771