Abstract
The clinical laboratory uses commercial products with limited shelf life or certain
expiry dates requiring frequent lot changes. Prior to implementation for clinical
use, laboratories should determine the performance of the new reagent lot to ensure
that there is no significant shift in reagent performance or reporting of patient
data. This guideline has been written on behalf of the International Council for Standardization
in Haematology (ICSH) to provide the framework and provisional guidance for clinical
laboratories for evaluating and verifying the performance of new lot reagents used
for coagulation testing. These ICSH Working Party consensus recommendations are based
on good laboratory practice, regulatory recommendations, evidence emerged from scientific
publications, and expert opinion and are meant to supplement regional standards, regulations,
or requirements.
Keywords
new lot reagent verification - coagulation testing - laboratory
