ECCLSEuropean Committee on Clinical Laboratory Standards
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We report our analytical and clinical evaluation of this assay performed over an 8-week period, following the guidelines of the ECCLS document (9).
To assess carryover we followed the protocol of the ECCLS [6] and used two serum pools of 91 mU/L (high) and 0.
Within-run precision (21 replicates per run) as described in the ECCLS guidelines [8] was determined in five laboratories, and between-run precision (two aliquots per sample on 20 days) in four laboratories.