2014-10-24-世界卫生组织-WHO_BS_2014.2244_Collaborative_study_of_the_1st_International_Reference_panel_Plasma_for_Lupus_anticoagulant_98页_1mb

The collaborative study evaluated three lyophilized plasma samples to establish the first International Reference Panel for Lupus Anticoagulant (LA). Conducted by 19 laboratories across various countries, the study used a range of assays (dRVVT, APTT, SCT, and others) to assess these samples for their suitability as reference materials.

Key findings confirmed that the samples (12/148, 12/150, 12/152) have defined lupus status: negative, moderate positive, and strong positive, respectively. Low intra- and inter-laboratory variability were observed for many methods, which suggests the reference panel has good reproducibility. Recalculating ratios relative to sample A (the negative reference) improved inter-laboratory agreement. The study also included stability assessments, showing that the plasmas remain stable under standard conditions. As a result, the panel was recommended for use in validating LA assay methods and improving diagnosis accuracy.