Gunson H H, Bowell P J, Kirkwood T B
J Clin Pathol. 1980 Mar;33(3):249-53. doi: 10.1136/jcp.33.3.249.
A collaborative study involving nine independent assays by eight laboratories has recalibrated the anti-D concentration of the International Reference Preparation of Anti-D Immunoglobulin (68/417) in terms of the International Standard for Anti-Rho (anti-D) Incomplete Blood Typing Serum (64/16). This study was carried out when it was found that 68/419 had been calibrated not against 64/16, as originally intended, but inadvertently against another preparation. Based on the results, a revised rounded off value of 300 IU anti-D per ampoule of 68/419 was assigned by the Expert Committee on Biological Standardisation of WHO at its 30th meeting. Many of the known variables in anti-D quantitation using the AutoAnalyzer were considered in the preparation of the protocol for this study. The remarkably close agreement of the results indicated that the format can be used as an acceptable model for interlaboratory studies in the future.
一项由八个实验室参与的九项独立检测的合作研究，已根据抗 - Rho（抗 - D）不完全血型分型血清国际标准品（64/16），重新校准了抗 - D免疫球蛋白国际参考制剂（68/417）的抗 - D浓度。开展这项研究是因为发现68/419并非如最初预期那样以64/16为标准进行校准，而是无意中以另一种制剂为标准。根据研究结果，世界卫生组织生物标准化专家委员会在其第30次会议上为每安瓿68/419指定了一个经修订的四舍五入后的值，即每安瓿含300 IU抗 - D。在制定本研究方案时，考虑了使用自动分析仪进行抗 - D定量分析时的许多已知变量。结果之间惊人的高度一致表明，该模式未来可作为实验室间研究的可接受模型。
