血液成分质量抽检特征曲线方案探讨

Blood component quality sampling: the use of characteristic curve scheme

目的探讨分析血液成分质量功能性指标抽检的最佳方案,保障抽检准确性。方法基于抽样检验的特征曲线理论,绘制(4,1)、(6,1)、(8,2)、(10,2)、(12,3)5个抽样方案操作特性曲线,比较5个抽检方案的鉴别能力,并对抽检方案的错判和漏判风险进行分析。结果 5个抽样方案的鉴别能力由高到低依次为(10,2)、(6,1)、(12,3)、(8,2)、(4,1),且在不合格率P<0.25时,方案(10,2)与(6,1)、(12,3)与(8,2)的操作特征曲线基本重合;5个抽样方案的错判风险均较低,方案(4,1)漏判风险高(0.738 3),方案(10,2)和(6,1)漏判风险最低(分别为0.525 6、0.533 9)。结论在严格控制采供血过程保证血液制剂质量的前提下,(4,1)的抽检方案能够有效监控采供血过程的稳定性,但对于不合格率偏高的血液制剂,应适当增加抽样量,建议可采取(6,1)或(10,2)抽检方案。

Objective To explore the optimal sampling scheme for functional indexes of blood components, so as to ensure the accuracy of sampling. Methods The operation characteristic curves of 5 sampling schemes as(4,1),(6,1),(8,2),(10,2) and(12,3) were drawn based on the characteristic curve theory of sampling inspection, the discriminability of those 5 sampling schemes was compared, and the risk of misjudgment and omission of sampling schemes was analyzed. Results The discriminability of 5 sampling schemes from high to low were(10,2),(6,1),(12,3),(8,2) and(4,1),;the operation characteristic curves of scheme(10,2) were in basic concordance with(6,1),(12,3) and(8,2) as the percent defective was <0.25. The risk of misjudgment of the 5 sampling schemes was low, and the risk of omission was high in scheme(4,1)(0.738,3), and low in(10,2) and(6,1)(0.525 6 and 0.533 9, respectively). Conclusion On the premise of strictly controlling the process of blood collection and supply and ensuring the quality of blood preparations, the sampling scheme(4,1) can effectively monitor the stability of the whole process. However, for blood preparations with high nonconforming rate, sampling scheme(6,1) or(10,2) was recommended as the sampling amount should be elevated appropriately.