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对英国专业使用的血红蛋白产品进行八项定性FIT的分析评估

Carolyn Piggott¹, Cerin John¹, Shane O'Driscoll¹

¹NHS Bowel Cancer Screening Programme - Southern Hub, Royal Surrey County Hospital, Guildford, England.

Clinical chemistry and laboratory medicine

|October 8, 2024

概括

质量便免疫化学测试对血红蛋白 (FIT) 显示可变的分析灵敏度,一些产品的性能低于制造商的声明. 虽然这些大肠直肠癌查工具通常可以由医疗保健专业人员使用,但建议对这些大肠直肠癌查工具的说明和样品处理进行改进.

科学领域:

临床诊断临床诊断临床诊断
胃肠病学胃肠病学
生物化学生物化学

背景情况:

定性便免疫化学测试 (FIT) 用于结直肠癌 (CRC) 查.
这些横向流量测试是专业用于患者分组的.
这些特定的FIT设备尚未发表任何先前的分析评估.

研究的目的:

通过分析来评估定性FIT设备的性能.
将它们的分析灵敏度 (AS) 与制造商规格和定量设备进行比较.
评估与外部质量评估体系 (EQAS) 和前区效应的兼容性,以及易用性.

主要方法:

分析灵敏度是使用样 (水性和便) 和天然便样本来确定的.
进行了与制造商报价的AS和定量设备 (OC-SENSOR PLEDIA) 的比较.
进行了Prozone效果测试,EQAS兼容性和易用性评估.

主要成果:

七种产品使用水样显示AS低于报价;五种产品使用便样显示AS低于报价.
对低度的结果线解释可能具有挑战性.
普罗的限值值和EQAS结果大多符合预期;易用性得分各不相同 (68.5-85.6%).

结论:

几种定性FIT设备的分析灵敏度低于声称的,特别是便矩阵.
尽管存在一些变化和潜在的解释问题,但这些测试在很大程度上适合专业使用.
测试说明和样本采集套件的改进可以提高用户体验和测试性能.

关键词:

FIT 便中的血球蛋白侧向流量测试试验侧向流量测试关心点检测检测的测试点.质量上的影响是有质量的.

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