粪便隐血试验简易质控方法的建立及其临床研究  

Establishment and clinical application of fecal occult blood test quality control method

作　　者：张峰[1] 郭野[1] 杜娟[1] 李悦[1] 徐丹菲 崔巍[1] 

机构地区：[1]中国医学科学院北京协和医院检验科,北京100730

出　　处：《中国卫生检验杂志》2014年第3期397-398,400,共3页Chinese Journal of Health Laboratory Technology

摘　　要：目的保证粪便隐血试验的稳定、准确,需要对每一批试带进行质量检测。方法选择5例Hb浓度为100 g/L的标本,每例取样100μl,共500μl,充分混匀,定为Hb原液备用。制备8个浓度梯度,覆盖最高浓度到阴性对照的Hb浓度梯度(2 mg/ml,1 mg/ml,0.5μg/ml,0.2μg/ml,0.1μg/ml,0.05μg/ml,0μg/ml),根据试带声明检测浓度范围判定是否合格。结果本实验室使用的隐血试带检测范围为0.2μg/ml^2 mg/ml,对20个批号均进行验证,发现其中二个批号不合格,分别是检测浓度在2 mg/ml和1 mg/ml均显示阴性,检测隐血范围变窄,会导致临床标本假阴性;检测浓度在0.1 mg/ml阳性,检测隐血范围变宽,会导致临床标本假阳性。结论粪便隐血试验缺乏标准的商品化质控品,本室的检测方法可以有效的监测粪便隐血试带的质量,保证粪隐血试验的准确。Objective To run quality control on each batch of fecal occult blood （FOB） test papers, so as to guarantee the sta- bility and accuracy of the FOB test. Methods 100 μl blood was sampled from 5 whole blood specimens（ Hb concentration all at 100 g/L） with pipette respectively. The total 500 μl blood was mixed completely as original Hb reagent. Eight concentration gradients of Hb solution were prepared, covering the maximum concentration to negative control （2 mg/ml, 1 mg/ml, 0.5 μg/ml, 0.2μg/ml, 0.1μg/ml, 0. 05μg/ml, 0 μg/ml）. Finally, the detection range of the FOB test papers was esti- mated based on instruction. Results The detection range of the FOB test papers used in the lab was from 0.2 /.μg/ml to 2 mg/ml. Among the 20 batches under validation, 2 batch numbers were below standard. One was negative at concentration of 2 mg/ml and the other was at 1 mg/ml, indicating narrowing detection range may lead to false negative resuhs of clinical speci- mens. One showed positive at concentration of 0.1 mg/ml, indicating widening detection range may lead to false positive re- sults. Conclusion FOB test was short of standard commercial quality control material, while the established method is effective in monitoring the quality of FOB test papers, which can ensure the accuracy of FOB test.

关 键 词：粪便隐血试验 质量控制 胶体金法 

分 类 号：R446.133[医药卫生—诊断学]