一种分离胶促凝真空采血管的性能验证  

Performance Verification of a Separating Gel Procoagulant Vacutainer

作　　者：邵燕[1] 孙璟[1] 程雷 韩玉霞[1] 邢国征 于洪远[1] Shao Yan;Sun Jing;Cheng Lei(Laboratory Department,Beijing Aerospace General Hospital,Beijing,100076,China)

机构地区：[1]北京航天总医院检验科,北京100076

出　　处：《黑龙江医学》2025年第7期826-829,共4页Heilongjiang Medical Journal

基　　金：“国家质量基础的共性技术研究与应用”重点专项基金(2017YFF0205401)。

摘　　要：目的:验证一种分离胶促凝真空采血管的性能,评估其是否可以用于肿瘤标志物和甲状腺激素的临床检测。方法:参考WS/T224-2018文件方法,对真空采血管的外观、抽吸量、管体强度、纤维蛋白挂壁、离心后溶血情况和结果可比性等指标进行验证。选取2021年10月—2022年3月北京航天总医院住院的20例患者清晨空腹静脉血,分别置于两种真空采血管中,分离血清后采用化学发光免疫分析法对10项肿瘤标志物和5项甲状腺激素进行检测,差异均无统计学意义(P>0.05)。以对比管的检测值为X轴,考察管的检测值为Y轴进行线性拟合。计算医学决定水平处的偏倚,符合国家认可机构设置的分析质量最低标准即可。结果:随机抽查的真空采血管外观透明、无异物、无变形、破损、标识清晰、管盖颜色无异常及脱落,管内分离胶呈凝胶状;实际抽吸量与理论值的偏倚在-4.64%~7.41%之间,符合厂家声称的偏倚范围±10%以内;采血管装满水离心后未发生破裂,外壁也无液体渗漏;静脉采血离心后管内无纤维蛋白挂壁、溶血或分离胶翻转的现象。两种真空采血管肿瘤标志物和甲状腺激素的结果除促甲状腺激素(TSH)其他项目,差异均无统计学意义(P>0.05);在医学决定水平(参考区间下限、参考区间上限、参考区间上限2倍、参考区间上限5倍)处的相对偏倚<1/2允许总误差为临床可接受。结论:临床实验室在选择采血管时应按行业标准文件的要求对其质量进行评估;本研究选择的真空采血管质量符合卫生行业要求,可以用于肿瘤标志物和甲状腺激素的临床检测。Objective:To validate the performance of a separating gel procoagulant vacutainer and evaluate its potential for clinical detection of tumor markers and thyroid hormone.Methods:According to the method of WS/T224-2018 document,the external appearance of the vacutainer,the amount of suction,the strength of the tube body,the hanging of fibrin,the hemolysis after centrifugation and the comparability of the results were verified.The comparability of the results was verified by taking the morning fasting venous blood of 20 hospitalized patients from the hospital from October 2021 and March 2022,and placing them in either vacutainer after serum isolation,10 tumor markers and 5 thyroid hormone were detected by chemiluminescent immunoassay,with no statistically significant difference(P>0.05).Linear fitting was made making the detection value of the contrast tube as X-axis,and the detection value of the inspection tube as Y-axis.The bias at the level of medical decision was calculated,which need meet the minimum standard of analytical quality set by the national authorized institution.Results:The random Vacutainers were transparent in appearance,no foreign body,no deformation,no damage,no clear identification,no abnormal color and no falling off of the pipe cover,and the separated colloid in the pipe was gelatinous.The deviation between the actual suction volume and the theoretical value was between-4.64%and 7.41%,which was within±10%of the deviation range claimed by the manufacturer.There was no fibrin hanging on the wall,hemolysis or gel turnover in the tubes after centrifugation.There was no significant difference between the two vacutainers of tumor markers and Thyroid hormone except for TSH(P>0.05).The relative bias at the medical decision level(lower limit of the reference interval,upper limit of the reference interval,2 times of the upper limit of the reference interval,5 times of the upper limit of the reference interval)was 1/2TEa,which was clinically acceptable.Conclusion:Clinical laboratories should evaluate th

关 键 词：真空采血管 肿瘤标志物 甲状腺激素 

分 类 号：R318.11[医药卫生—生物医学工程]