CN111983207A - 一种血栓弹力图仪全血质控品及配制方法 - Google Patents
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Abstract
本发明涉及一种血栓弹力图仪全血质控品,包括正常水平质控品N和低值水平质控品L;其特征在于:正常水平质控品N,包括以下体积比原料,3人或3人以上健康人等量血液,抗凝剂与血液的比例为1:9;所述低值水平质控品L由所述正常水平质控品N稀释而成,其中正常水平质控品N与稀释液体积比为3‑6,所述稀释液为生理盐水,晶体液,或胶体液。本发明构思新颖、打破传统思维、另辟蹊径,具有原料易得、配制简单的特点。
Description
技术领域:
本发明属于凝血检测质量控制领域,特别涉及一种血栓弹力图仪全血质控品配制方法,尤其采用新鲜人血全血配制而成,适合作为室内质控品。
背景技术:
常规凝血实验室检查包括:凝血酶原时间(PT)、部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(Fg)、D-二聚体(D-Dimer)以及血小板计数(platelet count,PLT)等指标,仅是检查离体血浆中凝血级联反应中一部分,即内源性或外源性凝血途径或纤维蛋白溶解部分的情况,是凝血全过程片段地、部分地描记,而且其结果常常受肝素类物质的影响。
血栓弹力图仪(thrombelastography,TEG)能够完整地监测血样从凝血激活至血凝块形成及纤维蛋白溶解的全过程,实现对凝血因子、纤维蛋白原、血小板聚集功能以及纤维蛋白溶解等方面进行凝血全貌的检测和评估。由于其监测时间较短,且结果不受肝素类物质的影响,已广泛应用于心脏外科、器官移植、术后出血和血栓形成的情况监测以及临床成分输血的指导。
血检弹力图(thrombelastography,TEG)主要在临床用于全血样本的凝血功能检测。血栓弹力图样本为患者的全血标本,检测时患者的全血标本置于样品杯中,将连接运动感应及传导系统的检测杆插入样本杯,使样本在37℃的恒温下由高岭土激活后进行检测。样品杯以4度45分的角速度匀速转动,检测杆则感应样本运动的阻力并进行记录产生描记图及参数。
凝血曲线图所涉及的重要的参数有R值、K值、Angle值、MA值,其分别代表的意义如下:
R值为检测起始至曲线振幅上升至2mm所需时间,对应多种凝血因子逐步激活导致纤维蛋白开始形成的过程。
K值为曲线振幅由2mm上升至20mm所需时间,对应纤维蛋白交联及其与血小板的相互作用。
Angle值为描记图最大曲线弧度的切线与水平线的夹角,与K时间共同反映纤维蛋白与血小板的相互作用,在患者严重低凝K值无法测出的时候成为重要的替代指标。
MA值(最大振幅maximum amplitude,MA)为描记图最高振幅,对应血块最大强度,与血小板浓度、血小板功能以及血小板-纤维蛋白相互作用有关。血块达到最大强度后便进入纤溶阶段,其中较常用的指标为Ly30及Ly60,分别代表描记图达到MA后30分钟和60分钟时血栓纤溶的百分比,由减小的曲线下面积计算得出,反应纤维蛋白溶酶溶解血栓的程度。
血栓弹力图仪是精密仪器,在使用中要求每天检测前对仪器进行检验和校正,随着血栓弹力图仪检测项目不断拓展到疾病诊断和治疗的各个领域,检测血栓弹力图仪稳定性的质控品也就成为了血栓弹力图在临床应用的关键。
现有的矫正和检验质控品是以冻干牛血清(进口产品)或者冻干猪血清(国产)为原材料制备而成。
国内已经申请专利的血栓弹力图仪质控品有五项。以猪血为材料的3项,以羊血为材料的1项,以化学物品的无血清质控品的1项。进口产品价格昂贵,每一支约100元RMB,且不轻易购得(包括购买他们仪器的用户)。国产产品虽然比进口产品易得,但价格仍然不便宜。上述质控品的制备过程复杂,生产过程比较漫长,能耗很高,储存和运输条件较严格,需要在2-8度低温保存,易变质失效,采用非人血的物质,存在明显的基质效应。因此,这些质控品可以作为仪器安装时的校正质控品,而作为室内质控品不太理想。
室内质控的主要目的是检测和控制本实验室常规工作的精密度,并检测其准确度的改变,以提高本实验室常规工作中,批间和日间标本检测的一致性。如果要求用户每天对其仪器进行用上述购买的质控品进行每台血栓弹力图仪进行室内质控检测,对用户而言是一笔不小的负担。因此,急需一种生成过程简单,成本低廉,室温保存和稳定性好的质控品,用户可以用很低廉的成本,实现每天对每台血栓弹力图仪工作状态的检验,保证检测数据的稳定和可靠。
发明内容:
本发明的目的是发明一种采用新鲜人血混合全血的血栓弹力图仪全血质控品及配制方法。
本发明技术方案是这样实现的:一种血栓弹力图仪全血质控品,包括正常水平质控品N和低值水平质控品L;其特征在于:正常水平质控品N,包括以下体积比原料,3人或3人以上健康人等量血液,抗凝剂与血液的比例为1:9;所述低值水平质控品L由所述正常水平质控品N稀释而成,其中正常水平质控品N与稀释液体积比为3-6,所述稀释液为生理盐水,晶体液,或胶体液。
一种血栓弹力图仪全血质控品的配制方法,其特征在于:包括如下步骤:
一、血液采集,选择健康人群,3人或3人以上,用含3.2%的枸橼酸钠真空采血管或者试管采集静脉血,抗凝剂与血液的比例为1:9;
二、全血配制,选用采集不超8小时的血液,根据血栓弹力图仪的台数,算出需用血液的总量,从上述采集的多人份血液中,取等量体积的血液,加入洁净大塑料试管中,轻轻颠倒10次以上,混匀,制成正常水平质控品N;
三、全血稀释,取上述混合所得的正常水平质控品N,根据需要加入3-6倍稀释液,搅拌均匀,制得低值水平质控品L。
所述血液采集是指直接取用医院当天进行凝血象检验后,凝血象正常的血液。
本发明构思新颖、打破传统思维、另辟蹊径,具有原料易得、配制简单的特点;克服现有技术中弹力图仪质控品准确性、稳定性差这一缺陷,进而提供一种能够快速有效检测血栓弹力图稳定性和重复性的质控品,用来对实验室每台血栓弹力图仪进行室内质控检测,以期获得更好的检测效果;对于医院来说,具有血液来源方便,配制过程简单、立即检测,几乎不需成本和额外保藏措施。可以经过稀释新鲜混合全血,很好的模拟血液在低凝、正常凝血两种状态下的动力学参数;用户可以用很低廉的成本实现每天对每台仪器进行低凝、正常凝血两种状态下工作状态的检验,保证每台仪器的稳定以及每台仪器检测结果间的一致性,保证检测数据的稳定和可靠。
附图说明:
下面结合具体图例对本发明做进一步说明:
图1为血栓弹力图正常水平质控品N输出示意图
图2为血栓弹力图低值水平质控品L(3倍稀释)输出示意图
图3为血栓弹力图低值水平质控品L(4倍稀释)输出示意图
图4为血栓弹力图低值水平质控品L(5倍稀释)输出示意图
图5为血栓弹力图低值水平质控品L(6倍稀释)输出示意图
具体实施方式:
一种血栓弹力图仪全血质控品,包括正常水平质控品N和低值水平质控品L;其中:正常水平质控品N,包括以下体积比原料,3人或3人以上健康人等量血液,抗凝剂与血液的比例为1:9;这里涉及的健康人是指:排除ICU患者、血液病患者、外伤或消化道出血、心血管内科(可以服用抗凝药)患者之外的人群。
低值水平质控品L,由所述正常水平质控品N稀释而成,其中正常水平质控品N与稀释液体积比为3-6,所述稀释液为生理盐水,晶体液,或胶体液。
采用3人以上(包括3人)血液,直接采用本医院当天进行凝血象检验后,凝血象正常的血液,获得途径简单,也不会造成浪费。经过试验,越多人份的血液混合,就会更好反应正常水质控品N的结果,最低要求为3人份。
由于采用新鲜全血,配制后立即使用。
血栓弹力图仪全血质控品的配制方法,包括如下步骤:
一、血液采集,选择健康人群,3人或3人以上,用含3.2%的枸橼酸钠真空采血管或者试管采集静脉血,抗凝剂与血液的比例为1:9;所述血液采集是指直接取用医院当天进行凝血象检验后,凝血象正常的血液。血栓弹力图仪拥有者几乎是医院或体检部门,对这些机构来说,直接取用当天凝血象检验的血液,是非常方便和易得的,既无需特意去找献血人群,又可对体检者多余血液再利用,无需额外费用,又能保证血液新鲜。
二、全血配制,选用采集不超8小时的血液,根据血栓弹力图仪的台数,算出需用血液的总量,从上述采集的多人份血液中,取等量体积的血液,加入洁净大塑料试管中,轻轻颠倒10次以上,混匀,制成正常水平质控品N。
血栓弹力图正常水平质控品N输出示意图,如图1,该检测结构如表1:
三、全血稀释,取上述混合所得的正常水平质控品N,根据需要加入3-6倍稀释液,搅拌均匀,制得低值水平质控品L。更具体地说:
可选的,制备得到的所述正常水平质控品N,R值为2.5—6.5min、K值为1.0—3.0min、Angle值为45—75deg、MA值为45—75mm。
可选的,所述低值水平质控品L(3倍稀释):R值为3.5—7.5min、K值为2.0—13.0min、Angle值为25—75deg、MA值为25—55mm。
血栓弹力图低值水平质控品L(3倍稀释)输出示意图,如图2,检测结果如表2:
可选的,所述低值水平质控品L(4倍稀释):R值为4.0—9.0min、K值为3.0—25.0min、Angle值为20—55deg、MA值为24—50mm。
血栓弹力图低值水平质控品L(4倍稀释)输出示意图,如图3,检测结果如表3:
可选的,所述低值水平质控品L(5倍稀释):R值为4.0—11.0min、K值为5.0min—无法计算、Angle值为15—60deg、MA值为20—45mm。
血栓弹力图低值水平质控品L(5倍稀释)输出示意图,如图4,检测结果如表4:
可选的,所述低值水平质控品L(6倍稀释):R值为6.0—11.0min、K值为5.0min—无法计算、Angle值为15—35deg、MA值为17—20mm。
血栓弹力图低值水平质控品L(6倍稀释)输出示意图,如图5,检测结果如表5:
Claims (3)
1.一种血栓弹力图仪全血质控品,包括正常水平质控品N和低值水平质控品L;其特征在于:正常水平质控品N,包括以下体积比原料,3人或3人以上健康人等量血液,抗凝剂与血液的比例为1:9;所述低值水平质控品L由所述正常水平质控品N稀释而成,其中正常水平质控品N与稀释液体积比为3-6,所述稀释液为生理盐水,晶体液,或胶体液。
2.一种血栓弹力图仪全血质控品的配制方法,其特征在于:包括如下步骤:
一、血液采集,选择健康人群,3人或3人以上,用含3.2%的枸橼酸钠真空采血管或者试管采集静脉血,抗凝剂与血液的比例为1:9;
二、全血配制,选用采集不超8小时的血液,根据血栓弹力图仪的台数,算出需用血液的总量,从上述采集的多人份血液中,取等量体积的血液,加入洁净大塑料试管中,轻轻颠倒10次以上,混匀,制成正常水平质控品N;
三、全血稀释,取上述混合所得的正常水平质控品N,根据需要加入3-6倍稀释液,搅拌均匀,制得低值水平质控品L。
3.根据权利要求2所述的一种血栓弹力图仪全血质控品的配制方法,其特征在于:血液采集是指直接取用医院当天进行凝血象检验后,凝血象正常的血液。
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