CN114216871B - 用于胆固醇试剂盒中替代胆酸钠的复合稳定剂 - Google Patents
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Abstract
本发明属于体外诊断试剂领域,具体涉及一种用于胆固醇试剂盒中替代胆酸钠的复合稳定剂,复合稳定剂由以下含量的组分组成:十二烷基苯磺酸钠1.0~5.0g/L、二硫苏糖醇0.1~1.0g/L、乙二醇0.5~3.0mL/L、底物稳定剂CCD 2.0~5.0g/L。本发明旨在消除对胆汁酸测定的影响,在此前提下提供了一种胆酸钠的替代物,该复合稳定剂在不影响测值及试剂稳定性的前提下,消除对胆汁酸测定结果的影响,避免了试剂之间的交叉污染。本发明通过复合稳定剂中的乙二醇降低试剂的空白吸光度,而十二烷基苯磺酸钠和二硫苏糖醇的组合则能够显著提高酶的稳定性,提高试剂盒准确度,有效延长了胆固醇试剂盒的保存时间。
Description
技术领域
本发明属于体外诊断试剂领域,具体涉及一种用于胆固醇试剂盒中替代胆酸钠的复合稳定剂。
背景技术
血清胆固醇是血液中所有脂蛋白所含胆固醇的总和,包括胆固醇酯和游离性胆固醇。胆固醇参与细胞膜的形成,也是胆汁酸、维生素D等生物活性物质的重要原料,其含量的测定对心脑血管疾病诊断、疗效判断和预后分析都有一定的参考意义。临床上常用的检测方法包括化学法和酶法,化学法一般采用有机溶剂提取胆固醇,操作复杂,显色条件要求高;酶法测定特异性强,测定准确度和灵敏度较高,且操作简单,但是酶法检测也存在一定的缺陷,即酶法检测方法中添加了胆酸钠等类似物,会影响测定结果。
目前常用的胆固醇检测试剂中通常都包括胆酸钠,如果直接去掉胆酸钠,会影响测值及其试剂的稳定性。但是胆酸钠的存在又会影响血清中胆汁酸的测定。现在大多数实验是将干扰项目和被干扰项目安排在生化仪的不同模块中,对分析的项目必须注意位置和程序,加强对生化仪的维护和保养力度,以降低交叉感染发生率,这样不仅增加了实验人员的工作量,而且只是降低干扰,并没有完全消除干扰。
发明内容
本发明的目的在于解决现有技术中存在的上述问题,提出了一种用于胆固醇试剂盒中替代胆酸钠的复合稳定剂,作为胆酸钠的替代物,从试剂自身角度消除对胆汁酸测试的影响,避免了试剂之间的交叉污染,提高试剂盒的检测准确度。
本发明的技术方案是:
一种用于胆固醇试剂盒中替代胆酸钠的复合稳定剂,其特征在于,所述复合稳定剂为十二烷基苯磺酸钠、二硫苏糖醇、乙二醇和底物稳定剂CCD的组合。
进一步的,所述复合稳定剂由以下含量的组分组成:十二烷基苯磺酸钠1.0~5.0g/L、二硫苏糖醇0.1~1.0g/L、乙二醇0.5~3.0mL/L、底物稳定剂CCD 2.0~5.0g/L。
进一步的,所述复合稳定剂中各组分的含量为:十二烷基苯磺酸钠2.0~4.0g/L、二硫苏糖醇0.3~0.7g/L、乙二醇1.5~2.5mL/L、底物稳定剂CCD 3.0~4.0g/L。
进一步的,所述复合稳定剂中各组分的含量为:十二烷基苯磺酸钠1.0g/L、二硫苏糖醇0.1g/L、乙二醇1.0mL/L、底物稳定剂CCD 2.4g/L。
本发明还提供了所述的复合稳定剂在总胆固醇检测试剂盒中的应用。
进一步的,所述总胆固醇检测试剂盒为单试剂,所述总胆固醇检测试剂盒的组分如下:
上述所述的复合稳定剂(十二烷基苯磺酸钠1.0~5.0g/L、二硫苏糖醇0.1~1.0g/L、乙二醇0.5~3.0mL/L、底物稳定剂CCD 2.0~5.0g/L);
进一步的,所述总胆固醇检测试剂盒的组分如下:
本发明的有益效果:
本发明旨在消除对胆汁酸测定的影响,在此前提下提供了一种胆酸钠的替代物,该复合稳定剂在不影响测值及试剂稳定性的前提下,消除对胆汁酸测定结果的影响,避免了试剂之间的交叉污染。本发明通过复合稳定剂中的乙二醇降低试剂的空白吸光度,而十二烷基苯磺酸钠和二硫苏糖醇的组合则能够显著提高酶的稳定性,提高试剂盒准确度,有效延长了胆固醇试剂盒的保存时间。
具体实施方式
为了进一步理解本发明,下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
总胆固醇测定试剂盒的组分如下:
复合稳定剂;
其中,复合稳定剂组分的含量为二硫苏糖醇0.1g/L、十二烷基苯磺酸钠1g/L、底物稳定剂CCD 2.4g/L、乙二醇1mL/L,将上述各组分充分溶解。
实施例2
总胆固醇测定试剂盒的组分如下:
复合稳定剂;
其中,复合稳定剂组分的含量为二硫苏糖醇0.5g/L、十二烷基苯磺酸钠3.0g/L、底物稳定剂CCD 3.5g/L、乙二醇1.5mL/L,将上述各组分充分溶解。
实施例3
总胆固醇测定试剂盒的组分如下:
复合稳定剂;
其中,复合稳定剂组分的含量为二硫苏糖醇0.1g/L、十二烷基苯磺酸钠1.0g/L、底物稳定剂CCD 2.0g/L、乙二醇0.5mL/L,将上述各组分充分溶解。
实施例4
总胆固醇测定试剂盒的组分如下:
复合稳定剂;
其中,复合稳定剂组分的含量为二硫苏糖醇1.0g/L、十二烷基苯磺酸钠5.0g/L、底物稳定剂CCD 5.0g/L、乙二醇3.0mL/L,将上述各组分充分溶解。
试验例1稳定性试验
将复合稳定剂加入总胆固醇测定试剂盒中,另一份不添加复合稳定剂,分别测定样本中总胆固醇的含量。本试验采用朗道质控水平2和质控水平3为样本,采用自动生化分析仪进行检测。项目参数:主波长505nm,副波长660nm;试剂和样本比例为100μL:1μL。样本与试剂混匀后,37℃孵育5min后读取吸光度的值。然后根据公式CHOL含量=(A样品-A空白)/(A校准品-A空白)×校准品浓度,计算样本中总胆固醇的含量。
根据以上测试方法,选用同一瓶质控水平2和质控水平3,同时测试含复合稳定剂的胆固醇试剂盒和未含复合稳定剂的胆固醇试剂盒。37℃加速测试7天,每天测试一次,计算相对偏差,统计数据如下表所示:
表1稳定性试验数据表
由上表数据可以得出,在37℃破坏7天的条件下,含复合稳定剂的试剂盒稳定性很好,其相对偏差较小,而未含复合稳定剂试剂盒的稳定性则相对较差。
试验例2抗干扰试验(消除对胆汁酸测定的影响)
按照实施例1至4制备得到四份含复合稳定剂的胆固醇试剂盒,同时另外四份胆固醇试剂盒中不含复合稳定剂而是添加2g/L胆酸钠作为对比1、对比2、对比3和对比4,进行试验。
先测试样本中胆汁酸的值,然后再同时测试胆固醇和胆汁酸的值(生化仪加样顺序为胆固醇-胆汁酸),胆固醇分别用上述两种胆固醇试剂测试。得到的试验数据统计如下表所示:
表2抗干扰试验数据表
由以上两种试验方式可知,添加复合稳定剂的胆固醇试剂盒,37℃连续破坏7天,相对偏差在10%以内,改善了胆固醇试剂盒的稳定性;而且同时测试胆固醇和胆汁酸,显然含复合稳定剂的胆固醇试剂盒对胆汁酸测值几乎无影响,而加入胆酸钠的胆固醇试剂盒对胆固醇测试影响较大。
上述说明仅为本发明的优选实施例,并非是对本发明的限制,尽管参照前述实施例对本发明进行了详细的说明,对于本领域技术人员来说,其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改型等,均应包含在本发明的保护范围之内。
Claims (5)
1.一种用于胆固醇试剂盒中替代胆酸钠的复合稳定剂,其特征在于,所述复合稳定剂由以下含量的组分组成:十二烷基苯磺酸钠1.0~5.0g/L、二硫苏糖醇0.1~1.0g/L、乙二醇0.5~3.0mL/L、底物稳定剂CCD 2.0~5.0g/L。
2.根据权利要求1所述的复合稳定剂,其特征在于,所述复合稳定剂中各组分的含量为:十二烷基苯磺酸钠2.0~4.0g/L、二硫苏糖醇0.3~0.7g/L、乙二醇1.5~2.5mL/L、底物稳定剂CCD 3.0~4.0g/L。
3.根据权利要求1所述的复合稳定剂,其特征在于,所述复合稳定剂中各组分的含量为:十二烷基苯磺酸钠1.0g/L、二硫苏糖醇0.1g/L、乙二醇1.0mL/L、底物稳定剂CCD 2.4g/L。
4.权利要求1至3任一项所述的复合稳定剂在总胆固醇检测试剂盒中的应用。
5.根据权利要求4所述的应用,其特征在于,所述总胆固醇检测试剂盒为单试剂,所述总胆固醇检测试剂盒的组分如下:
权利要求1至3任一项所述的复合稳定剂;
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