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CN108350482B - 用于侧流测试条固定器的系统和方法 - Google Patents

用于侧流测试条固定器的系统和方法 Download PDF

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CN108350482B
CN108350482B CN201680056948.6A CN201680056948A CN108350482B CN 108350482 B CN108350482 B CN 108350482B CN 201680056948 A CN201680056948 A CN 201680056948A CN 108350482 B CN108350482 B CN 108350482B
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阿尼鲁达·帕特沃德韩
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Abstract

检测血液分析物的系统包括侧流测试条和测试条固定器，所述侧流测试条位于所述测试条固定器中。所述系统进一步包括用于接纳所述测试条固定器的测量仪。

Description

用于侧流测试条固定器的系统和方法
背景技术
存在各种用于即时检测血液分析物的系统。许多用于测试血液分析物的系统包括侧流测试条。这种侧流测试条通常需要一个盒子或其他类型的固定器以支撑测试条并允许用户操作而不会受到污染。希望有一个这样的测试条固定器：它需要最少的材料，并且可以很好地与测量仪和其他设备接合。
发明内容
在一个实施方案中，检测血液分析物的系统包括侧流测试条和测试条固定器，侧流测试条位于测试条固定器中。所述系统进一步包括用于接纳测试条固定器的测量仪。可选地，所述系统进一步包括位于测试条固定器中的芯吸膜。或者，测试条固定器包括盖子和底座。在一个替代方案中，盖子包括加样窗口，并且芯吸膜位于加样窗口下方。在另一个替代方案中，底座包括读取窗口。可选地，底座包括接纳侧流测试条和芯吸膜的底座腔。或者，底座腔包括凸缘，其使样品从芯吸膜流向侧流测试条。在一种配置中，当盖子与底座接合时，盖子与侧流测试条的顶部齐平，使得过量的流体不会流到侧流测试条的顶部。在另一种配置中，盖子与底座以压合配置方式接合。可选地，盖子包括侧翼并卡入底座中。或者，盖子的下侧包括用于将侧流测试条固定就位的肋状凸条(rib)。在一个替代方案中，盖子将侧流测试条压到底座中。在另一种替代方案中，测量仪包括用于接纳侧流测试条和测试条固定器组合的狭槽，并且读取窗口与测量仪的传感器对齐。
在一个实施方案中，测试条组件包括侧流测试条和测试条固定器，侧流测试条位于测试条固定器中。可选地，所述系统进一步包括位于测试条固定器中的芯吸膜。或者，测试条固定器包括盖子和底座。可选地，盖子包括加样窗口，并且芯吸膜位于加样窗口下方。在一种配置中，底座包括读取窗口。在另一种配置中，底座包括接纳侧流测试条和芯吸膜的底座腔。可选地，底座腔包括凸缘，其使样品从芯吸膜流向侧流测试条。或者，当盖子与底座接合时，盖子与侧流测试条的顶部齐平，使得过量的流体不会流到侧流测试条的顶部。可选地，盖子与底座以压合配置方式接合。在一种替代方案中，盖子包括侧翼并卡入底座中。在另一种替代方案中，盖子的下侧包括用于将侧流测试条固定就位的肋状凸条。可选地，盖子将侧流测试条压到底座中。
在一个实施方案中，测试血液分析物的方法包括提供测试条组件，所述测试条组件包括侧流测试条和测试条固定器，侧流测试条位于测试条固定器中。所述方法进一步包括将样品引入侧流测试条。所述方法进一步包括使样品沿侧流测试条流动，对样品产生有色响应，并用测量仪测量所述有色响应。
附图说明
图1和2显示了测试条固定器的一个实施方案，其包括侧流测试条；
图3显示了图1的测试条组件的分解图；
图4显示了图1的测试条组件的剖视图；
图5显示了测试条组件的盖子的一个实施方案；
图6和图7显示了测试条组件的底座的一个实施方案；
图8显示了加有15μL全血的测试条的一个实施方案；和
图9显示了图8测试条的背面，其显示当加入全血时蓝色颗粒的位置。
具体实施方式
这里仅为了方便而使用了某些术语，而不是将其视为对侧流测试条固定器的系统和方法的实施方案的限制。在附图部分，在几个附图中使用相同的参考字母来指定相同元件。所提出的系统提供了可以与测量仪相配的测试条固定器而非盒子(cassette)，其通常更具成本效益，因为测试条固定器可以更小并且使用更少的材料，因此降低成本。
实施方案包括一种新型测试条设计，其中容纳了一个侧流膜。在一些实施方案中，该设计使得其印记适合于
Figure BDA0001612397410000031
Plus分析仪的光学模块。该测试条使用了
Figure BDA0001612397410000032
平台的现有功能。
测试条固定器设计的实施方案提供了侧流测试条与测量仪一起使用的机会，目前这些测量仪由于被设计成接纳盒子而不接纳侧流测试条。具体而言，关于一些实施方案，目前Polymer Technology Systems公司(PTS)提供了侧流形式的HbA1c和可替宁(cotinine)测定。该系统包括位于盒子中的侧流测试条。替代性的，侧流测试条可以被转移到这样的测试条上：该测试条允许其被通常为垂直流测试条设计的测量仪(例如由PolymerTechnology Systems公司设计的
Figure BDA0001612397410000033
系列测量仪)接纳。
Figure BDA0001612397410000034
Plus测量仪提供了许多集成到测量仪中可能需要的功能，包括无线通信，蓝牙通信，打印机，以及访问由Polymer Technology Systems公司提供的健康风险评估程序的路径。
此外，测试条固定器中侧流测试条的实施方案降低了样品需求；因此，采样器中的缓冲液体积需求降低，从而节省额外成本。
图1和2显示了测试条固定器的一个实施方案，其包括侧流测试条。测试条固定器的盖子和腔已经设计成容纳侧流测试条。测试条固定器和测试条包括加样窗口、芯吸膜和侧流膜。图1显示了测试条组件100的一个实施方案。测试条组件100包括底座110和盖子115。盖子115包括加样窗口120。还包括标识部分125。标识部分125还可用于固定测试条组件100。图2显示了固定器的底座110的一个实施方案的底部视图。底座包括读取窗口130，用于读取测量仪的颜色变化。
图3显示了测试条组件100的分解图。显示了盖子115和底座110。另外，显示了侧流膜310和芯吸垫320。在截面图中显示了加样窗口、芯吸膜和侧流膜组件之间的关系(参见图3)。
如图4中可见，芯吸垫320与盖子115的加样窗口120对齐。另外，显示了芯吸垫320和侧流膜310垂直对齐。
图5显示了测试条组件100的盖子115的一个实施方案。盖子被设计成允许在测试条的远端进行加样。为了易于制造，盖子通过斜面“侧翼”510卡入底座110中。样品端口开口或加样窗口120的直径为0.125英寸(3.175mm)，深0.071英寸(1.8mm)，产生总体积(0.179cumm)。可以改变加样窗口120的深度以容纳更大体积的样品。可以通过简单的拾取和放置自动化机构来将盖子115放置在测试条组件100上。另一个特征是盖子115的底部(未显示)具有四个小肋状凸条或脊，其允许将侧流膜“压固”就位并且不允许其“滑动”。重要的是，盖罩或盖子115提供恰当的压力以允许有效芯吸样品并在合理的时间内获得响应。
图6和图7显示了底座110的一个实施方案。底座110长1.8英寸(45.72)，宽0.37英寸(9.39mm)，其适合当前
Figure BDA0001612397410000041
测量仪中的光学模块组件，但是在替代实施方案中，可以使用任意测量仪配置。底座腔610长0.961英寸(24.04mm)，宽0.185英寸(4.7mm)，侧流测试条310和芯吸膜320将位于其中。底座具有凸缘710(参见图7)，其允许流体仅在一个方向上朝向侧流测试条组件流动。
利用上述实施方案进行雏形测试。创建雏形，这些雏形显示来自PTS可替宁测定的侧流测试条能够被输入并且提供百分比反射率读数。底座特意由透明塑料制成，以观察和确定流体在测试条中的运动。图8显示了加有15μL全血的测试条的一个实施方案(无需稀释)。图9显示了测试条的背面，其显示当加入全血时蓝色颗粒的位置。
虽然已经在上述具体实施方式中详细描述并在附图中阐明了具体的实施方案，本领域技术人员将会理解，根据本公开的总教导及其广泛的发明构思，可以针对这些详细描述发挥多种修改和替代。因此，应该理解的是，本公开的范围不限于本文公开的特定实施例和实施方式，而是旨在覆盖由所附权利要求所限定的精神和范围内的修改及其任意和所有等同内容。注意，虽然示出了特定实施方案，但是每个实施方案的特征可以在实施方案间互换。

Claims (13)

1.一种检测血液分析物的系统，其包括：
测试条固定器，所述测试条固定器包括底座，所述底座限定具有第一端和第二端的底座腔，所述底座腔限定邻近所述底座腔的第二端的读取窗口，所述测试条固定器还包括在所述底座腔上方固定到所述底座的盖子，所述盖子限定邻近底座腔的第一端的加样窗口；
接纳在底座腔内的芯吸膜，其邻近底座腔的第一端并在加样窗口下方对齐；
接纳在底座腔内的侧流测试条，所述侧流测试条具有加样端和测试端，所述加样端抵靠芯吸膜定位，使得所述侧流测试条的边缘与加样窗口的边缘对齐；和
接纳所述测试条固定器的测量仪，所述测量仪包括传感器，其中所述盖子与侧流测试条的顶部齐平，使得流体不会流到侧流测试条的顶部。
2.权利要求1所述的系统，其中所述底座腔包括位于所述底座腔的第一端的凸缘，所述芯吸膜位于凸缘和侧流测试条之间，所述凸缘使样品从所述芯吸膜流向所述侧流测试条。
3.权利要求1所述的系统，其中所述盖子与所述底座以压合配置方式接合。
4.权利要求3所述的系统，其中所述盖子包括侧翼并且卡入所述底座中。
5.权利要求1所述的系统，其中所述盖子的下侧包括用于将所述侧流测试条固定就位的肋状凸条。
6.权利要求5所述的系统，其中所述盖子将所述侧流测试条压到所述底座中。
7.权利要求1所述的系统，其中所述测量仪包括用于接纳所述测试条固定器的狭槽，并且所述读取窗口与所述测量仪的传感器对齐。
8.一种测试条组件，其包括：
测试条固定器，所述测试条固定器包括底座，所述底座限定具有第一端和第二端的底座腔，所述底座腔限定邻近所述底座腔的第二端的读取窗口，所述测试条固定器还包括在所述底座腔上方固定到所述底座的盖子，所述盖子限定邻近底座腔的第一端的加样窗口；
接纳在底座腔内的芯吸膜，其邻近底座腔的第一端并在加样窗口下方对齐；
接纳在底座腔内的侧流测试条，所述侧流测试条具有加样端和测试端，所述加样端抵靠芯吸膜定位，使得所述侧流测试条的边缘与加样窗口的边缘对齐，其中所述盖子与侧流测试条的顶部齐平，使得流体不会流到侧流测试条的顶部。
9.权利要求8所述的测试条组件，其中所述底座腔包括位于所述底座腔的第一端的凸缘，所述芯吸膜位于凸缘和侧流测试条之间，所述凸缘使样品从所述芯吸膜流向所述侧流测试条。
10.权利要求8所述的测试条组件，其中所述盖子与所述底座以压合配置方式接合。
11.权利要求10所述的测试条组件，其中所述盖子包括侧翼并且卡入所述底座中。
12.权利要求8所述的测试条组件，其中所述盖子的下侧包括用于将所述侧流测试条固定就位的肋状凸条。
13.权利要求12所述的测试条组件，其中所述盖子将所述侧流测试条压到所述底座中。
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