CN107942044A - 一种排泄物检测测试盘及其制作方法 - Google Patents

一种排泄物检测测试盘及其制作方法 Download PDF

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CN107942044A
CN107942044A CN201711087603.XA CN201711087603A CN107942044A CN 107942044 A CN107942044 A CN 107942044A CN 201711087603 A CN201711087603 A CN 201711087603A CN 107942044 A CN107942044 A CN 107942044A
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王忠堂
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Xiamen Bonai Mold Design Co Ltd
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Abstract

一种排泄物检测测试盘及制作方法，排泄物检测试剂块和对照试剂块粘贴于测试盘轮辐状排列扇叶状基片，容纳更多检测项目，同时，基片间为空隙，避免不同检测项目试剂间相互干扰。改变基片宽度、形状，将个性化检测项目和通用性检测项目共存于同一测试盘，从而，集合多种不同类型检测项目。每个检测项目均设置阴性对照，提高检测结果可靠性。测试盘外形为圆盘状，可以正向或逆向旋转，缩短检测时间。

Description

一种排泄物检测测试盘及其制作方法
技术领域
本发明是关于体外诊断的医疗用耗材，特别是指一种定性或定量检测尿液和粪便等排泄物特定成分的测试盘。
背景技术
人体排泄物，尤其尿液、粪便，包含大量生理病理信息，所以，尿液、粪便检查成为临床常规必查项目。
借助于尿常规检测项目相关的干化学试纸条及配套扫描检测设备进步，尿液常规检查基本实现自动化；粪便常规自动化检测近年来也取得明显进展。
尿或粪便检测项目的检测试剂“多合一”集合于试纸条，提高检测效率。但仍有不足之处，包括：
(1)检测项目增多，试纸条长度增加，相应的检测设备体积增大，需要排泄物样本量增多；
(2)检测项目试剂间相互干扰，影响结果准确性；
(3)检测原理明显不同的项目无法共存于同一试纸条，比如，需要加热、制冷、添加特定试剂等；
(4)试纸条前后左右移动，较圆周运动，耗能多，效率低；
(5)多项检测共用一个空白对照，误差大，难以实现定量检测；
鉴于以上，将试纸条设计成轮辐状圆盘，完全区隔检测试剂间干扰，成倍增加检测项目设置空间，个性化检测项目与通用性检测项目可混搭共存，协助以往手工操作项目实现自动化，检测结果更准确，检测工作更高效。
发明内容
人体排泄物，尤其尿液、粪便，包含大量生理病理信息，所以，尿液、粪便检查成为临床常规必查项目。
借助于尿常规检测项目相关的干化学试纸条及配套扫描检测设备进步，尿液常规检查基本实现自动化；粪便常规自动化检测近年来也取得明显进展。
尿或粪便检测项目的检测试剂“多合一”集合于试纸条，提高检测效率。但仍有不足之处，包括：
(1)检测项目增多，试纸条长度增加，相应的检测设备体积增大，需要排泄物样本量增多；
(2)检测项目试剂间相互干扰，影响结果准确性；
(3)检测原理明显不同的项目无法共存于同一试纸条，比如，需要加热、制冷、添加特定试剂等；
(4)试纸条前后左右移动，较圆周运动，耗能多，效率低；
(5)多项检测共用一个空白对照，误差大，难以实现定量检测；
鉴于以上，将试纸条设计成轮辐状圆盘，完全区隔检测试剂间干扰，成倍增加检测项目设置空间，个性化检测项目与通用性检测项目可混搭共存，协助以往手工操作项目实现自动化，检测结果更准确，检测工作更高效。
附图说明
图1、基板
图2、检测试剂块和本底对照试剂块与基片粘贴
图3、基板卡槽与检测设备联结
图4A、机械手夹持测试盘第1工作位
图4B、机械手夹持测试盘第2工作位
图4C、机械手夹持测试盘第3工作位
图5、基环上插口
图6、可插拔基片与基柄
图7、基片与基柄插入基环插口
图8、多层基片组成的基板
图9、基片上检测试剂块与本底对照试剂块串联排列
图10、基片上2个检测试剂块与同一本底对照试剂块串联排列
图11、基片上依据试剂块pH值顺序环状排列
图12、基片上检测试剂块槽体与本底对照试剂块槽体串联排列
图13、测试盘制作流程
具体实施方式
为详尽本发明之技术内容、结构特征、所达成目的及功效，以下将例举实施例并配合说明书附图进行详细说明。
如图1至图11所示，本发明揭示了一种排泄物检测测试盘，包括基板和试剂块。
所述基板包括轮辐状排列的扇叶状基片1、基柄2、基环3，基片1与基环3通过基柄2联结；所述基片1分为正面和反面。
所述基片1正面设置识别码，粘贴试剂块11；所述基片1设置识别码，用于扫描设备识别排泄物类型及检测项目，选择合适的照射波长；所述基环3中心为卡槽4，卡槽4可与检测设备7对应部件联结，对应部件7固定于电机转动轴，完成测试条传递运输、旋转，完成扫描。
所述卡槽4与夹持机械手5匹配；机械手5吸附基环3或夹持卡槽4，第1工作位完成夹持测试盘，第2工作位完成夹持测试盘浸润排泄物样品容器6，第3工作位完成将测试盘从排泄物样品容器6取出，并送入检测设备7，实现自动化操作。
所述试剂块11包括化学试剂块、酶学试剂块、免疫学试剂块、生物芯片试剂块、本底对照试剂块12；所述化学试剂块包括胆红素、胆原、酮体、比重、pH值、亚硝酸盐、蛋白质、淀粉、脂肪、无机盐；所述酶法试剂块包括葡萄糖、血红蛋白、白细胞；所述免疫法试剂块包括血红蛋白、转铁蛋白、病原微生物、激素；所述生物芯片试剂块包括微生物基因芯片、癌细胞基因芯片。
所述基片1宽度3mm～6mm、长度10mm～20mm，基片1与基片1间隔不少于2.5mm；基片1与基片1间无直接接触，避免不同检测项目试剂干扰。
所述基柄2宽度为2.5mm，长度2.5mm；所述基环3呈圆盘状，直径10mm～15mm。
基板直径50mm，且可以旋转，减小传输及扫描检测设备7体积，缩短检测时间。
所述基环3的外环边缘还设置插口8；所述插口8与基柄2适配，基柄2长度5mm，其中可插入插口段22长度2.5mm，显露段21长度2.5mm，基柄2与插口8间可自由插入、分离、更换，实现模块化设计，检测项目依据需要随机组合，节约资源。
轮辐状排列的扇叶状基片1还可制成多层的扇叶状基片1的立体结构，层与层之间由基轴10联结，基轴10与上下基板的卡槽4可插拔，基片1层与层间距5mm，多层基片1交错排列，相应增加基片1数量，增加试剂块11数量；所述交错排列将使基片1主体设置的试剂块可以被扫描设备7检测到。
所述试剂块包括项目检测试剂块11和本底对照试剂块12，每个检测项目均设置阴性对照12，消除排泄物自身色泽、试剂本底、不同试纸块染色影响，提高检测结果可靠性；另外，必要时设置检测成分的标准对照，实现精准定量检测；所述项目检测试剂块11和本底对照试剂块12间隔2.5mm，串联或并联排列；所述本底对照试剂块12可以共用者，同一基片可设置第3个项目检测试剂块13，节约空间，容纳更多检测项目。
所述项目检测包括尿液检测、粪便检测、唾液检测、前列腺液检测、乳汁检测、人体引流物检测；所述尿液检测包括尿比重、酸碱度、维生素C、亚硝酸盐、蛋白质、白蛋白、白细胞、隐血、肌酐、尿胆原、胆红素、葡萄糖、酮体、激素、无机盐、其他代谢产物；所述粪便检测包括粪便：酸碱度、白细胞、隐血(血红蛋白、转铁蛋白)、癌细胞成分、粪胆原、粪胆素、葡萄糖、蛋白质、淀粉、脂肪、病原微生物、肠道菌群。
试剂块设置在轮辐状基片1上按照试剂pH值顺序排列；所述pH值顺序从3.0、4.0、5.0、6.0、7.0、8.0、7.0、6.0、5.0、4.0环状排列，完全避免检测项目试剂相互接触沾染，改变pH环境，导致成色反应不真实。
所述基片1宽度可以增加或减少；所述基片1还可以分隔成检测项目槽体14和本底对照槽体15，装盛液体；所述槽体14由基片1上沟槽、边框组成；所述槽体14底部设置试剂块，用于酶学、化学、免疫学方法检测排泄物样品成分，或生物芯片方法检测；所述槽体14亦可空白，承载样品，用于排泄物样品有形成分识别、分类、计数。
如图12所示，测试盘制作步骤包括基板制备、大张吸附试剂载体制备、大张试剂载体切割、试剂块与基板粘合、封装；所述基板制备包括3D设计、开模、PVC注塑成型、喷涂识别码；所述大张吸附试剂载体制备包括检测试剂制备、载体制备、载体吸附试剂；所述试剂块与基板粘合指试剂块与基板的基片正面粘贴。
以上所述，仅是本发明实施例而已，并非对本发明的技术范围作任何限制，故凡是依据本发明的技术实质对以上实施例所作的任何细微修改、等同变化与修饰，均仍属于本发明技术方案的范围内。

Claims (9)

1.一种排泄物检测测试盘，其特征在于：测试盘包括基板和试剂块；所述基板包括轮辐状排列的扇叶状基片、基柄、基环，基片与基环通过基柄联结；所述基片分为正面和反面；所述基片正面设置识别码，粘贴试剂块；所述基环中心为卡槽，卡槽与检测设备对应部件联结，对应部件固定于电机转动轴；所述试剂块包括化学试剂块、酶学试剂块、免疫学试剂块、生物芯片试剂块、本底对照试剂块。
2.如权利要求1所述的排泄物检测测试盘，其特征在于：所述基片宽度3mm～6mm、长度10mm～20mm，基片与基片间隔不少于2.5mm；所述基柄宽度为2.5mm，长度2.5mm；所述基环呈圆盘状，直径10mm～15mm；所述基片宽度可以增加或减少。
3.如权利要求1所述的排泄物检测测试盘，其特征在于：所述基片还可以分隔成多个槽体；所述槽体由基片上沟槽、边框组成；所述槽体内设置试剂块，或空白；所述空白用于排泄物样品有形成分识别、分类、计数。
4.如权利要求1所述的排泄物检测测试盘，其特征在于：轮辐状排列的扇叶状基片还可制成多层的扇叶状基片的立体结构，层与层间距5mm，多层基片交错排列，相应增加基片数量，增加试剂块数量。
5.如权利要求1所述的排泄物检测测试盘，其特征在于：所述基环的外环边缘还设置插口；所述插口与基柄适配，基柄可插拔、更换。
6.如权利要求1所述的排泄物检测测试盘，其特征在于：所述试剂块包括项目检测试剂块和本底对照试剂块；所述项目检测试剂块和本底对照试剂块间隔2.5mm，串联或并联排列于基片上；所述本底对照试剂块还可以是质量控制试剂块；所述本底对照试剂块可以共用者，同一基片可设置2个或2个以上项目检测试剂块。
7.如权利要求1所述的项目检测试剂块，其特征在于：所述项目检测包括尿液检测、粪便检测、唾液检测、前列腺液检测、精液检测、乳汁检测、人体引流物检测。
8.如权利要求1所述的项目检测试剂块，其特征在于：试剂块设置在轮辐状基片上，按照试剂pH值顺序排列；所述顺序pH值从小到大、再到小，环状排列。
9.一种排泄物检测测试盘制作方法，其特征在于：测试盘制作步骤包括基板制备、大张吸附试剂载体制备、大张试剂载体切割、试剂块与基板粘合、封装；所述基板制备包括3D设计、开模、PVC注塑成型、喷涂识别码；所述大张吸附试剂载体制备包括检测试剂制备、载体制备、载体吸附试剂；所述试剂块与基板粘合指试剂块与基板的基片正面粘贴。
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