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    • 6. 发明授权
    • Detachable-element assay device
    • 可拆分元素测定装置
    • US5939252A
    • 1999-08-17
    • US853760
    • 1997-05-09
    • Donald J. LennonRoger N. Piasio
    • Donald J. LennonRoger N. Piasio
    • G01N21/01G01N21/27G01N30/00G01N30/88G01N33/543C12Q1/00
    • G01N33/54386Y10S435/97Y10S435/975Y10S436/807Y10S436/808Y10S436/825
    • An assay device for detection or determination of an analyte in a sample uses either removably attachable components or hinged panels to provide greater flexibility and reduce manufacturing and storage costs. In one embodiment of the device, the device comprises: (1) a first opposable component including:(a) a first panel; (b) a second panel mounted on the first panel generally parallel to the first panel with space between the first and second panel, the second panel having an opening forming a first receptacle for a sample collection device; and (c) a second receptacle for a test strip formed by the first panel and the second panel; and (2) a second opposable component hingedly attached to the first opposable component. In this device, the first and second opposable components can be brought into operable contact so that fluid is expressed from the sample collection device and applied to the test strip for detection or determination of an analyte by a test performed on the test strip. Other embodiments of devices are included, as well as test kits and method of use of the devices.
    • 用于检测或确定样品中分析物的测定装置使用可拆卸地附接的部件或铰接板来提供更大的灵活性并降低制造和存储成本。 在该设备的一个实施例中,该装置包括:(1)第一可反对组件,包括:(a)第一面板; (b)安装在所述第一面板上的大致平行于所述第一面板的第二面板,所述第一面板具有位于所述第一面板与所述第二面板之间的空间,所述第二面板具有形成用于样品收集装置的第一容器的开口; 和(c)由第一面板和第二面板形成的用于测试条的第二容器; 和(2)铰接地附接到第一可反涂组分的第二可反涂组分。 在该装置中,可以使第一和第二可反映部件可操作地接触,使得流体从样品收集装置表达并施加到测试条上,以通过在试纸上进行的测试来检测或确定分析物。 包括设备的其他实施例,以及测试套件和设备的使用方法。
    • 8. 发明申请
    • Modification of Bioassays for Detection of Antigens Characteristic of Bacteria that are Causative of Ear and Respiratory Infections to Eliminate False Positive Results Caused by Nasopharyngeal Colonization of Children
    • 用于检测引起耳朵和呼吸道感染的细菌的抗原特征的生物测定的修改以消除儿童鼻咽殖民化引起的假阳性结果
    • US20110104819A1
    • 2011-05-05
    • US12752796
    • 2010-04-01
    • Roger N. PiasioMadeline Wareing
    • Roger N. PiasioMadeline Wareing
    • G01N33/68
    • G01N33/56911G01N33/558
    • The present invention relates to modifying rapid immunochromatographic (“ICT”) tests for the detection of characteristic carbohydrate antigens of bacteria that are known to be causative of otitis media and respiratory diseases in children under the age of approximately 12 years. Children of this age group are also prone to nasopharyngeal colonization with the same bacteria, and urine samples taken from colonized, but otherwise healthy, children were shown to exhibit an unduly high incidence of test results that were false positive for the presence of disease.The test modifications, which maintain the test sensitivity unchanged and the test specificity at a value above 90% were developed to insure that healthy, albeit colonized, children were not medicated for disease the bacteria are known to cause. The modifications involve either (1) reducing the total amount of antibodies to the carbohydrate antigen employed in each test, (2) adding at least one fixed “scrub” line located just prior to the capture line in the sample flow path to the preprepared ICT test strip to “scrub” out an identical amount of target antigen from all bodily fluid test samples obtained from both colonized but otherwise healthy children and diseased children, or (3) combinations of (1) and (2).
    • 本发明涉及修改用于检测已知在12岁以下儿童中已知引起中耳炎和呼吸系统疾病的细菌的特征性碳水化合物抗原的快速免疫色谱(“ICT”)测试。 这个年龄组的孩子也容易患有相同细菌的鼻咽定植,并且从殖民地健康的儿童中取出的尿液样本显示出对于存在疾病的假阳性的测试结果过高的发生率过高。 开发了保持测试灵敏度不变并且测试特异性在90%以上的测试修饰,以确保健康的,尽管被定殖的儿童没有被用来治疗细菌已知的疾病。 修饰涉及(1)减少每次试验中使用的碳水化合物抗原的抗体总量,(2)将至少一个位于样品流动路径中的捕获线之前的固定的“擦洗”线添加到预备的ICT 测试条从从定殖但其他健康的儿童和患病儿童获得的所有体液测试样品中“洗出”相同量的靶抗原,或(3)(1)和(2)的组合。
    • 9. 发明申请
    • Dry Chemistry, Lateral Flow-Reconstituted Chromatographic Enzyme-Driven Assays
    • 干化学,侧流重构色谱酶驱动测定
    • US20090011436A1
    • 2009-01-08
    • US12211304
    • 2008-09-16
    • Roger N. PiasioNathan Turner
    • Roger N. PiasioNathan Turner
    • G01N33/53
    • C12Q1/32B01J20/28033B01J20/281G01N21/78G01N33/523G01N33/54326G01N33/558G01N2333/902G01N2333/904G01N2333/986
    • A lateral flow chromatographic assay format for the performance of rapid enzyme-driven assays is described. A combination of components necessary to elicit a specific enzyme reaction, which are either absent from the intended sample or insufficiently present therein to permit completion of the desired reaction, are predeposited as substrate in dry form together with ingredients necessary to produce a desired color upon occurrence of the desired reaction. The strip is equipped with a sample pad placed ahead of the substrate deposit in the flowstream, to which liquid sample is applied. The sample flows from the sample pad into the substrate zone where it immediately reconstitutes the dried ingredients while also intimately mixing with them and reacting with them at the fluid front. The fluid front moves rapidly into the final “read zone” wherein the color developed is read against predetermined color standards for the desired reaction. Pretreatment pads for the sample, as needed, (e.g. a lysing pad for lysing red blood cells in whole blood) are placed in front of the sample pad in the flow path as appropriate. The assay in the format of the invention is faster and easier to perform than analogous wet chemistry assays.Specific assays for glucose-6-phosphate dehydrogenase (“G-6PD”), total serum cholesterol, β-lactamase activity and peroxidase activity are disclosed.
    • 描述了用于快速酶驱动测定的侧流色谱测定方法。 将引起特定酶反应(其不在预期样品中或不充分存在于其中以允许完成所需反应)所需的组分的组合预先沉积为干燥形式的底物以及在发生时产生所需颜色所需的成分 的所需反应。 带材上装有样品垫,放置在流动的衬底沉积物的前面,并向其施加液体样品。 样品从样品垫流入基底区域,在那里它立即重构干燥的成分,同时与它们充分混合并在流体前面与它们反应。 流体前沿快速移动到最终的“读取区域”,其中根据预期的颜色标准读取显色的颜色用于所需的反应。 如果需要,将样品的预处理垫(例如用于裂解全血中的红细胞的裂解垫)放置在适当的流路中的样品垫的前方。 本发明形式的测定比类似的湿化学测定更快更容易进行。 公开了葡萄糖-6-磷酸脱氢酶(“G-6PD”),总血清胆固醇,β-内酰胺酶活性和过氧化物酶活性的特异性测定。
    • 10. 发明授权
    • Method of assaying glucose-6-phosphate dehydrogenase on a chromatographic test strip
    • 在色谱测试条上测定葡萄糖-6-磷酸脱氢酶的方法
    • US08354245B2
    • 2013-01-15
    • US12211304
    • 2008-09-16
    • Roger N. PiasioNathan Turner
    • Roger N. PiasioNathan Turner
    • C12Q1/32
    • C12Q1/32B01J20/28033B01J20/281G01N21/78G01N33/523G01N33/54326G01N33/558G01N2333/902G01N2333/904G01N2333/986
    • A lateral flow chromatographic assay format for the performance of rapid enzyme-driven assays is described. A combination of components necessary to elicit a specific enzyme reaction, which are either absent from the intended sample or insufficiently present therein to permit completion of the desired reaction, are predeposited as substrate in dry form together with ingredients necessary to produce a desired color upon occurrence of the desired reaction. The strip is equipped with a sample pad placed ahead of the substrate deposit in the flowstream, to which liquid sample is applied. The sample flows from the sample pad into the substrate zone where it immediately reconstitutes the dried ingredients while also intimately mixing with them and reacting with them at the fluid front. The fluid front moves rapidly into the final “read zone” wherein the color developed is read against predetermined color standards for the desired reaction. Pretreatment pads for the sample, as needed, (e.g. a lysing pad for lysing red blood cells in whole blood) are placed in front of the sample pad in the flow path as appropriate. The assay in the format of the invention is faster and easier to perform than analogous wet chemistry assays.
    • 描述了用于快速酶驱动测定的侧流色谱测定方法。 将引起特定酶反应(其不在预期样品中或不充分存在于其中以允许完成所需反应)所需的组分的组合预先沉积为干燥形式的底物以及在发生时产生所需颜色所需的成分 的所需反应。 带材上装有样品垫,放置在流动的衬底沉积物的前面,并向其施加液体样品。 样品从样品垫流入基底区域,在那里它立即重构干燥的成分,同时与它们充分混合并在流体前面与它们反应。 流体前沿快速移动到最终读取区域,其中显色的颜色针对期望的反应的预定颜色标准读取。 如果需要,将样品的预处理垫(例如用于裂解全血中的红细胞的裂解垫)放置在适当的流路中的样品垫的前方。 本发明形式的测定比类似的湿化学测定更快更容易进行。