首页> 外国专利> Cervical acid phosphatase - papanicolaou (CAP-PAP) test kit, method and accesories, processes for producing and using the same

Cervical acid phosphatase - papanicolaou (CAP-PAP) test kit, method and accesories, processes for producing and using the same

机译:宫颈磷酸酶-papanicolaou(CAP-PAP)测试试剂盒,方法和配件,生产和使用该试剂盒的方法

摘要

Cervical Acid Phosphatase-Papanicolaou Test Kit (CPK) is an assembly of reagents, controls and instructions for visualization of cervical acid phosphatase on smears or monolayers of cervical specimens, and for performing the CAP-PAP Test (CPT). ;CPT is a single-slide, double-staining method for demonstration of cervical acid phosphatase activity inside abnormal cervical cells on Papanicolaou stained smears, and a set of criteria for using this test for cervical cancer screening. In previous clinical trials this method was found to enable Pap test screeners to improve test sensitivity (detection of abnormal cells) for more than 10% (from 0.8 to 0.9), and to reduce false negative readings (missing abnormal cells) for more than 50% (from 0.1 to 0.02). Due to better accuracy and the low cost, when approved, CPT may begin to replace current technologies for cervical cancer screening. ;CPK is designed to meet requirements for testing large series of specimens on regular basis—the usual practice in cytopathology laboratories performing the Pap test. CPK brings consistency for staining and interpretation, makes internal and external controls easier, and improves the test accuracy for lower cost, while increases laboratory productivity for less liability.
机译:宫颈磷酸酶-帕帕尼科拉氏试剂盒(CPK)是试剂,对照品和说明书的组合,用于可视化宫颈标本涂片或单层上的宫颈酸磷酸酶,以及进行CAP-PAP检测(CPT)。 ; CPT是一种单幻灯片,双染色方法,用于在Papanicolaou染色涂片上显示异常子宫颈细胞内的子宫颈酸磷酸酶活性,这是使用该测试进行子宫颈癌筛查的一套标准。在先前的临床试验中,发现该方法可使Pap测试筛查仪的测试灵敏度(检测异常细胞)提高10%以上(从0.8到0.9),并减少错误阴性读数(缺失异常细胞)超过50%。 %(从0.1到0.02)。由于更好的准确性和低成本,经批准,CPT可能会开始取代当前的宫颈癌筛查技术。 ; CPK旨在满足定期测试大批标本的要求-这是执行Pap测试的细胞病理学实验室的常规做法。 CPK带来了染色和解释的一致性,简化了内部和外部控制,并提高了测试准确性,从而降低了成本,同时提高了实验室生产率,减少了责任。

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