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3.发明公开SYSTEM AND METHOD FOR PRODUCING STATISTICALLY VALID ASSAY MEANS AND RANGES FOR QUALITY CONTROL MATERIALS 审中-公开系统及其制造方法有效的统计分析介质和质量控制材料等领域
公开(公告)号：EP2691872A2
公开(公告)日：2014-02-05
申请号：EP12764158.7
申请日：2012-03-27
CPC分类号： G06Q10/20
摘要： A method of establishing statistically valid assay means and ranges for quality control materials, used to qualify medical testing machines, utilizes tests on a new lot of quality control material to establish an assay mean, and uses data from a database of historical test results to establish an assay range. The system may estimate the variability of test results from prior lot data, and then compute the limits of the assay range such that a new test on a new lot of the quality control material will be expected to fall within the range with a specified probability. Because historical data is used to estimate the test variability, the number of new tests required to specify a statistically valid mean and range may be dramatically reduced, as compared with establishing the mean and range based only on tests of the new lot of material.
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4.发明公开
公开(公告)号：EP4268234A1
公开(公告)日：2023-11-01
申请号：EP20967176.7
申请日：2020-12-22
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公开(公告)号：EP4264434A1
公开(公告)日：2023-10-25
申请号：EP20967171.8
申请日：2020-12-21
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6.发明公开
公开(公告)号：EP2457091A1
公开(公告)日：2012-05-30
申请号：EP10802578.4
申请日：2010-04-12
IPC分类号： G01N33/50
CPC分类号： G16H10/40
摘要： A system and method for determining a sigma of a clinical diagnostic process are disclosed. Specimen data are collected from a plurality of laboratory instruments. The specimen data are evaluated to determine a concentration and an analytical standard deviation for each data point. A clinical diagnostic process is run and patient analyte values are acquired, and a standard deviation is assigned to each patient analyte value based on the standard deviation of specimen data having a corresponding concentration. A single sigma-metric is computed based on the patient analyte assigned standard deviations, the sigma-metric representing the sigma of the clinical diagnostic process. The computed sigma-metric is reported to a user or laboratory manager.
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7.发明公开SYSTEM AND METHOD FOR AUTOMATIC QUALITY CONTROL OF CLINICAL DIAGNOSTIC PROCESSES 审中-公开系统和方法的临床诊断步骤自动质量控制
公开(公告)号：EP2433142A1
公开(公告)日：2012-03-28
申请号：EP10778078.5
申请日：2010-04-15
IPC分类号： G01N35/00
CPC分类号： G06Q50/22 , G16H40/20 , Y02A90/22 , Y02A90/26 , Y10T436/10
摘要： A system and method to automatically implement quality control of a clinical diagnostic process are disclosed. Upon generation of an internal error flag, a confirmation rule automatically checks a questionable patient statistic alert by testing a quality control specimen, applying event-related quality control rules to the results of that test, and provides an alert to the operator only upon a confirmed patient signal. The automatic quality control process thus eliminates the uncertainty of operator reaction to an alert signal and implements the quality control run automatically, without operator intervention.
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8.发明公开SYSTEM AND METHOD FOR IMPLEMENTING QUALITY CONTROL RULES FORMULATED IN ACCORDANCE WITH A QUALITY CONTROL RULE GRAMMAR 审中-公开系统和方法实施质量控制规则下，提供高质素控制规则语法制定
公开(公告)号：EP1652105A2
公开(公告)日：2006-05-03
申请号：EP04776847.8
申请日：2004-06-21
发明人： YUNDT-PACHECO, John
IPC分类号： G06F17/00
摘要： A system and method that enables the implementation of quality control rules formulated in accordance with a quality control rule grammar. The system comprises a storage device and a processor operable to maintain in the storage device a database identifying a plurality of laboratory tests and corresponding quality control rules. The processor is also operable to receive a quality control rule for a specified laboratory test, wherein the quality control rule is expressed in accordance with a quality control rule grammar. The processor is further operable to transfer the quality control rule to the database for storage in relation to the specified laboratory test. Various exemplary embodiments of the system and associated method are provided.
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9.发明公开SYSTEM AND METHOD FOR INTEGRATING THE INTERNAL AND EXTERNAL QUALITY CONTROL PROGRAMS OF A LABORATORY 审中-公开用于集成实验室的内部和外部质量控制程序的系统和方法
公开(公告)号：EP1620736A1
公开(公告)日：2006-02-01
申请号：EP04750905.4
申请日：2004-04-29
发明人： YUNDT-PACHECO, John
摘要： A system and method that enables a laboratory to integrate its internal and external quality control programs to thereby control the quality of its laboratory testing services. The system has a storage device and a processor operable to maintain in the storage device a database identifying a plurality of laboratory tests and the corresponding internal laboratory statistical data, group statistical summary data and control rules. The processor is also operable to calculate a control range for a specified laboratory test by applying the group statistical summary data (and, in some cases, the internal laboratory statistical data) to the control rule corresponding to the specified laboratory test. Preferably, the processor is also operable to receive a test result from a laboratory instrument, and determine whether the test result falls within the calculated control range for the specified laboratory test. Various exemplary embodiments of the system and associated method are provided.
摘要翻译： 一个系统和方法，使实验室整合其内部和外部的质量控制程序，从而控制其实验室检测服务的质量。 该系统包括存储装置（28）和处理器（26），其可操作以在存储装置（28）中保存标识多个实验室测试（34a，36a，38a，40a）和相应的内部实验室 统计数据（36b），组统计摘要数据（38b）和控制规则（40b）。 处理器（26）还可操作用于通过将组统计摘要数据（以及在一些情况下，内部实验室统计数据）应用于与指定的实验室测试相对应的控制规则来计算指定实验室测试的控制范围。 优选地，处理器（26）还可操作以接收来自实验室仪器（20）的测试结果，并确定测试结果是否落入指定实验室测试的计算控制范围内。 提供了系统和相关方法的各种示例性实施例。
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