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公开(公告)号：US20190120865A1
公开(公告)日：2019-04-25
申请号：US16228597
申请日：2018-12-20
Applicant: Bio-Rad Laboratories, Inc.
Abstract: Methods, apparatuses, and systems are disclosed for analyzing quality control (QC) strategies that are applied to testing processes an analyte in order to meet an acceptable level of probability of patient harm that could result from incorrect test results. The measure of patient harm takes into account severity of patient harm, as well as its occurrence. Methods include calculating, based on the parameters of the QC strategies and the test apparatus, an expected number of incorrect final results E(Nuf) due to a test system failure. The value of E(Nuf) can be used as part of a calculation of a predicted level of probability patient harm. The ratio of the acceptable level of probability of patient harm to the predicted level of probability patient harm can determine the adequacy of the QC strategies.
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Patent Agency Ranking
2.发明申请公开(公告)号：US20140223234A1
公开(公告)日：2014-08-07
申请号：US14245333
申请日：2014-04-04
Applicant: Bio-Rad Laboratories, Inc.
Inventor： Curtis Alan Parvin , John C. Yundt-Pacheco
IPC: G06F11/24
CPC classification number: G06F11/24 , G06F15/781 , G06F19/00 , G06N99/005 , G16H10/40 , G16H40/20
Abstract: A method analyzes a quality control strategy. A quality control rule can define quality control events and specifying a control limit for determining whether a quality control event passes or fails. The quality control rule and a number of patient samples tested between quality control events can be received. A first expected number of correctible errors when a quality control event fails can be computed based on the quality control rule and the number of patient samples tested between quality control events. A second expected number of final errors that are not correctible when a quality control event fails can be computed based on the quality control rule and the number of patient samples tested between quality control events. An assessment of the quality control rule can include the first expected number of correctible errors and the second expected number of final errors as separate values.
Abstract translation: 一种方法分析质量控制策略。 质量控制规则可以定义质量控制事件并指定用于确定质量控制事件是否通过或失败的控制限制。 可以接收质量控制规则和在质量控制事件之间测试的多个患者样本。 可以基于质量控制规则和在质量控制事件之间测试的患者样本的数量来计算质量控制事件失败时的第一预期数量的可纠正错误。 可以基于质量控制规则和在质量控制事件之间测试的患者样本的数量来计算质量控制事件失败时不可校正的最终错误的第二预期数量。 质量控制规则的评估可以包括第一预期数量的可纠正错误和第二预期数量的最终错误作为单独的值。
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公开(公告)号：US11579155B2
公开(公告)日：2023-02-14
申请号：US16228597
申请日：2018-12-20
Applicant: Bio-Rad Laboratories, Inc.
Abstract: Methods, apparatuses, and systems are disclosed for analyzing quality control (QC) strategies that are applied to testing processes an analyte in order to meet an acceptable level of probability of patient harm that could result from incorrect test results. The measure of patient harm takes into account severity of patient harm, as well as its occurrence. Methods include calculating, based on the parameters of the QC strategies and the test apparatus, an expected number of incorrect final results E(Nuf) due to a test system failure. The value of E(Nuf) can be used as part of a calculation of a predicted level of probability patient harm. The ratio of the acceptable level of probability of patient harm to the predicted level of probability patient harm can determine the adequacy of the QC strategies.
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公开(公告)号：US10161947B2
公开(公告)日：2018-12-25
申请号：US14702019
申请日：2015-05-01
Applicant: Bio-Rad Laboratories, Inc.
Abstract: Methods, apparatuses, and systems are disclosed for analyzing quality control (QC) strategies that are applied to testing processes an analyte in order to meet an acceptable level of probability of patient harm that could result from incorrect test results. The measure of patient harm takes into account severity of patient harm, as well as its occurrence. Methods include calculating, based on the parameters of the QC strategies and the test apparatus, an expected number of incorrect final results E(Nuf) due to a test system failure. The value of E(Nuf) can be used as part of a calculation of a predicted level of probability patient harm. The ratio of the acceptable level of probability of patient harm to the predicted level of probability patient harm can determine the adequacy of the QC strategies.
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5.发明申请公开(公告)号：US20160320420A1
公开(公告)日：2016-11-03
申请号：US14702019
申请日：2015-05-01
Applicant: Bio-Rad Laboratories, Inc.
IPC: G01N35/00
CPC classification number: G01N35/00623 , G06F19/00 , G06F19/36 , G16H50/30
Abstract: Methods, apparatuses, and systems are disclosed for analyzing quality control (QC) strategies that are applied to testing processes an analyte in order to meet an acceptable level of probability of patient harm that could result from incorrect test results. The measure of patient harm takes into account severity of patient harm, as well as its occurrence. Methods include calculating, based on the parameters of the QC strategies and the test apparatus, an expected number of incorrect final results E(Nuf) due to a test system failure. The value of E(Nuf) can be used as part of a calculation of a predicted level of probability patient harm. The ratio of the acceptable level of probability of patient harm to the predicted level of probability patient harm can determine the adequacy of the QC strategies.
Abstract translation: 公开了用于分析用于测试分析物的质量控制（QC）策略的方法，装置和系统，以便满足可能由不正确的测试结果导致的可接受的患者伤害概率。 患者伤害的测量考虑到患者伤害的严重程度及其发生。 方法包括根据QC策略和测试设备的参数计算由于测试系统故障导致的不正确的最终结果E（Nuf）的预期数量。 E（Nuf）的值可以用作预测患者危害概率水平的计算的一部分。 患者伤害概率的可接受水平与预测的患者危害概率水平的比例可以确定QC策略的适当性。
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公开(公告)号：US08938409B2
公开(公告)日：2015-01-20
申请号：US14245333
申请日：2014-04-04
Applicant: Bio-Rad Laboratories, Inc.
Inventor： Curtis Alan Parvin , John C. Yundt-Pacheco
CPC classification number: G06F11/24 , G06F15/781 , G06F19/00 , G06N99/005 , G16H10/40 , G16H40/20
Abstract: A method analyzes a quality control strategy. A quality control rule can define quality control events and specifying a control limit for determining whether a quality control event passes or fails. The quality control rule and a number of patient samples tested between quality control events can be received. A first expected number of correctible errors when a quality control event fails can be computed based on the quality control rule and the number of patient samples tested between quality control events. A second expected number of final errors that are not correctible when a quality control event fails can be computed based on the quality control rule and the number of patient samples tested between quality control events. An assessment of the quality control rule can include the first expected number of correctible errors and the second expected number of final errors as separate values.
Abstract translation: 一种方法分析质量控制策略。 质量控制规则可以定义质量控制事件并指定用于确定质量控制事件是否通过或失败的控制限制。 可以接收质量控制规则和在质量控制事件之间测试的多个患者样本。 可以基于质量控制规则和在质量控制事件之间测试的患者样本的数量来计算质量控制事件失败时的第一预期数量的可纠正错误。 可以基于质量控制规则和在质量控制事件之间测试的患者样本的数量来计算质量控制事件失败时不可校正的最终错误的第二预期数量。 质量控制规则的评估可以包括第一预期数量的可纠正错误和第二预期数量的最终错误作为单独的值。
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