The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Dec. 25, 2018

Filed:

May. 01, 2015
Applicant:

Bio-rad Laboratories, Inc., Hercules, CA (US);

Inventors:

John Christopher Yundt-Pacheco, Fairview, TX (US);

Lakshmi Kuchipudi, Wylie, TX (US);

Curtis Alan Parvin, McKinney, TX (US);

Assignee:

Bio-Rad Laboratories, Inc., Hercules, CA (US);

Attorney:
Primary Examiner:
Int. Cl.
CPC ...
G01N 35/00 (2006.01); G16H 50/30 (2018.01); G06F 19/00 (2018.01);
U.S. Cl.
CPC ...
G01N 35/00623 (2013.01); G06F 19/00 (2013.01); G16H 50/30 (2018.01); G06F 19/36 (2013.01);
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(N) due to a test system failure. The value of E(N) 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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