Inventors:
Randy Kristopher Bower - Pittsford NY, US
Stuart Gilmour MacDonald - Pultneyville NY, US
James David Shaw - Hilton NY, US
Mark Alan Simon - Pittsford NY, US
Michael Avdenko - Rochester NY, US
Joseph John Dambra - Rochester NY, US
David Donald Hyde - Ontario NY, US
Merrit Nyles Jacobs - Fairport NY, US
James Daniel Riall - Roanoke VA, US
Assignee:
Ortho-Clinical Diagnostics, Inc. - Rochester NY
International Classification:
B01L 3/02
US Classification:
436 43, 436 54, 436180, 422501
Abstract:
The invention is a method for detecting failures in an analyzer for conducting clinical assays. Potential errors that can result in assay failures in an analyzer are identified, as are their potential sources. The probability that an error source so identified will result in a clinically significant error is also determined. Available potential detection measures corresponding to the source of potential errors are identified with a combination of such measures selected and implemented based on their probability of detecting such errors within an acceptable limit with a concomitant low probability of the false detection of an assay failure. Each of the measures selected are functionally independent of others chosen to address the source of the error and are not subject to the same inherent means of failed detection. Applications of the method in a clinical analyzer are also presented.