FAILURE DETECTION IN AUTOMATED CLINICAL ANALYZERS

• Main Authors: HYDE, DAVID DONALD, JACOBS, MERRIT NYLES, RIALL, JAMES DANIEL, DAMBRA, JOSEPH JOHN, MACDONALD, STUART GILMOUR, SHAW, JAMES DAVID, BOWER, RANDY KRISTOPHER, AVDENKO, MICHAEL, SIMON, MARK ALAN
• Format: Patent
• Language: English; French
• Published: 13.03.2012
• Subjects: GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION; TECHNICAL SUBJECTS COVERED BY FORMER USPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS; TESTING

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.