Ortho-clinical Diagnostics, Inc

Joseph John Dambra

Randy Kristopher Bower

Zhong Ding

Raymond Francis Jakubowicz

David Angelo Tomasso

James Ellis Robinson

Dale Robert Ryan

Stuart Gilmour MacDonald

Merrit Nyles Jacobs

James D Shaw

James Daniel Riall

Michael Avdenko

David Donald Hyde

Robert Anthony Burkovich

Theodore J DiMagno

Nicholas VanBrunt

Jean-Christophe Hurpeau

Mark Alan Simon

Mark D Reed

Disclosed is a clinical diagnostic analyzer employing a redundant error detection capability to further examine the internal message traffic for possible errors or questionable results by comparing the actual parameters against a fingerprint generated for each assay using an assay database and a configuration file. This testing does not rely on inputs from the software module being tested, and hence is an independent test. Further, a testing mechanism is provided to test the Redundant Error Detection ('RED') capability itself.

Redundant error detection in a clinical diagnostic analyzer

An assay device includes a support, test elements arranged thereover, and a diverter defining a common sample addition area of the device. The diverter conducts respective portions of a fluidic sample from the area to each of the test elements. Another assay device includes the test elements, one a dry slide element, disposed over the support at least partly in proximity to each other to define a common sample addition area. Apparatus for analyzing a sample includes an assay device having the test elements, one a dry slide element. A controller operates a metering mechanism, to apply the sample to the assay device, an incubator, and a measurement device per a timing protocol to determine a characteristic of the sample. Methods for enabling an assay device to perform multiple tests based upon a single sample metering event include are also described.

Multiplexing with single sample metering event to increase throughput

A lateral flow device for use in a mainframe or point-of-care clinical analyzer, in which the lateral flow device includes a planar support having at least one sample addition area and at least one reaction area disposed thereon. The sample addition area and reaction area are fluidly interconnected to one another and form at least one lateral fluid flow path. The lateral flow device is sized for retention within a storage cartridge of the analyzer defined by a hollow interior and having a plurality of lateral flow assay devices retained in stacked relation therein.

Lateral flow assay devices for use in clinical diagnostic apparatus and configuration of clinical diagnostic apparatus for same

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.

Failure detection in automated clinical analyzers

A method for measuring the amount of fluid contained in a reaction vessel in a clinical analyzer includes the steps of adding a first aliquot of fluid to the reaction vessel and measuring the quantity of fluid contained therein. A second aliquot of fluid is then added to the reaction vessel and the quantity of fluid contained therein is also measured. Measurement of the two fluid quantities can occur with or without removal of the first aliquot in between measurements. In obtaining the two quantity measurements and comparing them against a standard, the effects of well geometry can be minimized. Preferably, a delta or ratio measurement is obtained between the first and second liquid volume measurements which can be compared against a standard so as to normalize apparent volume losses or gains due to reaction well dimensional variation. This approach enhances the analytical capability to detect true fluid delivery errors.

Fluid measurements in a reaction vessel used in conjunction with a clinical analyzer

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Rochester, NY, United States of America

Joseph John Dambra