Siemens Healthcare Diagnostics Gmbh

Bayer Corporation

Miles Inc.

Chris Thomas Zimmerle

Michael J Pugia

Gary W Rheinheimer

James Arthur Profitt

Aaron Kauffmann

Hai-Hang Kuo

David Ledden

Lloyd S Schulman

Linda Anderson-Mauser

Amy Zercher

Jennifer Ann Goldsburg

Jon Stradinger

Meitak Teresa Yip

David A Brock

David J Ledden

Jeffrey Mayfield

Julie Chaney

Dayaweera Wijesuriya

Carol A Miller

Michael Celentano

Disclosed herein are methods for rapid detection of suspension of a blood sample from a subject and methods for improving the processing time of a point of care blood analysis. Specifically, the disclosed methods provide a rapid detection of hemoglobin concentration, more specifically glycated hemoglobin A1c, and determination of sugar concentration in the blood sample from the subject. Further disclosed herein are methods for rapidly diagnosing diabetes in a subject.

Methods of blood sample suspension

Methods of minimizing hook effect interference in an immunoassay are disclosed. Also disclosed are reagents, kits, and immunoassay devices that may be utilized in accordance with the method.

Devices and methods for minimizing hook effect interference in immunoassays

Devices and methods for the hook effect detection associated with analytes of interest in the conductance of one or more diagnostic assays, including, without limitation, immunoassays.

Methods for detecting hook effect(s) associated with anaylte(s) of interest during or resulting from the conductance of diagnostic assay(s)

A method for calibrating an imager of a reagent analyzer, comprises positioning a dry reagent pad at a first read position in a field of view of the imager, the first read position illuminated by an illumination source with a first intensity, detecting a reference optical signal by the imager, indicative of a first reflectance value of the dry reagent pad at the first read position, positioning the dry reagent pad at a second read position, the second read position illuminated with a second intensity different from the first intensity, detecting a first optical signal by the imager, indicative of a second reflectance value of the dry reagent pad at the second read position, and calculating, by a processor, a calibration factor for the dry reagent pad at the second read position based on a difference between the reference optical signal and the first optical signal.

Calibration method for reagent card analyzers

Devices, kits, and methods are disclosed for use in detecting a concentration of an analyte of interest in a patient's liquid test sample. The devices, kits, and methods employ the use of one or more solid reagent zones that includes at least one analytical reagent for detection of an analyte of interest. The solid reagent zone(s) also includes at least one dye for determining whether results obtained from the diagnostic assay for the at least one analyte of interest are biased or inaccurate due to a loss of volume of a liquid reagent during the dispensing of the liquid reagent.

Dye-based liquid reagent volume indicator for use in analyte detection assays

The timing of the reaction of moisture-sensitive reagents for detecting the presence of analytes, e.g. leukocytes in urine samples, is used to detect when the reagents have been compromised by excess humidity. The ratio of light reflectance at wavelengths characteristic of the products of reaction between the reagents and the analyte and an infra-red reference dye is measured at two preset times after a urine sample has been applied to a test strip and used to determine whether the reagents have been compromised by excessive humidity. The presence of unusually dark samples is determined from the reflected light at 470 and 625 nm in order to confirm that the test strips are humidity-compromised.

Device and method for detection of humidity-compromised urine test strips

Provided herein are color charts and water color pigment solutions useful, for example, in the calibration of reflectance-based diagnostic analyzers.

Water color pigment solutions for use with reflectance-based diagnostic analyzers

Disclosed herein are methods of detecting ascorbic acid in a urine sample from a subject, including contacting at least a portion of the urine sample with a test strip including a reagent pad and detecting whether ascorbic acid is present in the urine sample by measuring an intensity of color on the reagent pad, wherein a reduction in the intensity of color on the reagent pad indicates the presence of ascorbic acid.

Detection of ascorbic acid in a urine sample

The inventive concepts disclosed herein are generally directed to the use of a hand-held mobile computing device, such a smartphone or tablet, to interpret the results of a medical assay device. By controlling conditions like image placement and illumination and correcting for imperfect illumination, accurate results can be obtained with hand-held mobile computing device.

Optical interpretation of assay results

Methods and systems are disclosed including a reagent analyzer, comprising a test analyzing mechanism, such as an optical imaging system, configured to read a first sample of a specimen combined with a reagent configured to react with the sample in a presence of an analyte of interest and a second sample of the specimen that is not combined with a reagent, and to output one or more first signals indicative of the test analyzing mechanism reading the first and second samples; and a processor receiving the one or more first signals and executing logic to analyze the second sample responsive to the processor determining that the analyte of interest is present in the first sample. The processor may execute logic to analyze the second specimen utilizing one or more ratio algorithm and comparing the results of the algorithm against predetermined values indicative of expected color.

Reduction of false positive on reagent test devices

Sample media for the analysis of analytes in a fluid test sample includes a carrier, at least one test field on the surface of the carrier including at least one reagent reactive with the analytes and capable of providing a detectable response. A non-visible bar code formed by at least two distinct non-visible marker fields is located on the carrier. The marker fields are configured to reflect electro-magnetic (EM) radiation within one or more ranges of non-visible wavelengths to form a coded sequence of reflectances correlated to identification of the sample media.

Growing community of inventors

Goshen, IN, United States of America

Chris Thomas Zimmerle