Miles Inc.

Lowry J Messenger

Kin F Yip

Frances M Yeager

Frank W Wogoman

Christine D Nelson

Kin-Fai Yip

Lynette A Lewis

Analytical reaction cassette and method for performing sequential analytical assay procedures to determine the amount of an analyte in a liquid test mixture. The reaction cassette can be in the form of a substantially square container having a substantially horizontal axis of rotation and incorporated with one or more analytical reagents such that they are contacted with a liquid test mixture in a desired ordered sequence to perform a particular assay procedure. Corners provided by the substantially square configuration of the reaction cassette disrupt the flow of liquids disposed in the reaction cassette upon contact therewith to thereby agitate and mix such liquids. A liquid disposed in the reaction cassette is capable of being manipulated and mixed therein by rotating the reaction cassette about the horizontal axis at sufficiently low velocities wherein the transport of such liquid is noncentrifugal and due substantially only to gravitational force. The reaction cassette is particularly useful for performing immunoturbidimetric assays, e.g., for the determination of glycated hemoglobin.

Reaction cassette for preforming sequential analytical assays by

An analytical method for determining the relative amount of a particular hemoglobin derivative, e.g., glycated hemoglobin, in a blood sample wherein the amounts of both total hemoglobin and the hemoglobin derivative are measured and related mathematically, e.g., as a percentage. The blood sample is treated with the combination of a thiocyanate salt and an oxidant to denature the hemoglobin in the sample and to convert hemoglobin to met-hemoglobin. Met-hemoglobin is measured spectrophotometrically to give the amount of total hemoglobin present, and the denatured hemoglobin derivative can be distinguished and measured by immunoassay. The presence of the oxidant in the denaturant solution has been found to increase the rate of enaturation of hemoglobin thereby reducing the overall assay time and improving the reliability of the determination.

Denaturant reagents for convenient determination of hemoglobin

A latex agglutination immunoassay method for determining an analyte in a blood sample in which the pH of the reaction mixture is maintained at about 8.5 or greater in order to overcome nonspecific agglutination of latex particles by hemoglobin present in the sample. The method is particularly applicable to the determination of glycated hemoglobin, e.g., Hb Alc. In another embodiment, native hemoglobin (Ao) can be determined based on its ability to cause agglutination of latex particles suspended in an aqueous solution having a pH of about 8 or below.

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Granger, IN, United States of America

Lowry J Messenger