Streck, Inc.

Streck Laboratories, Inc.

Jiong Wu

Wayne L Ryan

Disclosed are cellular hemoglobin A1c (Hb A1c) normal and abnormal (high) controls for use in detecting Hb A1c levels. The present invention also relates to methods for generating cellular Hb A1c controls using red blood cells and methods for using the cellular controls. The present invention encompasses several methods for the preparation of Hb A1c cellular controls including: (1) a boronate method where the glycation occurs non-specifically; (2) a stabilized diabetic blood method where the glycation occurs specifically on Hb A1c, and (3) the glycation of normal blood method that is achieved by controlling conditions such that glycation occurs predominantly on Hb A1c. These methods produce cellular Hb A1c controls with desirable stability and that can be detected on a variety of instruments.

Cellular controls for glycated hemoglobin Hb A1c

A reagent system is provided for substantially lysing red blood cells in a whole blood sample prior to leukocyte analysis, which system includes a first reagent for substantially lysing the red blood cells in the whole blood sample, and a second reagent for quenching the activity of the first reagent. The first reagent is formulated to include an autoclaved saponin compound and an acid selected from the group consisting of a halogenated carboxylic acid, a phosphoric acid and a combination thereof. The second reagent includes a base and has a pH value of about 8 to 12. Also provided is a method of lysing the red blood cells and stabilizing white blood cells present in a sample of whole blood.

Hematology reagent and methods

A method of emulating with a cyanide-free lyse solution, the measurement of hemoglobin in whole blood using a cyanide-containing lyse solution. Such an illustrative method includes: a) combining a predetermined amount of the whole blood sample with a predetermined amount of a cyanide-free lyse solution to form a mixture, b) developing the mixture to a molar absorbtivity (&#x3b5;) in the range of about 12.4 to 12.6 mMcm, and c) measuring a level of light absorbance of the mixture at a wavelength of about 540 nm. In one preferred illustrative embodiment, the cyanide-free lyse solution includes: a quaternary ammonium salt surfactant, an anionic surfactant, a hemoglobin binding agent selected from the group consisting of imidazole or hydroxylamine, and an aqueous medium. In one preferred embodiment, the molar absorbtivity is developed to a value of about 12.5 mMcm. That is to say to a level that is substantially identical to that of the prior art standard, cyanomethemoglobin. By achieving this level of molar absorbtivity, the final calculated results do not have to be corrected for the different molar absorbtivity exhibited by imidazolemethemoglobin or hydroxylaminemethemoglobin.

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La Vista, NE, United States of America

Jiong Wu