Electrochemical test sensors and analysis methods are described that reduce or eliminate the pre-treatment or dilution of blood samples prior to HbA1c analysis. Thus, a blood sample obtained from a blood draw or phlebotomy may be introduced to the electrochemical test sensor for HbA1c analysis. The described test sensors immobilize or deactivate incompatible reagents, enzymes, and antibodies so they do not substantially interfere with each other during the analysis. The test sensors also use heat to catalyze reactions that otherwise would proceed at too slow of a rate to be practical.

Described are immunoassay kits having a conjugate structure separate from an immunochromatographic strip in which the conjugate structure is freeze-dried with uniform droplet size, and related compositions and methods. The unique structure of the kits described here permits sample containing analyte to be reacted uniformly with the conjugate structure before being subjected to immunochromatography by application to the strip. This results in improved performance of the assay. In addition, the freeze-dried conjugate structure can be stored without contamination and is easy to carry. In addition, the freeze-dried conjugate structure can be rapidly and uniformly dissolved so that it is immediately allowed to react with a mixture of a buffer and a sample, the reaction product then being analyzed by immunochromatography, making it suitable for use in point-of-care testing.

A biomedical measuring device, such as a test strip, has a simple structure, by which analyte can be measured easily using a small amount of specimen. In embodiments, the test strip generally includes a plastic first film layer having structure defining an aperture for retaining the reacting components, a porous membrane coupled to an inner-facing surface of the first film layer and configured to reduce background signal, an absorbent pad coupled to the porous membrane and first film layer to sandwich the porous membrane therebetween, the absorbent pad being configured for rapid absorption, and a plastic second film layer coupled to the absorbent pad, the second film layer being configured to provide a barrier to prevent liquid from leaking out of the test strip during use. The test strip can be easily used with an optical sensing device coupled to or containing an analyzer device (or reader device) for quickly detecting and measuring the analyte concentration. In a particular embodiment, the analyte comprises glycated hemoglobin or HbA1c, and the optical reader device is configured to determine HbA1c concentration.

A method for determining the amount of glycated haemoglobin (HbA1c), in whichif requiredthe erythrocytes in a sample are haemolysed, the haemoglobin that is then releasedif requiredis contacted with a proteolytic agent and the glycated haemoglobin degradation products obtained in this way or otherwise are quantified is disclosed. In order to provide such a process and reagents employable therein that has/have the property of sufficient stability of the chemical compounds that are essential to the reaction, the provision of the requisite proteolytic agent in the form of an inactivated protease is proposed, which is then only reactivated in situ. For the stabilization of the haemoglobin, which is unfolded at a very low pH in the range from 1 to 3, at least one suitable stabilizer should be present in the haemolysis solution, and, where a leuco dye is used in connection with the determination of the amount of HbA1c, it is proposed that the latter be stabilized with particular phosphine compounds and/or thio compounds.

Hemoglobin, its variants, and glycated forms of each are determined individually in a multiplex assay that permits correction of the measured level of HbA1c to account for glycated variants and other factors related to the inclusion of the variants in the sample. New antibodies that are particularly well adapted to the multiplex assay are also provided.

Methods, devices, and reagents are described for performing assays for hemoglobin Ale, glycated albumin, and other glycated proteins. The methods involve a ratio determination between glycated protein and non-gtycated protein. In some applications, the assay utilizes LOCI for signal generation. This invention is directed to assays and corresponding devices and reagents for detection of glycated protein, particularly including glycated hemoglobin. As is generally understood, such detection is useful in the management of blood glucose levels in diabetic patients and for monitoring the status of pre-diabetic individuals.

A system for determining a concentration of hemoglobin A1C includes a first lateral flow test strip, the first lateral flow test strip providing for a percent of HbA1C concentration; a second lateral flow test strip, the second lateral flow test strip providing for the total amount of hemoglobin; an antibody-microparticle stripe on each of the first and second lateral flow test strips; a conjugate stripe on each of the first and second lateral flow test strips; and a sample treatment buffer. The sample treatment buffer is strongly denaturing, and antibodies in the antibody-microparticle strip are covalently bound to microparticles.

The current invention relates to cell-cell interaction and in particular to cellular avidity. Provided are improved means and methods to study cell-cell interaction and characterizing cellular avidity, in particular from heterogeneous cell populations. Means and methods are provided which allows for the screening and identification of cells, carrying defined receptors while at the same time determining cellular avidity. This way, highly advantages methods can be provided that allow efficient screening of libraries or heterogeneous cell population for identifying for example receptors of interest.

A method of calculating at least one physiological parameter using a reticulocyte production index (RPI) value can include: measuring a plurality of first glucose levels over a first time period; measuring a first glycated hemoglobin (HbA1c) level corresponding to an end of the first time period; measuring the RPI value; calculating a red blood cell elimination constant (k.sub.age) based on the RPI value; and calculating the at least one physiological parameter selected from the group consisting of: a red blood cell glycation rate constant (k.sub.gly), a red blood cell generation rate constant (k.sub.gen), and an apparent glycation constant (K), based on (1) the plurality of first glucose levels, (2) the first HbA1c level, and (3) the k.sub.age. Further, one or more related analyses (e.g., personalized-target glucose range, personalized-target average glucose, cHbA1c, and the like) can be estimated and/or adjusted based on the at least one physiological parameter.

A method for evaluating a risk of a morbidity associated with elevated red blood cell (RBC) volume variation (RDW) includes measuring, using a hematology analyzer, a complete blood count (CBC) of a blood sample including a population of RBCs from a subject. In some embodiments, the method includes estimating a normalized clearance volume of the population of the RBCs based on the CBC. In some embodiments, the method includes comparing the normalized clearance volume to a reference value. In some embodiments, the method includes determining a risk level for the patient to develop the morbidity associated with elevated RDW within a specified time period. In some embodiments, the risk level is high if the normalized clearance volume is below the reference value, and the risk level is low if the normalized clearance volume is above the reference value. In some embodiments, the method further includes selecting the patient for diagnostic workup for the morbidity if the risk level is high. In some embodiments, the morbidity is not anemia.