The method describes rapid screening of whole blood samples, pin prick and blood spot cards, subjected to MALDI-ToF Mass spectrometry. The spectra is generated and compared to those from normal healthy controls. Characteristic spectra are indicative of the presence of a hemoglobinopathy and the method can be used to screen/diagnose all sickle cell diseases, alpha and beta Thalassemias.

Non-limiting embodiments of methodologies for preparing diagnostic assay(s) calibrator(s), calibration material(s), and/or control(s), as well as kits, devices, and method(s) of calibration related thereto.

Non-limiting embodiments of a modified devices that comprise at least one dye for determining whether results obtained from the conductance of at least one diagnostic assay are biased, as well as kits and methods of use related thereto.

A problem to be solved is to provide a glycated hemoglobin (%) assay method and assay reagent capable of accurate measurement of glycated hemoglobin (%) in blood even when a blood specimen containing hemoglobin contains abnormal hemoglobin such as HbS or HbC.

The present invention provides a method capable of accurate measurement of glycated hemoglobin (%) in blood even in a specimen containing abnormal hemoglobin by combining two types of monoclonal antibodies, i.e., an anti-glycated hemoglobin monoclonal antibody and a monoclonal antibody to the anti-glycated hemoglobin monoclonal antibody, and an assay reagent for performing the method.

The present invention provides a composition that enables measurement of glycated hemoglobin in the presence of a stronger surfactant than conventional surfactants. To this end, the present invention provides an amadoriase in which one or more amino acids have been substituted at positions corresponding to positions selected from the group consisting of positions 80, 71, 175, 172, 279, 12, 9, 77, 30, 28, 13, 3, 4, 286, 204, 338, 44, 340, and 194 of the amadoriase derived from the genus Coniochaeta having the amino acid sequence as shown in SEQ ID NO: 1 as well as a composition for measurement of glycated hemoglobin comprising an amadoriase that retains activity in the presence of an anionic surfactant. The present invention can provide an enzyme and a composition for measurement of glycated hemoglobin that sufficiently remain stable even when exposed to anionic surfactants.

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.

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.

Methods, devices, and reagents are described for performing ratiometric assays for hemoglobin A1c. The methods involve a direct ratio determination between Hb A1c and normalized total hemoglobin utilizing a saturating amount of hemoglobin so that Hb A1c binds proportionately to a substrate. In some applications, the assay utilizes a proximity label system for signal generation and/or labeled magnetic beads. The methods can be configured as homogeneous or heterogeneous assays.

The invention relates to a method for the diagnosis of non-alcoholic steatohepatitis (NASH), for determining the activity, the stage, or the severity of NASH or for classifying a subject as a potential receiver or non receiver of a treatment of NASH using circulating miRNAs and other blood circulating markers of liver damage, e.g. alpha 2 macroglobulin, HbA1c, N-terminal pro-peptide of collagen type III, miR-34 and miR-200. It also relates to a kit for implementing the method of the invention, and the compounds for use in a method for the treatment of NASH, wherein the subject to be treated is identified, evaluated or classified according to the method of the invention.

Methods of detecting aberrant results caused by delivery issues for a polyhapten reagent in the context of immunoassays are disclosed.