Applicants have identified biomarkers that can be expressed at elevated levels in subjects who are prone to developing diabetes. The biomarkers can include misfolded proinsulin, correctly folded proinsulin, follistatin, hemoglobin A1c, C-Reactive Protein, Interleukin 18 and Interleukin 1 Receptor Antagonist, glutamic decarboxylase autoantibodies, islet cell autoantibodies, insulin autoantibodies, zinc transporter protein autoantibodies, insulinoma associated-2 autoantibodies, C-reactive protein, protectin D1, a lipoxin and a maresin. Embodiments include methods of predicting or assessing a subject's risk of developing diabetes before onset of the disease. The methods can also determine the progression and/or prognosis of diabetes. A subject who is at risk of developing the disease can be any of Type 1, Type 1.5 or Type 2 diabetes.

Provided is a glycated hemoglobin measuring apparatus. The apparatus for measuring glycated hemoglobin includes a cartridge for receiving blood and a plurality of chemicals, a rotating tray for rotating the cartridge, wherein the cartridge is disposed inside the rotating tray, a driver having a nozzle disposed above the cartridge and movable in a vertical direction, and a measurement unit located above the cartridge and measuring glycated hemoglobin of the blood, wherein the driver sucks at least one of the blood, the plurality of chemicals, and mixed solution of the blood and the plurality of chemicals into the nozzle or discharges the sucked at least one into the cartridge such that the blood is chemically treated through the plurality of chemicals.

The present disclosure provided methods and systems for diagnosing diseases and monitoring their progression and therapeutic responses by detecting a presence or absence, or an increase or decrease, of one or more substances in a sample.

Methods of detecting and flagging and/or suppressing aberrant results caused by incomplete dispersion of an immunoassay reagent used in a turbidimetric immunoassay are disclosed.

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.

The invention concerns a method for determining, by flow cytometry, the hemoglobin content of each erythroid cell of a set of erythroid cells. This method applies in particular to determining the hemoglobin content of each red blood cell of a set of red blood cells. The invention also concerns a method for determining the amount of red blood cells transfused into a patient and for monitoring the therapeutic efficacy of a treatment for sickle cell disease or -thalassemia.

The present invention refers to a method for determining intact glycated hemoglobin A (HbA1c) by mass spectrometry (MS), a kit and a diagnostic system adapted for performing the method.

Methods of determining the risk of an adverse cardiovascular event or death in a mammal are provided which include determining in a biological sample obtained from the mammal the level of a combination of biomarkers selected from a glucose metabolism biomarker, a heart function biomarker, a renal function biomarker and at least one biomarker of cardiac injury. A score is allotted based on the level of each biomarker, and the cumulative score is indicative of the risk of an adverse cardiovascular event.

A system for testing for an analyte includes a test strip. The test strip includes a test strip detection conductor. The test strip includes a first flow path, the first flow path including a heating area, the test strip detection conductor in the heating area, the test strip detection conductor configured to be activated to heat a sample in the heating area.

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.