Abstract: Provided herein are assay control materials comprising stable analytes and lyophilized unstable analytes, and methods of making and using the same.

Abstract: Intact erythrocytes with selected and often elevated levels of hemoglobin A1c (HbA1c) for use as quality controls for HbA1c assays and assay instruments are prepared by hypotonic dialysis of erythrocytes from a healthy mammal to permeabilize the erythrocyte membranes, infusion of the permeabilized erythrocytes with hemoglobin A1c, and de-permeabilization of the infused erythrocytes. Quality controls of essentially any level of HbA1c can be prepared in this manner and once prepared will be useful for monitoring the entire assay procedure, including the lysis of the erythrocytes in a typical sample.

Abstract: Solid beads each containing a selected quantity of analyte are combined and a liquid base matrix that contains attributes of a biological fluid that is to be assayed, together constitute a kit from which a laboratory technician can, at the point of use, prepare a liquid control for a particular analyte, and preferably a series of such controls at different levels of the same analyte customized for a particular assay.

Abstract: A whole-blood-based substitute composition that is useful in coagulation assays as a standard, reference, control, calibrator, linearity verifier, or training material is prepared by combining a red blood cell lysate that is free of plasma, leukocytes, and platelets with a platelet-free plasma of human origin and an antimicrobial agent.

Abstract: The present invention provides a cellular whole-blood D-dimer composition for use with diagnostic test procedures for D-dimer, and a method of its preparation. The composition comprises human erythrocytes and processed plasma to which D-dimer, and stabilizers, and optionally antimicrobial agents, are added and can be used as a standard and control for D-dimer testing.

Abstract: A whole-blood-based substitute composition that is useful in coagulation assays as a standard, reference, control, calibrator, linearity verifier, or training material is prepared by combining a red blood cell lysate that is free of plasma, leukocytes, and platelets with a platelet-free plasma of human origin and an antimicrobial agent.

Abstract: The present invention provides a cellular whole-blood D-dimer composition for use with diagnostic test procedures for D-dimer, and a method of its preparation. The composition comprises human erythrocytes and processed plasma to which D-dimer, and stabilizers, and optionally antimicrobial agents, are added and can be used as a standard and control for D-dimer testing.

Abstract: Stabilized compositions of natriuretic peptides comprise the peptide and an effective stabilizing amount of (i) an alkyl or aryl sulfonyl fluoride protease inhibitor, or (ii) benzamidine:

Abstract: An apparatus for determining exposure to an oxidative sterilant is described. The apparatus includes a chemical indicator for indicating exposure to the oxidative sterilant and a biological indicator for determining the effectiveness of the exposure to the oxidative sterilant. The chemical indicator has a metallic surface with a non-pH sensitive permanent indicator on the surface for indicating exposure to the oxidative sterilant. The chemical indicator may be on a self-contained biological indicator. The biological indicator and chemical indicator may be inside a test pack, where the test pack restricts sterilant flow to the indicators.

Abstract: Low-concentration reference controls for C-reactive protein assays are prepared from higher-level starting materials by simple filtration using silica-type filter media formerly used for removing lipids. This process avoids the need for antibodies to capture the protein and resuspend it. Surprisingly, the removal of CRP by the silica-type filter media is selective toward CRP, having little or negligible effect on other proteins in the starting matrix, and accordingly little or negligible change in the total protein content.

Abstract: An apparatus for determining exposure to an oxidative sterilant is described. The apparatus includes a chemical indicator for indicating exposure to the oxidative sterilant and a biological indicator for determining the effectiveness of the exposure to the oxidative sterilant. The chemical indicator has a metallic surface with a non-pH sensitive permanent indicator on the surface for indicating exposure to the oxidative sterilant. The chemical indicator may be on a self-contained biological indicator. The biological indicator and chemical indicator may be inside a test pack, where the test pack restricts sterilant flow to the indicators.

Abstract: References, i.e., solutions of known concentration for use as controls, calibrators, or standards, for assays of carbohydrate-deficient transferring in bodily fluids are obtained from units of bodily fluids from normal healthy individuals by digesting the transferring in these units with exogenous neuraminidase to achieve concentrated CDT solutions, which are then added in preselected proportions to a base matrix to achieve target concentrations.

Abstract: A method and apparatus detect exposure to an oxidation-type sterilant using a non-PH-sensitive bleachable dye as a chemical indicator. A change in color indicates exposure to oxidation-type sterilant.

Abstract: A method and apparatus for detecting exposure to an oxidation-type sterilant using a chemical indicator comprising bleachable dye is disclosed. Using the method and apparatus disclosed, a bleachable azo dye is incorporated with an anodized aluminum or chromate conversion coated surface and exposed to an oxidation-type sterilant, such as hydrogen peroxide, and inspected upon completion of the sterilization process for color change. If exposed to sterilant for an appropriate amount of time the bleachable dye changes color thereby indicating adequate sterilization. The surface incorporating bleachable dye may be made to change color after a predetermined number of exposures to a oxidation-type sterilant.

Abstract: A stable reticulocyte reference control which may be used with both manual and flow cytometric reticulocyte counting devices is provided. The reference control contains erythrocytes loaded with nucleic acids or polyanions capable of binding with a cationic dye. The loaded erythrocytes are suspended in an aqueous preserving medium. Methods of making and using the reticulocyte reference control are also provided.