Abstract: This invention provides a standard specimen useful for the quantitative evaluation of performance of stains, staining solutions and staining processes used on biological specimens, and also for the evaluation of dyestuffs. The standard specimens are comprised of extracts of biological materials containing protein and/or nucleic acid which are incorporated into a reproducible plastic matrix of controlled thickness. The standard specimen so produced is useful in the quantitative performance evaluation of a dyeing or staining process, thereby providing information for process control and quantitative analysis and comparisons. The invention also provides for the method of preparing the standard specimen of the invention, as well as for the method of using the standard specimen.

Abstract: A process is disclosed for producing steroid hormone receptor samples to be utilized as controls during assays of various human tissue for steroid hormones, especially estrogen and progesterone. The process comprises collecting tissue known to include such receptors, adding a buffer solution to the tissue, homogenizing the tissue and buffer solution, centrifuging the homogenized mixture, and thereafter collecting the supernatant. The supernatant which contains the desired receptors is subdivided into suitable control sample size and preferably lyophilized to a flake. A process is described for maximizing the number of receptors found in the samples.

Abstract: An enzyme conjugate composition comprising an enzyme conjugate, a calcium salt and a polyethylene glycol is disclosed. The enzyme conjugate composition is effectively stabilized by the presence of the calcium salt and the polyethylene glycol.

Abstract: A blood gas-hemoglobin analysis control which simulates whole human blood characteristics comprising a buffered suspension medium containing erythrocytes which have been stabilized with an imidoester protein cross-linking agent while being contacted with a gas consisting of pure oxygen or pure carbon monoxide.

Abstract: This invention primarily is directed to a hematology reference control solution, the three separate white cell control portions thereof consisting of three types of fixed red cells of determined size distribution for checking the operation of a particle analyzing instrument, including its predetermined lower and upper threshold settings for each class or subclass of leukocytes.For preparing a human granulocyte analogue, nurse shark erythrocytes are altered and fixed in a chilled solution to simulate in number, size and distribution the granulocytes in human whole blood.

Abstract: Methods are provided for determining the presence or absence of ragged ends in polymeric proteins or protein products, by means of fast atom bombardment and high mass mass spectrometry (preferably high field magnet mass spectrometry). The methods may be modified for locating N- or C-terminal peptide in a polymeric protein or protein product and for assigning disulphide bridges in polymeric protein or protein products. The methods are applicable to other biopolymers such as nucleotides and carbohydrates.

Abstract: This invention relates to the field of clinical controls useful for calibrating clinical chemistry analyzers and in manual testing methods, as well as clinical standards and reagents. In addition, it relates to methods for producing stabilized liquid clinical control, standards, and reagents.

Abstract: The determination of fructosamine levels in at least part of a blood sample for use in detecting diabetes in patients or deciding treatment levels is effected by controlling the temperature and pH of the sample, adding a coloring agent such as a nitro-blue tetrazolium and after a first delay in time taking a first color measurment at a predetermined wavelength and after a second delay in time taking a second color measurement at the predetermined wavelength, then comparing any resultant change between the first and second color measurements with those of standard solutions, the selected timing delays, wavelength, coloring agent and pH conditions being such that any change of color in the coloring agent between the first and second color measurements is caused predominantly by the glucose in the sample that is reacted with an amine group of protein and has undergone a molecular rearrangement to form fructosamine and not materially by any non-specific reducing substance which may be present in the sample.

Abstract: This invention relates to the field of clinical controls useful for calibrating clinical chemistry analyzers and in manual testing methods, as well as clinical standards and reagents. In addition, it relates to methods for producing stabilized liquid clinical control, standards, and reagents.

Abstract: The determination of fructosamine levels in at least part of a blood sample for use in detecting diabetes in patients or deciding treatment levels is effected by controlling the temperature and pH of the sample, adding a coloring agent such as a nitro-blue tetrazolium and after a first delay in time taking a first color measurement at a predetermined wavelength and after a second delay in time taking a second color measurement at the predetermined wavelength, then comparing any resultant change between the first and second color measurements with those of standard solutions, the selected timing delays, wavelength, coloring agent and pH conditions being such that any change of color in the coloring agent between the first and second color measurements is caused predominantly by the glucose in the sample that is reacted with an amine group of protein and has undergone a molecular rearrangement to form fructosamine and not materially by any non-specific reducing substance which may be present in the sample.

Abstract: A preservative solution for fixed avian erythrocytes for the viral hemagglutination test of this invention comprises purified water which may contain serum albumin, glycerol or dimethyl sulfoxide and, additionally, a preventive against the growth of bacteria as occasion demands. Fixed avian erythrocytes can stably be preserved in this solution. HA and HI test can precisely be performed by employing fixed avian erythrocytes suspended in this invention.

Abstract: A composition which reduces the turbidity of samples of artificial or naturally occurring biological fluids comprising:a buffering agent;a nonionic surfactant;alpha-cyclodextrin;a lipase; andwater.The composition provides a catalyst for and agents which hydrolyze triglycerides present in the sample to glycerol and free fatty acids. Also present in the composition is a complexing agent or agents to render the catalyzed fatty acids water-soluble.

Abstract: A process for the preparation of a glucose-free glycosylated hemoglobin standard in which hemoglobin with a known content of glycosylated hemoglobin HbA.sub.Ia+b+c is converted to cyanmethemoglobin by means of a K.sub.3 (FeCN).sub.6 /KCN solution, stabilized with a sodium phosphate-cyanide buffer and preserved by lyophilizing at -40.degree. C. with a subsequent increase in temperature to -20.degree. C. under a high vacuum and stored at this temperature with the exclusion of light, whereupon the glucose-free glycosylated hemoglobin standard may be reconstituted by the addition of an aqueous medium.

Abstract: An improved reagent provides combined diluting and lysing of whole blood for use in instruments performing electronic blood cell counting and hemoglobin determination. The reagent prevents platelet aggregation and improves the accuracy of the white blood cell count.

Abstract: An isotonic multipurpose blood diluent, and a method for use of this diluent with a weak lysing reagent system which is especially suitable for routine enumeration of traditional hemogram values, and also the determination of lymphoid-myeloid populations of leukocytes, particularly in automatic particle counting systems.This blood diluent is capable of affording accurate, reproducible test results. It is an osmotically balanced aqueous solution of preselected pH containing Procaine hydrochloride for maintaining erythrocyte morphology during operation, N-(2-acetamido)iminodiacetic acid (ADA) as a blood cell stabilizing agent, and bacteriostatic agents including sodium 1-hydroxypyridine-2-thione, and dimethylolurea which, together with the ADA, allow preferential determination of myeloid-lymphoid leukocytes, and other hematological values.The lysing agent is a mixture of an aqueous solution of at least one quaternary ammonium salt having surface active properties, and an alkali metal cyanide.

Abstract: An improved multi-purpose blood diluent is provided which is isotonic, with a neutral pH for avoiding cell volume change. The diluent of the invention provides balance between the effects on cell volume of a preservative for the solution, and the effects of a surfactant. The diluent of the invention is particularly useful as a carrier for blood samples in instruments which automatically provide medical diagnostic determinations of blood samples. The diluent herein includes conventional sodium and potassium chlorides as electrolytes, pH buffers, such as monobasic and dibasic phosphate, and ethylene diamine tetraacetic acid to control and chelate the divalent cations. The balanced preservative-surfactant combination may include, for example, 2-phenoxyethanol with certain ethylene oxide-polypropylene glycol condensation products.

Abstract: A method for eliminating turbidity in a biological fluid by combining said fluid with a surfactant and an enzyme is disclosed as well as a diagnostic reagent formulation for that purpose.

Abstract: Hematologic control and calibration standards are disclosed which are essentially plasma-free. These controls are prepared by the suspension of red blood cells in an appropriate buffer containing a stabilization effective amount of disaccharides, and other optional ingredients. Control and calibration standards prepared in the foregoing manner are suitable in the control and calibration of hematology analyzers for the following parameters: white cell count, red cell count, hemoglobin, hematocrit and the common derived parameters (i.e., mean cell volume, mean cell hemoglobin and mean cell hemoglobin concentration). The addition of platelets to the foregoing suspensions is also contemplated to provide a control for platelet parameters.

Abstract: The present invention provides a process for the direct turbidimetric determination of .beta.-lipoproteins (LDL) in body fluids by precipitation with polyanions and divalent cations, wherein the precipitation is carried out in the presence of a complex former at a pH value of from 7 to 9.The present invention also provides a reagent for the direct turbidimetric determination of .beta.-lipoproteins (LDL) in body fluids, comprising a polyanion, a salt of a divalent metal, a complex former and a substance buffering at pH 7 to 9.

Abstract: Blood gas control containing hemoglobin, a pH buffering agent, and a reduced pyridine nucleotide capable of participating in a reaction which reduces methemoglobin to normal hemoglobin.

Abstract: A reference fluid for the calibration and control of blood gas instruments is comprised of substantially pure stroma-free hemoglobin solution, a buffering agent, a source of bicarbonate ion and predetermined amounts of gases found in in vivo blood.

Abstract: A control material for use in the determination of glycosylated and total hemoglobin, and a method of preparing the same, are disclosed. The control is prepared by the steps of hemolyzing red blood cells, preferably in the presence of a detergent, followed by removal of stroma and lipids from the hemoglobin with an organic solvent such as toluene in the presence of a polyhydroxy compound such as sucrose. A hemoglobin-rich fraction is separated from the resulting mixture and dialyzed against a solution of a polyhydroxy compound. The dialysate may be lyophilized to provide a stable, dry product suitable for reconstitution.

Abstract: Disclosed are cell-free, stable, aqueous blood gas controls containing a proteinaceous foaming agent. The addition of foaming agent to the blood gas control permits generation of a gas impermeable foam within the head space of a sealed ampule in which the control is packaged. Upon agitation of the ampule prior to opening, the foam thus generated effectively isolates the control fluid from the ambient environment, thereby maintaining the concentration of gases dissolved within the fluid at their assigned values.

Abstract: Artificially constituted storage-stable hemoglobin compositions for use in the temperature correction of a cation exchange column chromatographic assay for hemoglobin A.sub.1 or A.sub.1c in a sample of human blood. The relative amounts of hemoglobin components in the composition conform approximately to the following formula:______________________________________ y = mx + b where y = weight percent A.sub.1c with respect to A.sub.1 x = weight percent A.sub.1 with respect to total hemoglobin m = -1.7 and b = 85 when x < 10, and m = -1.2 and b = 80 when x > 10. ______________________________________The compositions when analyzed in a cation exchange assay produce a result which varies with temperature in substantially the same manner as that from a true sample of human blood.

Abstract: An acidic solution of glycine and a fatty acid of 3 to 12 carbon atoms provides an improved solution for cleaning and storing blood dialyzers and other separation devices, particularly those intended for contact with blood after they have once been used.

Abstract: The present invention provides a stabilized thrombin preparation in solid or dissolved form, especially for analytical purposes, containing, as a stabilizer, serum albumin together with at least one protease inhibitor and at least one chelate former.

Abstract: Synthetic stool, adaptable to use as a control standard in the diagnostic detection of substances contained in stools and for demonstration purposes, said stool comprising a matrix of a member selected from the group consisting of oxygen-containing organic polymers which are difficultly soluble in water and oxygen-containing inorganic solids difficultly soluble in water, a non-bleeding coloring agent adherent to said matrix and simulating the color of a stool, and a liquid selected from the group consisting of water and lubricants.