Abstract: The invention is a sterile, plasma-free storage medium for blood components including red blood cells and for platelets processed separately or together. The red cell storage medium includes a physiologically compatible, aqueous electrolyte solution. In one liter of this electrolyte solution there is between about 3.0 grams and about 25.0 grams of dextrose, between about 3.0 grams and about 6.0 grams of sodium citrate, and between about 2.0 grams and about 4.2 grams of sodium bicarbonate. The red cell storage medium is isotonic and has a pH in a range of between about 6.8 and about 7.4. The red cell storage medium is capable of storing and preserving red cells for at least 49 days.

Abstract: The present invention is intended to provide an EIA method utilizing bioluminescence using a firefly luciferase. The EIA method of the present invention is characterized by using an ATP-generating enzyme as a labeling enzyme, subjecting ATP generated to bioluminescence by the use of the firefly luciferase, and measuring the quantity of light emitted. Acetate kinase is a preferred enzyme used in the method.

Abstract: A method of immunologically staining a formalin-fixed tissue preparation, which comprises (a) subjecting a formalin-fixed tissue preparation to microwave energy while the tissue preparation is submersed in water for a time sufficient to increase immunostaining efficiency; (b) removing the tissue preparation from the water and cooling; and (c) contacting the tissue preparation with an immunological staining reagent.

Abstract: The present invention provides an improved assay for measuring thyroxine uptake by thyroxine binding globulin in which thyroxine binding globulin (TBG) activity is measured directly. The method comprises combining a sample in an aqueous solution with an enzyme donor (ED) conjugated to an analogue of polyiodothyronine that competes with thyroxine for thyroxine binding globulin binding sites. An enzyme acceptor (EA) characterized by providing a modulated enzyme activity in relation to the amount of TBG activity is combined with an enzyme donor and sample in an aqueous solution. The amount of enzyme activity in comparison to a control solution having a known amount of available TBG binding sites is determined.

Abstract: A method and apparatus for performing determinations of immune reactants (e.g., antigens, antibodies) in bodily fluids utilize multiple test units having respective elongated rods with transversely-expanded polymer tips at their distal ends. The tip surfaces contain microgrooves and are coated with respective immune reactants (e.g., allergens) of the type which react in a known manner with respective allergen-specific or allergen-binding antibodies in human serum. The supporting strip for the test units has through-holes which frictionally or adhesively engage the proximal ends of the test unit rods with a spacing that permits all of the supported test units to be simultaneously inserted into a reaction vessel permitting simultaneous determination of reactants and degrees thereof against multiple immune reactants of varying kinds (i.e., allergens, antigens, antibodies) in a common sample of body fluid (i.e., serum, plasma, whole blood, etc.).

Abstract: Antiserum which can recognize all subtypes of human leukocyte interferon is prepared from the blood of an animal immunized with partially purified human leukocyte interferon obtained from a culture of human leukocyte stimulated with Sendai virus.The antiserum is added to a column whereon concentrated culture broth of human leukocyte has been immobilized to adsorb impurities, the effluent is added to a column whereon partially purified human leukocyte interferon has been immobilized to adsorb anti-human leukocyte interferon antibody and then the antibody is eluted from the column.The antibody thus obtained recognizes all subtypes of human leukocyte interferon and can be separated by a chromatography to each monoclonal antibody which recognizes a single subtype.Employing these antibodies, the subtypes of human leukocyte interferon or their antibodies in a sample can be analized or assayed.

Abstract: This invention relates to the diagnosis of preeclampsia using an assay to measure a mitogenic factor in blood. Preeclampsia is a serious problem in pregnant women. It is an idiopathic life threatening hypertensive condition. The condition of preeclamptic women can often deteriorate to a point where serious injury will occur to either the mother, child or both. Preeclampsia is a leading cause of death both maternal and infant.

Abstract: An antigen-antibody complex in which two molecules of IgG class monoclonal anti-D are bound to one or two molecules of monoclonal or polyclonal anti-IgG antibody specific to the IgG class monoclonal anti-D. It reacts with Rh(D) positive blood cells, causing an observable agglutination and is useful for quick Rh blood typing.

Abstract: Enzymatic immunoassay for estimating the concentration of antigen or antibody comprising bringing an antigen-antibody complex, which is labelled by an enzyme and is present heterogeneously in a solution, into contact with a substrate where pH of the solution is so adjusted as to be suitable for the enzyme to be activated and also for measuring the fluorescence of the substrate, measuring the time-variation of fluorescent intensity of the substrate produced by the enzyme reaction, and estimating the concentration of the antigen or the antibody from the slope of the substantially linear portion, on a characteristic curve representing variation of the fluorescence intensity with the time.Fluorescence is measured while magnetic beads with antigen-antibody complex attached are oscillated at a specific frequency.

Abstract: A method of high sensitivity immunoassay characterized by inclusion of processes (A), (B), (C) and (D) described below.Process (A): A process of binding of a solid carrier and a complex comprising the specific antibody or antigenic substance to be assayed in the test solution and one or more active components.Process (B): A process of dissociating said complex from the solid carrier.Process (C): A process of binding this complex to another solid carrier.Process (D): A process of assay for the complex on the solid carrier mentioned in the description of process (C) above.Permitting rapid, high sensitive immunoassay irrespective of whether the subject of assay is an antibody or an antigen, the method of the present invention is very useful for quick diagnosis of various diseases.

Abstract: A carrier having at least one kinetics and fluorescence enhancing support and a dry substance selected from the group consisting of fluorogenic substrates, B methylumbelliferone, 7-amino-4-methyl coumarin, B-napthylamine, fluoroscein, and resorufin deposited on the support demonstrates substantial enhancement of hydrolysis kinetics and fluorescence over pure liquid systems. When the device has a plurality of supports and the supports have different fluorogenic substrates an enzyme rate-of-reaction profile representative of a microorganism in the suspension can be determined and used to identify the organism. The device can also be used to characterize enzymes expressed by other biological specimens.

Abstract: A method for determining ectopic pregnancy in pregnant persons comprises obtaining a test sample; and determining the absence of a fetal restricted antigen in the sample. The sample is obtained from the vaginal cavity in the vicinity of the cervical canal or the cervical os. One fetal restricted antigen is fetal fibronectin. In one embodiment of this invention, the sample is contacted with an insoluble support to which anti-(fetal restricted antigen) antibody is adhered, and the fetal restricted antigen binding to the support is determined. Alternatively, a class of substances of which the fetal restricted antigen is a member is captured with a general binding antibody such as an anti-(fibronectin) antibody; an anti-(fetal restricted antigen) antibody such as anti-(fetal fibronectin) antibody is bound to the support; and the absence of binding with fetal restricted antigen is determined. Competition or sandwich assay procedures can be used. Reagents and reagent kits are also included.

Abstract: A wash solution having a pH of from about 7 to about 12 comprises at least about 0.1 weight percent of one or more cationic surfactants. This wash solution is useful in assays for chlamydial or gonococcal organisms, such as Chlamydia trachomatis or Neisseria gonorrhoeae. In particular, it can be used to remove uncomplexed materials from the insolubilized complexes formed between antigen and antibodies.

Abstract: The invention relates to an assay for determining an analyte in a fluid sample. Three receptors are used, with formation of a quaternary or four member complex. One of the receptors is bound to a solid phase, and binds to complexes of another receptor and the analyte. A third receptor is labelled, and it, too, binds analyte. The invention also involves the use of a displacement solution to wash fluid sample from solid phase after the first portion of the quaternary complex forms, i.e., prior to binding with the labelled receptor.

Abstract: A monoclonal antibody specifically reactive to hamster immunoglobulins, a hybridoma producing said monoclonal antibody, and an immunoassay utilizing said monoclonal antibody are provided. The monoclonal antibody is useful in an immunoassay as a secondary antibody to a hamster-derived primary antibody or antiserum raised against various antigens.

Abstract: Method of detecting chronic exposure of an organism to a pollutant, and for evaluating biological damage due to chronic exposure to sublethal levels of pollutants and kits for carrying out the method are disclosed. The methods comprise:(a) sampling at least one organism in order to determine whether it has been chronically exposed to a sublethal concentration of one or more pollutants in its environment, under sampling conditions that do not induce any additional heat shock protein (hsp) response in the organism;(b) obtaining a sample of cells or secretions of said organism, suspected of having elevated levels of heat shock proteins and solubilizing the heat shock proteins in the sample; and(c) measuring the concentration of a heat shock protein selected from hsp 70, hsp 60 and ubiquitin, in said sample.

Abstract: Dense microspheres can be extracted and purified to substantial homogeneity from mammalian brain tissue, and used in the screening of therapies for potential effectiveness in impeding the formation of amyloid fibrils associated with Alzheimer's disease and other forms of cerebral amyloidosis. Compounds that, at in-tissue concentrations of 10.sup.-5 M or less, inhibit amyloid formation in a test animal injected intracerebrally with dense microspheres are particularly useful in inhibiting treating cerebral amyloidosis. Antibodies to DMS (dense microspheres) are also disclosed.

Abstract: A process for preparing a vaccine against malaria comprising at least one polypeptide extracted from a schizont form of a strain of Plasmodium containing polypeptides antigenic to malaria. The polypeptides are recognized by immunoglobulin from a Saimiri Sciureus monkey resistant to the strain. The process includes the steps of:(a) treating a preparation of a strain of Plasmodium with a solution of a detergent which is able to separate the cellular structures from the parasite proteinic constituents;(b) recovering from the treated preparation, a polypeptide fraction having intact polypeptides of molecular weight ranging from about 70,000-85,000 or 90,000-120,000. The polypeptide fraction induces, in a first splenectomized Saimiri Sciureus monkey, a protective antibody against such strain, the polypeptides being recognized by immunoglobulin from a second Saimiri Sciureus monkey resistant to the strain.

Abstract: A method for purifying an aqueous intrinsic factor solution which contains R-protein is disclosed. The method involves adding to the intrinsic factor solution an amount of colloidal silica to disperse lipid emulsion, an amount of cobinamide sufficient to bind substantially all of the R-protein in the solution and an amount of an intrinsic factor affinity resin sufficient to bind the intrinsic factor in the solution, washing the bound cobinamide and the R-protein from the resin, eluting the intrinsic factor from the resin, and dialyzing the eluted intrinsic factor. The purified intrinsic factor possesses less than 0.004 percent cross reactivity with cobinamides, and at least 95 percent of the proteins in the purified material can bind cobalamins. A conjugate of microparticles and the purified intrinsic factor is also disclosed, as is a kit for conducting an assay for cobalamins which includes a conjugate of microparticles and purified intrinsic factor.

Abstract: Sperm are encapsulated in a nontoxic polymer which is freely flowing at body temperature and a gel or solid at temperatures of storage and transfer. On delivery to the reproductive tract, the polymer microcapsule liquifies and the sperm are released.