Abstract: An aqueous wash solution is useful for the detection of herpes simplex virus in a biological specimen. This solution has a pH of from about 9 to about 11.5, and consists essentially of an alcoholamine or a salt thereof and a nonionic surfactant. The solution is used to was uncomplexed materials from a complex of herpes simplex antigen and antibodies thereto. The wash solution can be supplied as part of a diagnostic test kit.

Abstract: The present invention relates to a method for an early stage detection of three specific pregnancy-related disorders: preeclampsia, intrauterine growth retardation and preterm delivery. According to the method, an antigen consisting of a specific human-derived placental soluble protein, known as PP-13, is determined by radioimmunoassay or ELISA. In the radioimmunoassay method, the PP-13 is labelled by a radioactive iodine and the bounded iodine is counted and correlated with standard curves. The best results are obtained when the protein to be labelled by radioactive iodine is present at a concentration of above 0.71 mg/ml. In case of the ELISA method, the quantitative determination of PP-13 is carried out with an alkaline phosphatase substrate and measured at an optical density of 405 nm.

Abstract: A test kit useful for the determination of an immunological ligand includes a labeled receptor for that ligand, a specific wash solution and a test device. The wash solution is buffered to a pH of from about 5 to about 9 and contains at least 0.01 weight percent of a compound having a dodecyl sulfate anion and an alkali metal or ammonium cation. One such compound is sodium dodecyl sulfate. The test device has several test wells, and in each well there is a microporous membrane. A receptor for the ligand of interest is immobilized in one test well. The kit is particularly useful for measuring human chorionic gonadotropin as an early indicator of pregnancy.

Abstract: A method for determining normal intrauterine pregnancy during the first 20 weeks of pregnancy comprises obtaining a test sample; and determining the presence of a fetal restricted antigen in the sample. The test sample is removed the vaginal cavity in the vicinity of the cervical canal and/or the cervical os. One fetal restricted antigen is fetal fibronectin.In one embodiment of this invention, the test 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, the test sample is contacted with an insoluble support to which is adhered an antibody which binds a class of substances including the fetal restricted antigen; and the fetal restricted antigen binding to the support is determined. Reagents and reagent kits are also included.

Abstract: A buffered aqueous composition is useful simultaneously as a wash solution and a dye-providing composition in specific binding assays involving enzyme-labeled specific binding reagents. The wash composition includes a dye-providing composition, a buffer and an organic solvent having a certain molecular weight and water-solubility. Another useful composition includes a particulate substrate having avidin attached thereto, and a peroxidase reducing agent. Either composition can be provided in a diagnostic test kit, and can be used to detect a specific binding ligand in assays.

Abstract: A method for determining whether an infertile patient is likely to benefit from combined GH/gonadotropin or GHRH/gonadotropin therapy comprising the steps of (1) administering a predetermined dose of clonidine or a pharmaceutically acceptable derivative thereof to the patient; (2) monitoring the blood level of GH following the administration of clonidine or a derivative thereof; and (3) detecting whether the peak blood level of GH is above a predetermined level.

Abstract: The subject invention describes a method of determining the secretor status of an individual which comprises obtaining a sample of a biological fluid from the individual and determining whether the sample includes the Lewis.sup.a or Lewis.sup.b antigens, the presence of the Lewis.sup.a antigen in the sample indicating that the individual is a nonsecretor, the presence of the Lewis.sup.b antigen in the sample indicating that the individual is a secretor, and the presence of neither antigen indicating the secretor status of the individual is inconclusive. The invention also provides a method of further determining the secretor status of an individual of having an inconclusive secretor status which comprises determining whether the biological fluid sample from the individual includes A, B or precursor type 1 chain antigens, the presence of any such antigens in the sample indicating that the individual is a secretor, the lack of any such antigens in the sample indicating that the individual is a nonsecretor.

Abstract: A kit for testing materno-fetal immunoincompatibility in women, particularly in women whose fetuses are in danger, comprises two containers containing an identical amoung of HLA-D antigen-containing material and one container containing male serum as control. In the test, maternal serum of the patient is added to one container of antigen while the control serum is mixed with the other container of antigen. The amount of expressed HLA-D antigen remaining in each case is established by conventional HLA-D directed monoclonal antibody immunoassay techniques such as conventional radio-immunoassay. The maternal serum assay divided by the control serum assay gives an immunoincompatibility quotient (IQ). The IQ is from 40 to 50% in healthy pregnant women and is about 70% in pathological cases. The test provides reliable results since the antigenic portion is non-living and therefore does not offer the inconstances of living test reagents.

Abstract: An extraction method for lysing chlamydial, gonococcal or herpes organisms and extracting detectable antigen therefrom involves the use of a protease. In particular, the antigen can be effectively extracted from a biological specimen which contains whole blood or mucous using a protease. The extracted antigen can be effectively detected in an immunoassay involving antibodies directed to the antigen. The protease is novel to the process and is obtained from Bacillus subtilisin.

Abstract: A natural birth control method comprises observance of the first day of menses followed by measurement of urinary progesterone metabolite levels beginning a predetermined number of days after the first day of menses. Urinary progesterone metabolite measurement is performed on days of planned sexual activity until the concentration level exceeds a threshold value indicative of ovulation occurring more than 24 hours previously. Once such a threshold value is observed, the woman may discontinue testing and can consider herself unable to conceive until after the beginning of the subsequent menstrual cycle.

Abstract: An antibody matrix immunoassay device for determination of number and proportion of subpopulations of leukocytes is described. The device can be used to evaluate and monitor the immune status of an individual and to diagnose and monitor the progression of AIDS.

Abstract: A method for determining increased risk of labor and fetal membrane rupture after week 20 of pregnancy comprises obtaining a secretion sample from the vaginal cavity; and determining the presence of a fetal restricted antigen in the sample. The sample can be removed from anywhere in the vaginal cavity, but is preferably removed from the posterior fornix or and/or 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, the class of substances of which the fetal restricted antigen is a member is captured with a general binding antibody (such as anti-human fibronectin antibody), anti-(fetal restricted antigen) antibody (such as anti-fetal fibronectin antibody) is conjugated with the support, and binding with fetal restricted antigen is determined.

Abstract: Preeclampisa, pregnancy induced hypertension (PIH) and eclampsia are determined by identifying the presence of an endothelial cell marker in a sample of blood, plasma or serum of a pregnant woman using a sandwich or competition immunoassay. Cellular fibronectin marker in a sample is determined by binding with an anti-(cellular fibronectin) antibody. Reagents for these methods are also an aspect of the invention.

Abstract: In an assay where a ligand or organism is detected by a detector binding protein ("DBP") capable of generating a signal in proportion to the amount of ligand or organism bound to the DBP, the presence of the ligand or organism is confirmed by the use, prior to or concurrently with the DBP, of a confirmatory binding protein ("CBP") which binds to a second site on the ligand or organism, and thereby prevents the DBP from binding to the first site. Thus, a reduction in signal of a predetermined amount indicates the true presence of the ligand or organism, while failure to obtain signal reduction of a predetermined amount indicates that the original signal was a false positive due to assay artifact or detection of related ligands or organisms. In a preferred embodiment, the CBP is a monoclonal antibody and the organism is derived from Chlamydia species.

Abstract: A method is provided for determining specific nucleotide sequences useful in forming a probe which can identify specific chromosomes, preferably through in situ hybridization within the cell itself. In one embodiment, chromosome preferential nucleotide sequences are first determined from a library of recombinant DNA clones having families of repetitive sequences. Library clones are identified with a low homology with a sequence of repetitive DNA families to which the first clones respectively belong and variant sequences are then identified by selecting clones having a pattern of hybridization with genomic DNA dissimilar to the hybridization pattern shown by the respective families. In another embodiment, variant sequences are selected from a sequence of a known repetitive DNA family. The selected variant sequence is classified as chromosome specific, chromosome preferential, or chromosome nonspecific.

Abstract: Antigens from chlamydial or gonococcal organisms in specimens containing whole blood, mucus or components thereof can be rapidly and sensitively determined using a polyamide microporous membrane which is coated with a surfactant. This determination is accomplished by contacting extracted antigen with the coated polyamide microporous membrane which is substantially free of any particulate matter. The membrane has an average pore size of from about 1 to about 10 .mu.meter. Within about 10 minutes of that contacting, antigen bound to the coated membrane is contacted with chlamydial or gonococcal antibody, respectively, so as to form an immunological complex on the membrane. The presence of the complex on the membrane is then determined as a measure of the amount of chlamydial or gonococcal antigen present in the specimen.

Abstract: A method for assaying of Chlamydia includes adhering Chlamydia antigen to amidine modified latex particles, binding of adhered antigen to an anti-Chlamydia antibody conjugated to an enzyme, separating the particles from the liquid phase of the assay and detecting bound enzyme by color development when the separated particles are contacted with a substrate for the enzyme. The invention includes a kit of materials for preforming an assay in accordance with the method of the invention.

Abstract: An aqueous wash solution is buffered to a pH of from about 5 to about 9 and contains at least about 0.01 weight percent of a compound comprising a dodecyl sulfate anion and an alkali metal or ammonium cation, such as sodium dodecyl sulfate. This wash solution is particularly useful in a method for the determination of an immunological ligand. Particularly, it is useful for washing the immunological complex formed between the ligand and a receptor molecule therefor. Unreacted materials can be readily separated from the complex by the washing, particularly if the separation is carried out using a filtration membrane in a test device. a test kit for ligand determination comprises the wash solution as well as one or more receptors for the ligand, at least one of which is labeled for detection. This kit is particularly useful for measuring human chorionic gonadotropin (hCG) as an early indicator of pregnancy.

Abstract: Monoclonal receptors raised to immunogenic polypeptides whose amino acid residue sequences correspond to sequences of oncoprotein ligands are disclosed, as are method for the production of those receptors and products and methods that utilize them. The monoclonal receptors bind both to the oncoprotein ligand to a portion of which the polypeptide corresponds in sequence, and to the immunogenic polypeptide to which the receptors were raised.

Abstract: The present invention is directed to the measurement of soluble T cell growth factor receptors, soluble T cell differentiation antigens, or related soluble molecules or fragments thereof, and the use of such measurements in the diagnosis and therapy of diseases and disorders. The measurement of such molecules can be valuable in monitoring the effect of a therapeutic treatment on a subject, detecting and/or staging a disease in a subject, and in differential diagnosis of a physiological condition in a subject. These measurements can also aid in predicting therapeutic outcome and in evaluating and monitoring the immune status of patients.In specific embodiments, measurements of serum or plasma interleukin-2 receptor levels can be made, to detect or stage leukemia or lymphoma. In other embodiments, IL2R levels, or CD8 levels, can be used to differentially diagnose renal allograft rejection, as distinguished from Cyclosporin A nephrotoxicity.

Abstract: A method and an apparatus for detecting antigen-antibody reaction are disclosed in which a predetermined antigen or antibody is made to attach to the surface of an oscillator and the oscillator is immersed in the specimen blood so as to cause antigen-antibody reaction on the surface thereof. The oscillator is then made to oscillate and the amount of antibody or antigen attaching to the surface of the oscillator is determined in accordance with the data concerning the oscillation of the oscillator.

Abstract: A method for separating male and female determining spermatozoa includes the initial step of exposing freshly ejaculated spermatozoa in a substantially protein free diluent to an excess concentration of a monoclonal antibody directed against H-Y antigen that binds substantially exclusively with male determining spermatozoa. The method continues with the suspending of the exposed spermatozoa together with a conjugate of (1) an immunoglobulin G antibody that binds substantially exclusively to the monoclonal antibody and (2) an immunoabsorbant substrate in a substantially protein free diluent. This forms a conjugate/spermatozoa preparation. The method concludes with the recovering of the separated male and female determining spermatozoa.

Abstract: An immunoassay test device is disclosed with dried reagent drops applied to a sloping side wall of a reaction wall. A method of applying them as liquid drops is also described, wherein the slope of the side wall, and the composition and volume of the liquid drop are selected to insure that the liquid drops do not flow down to the bottom of the well.

Abstract: A device for carrying out chemical or clinical testing of a liquid sample, for example a urine sample, by a specific binding assay, said device comprising a test compoenent (2) which has a sensitised solid surface (2a) carrying an immobilized component of a specific binding pair relevant to the essay, and a handling piece (1), and characterized in that the test component (2) bearing the sensitized surface (2a) is removably mounted in spaced relationship with a removably mounted accessory component (4) carrying an accessory solid surface (5), and in that there is a space (4a) between the sensitized surface (2a) and the removable accessory component (4) to act as a container for sample liquid, so that when the device is contacted with a sample liquid source or immersed in liquid which is to provide the test sample, liquid of the sample can enter the space (4a) to contact the sensitized surface (2a), and the accessory surface (5) acts to retain and contain sample liquid in contact with the sensitized surface (2a

Abstract: A method for reducing the occurrence of falsely elevated results in a peroxidase-catalyzed, enzyme assay is described. Interference in an assay caused by blood or bood products in a clinical specimen is eliminated or reduced by reacting the specimen with an oxidizing agent such as sodium hypochlorite, hydrogen peroxide or sodium meta-periodate.

Abstract: The present invention provides for novel homogeneous immunoassay systems involving complement-mediated lysis of marker-encapsulating lipid vesicles (liposomes) for detection of analyte in a fluid sample. These systems do not require the separation of unbound antigens and/or antibody conjugates yet provide highly sensitive procedures for analyte detection. Liposomes containing a marker, are coupled to antibody fragments in a way which confers the liposomes with immunological specificity yet avoids sensitizing the liposomes to complement mediated lysis in the absence of analyte. Antibody sensitized liposomes (the first reagent) are sequentially incubated with an analyte-containing sample, and optionally "dummy" liposomes, which do not contain encapsulated marker, a second antibody (the second reagent), and finally with a complement source such as plasma. Complement is activated by the liposome-antibody-antigen-second antibody complex causing liposome lysis and a concomitant release of marker.

Abstract: An aqueous wash solution is buffered to a pH of from about 5 to about 9 and contains at least about 1.5 weight percent of a compound comprising a lower alcohol sulfate anion having from 6 to 10 carbon atoms and an alkali metal or ammonium cation, such as sodium decyl sulfate. This wash solution is useful in a method for the determination of an immunological ligand, and is not prone to crystallization at lower temperatures. Particularly, it is useful for washing the immunological complex formed between the ligand and a receptor molecule therefor. Unreacted materials can be readily separated from the complex by the washing, particularly if the separation is carried out using a filtration membrane in a test device. A test kit for ligand determination comprises the wash solution as well as one or more receptors for the ligand, at least one of which is labeled for detection. This kit is particularly useful for measuring human chorionic gonadotropin (hCG) as an early indicator of pregnancy.

Abstract: Methods are disclosed for detecting an antigen in a biological sample. The methods involve providing in combination a solid support, which is substantially free of specific binding proteins, and a medium comprising an antigen from the sample and an antibody for the antigen. The combination is incubated under conditions sufficient for the antibody when bound to the antigen to bind to the support. The presence or amount of antibody on the support or in the medium is determined and is related to the presence of antigen in the sample. The methods have particular application to the detection of gram-negative bacteria.

Abstract: The present invention relates to a method of diagnosis of pathological pregnancy which relies on an evaluation of the amount of placental isoferritin (PLF) in the serum or amniotic fluid of a pregnant woman. Diagnosis may also be achieved by observation of percentages of PLF-bearing lymphocytes in the pregnant female. Detection of PLF levels is achieved by immunoassay with a PLF-specific anitbody. Also described is a method of treating or preventing pathological pregnancies and transplant or graft rejection by administration of effective amounts of PLF and/or a PLF-specific antibody in combination with immunization.

Abstract: A method for calibrating a flow cytometer or fluorescence microscope in terms of number of binding antibodies as a function of fluorescence intensity value measured on the flow cytometer or fluorescence microscope, and subsequent measuring of a sample to which the antibodies are bindable. Also disclosed is a microbead calibration kit for carrying out the calibration method of the invention. The disclosed calibration methodology provides a direct relationship between instrument response and numbers of binding antibodies, independent of the fluorochrome employed to label the samples being measured. The method has utility in monitoring the status of an antigenic cellular condition in which the number of antibodies binding to successively obtained cellular samples is determined, to establish the progressionary character of the antigenic cellular condition, in a host from which the cellular samples are taken.

Abstract: An immunoassay procedure for the detection of chlamydia trachomatis antigen in a urogenital clinical specimen including a method for substantially eliminating the occurrence of false negative and false positive results of the immunoassay procedure. The method comprises treating a patent specimen with an aqueous solution having a final concentration of 0.1M NaOH or 0.1M KOH and then neutralizing the specimen-containing solution before conducting the immunoassay.

Abstract: An isolated, substantially pure bovine pregnancy antigen for detecting and determining pregnancy in cattle consisting of a glycoprotein obtained from a pregnant bovine animal which is characterized by having a specific immunological reaction with a monoclonal antibody directed specifically against said glycoprotein wherein said monoclonal antibody is produced from hybridoma ATCC HB 8846.

Abstract: A solid-phase immunoassay is provided for determination of HIV antigens in human physiological fluid. The immunoassay is characterized by the coating of a solid substrate with a unique monoclonal antibody which recognizes a common antigenic determinant of a group of HIV core antigens and no HIV envelope antigens of HIV. The test sample preferably also is subjected to a lysing reagent prior to the incubation for uniformly dispersing antigens which may be present in the test sample.

Abstract: A process for the detection of antibodies to HTLV III/LAV comprising:(A) mixing an unknown serum sample with a crude HTLV III/LAV viral antigen selected from the group consisting of(1) an antigen comprising P24 core protein and Penv protein;(2) a P24 antigen and(3) a Penv antigen,(B) incubating the resultant mixture from step (A);(C) contacting the mixture of step (B) with a solid substrate coated with antibody to HTLV III/LAV;(D) incubating the mass from step (C);(E) washing the mass from step (D);(F) contacting the mass from step (E) with a labeled antibody to HTLV III/LAV;(G) incubating the mass from step (F);(H) washing the mass from step (G);(I) assaying the label in the mass from step (H);(J) as a negative control, mixing a serum sample known to be negative to HTLV III/LAV antibody with a diluent;(K) subjecting the mass from step (J) to steps (B) to (I);(L) as a positive control, mixing a predetermined amount of the crude HTLV III/LAV viral antigen and the diluent;(M) subjecting the mass from step (L) t

Abstract: A method for the early detection of a pregnancy comprises determination of EPF in the blood or urine or in a biochemical derivative of the blood or urine of pregnant women, by measuring the influence of EPF on the production of electronically excited states or radicals, especially oxygen radicals, or their secondary products, in leukocyte or cell line preparations. The method can also be used to determine gonadal tumors.

Abstract: A solid-phase immunoassay is provided for determination of members of an immunological pair such as antigen and/or antibody of a single binding pair in human physiological fluid, wherein a single immunoassay enables simultaneous detection of antigen and/or antibody of a single binding pair in a test sample which may have circulating antigen and/or antibody. The immunoassay is characterized by the addition of an amount of antigen or "spike" of the binding pair to the test sample prior to incubation of the test sample in the presence of a solid-phase absorbed antibody of the binding pair. The test sample preferably also is subjected to a lysing reagent prior to the incubation for uniformly dispensing antigens which may be present in the test sample.

Abstract: Disclosed herein is a composition useful for stabilizing diagnostic reagent which functions to react with a specimen to determine the presence or absence of a biological condition comprising about 0.01 to 35 parts by weight protein or peptide and either (A) about 1 to 90 parts by weight of a saccharide polyol selected from the group consisting of corn syrup and dextrose and optionally up to about 25 parts by weight of a pyrrol, or (B) about 1 to 90 parts by weight of a saccharide polyol and about 0.01 to 25 parts by weight of a pyrrol. Also disclosed is a method of stabilizing such diagnostic reagents comprising using the stabilizing composition, and a diagnositc device comprising a non-absorbent base carrying at least one deposition area in which is carried the evaporative residue of such diagnostic reagent and the stabilizing composition.

Abstract: Novel and improved methods for diagnosis, prognosis, prophylaxis and therapy of viral infections are described. The novel methods employ a virus, viral antigen or fragment thereof in which "perturbation" of an oligosaccharide moiety renders the virus, viral antigen or fragment thereof more specifically recognizable or reactive with neutralizing antibody. As described, "perturbation" of an oligosaccharide moiety encompasses any modification that (1) alters the chemical or physical structure of a carbohydrate residue that is naturally present; (2) that removes, wholly or in part, a carbohydrate residue; and/or (3) that prevents or alters addition of a carbohydrate residue. A variety of methods for oligosaccharide "perpetuation" are also described.

Abstract: An immunoassay for detecting and measuring hCG in a sample includes an antibody directed to the carboxy terminal portion of the .beta. subunit of hCG and a monoclonal antibody directed to a determinant on hCG at a locus sufficiently remote from the carboxy terminal portion of the .beta. subunit of hCG that both antibodies can simultaneously bind to hCG, wherein at least one of the antibodies is delectable when both are bound to hCG.In a presently preferred embodiment, an immunoassay for hCG or hCB.beta. in urine includes a purified, labeled or detectable serum-derived antibody directed to the carboxy-terminal portion of the .beta. subunit of hCG and a matrix-bound monoclonal antibody directed to a locus on the .beta. subunit sufficiently remote from the carboxy-terminal portion that both antibodies can simultaneously bind to hCG or hCG.beta..

Abstract: A test kit is used in an agglutination immunoassay to determine a multivalent immune species, such as Streptococcus A antigen, in a biological sample. The method includes contacting an aqueous solution of the species with an agglutination indicator reagent having receptor molecules reactive with the species to form an agglutinate of the reaction product of species and receptor. These receptor molecules are bound to polymeric particles which contain tracer molecules. The resulting agglutinate is captured on a microporous membrane which has an average pore size which is at least five times greater than the average diameter of the polymeric particles. Unagglutinated residual materials are washed through the membrane using a wash solution. This solution has a pH of from about 5 to about 10 and an ionic strength of at least about 0.25. Tracer is then determined either in the agglutinate or in the residual materials.

Abstract: A method of testing a fluid sample for the presence of antibodies against a micro-organism, which comprises contacting the sample with fixed cells or fragments of cells infected with the micro-organism, and determining the presence of antibody bound to the cell-associated antigens, in which the determination is by virtue of a color change visible to the naked-eye at the site of the antibodies. For use in a testing method of this type, a test component comprises upper and lower layers, in which the upper layer has an array of apertures through which discrete areas on the lower layer are exposed, and in which the lower layer carries, in some at least of the discrete areas, fixed cells or cell fragments infected by a micro-organism.

Abstract: A highly sensitive and specific monoclonal-immuno-radiometric assay (M-IRMA) for hCG, using monoclonal antibodies (Mabs) directed against a 37-amino acid synthetic polypeptide analogous to the carboxyl terminus (CTP) of beta-hCG. Accordingly, in one embodiment, a method is described for the determination of human chorionic gonadotrThe present invention was made utilizing funds of the United States Government. The U.S. government is therefore granted a royalty-free, non-exclusive, world wide, paid-up license in this invention.

Abstract: Mixtures of monoclonal antibodies which contain effective assaying amounts of each of at least two monoclonal antibodies that bind to different antigenic sites on the antigen and are capable under appropriate conditions of binding simultaneously to an antigen are useful in enhanced sensitivity assays for the antigen. By utilizing such mixtures in diagnostic assays for important antigens such as the polypeptide human chorionic gonadotropin enhanced sensitivity can be achieved as compared with assays employing individual monoclonal antibodies.

Abstract: A bovine pregnancy antigen, determined to be a glycoprotein, has been isolated and purified. If is diagnostic for the presence of pregnancy in cattle when detected by the use of antibodies to the antigen.

Abstract: This invention relates to a method to measure natural human antibodies in sera which will neutralize HTLV-III infection in an in vitro assay. Basically, cell-free virus is incubated with serum and used to infect H9 cells, which are then put in culture for three days, and viral infectivity is assayed using a monoclonal antibody specific for HTLV-III p24 in an immune fluorescent assay.

Abstract: Solid phase assay for an analyte wherein binder is supported on a solid support, such as nitrocellulose, and the tracer is comprised of ligand labeled with a particulate label, such as a liposome, including a detectable marker which is not visible.

Abstract: A device for carrying out chemical or clinical testing of a liquid sample, for example a urine sample, by a specific binding assay, said device comprising a test component (2) which has a sensitized solid surface (2a) carrying an immobilized component of a specific binding pair relevant to the assay, and a handling piece (1), and characterized in that the test component (2) bearing the sensitized surface (2a) is removably mounted in spaced relationship with a removably mounted accessory component (4) carrying an accessory solid surface (5), and in that there is a space (4a) between the sensitized surface (2a) and the removable accessory component (4) to act as a container for sample liquid, so that when the device is contacted with a sample liquid source or immersed in liquid which is to provide the test sample, liquid of the sample can enter the space (4a) to contact the sensitized surface (2a), and the accessory surface (5) acts to retain and contain sample liquid in contact with the sensitized surface (2a)

Abstract: There is described an enzyme inhibitor labelled immunoassay for measuring the concentration of an analyte in a sample wherein the substrate for the enzyme forms at least a part of the sample. In a particular embodiment the sample comprises or consists of a milk sample and the inhibitor label is capable of inhibiting the activity of an enzyme capable of clotting milk. Examples are given of suitable inhibitors. The assay described may be used to measure the concentration of progestogens or oestrogens in milk using the techniques of heterogeneous or homogeneous enzyme inhibitor labelled immunoassay. The results of such an assay give an indication of the fertility of a milk producing domestic animal (e.g. a cow) and may be used to diagnose pregnancy of such an animal. Particular compounds for use in the assay are described, as is a kit of reagents for use in the assay.

Abstract: A novel method for the diagnosis of Acquired Immune Deficiency Syndrome (A.I.D.S.) is disclosed, involving the use of immunocytoadherence (rosette inhibition) techniques. The method is based on the discovery that the lymphocytes of A.I.D.S. patients are unusually resistant to antithymocyte serum, and that the plasma of A.I.D.S. patients is capable of conferring this resistance to normal lymphocytes. Accordingly, the diagnostic method involves performing rosette inhibition tests on the patient's lymphocytes or on lymphocytes from a healthy donor after treatment with the patient's plasma. Any observable lessening of inhibition in comparison with a control is related to the presence of A.I.D.S.

Abstract: A method is provided for determining the concentration of pregnanediol glucuronide (PG) in a woman's urine which is characterized by utilization of the reagent 20.alpha.-hydroxy-4-pregnen-3-one (20-.alpha. reagent) in a form in which it reacts with antibodies binding to PG. The method is adaptable to a visual color indication test which can be performed by the woman herself as well as by laboratory analysis. The method can be used to define the period in which conception can occur, to define a post-ovulation safe period in which conception is prevented, and as an early pregnancy indicator.