Abstract: A particularly efficient design for a nonbibulous lateral flow one step assay for an analyte in a biological sample is disclosed. In the improved device of the invention, three zones which are in nonbibulous lateral flow contact are employed: a sample receiving zone, a labeling zone, and a capture zone. The sample containing analyte is carried through the labeling zone and interacts with an assay label comprising visible moieties, preferably particles, which are coupled to specific binding reagent for analyte or to a competitor with analyte for a capture reagent. The flow continues into the capture zone where the visible moieties to which analyte or competitor are coupled are captured. Excess fluid is absorbed into an absorbent zone in contact with the capture zone. A positive result is obtained by visualizing the visible moieties in the capture zone.

Abstract: A particularly efficient design for a nonbibulous lateral flow one step assay for an analyte in a biological sample is disclosed. In the improved device of the invention, three zones which are in nonbibulous lateral flow contact are employed: a sample receiving zone, a labeling zone, and a capture zone. The sample containing analyte is carried through the labeling zone and interacts with an assay label comprising visible moieties, preferably particles, which are coupled to specific binding reagent for analyte or to a competitor with analyte for a capture reagent. The flow continues into the capture zone where the visible moieties to which analyte or competitor are coupled are captured. Excess fluid is absorbed into an absorbent zone in contact with the capture zone. A positive result is obtained by visualizing the visible moieties in the capture zone.

Abstract: Particles comprising an energy donor as a first component and a fluorescent dye as a second component positioned in said particles at an energy exchanging distance from one another, wherein the two components have a Stokes shift of greater than or equal to 50 nm, said particle having bound on its surface, a protein, polypeptide, nucleic acid, nucleotide or protein containing ligand analogue are disclosed and claimed. In addition, novel fluorescent dyes are described which exhibit intramolecular energy transfer for use to label various molecules, proteins, polypeptides, nucleotides and nucleic acids or to incorporate into particles.

Abstract: The present invention is for an immunoassay for the measurement of total insulin-like growth factor binding protein-1 (IGFBP-1) and is unaffected by the degree of phosphorylation of the protein. The invention is also for an immunoassay for assessing the phosphorylated variants of IGFBP-1.

Abstract: The invention is an improved single-step test device for detecting the presence of a pre-selected analyte in a urine stream. The device has a hollow outer casing and an assay material disposed within the casing. The outer casing defines: a urine inlet port; a viewing window; and at least one drainage vent spaced about the urine inlet port. The assay material is a sorptive material defining: a urine sample application region adjacent to, and in fluid communication with the urine inlet port; a capture region adjacent to the viewing window; and a fluid flow path for transporting liquid sample between the urine sample application region and the analyte capture region. The drainage vent is located to permit excess urine entering the casing from the urine stream to exit the casing thereby to minimize hydraulic pressure induced flooding of the assay material disposed within the casing and to reduce the frequency of false test results.

Abstract: Herein disclosed are methods for prenatally assessing risks of a pregnancy being affected by Down syndrome by testing maternal urine samples for levels of urinary gonadotropin peptide (UGP) elevated above normal. The methods employ immunoassays that are highly specific for UGP and have molar cross-reactivities of less than about 10% with intact hCG, with .beta.-subunit hCG, and with .alpha.-subunit hCG. The immunoassay methods of this invention are useful to test first trimester maternal urine samples. Among other benefits, first trimester prenatal screening provides the opportunity to terminate the pregnancy at an early gestational age, in the case of an unfavorable outcome.

Abstract: A test strip for a rapid immunoassay containing specific immunochemical reagent zones (7, 8, 9) is described. The test strip (10) has a backing sheet (1) and attached thereto a receiving end pad (3) and at a distance therefrom a finishing end pad (5). A test membrane (2) is provided between said pads (3, 5). Said membrane (2) is positioned in parallel relationship to said backing (1) at a distance therefrom so that said backing (1) and said membrane (2) limit between themselves an air gap (4) which is open at its edges. Said gap (4) functions as a sheltered reaction chamber for the immunolgical reaction taking place as a liquid is made to flow through said membrane (2). The test strip is simple to manufacture by lamination and easy to use and it is suitable for both diagnostic and environmental immunoassays.

Abstract: This invention relates to a lateral flow immunochromatographic assay device without a plastic housing. The assay includes a sample receiving region, analyte detection region and end region all made of porous material and capable of lateral flow. The analyte detection region includes labeling reagents, a capture reagent and a control reagent. The back of the porous material is laminated with a semi-rigid material with adequate mechanical strength. The top is partially covered with a thin plastic material so as to leave a portion of the sample receiving region exposed for sample application.

Abstract: Therapeutic and diagnostic methods of use for the growth factor transforming growth factor .beta., are provided by this invention. In accordance with preferred embodiments, methods of determining competence of a conceptus toward uterine implantation are provided as are methods for determining female infertility in mammals.

Abstract: A "one step" device for the detection of analytein clinical assays is disclosed. A visible label comprising a visible moiety and a ligand that binds to or competes with analyte is contained in a fluid conducting membrane or prefilter; and the analyte and associated ligand are conducted by the flow of sample into a detection zone. The detection zone contains a capture reagent that binds to label or to analyte bound to label.

Abstract: A method for the evaluation of the condition of a fetus by quantitative measurement of prostate specific antigen (PSA) is provided. In the method, a sample of amniotic fluid or maternal serum is obtained at a gestational week and the sample is assayed for the amount of PSA present. The amount of PSA in the sample is compared with the PSA mean for the given gestational week and evaluated for the risk of a phenotypic and/or genotypic disorder.

Abstract: The present invention relates to the purification of the human chorionic gonadotropin .beta.-core molecule which can then be used as the antigen in the preparation of antibodies to the .beta.-core molecule. The combination of the purified .beta.-core molecule and the antibodies can be used in an immunoassay kit to measure .beta.-core molecules in the presence of structurally similar molecules, i.e., hCG, LH, hCG.beta.-subunit and LH.beta.-subunit. Measurement of the .beta.-core molecule is particularly useful in testing for pregnancy and many malignancies.

Abstract: Methods for detecting and isolating acrosome-reacted sperm and complement receptor-bearing oocytes using the complement component C3, fragments, or variants thereof, antibodies to a complement receptor, or antibodies to C3, are disclosed. These methods have application in the assessment of fertility, in the preparation of sperm or oocytes for in vitro fertilization or for gamete intrafallopian tube transfer, in promoting or inhibiting fertilization in vitro and in vivo, and in diagnosing and treating infertility.

Abstract: A method and kit for measurement of asteroid by means of a competitive immunoassay, preferably a competitive enzyme immunoassay. The method and kit involve the use of asteroid analogue conjugated to a label. The steroids that are amenable to detection by the method and kit of the present invention include estradiol and progesterone.The method comprises the steps of:a. incubating a mixture of a test sample suspected of containing a given steroid, a solid phase coupled to an antibody specific for that steroid, and a conjugate of an analogue of that steroid to form steroid/antibody complexes and conjugate/antibody complexes on said solid phase;b. separating said solid phase from said mixture;c. measuring the amount of label present in said mixture or in said solid phase; andd. determining the amount of steroid in said sample from the amount of label.The kit comprises a solid phase coupled to an antibody specific for a steroid and a conjugate of an analogue of that steroid.

Abstract: A factor that indicates fertilization of an ovum before implantation, Preimplantation Factor (PIF), has been found. PIF also provides an early indication of pregnancy, malignancy, and autoimmune diseases. Assays for PIF are described. Detection of PIF in mammalian blood and other fluids is utilized in various diagnostic tests.

Abstract: An analytical test device useful for example in pregnancy testing, includes a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating an a

Abstract: An immunoassay process is provided for the detection of a target antigen in a fluid sample where an admixture of the target antigen and a labeled capture reagent against the target antigen is contacted by a solid polymeric carrier having bound to a portion of its surface a capture reagent against the target antigen and visual determination of a change in color of the bound labeled reaction product on the surface of the solid carrier member serves to readily detect the presence of the target antigen.

Abstract: Kits are provided for prenatal screening tests for risk of Down's syndrome which are carried out on a maternal serum sample obtained before the beginning of the third trimester of pregnancy. The kits contain immunoassay means to determine alpha-fetoprotein, unconjugated oestriol, human chorionic gonadotrophin, and/or dehydroepiandrosterone sulfate (DHEAS).

Abstract: A dry-type analytical element for immunoassay having at least one water-permeable layer for measuring a ligand in a sample according to enzyme immunoassay, which comprises,(A) a water-soluble macromolecular substrate, and(B) an enzyme conjugated with antibody reacting with the ligand in the sample capable to act on the above water-soluble macromolecular substrate. The above analytical element further comprises,(C) a macromolecular antigen which is a conjugate of the ligand or its derivative with a macromolecular compound in the above water-permeable layer of the above dry-type analytical element.The invention can conduct highly sensitive and simple enzyme immunoassay.

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: A rapid diagnostic method for detecting the rupture of fetal membranes is disclosed. The presence of insulin-like growth factor binding protein 1 (IGFBP-1) in a vaginal secretion sample, resulting from the rupture of fetal membranes, is detected with the aid of at least one specific binding substance for IGFBP-1 .

Abstract: Device for detecting the presence or amount of an analyte of interest, comprising a reflective solid, optical support and a label capable of generating fluorescent signal upon excitation with a suitable light source wherein said support comprises an attachment layer comprising a chemical selected from the group consisting of dendrimers, star polymers, molecular self-assembling polymers, polymeric siloxanes, and film forming latexes wherein the support provides an enhanced level of exciting photons to the immobilized fluorescent label compound, and wherein the support also increases the capture of fluorescent signal.

Abstract: The present invention provides an early, biochemical indication of increased risk of impending preterm delivery. The method comprises obtaining a cervicovaginal secretion sample from a pregnant patient after week 12 of gestation and determining the level of a local inflammatory product protein in the sample. The presence of an elevated level of the selected protein in the sample indicates an increased risk of delivery. The test is a screening assay that can detect women at risk of imminent delivery, as early as two to three weeks prior to delivery.

Abstract: A prenatal screening test for risk of Down's Syndrome in a foetus, which is carried out on a maternal blood sample before the beginning of the third trimester of pregnancy, by assaying the sample for a metabolite of feto-placental activity which is affected by the presence of Down's Syndrome, selected from unconjugated oestriol; progesterone; 16-alpha-hydroxy-dehydroepiandrosterone sulphate (16-alpha-hydroxy-DHEAS); and dehydroepiandrosterone sulphate (DHEAS). An additional assay for alpha-fetroprotein and/or human chorionic gonadotrophin may be included.

Abstract: Device for detecting the presence or amount of an analyte of interest, having a substrate possessing an optically active surface which exhibits a first color in response to light impinging thereon, and exhibits a second color comprising a combination of wavelengths of light different from the first color or comprising an intensity of at least one wavelength of light different from the first color, in response to the light when the analyte is present on the surface of any amount selected from 0.1 nM, 0.1 ng/ml, 50 fg, and 2.times.10.sup.3 organisms comprising the analyte.

Abstract: A method for detecting the onset of labor in a patient, which comprises analyzing a body fluid of the patient for estriol concentration; correlating the concentration with a standard value; and relating a higher concentration of estriol relative to the standard value as an indication of potential onset of pre-term labor. The standard is usually selected from the group consisting of (1) a predetermined range of estriol concentrations for the body fluid in normal pregnant humans at a preselected time relative to normal, full-term delivery, or (2) a previously measured estriol concentration of the same body fluid of the same pregnant human. Use of this method does not require determination of an estriol/progesterone concentration ratio in the body fluid being test.

Abstract: Methods for detecting and isolating acrosome-reacted sperm and complement receptor-bearing oocytes using the complement component C3, fragments, or variants thereof, antibodies to a complement receptor, or antibodies to C3, are disclosed. These methods have application in the assessment of fertility, in the preparation of sperm or oocytes for in vitro fertilization or for gamete intrafallopian tube transfer, in promoting or inhibiting fertilization in vitro and in vivo, and in diagnosing and treating infertility.

Abstract: The present invention provides an early, biochemical indication of increased risk of impending delivery. The method is particularly useful to identify those pregnant women who are at increased risk for preterm delivery and can also be used to identify those women at risk for a post-date delivery. The method comprises obtaining a cervicovaginal secretion sample from a pregnant patient after week 12 of gestation and determining the level of total fibronectin in the sample. The presence of an elevated fibronectin level in the sample indicates an increased risk of delivery. The test detects greater than 80% of women who deliver prematurely, as early as two to three weeks prior to delivery.

Abstract: A method of predicting ovulation and a test kit is described which allows one to accurately predict the time of ovulation in an animal in advance thus permitting the highest rate of pregnancy to be achieved and at the same time minimising embryonic death. Also described is a test kit for detecting and quantifying a given reproductive hormone and a method of optimising fertility in animals.

Abstract: The present invention relates to the purification of the human chorionic gonadotropin .beta.-core molecule which can then be used as the antigen in the preparation of antibodies to the .beta.-core molecule. The combination of the purified .beta.-core molecule and the antibodies can be used in an immunoassay kit to measure .beta.-core molecules in the presence of structurally similar molecules, i.e., hCG, LH, hCG.beta.-subunit and LH.beta.-subunit. Measurement of the .beta.-core molecule is particularly useful in testing for pregnancy and many malignancies.

Abstract: The present invention relates generally to test articles and assays for the detection of analytes in biological fluid samples. More particularly, the present invention relates to test articles an assays which employ dyed microorganisms as visual labels to detect suspected analytes.

Abstract: Optical assay device having an active receptive surface supported on a pedestal and held within a first container; the first container comprising first absorbent material located at the base of the pedestal, configured and arranged to absorb liquid draining from the surface, and having a second container, hingedly connected to one side of the first container, the second container comprising a second absorbent material, wherein the second container can be closed to the first container by rotation about the hinge, and wherein such closing causes the second absorbent material to contact the surface.

Abstract: Methods and devices are provided for carrying out assays with minimal technical training where quantitative visual determinations may be made. The devices provide for a flow-path where a sample receiving element is moved from a sample receiving position to a position where it serves to bridge a transport element and a measurement element, so that the sample may be transported from the sample element to the measurement region. Labelled conjugates are provided which migrate a distance into the measurement region related to the amount of analyte in the sample.

Abstract: A method and apparatus for performing assays in a single step which does not require the user to perform a washing step, does not require the user to add any reagent or other solution other than analyte sample fluid to the apparatus, and does not require the user to come into contact with the apparatus at any point during the assay procedure after the fluid suspected of containing a particular ligand is added to the apparatus. The apparatus for performing the assay consists of a single container with at least three ports disposed through different planes in the body of the apparatus beneath which labelled antiligand (the first port), unlabelled antiligand (the second port), and unlabelled ligand (the third port) are disposed. Said labelled antiligand is complementary to both the analyte of interest and the unlabelled ligand, the latter of which serves as a control display for comparison of any color changes mediated by the label visible through the second port.

Abstract: Disclosed are compounds having antigenic binding affinity with antibodies directed against human chorionic gonadotropin. The compounds typically include or consist of an oligopeptide with the sequence:AA1' AA2' AA3' AA4' AA5' AA6'wherein AA1' is Gly, Asn, Ser, Phe, Arg Leu, or Lys; AA2' is Pro, Trp, Ala, Val, or Glu; AA3' is Arg, Gln, Ile, Met, Val, Thr, Ser, Gly, or Phe; AA4' is Tyr, Glu, Leu, Phe, Pro, or Thr; AA5' is Asp, Asn, Leu, Met, Val, Tyr, Ser, Ile, Ala, Gly, or Phe; and AA6' is Phe, Trp, Ala, Thr, Arg, Asp, or Val.

Abstract: An assay procedure for predicting the onset of the ovulation in a human subject. Urine samples are obtained on consecutive days and assayed for total gonadotropal alpha peptide chain content. The alpha chain content surges to indicate ovulation and the onset of the fertile period.

Abstract: A method for detecting the progression or regression of a gynecologic cancer in a female by:(a) taking a first measurement of the amount of human chorionic gonadotropin beta-subunit core fragment in a bodily non-blood fluid sample from a female known to be suffering from a gynecologic cancer,(b) subsequent to step (a), taking one or more further measurements of human chorionic gonadotropin beta-subunit core fragment from a bodily non-blood fluid sample from the female,(c) comparing the first measurement to said one or more further measurements to ascertain if the human chorionic gonadotropin beta-subunit core fragment is increasing or decreasing, as an indication that the cancer is respectively progressing or regressing.

Abstract: A method for the detection of the presence of inflammation in a patient by measuring the amount of circulating intercellular adhesion molecule (cICAM-1) in a sample of one or more bodily fluids of the patient and then comparing the amount of cICAM-1 in the sample to standards normal for the bodily fluid or fluids assayed. The amount of cICAM-1 can be measured using anti-ICAM-1 antibodies. Higher than normal amounts of cICAM-1 indicate the presence of inflammation.

Abstract: The present invention relates to a method for detecting fetal Down syndrome (Trisomy 21), trisomy 13, trisomy 18 and other chromosomal anomalies during prenatal screening by analyzing blood samples from a pregnant woman. More particularly the present invention relates to a method for improving detection efficiency in screening for the anomalies by measuring the amount of the free beta human chorionic gonadotropin (HCG) and nicked or fragmented or aberrant forms of free beta (HCG), all of which are referenced throughout this application as free beta (HCG) in blood samples from pregnant women.

Abstract: A method and apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome, The method comprises measuring the pregnant woman's maternal blood levels of the free beta subunit of human chorionic gonadotropin. The level of free beta subunit of human chorionic gonadotropin individually or with other markers may be compared to reference data. A computerized apparatus for making the determination preferably using a probability density function generated from a set of reference data by a linear discriminant analysis procedure is disclosed.

Abstract: A screening method for fetal Down syndrome using free beta (HCG) as a marker. The maternal blood level of free beta (HCG) is measured and compared to reference data, at a similar gestational age, of the level of free beta (HCG) in pregnant women carrying a fetus with Down syndrome and pregnant women carrying an unaffected fetus. The method may advantageously be utilized during the first and second trimesters of pregnancy. Fragments of free beta and "nicked" free beta may also be utilized as markers.

Abstract: Methods are provided for detecting receptivity of mammalian endometrium to embryo implantation comprising obtaining a sample of the endometrium, contacting the endometrium with a monoclonal antibody for .beta..sub.3 integrin and detecting .beta..sub.3 integrin in the endometrium. The invention also provides for methods of diagnosing infertility in a mammal and methods of detecting the window of embryo implantation in endometrium. Methods of in vitro fertilization, methods of preventing embryo implantation and a method of monitoring endometrial maturation are also within the scope of the present invention. The present invention is also directed to contraceptives. Diagnostic kits useful in the practice of the methods of the invention are also provided.

Abstract: The invention relates to a method for early detection of pregnancy in canids and equids. The method involves introduction of a chemical, preferably from a group of chemicals essentially consisting of opioid antagonists, for use in elevating the concentration of the hormone prolactin of a pregnant canid or equid. Subsequent to introduction of the opioid antagonist to a suspected pregnant equid or canid, the concentration of the hormone prolactin may be measured for a determination as to the actual pregnancy of the animal. The prolactin concentration for an animal may be evaluated for a reliable determination of pregnancy as early as five days for canids and forty-eight hours for equids following insemination.

Abstract: A method and apparatus for determining if a pregnant woman is at significant risk of carrying a fetus with Down syndrome. The method comprises measuring the pregnant woman's maternal blood levels of the free beta subunit of human chorionic gonadotropin. The level of free beta subunit of human chorionic gonadotropin individually or with other marker may be compared to reference data. A computerized apparatus for making the determination preferably using a probability density function generated from a set of reference data by a linear discriminant analysis procedure is disclosed.

Abstract: The present invention relates to a method for detecting fetal Down syndrome (Trisomy 21), trisomy 13, trisomy 18 and other chromosomal anomalies during prenatal screening by analyzing a dried blood sample from a pregnant woman. More particularly the present invention relates to a method for improving detection efficiency in screening for the anomalies by measuring the amount of the free beta human chorionic gonadotropin (HCG) and nicked or fragmented or aberrant forms of free beta (HCG), all of which are referenced throughout this application as free beta (HCG) in dried blood samples from pregnant women.

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: Heme-containing proteins, such as cytochrome c, are useful in admixture with enzyme-labeled immunoreactants, such as peroxidase-labeled antibodies or fragments thereof. The heme-containing proteins and enzyme-labeled immunoreactants can be supplied in a buffered composition as part of a test kit. The buffered composition comprising the heme-containing protein and peroxidase-labeled immunoreactant excludes 4'-hydroxyacetanilide, which is a phenolic electron transfer agent. The composition can be used in immunoassays for detecting various immunologically reactive species, such as hCG, and chlamydial or gonococcal antigens.

Abstract: The invention provides a method for determining the presence of products of conception in a sample derived from the uterus during a D&C, or a therapeutic or spontaneous abortion, and comprises determining the presence in the sample of a fetal restricted antigen, which is found in products of conception but not found in significant amounts in maternal plasma or serum. Since the fetal restricted antigen is not present in significant quantities in maternal plasma or serum, the methods of this invention are reliable even when the sample is contaminated with maternal blood. 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.

Abstract: A method for the detection of the presence of inflammation in a patient by measuring the amount of circulating intercellular adhesion molecule (cICAM-1) in a sample of one or more bodily fluids of the patient and then comparing the amount of cICAM-1 in the sample to standards normal for the bodily fluid or fluids assayed. The amount of cICAM-1 can be measured using anti-ICAM-1 antibodies. Higher than normal amounts of cICAM-1 indicate the presence of inflammation. Also contemplated is a method for the detection of organ transplant or tissue graft rejection.

Abstract: A new diagnostic assay of sperm function has been found for infertility treatment and monitoring programs. The hemizona assay (HZA) measures tight binding of human spermatozoa to the human hemizona pellucida.