Abstract: The full amino acid and DNA sequences of placental protein 13 (PP13) are disclosed. Also described are various PP13 derived peptide fragments, and a recombinant method for the production of PP13. PP13 may be used in a screening and a diagnostic method for pregnancy-related complications.

Abstract: This invention provides bovine pregnancy test methods and devices. The test is also suitable for other ruminant and/or ungulate animals. Antigens from Group A (early pregnancy antigens), and/or Group B (mid-pregnancy antigens), and Group C (early, mid- and late pregnancy antigens) are detected in a fluid from the animal, and pregnancy is reliably determined. The pregnancy assays of this invention are preferably carried out using immunoassay devices which provide immediate results in the field.

Abstract: In qualitative or quantitative assays which employ a test device comprising a test strip pretreated for detection of a specified target analyte dissolved in a liquid medium, the presence of solid, semisolid and/or colloidal materials in the liquid medium may interfere with the assay results. The present invention involves collecting the sample from a flowing or quiescent pool of liquid also containing solid, semisolid or colloidal material with a swab comprised of a handle and a mass of fibrous material or foamed, open cell material which, when immersed in and thoroughly wetted by the liquid, entraps solid, semisolid and/or colloidal material and delivers only the liquid to the sample receiving zone of the test strip.

Abstract: The full amino acid and DNA sequences of placental protein 13 (PP13) are disclosed. Also described are various PP13 derived peptide fragments, and a recombinant method for the production of PP13. PP13 may be used in a screening and a diagnostic method for pregnancy-related complications.

Abstract: There are provided methods for assaying biological specimens for one or more of leptin, prorenin or renin in order to provide predictive information about the likelihood of a woman carrying a Downs Syndrome affected fetus.

Abstract: Antibodies to maternal status factors are produced and isolated. They are used in a diagnostic assay to determine maternal status in cattle. The maternal status is evaluated using a test device which contains immobilized antibody to the bovine factor. In addition, a liquid sampling device which allows only a predetermined amount of biological liquid sample to contact the test device is provided.

Abstract: The discovery of an association between two variants of the human interleukin-1 gene (IL1B) beta promoter region and a variant of the CD46 gene intron 1 and T-helper type 1 immunity in unexplained recurrent pregnancy loss (URPL) is disclosed. These two IL1B variants are characterized by a base C at position-511 (IL1B-511C) and a base T at position-31 (IL1B-31T) from the transcriptional start site of the IL1B gene. The CD46 gene intron 1 variant is characterized by a change in the HindIII site in this intron. These IL1B promoter variants and CD46 gene intron 1 variants, and reagents for detecting said variants, are useful as diagnostic markers for the diagnosis and management of recurrent pregnancy loss. Accordingly, the invention provides methods and compositions which identify these variants for determining a subject's propensity for having reproductive failure and, particularly, reproductive failure attributed to Th1 cytokines.

Abstract: The present invention provides a method of predicting pregnancy outcome in a subject by determining the amount of an early pregnancy associated molecular isoform of hCG in a sample. The present invention further provides a method for determining the amount of early pregnancy associated molecular isoforms of human chorionic gonadotropin (hCG) in a sample. The present invention also provides a diagnostic kit for determining the amount of early pregnancy associated hCG in a sample. The present invention additionally provides an antibody which specifically binds to an early pregnancy associated molecular isoform of human chorionic gonadotropin. Finally, the present invention provides methods for detecting trophoblast or non-trophoblast malignancy in a sample.

Abstract: A method and kit for determining whether an animal is not pregnant, or is pregnant following a breeding. The level of expression of a pregnancy induced protein is determined in an animal for which pregnancy status information is desired and the level is compared to that of the level in animals that are not pregnant.

Abstract: There are provided methods for assaying biological specimens for one or more of leptin, prorenin or renin in order to provide predictive information about the likelihood of a woman carrying a Downs Syndrome affected fetus.

Abstract: The present invention relates to a kit for diagnosing non-pregnancy and a method for diagnosing non-pregnancy of an animal using the same, and more particularly, to a kit for diagnosing non-pregnancy of animal comprising: an assay strip, formed of thin film type paper comprising a plurality of holes for moving a test sample, wherein progesterone-BSA conjugate is immobilized on one end portion as a test line and anti-IgG is immobilized on the other end portion as a control line; and anti-progesterone IgG-gold conjugate for reacting with the test sample such as blood or milk. The inventive kit for diagnosing non-pregnancy can test the non-pregnancy of milch cow without any special device about 20 days after the artificial insemination. Furthermore, more accurate result can be obtained by using the kit since the non-pregnancy diagnosis is performed by comparing color of the test line with that of the control line.

Abstract: A method for predicting treatment efficacy in pregnant mares affected by a disease or condition that alters placental function and results in a problematic pregnancy or delivery in the mare that is related to measurement of plasma relaxin levels is provided.

Abstract: The invention discloses a method for detecting and/or quantifying a hapten in a homogeneous phase, comprising the following steps: adding a known quantity of a hapten inhibitor complex to the solution containing the hapten to be detected and/or quantified; adding to the solution a quantity of antibodies corresponding to the quantity of the hapten/inhibitor complex; adding to the solution a type C &bgr;-lactamase having an active site for two substrates in antigenic competition in the said active site, the first substrate being a reporter substrate capable of being transformed into a detectable and/or quantifiable product, preferably by visible UV radiation measurement, the second substrate being the hapten/inhibitor complex acting on the hydrolysis rate of the reporter substrate; detecting and/or quantifying the concentration of the product resulting from the transformation of the reporter substrate, the Km constant of the reporter substrate being at least a hundred times higher than the Km constant of the ha

Abstract: A prenatal screening method for Down's syndrome involves assaying for hyperglycosylated gonadotropin in biological test samples such as urine, plasma or serum obtained from pregnant women. Hyperglycosylated gonadotropin comprises a variant population of chorionic gonadotropin, chorionic gonadotropin-free &bgr;-subunit, &bgr;-core fragment, and/or free &agr;-subunit exhibiting differences in the carbohydrate content from what is observed in samples obtained from pregnant women carrying normal fetuses. Qualitative or quantitative observation of differences in the carbohydrate content of the hyperglycosylated gonadotropin population from corresponding control samples containing a normal gonadotropin population, or direct observation of the variant species seen in Down's syndrome, indicates that the woman's fetus has Down's syndrome. Typical screens involve carbohydrate analyses, immunoassays, or combinations of these methods.

Abstract: An assay device comprises a sample-collecting wick made from non-woven fabric material laminated to plastics sheet. Preferably, the fabric is a 30:70 blend of viscose and polyester, and has a fibrous structure in which more than two thirds of the fibers run substantially parallel to the intended direction of liquid flow in the wick.

Abstract: Disclosed is a method for determining the fertility of mammals, in particular of humans, wherein

Abstract: It is an object of the present invention to provide the clinicians with a new application for ligands specific to MHC-class I antigens, especially HLA-ABC antigens, this new application residing in the detection and diagnosis of endometriosis. It is also an object of the present invention to provide a method and a test kit for diagnosing endometriosis, preferably by immunohistochemistry, using a monoclonal anti- HLA-ABC antibody as a preferred ligand or diagnostic reagent. This new method is non-invasive and is more reliable as a screening test than the conventionally used laparoscopy. When the endometrium of a woman tests negatively with the claimed method, it prevents the use of laparoscopy which is an invasive method for detecting endometriosis. This method can be practised on a specimen obtained from the endometrium of a patient and does not require a specimen sampled directly from the endometriotic foci.

Abstract: Test strip device for accepting a liquid sample and forming an even fluid front across the test strip. When the sample is applied to a contacting surface, it runs down the surface where it collects between the contacting surface and a slope surface. As the sample collects, it evenly reaches fluid flow contact with an absorbent membrane. As a result, the sample forms an even fluid front across the membrane, improving the performance of the test strip device. Methods for using the device to accept a sample and to detect an analyte in the liquid sample are also provided.

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: An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilised in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg.

Abstract: A method of testing a female mammal for pregnancy comprising the steps of first, providing a first vessel containing a liquid and having a removable surface wherein said removable surface is at least partially coated with an antibody and then introducing a bodily fluid from the female animal into said first vessel so that said bodily fluid contacts the liquid and then manipulating the first vessel so that the liquid contacts the antibody. Then, a second vessel containing a reporter hormone solution is provided and the removable surface from the first vessel is displaced to the second vessel and manipulating the second vessel so that the reporter hormone solution contacts the removable surface. Then, a third vessel containing an indicating solution which has an appearance which is related to the amount of the reporter hormone contacted is provided, and the removable surface is displaced from the second vessel to the third vessel.

Abstract: A method of determining the probability of an in vitro fertilization (IVF) or embryo transfer (ET) method being successful is disclosed. Relaxin can be measured directly in the serum or indirectly by culturing granulosa lutein cells extracted from the patient as part of an IVF/ET procedure. A method of enhancing the rate of a successful pregnancy resulting from an IVF/ET procedure is also disclosed whereby relaxin is administered and/or endogenous relaxin levels are enhanced by varying convention IVF/ET procedures.

Abstract: A method of identifying embryonic or fetal red blood cells in a sample containiing maternal blood cells and embryonic or fetal red blood cells or both, the method comprising determining which cell or cells contain or express an adult liver component. A method of isolating embryonic or fetal red blood cells from a sample containing maternal blood cells and embryonic or fetal red blood cells or both, the method comprising isolating the cells which contain or express an adult liver component. A method of determining a fetal abnormality the method comprising identifying or isolating embryonic or fetal cells according to the above methods and analysing said embryonic or early fetal cells for said abnormality. Use of a means for determining whether a cell contains or expresses an adult liver component for identifying or isolating an embryonic or fetal red blood cell.

Abstract: A method and apparatus for measuring binding between a plurality of molecules of a biological receptor protein and a plurality of molecules of a type which binds to said biological receptor is presented. Apparatus utilizes a sensor possessing a waveguide to which have been attached in close proximity to its surface, features resembling molecules having binding affinity for said biological receptor. Light is injected into said waveguide so as to produce an evanescent field at its surface. Molecules of receptor protein are tagged with a tag belonging to that class of chemicals which alters a characteristic of light, when said light passes through said chemical tag. Apparatus utilizes a rapid means of monitoring the change in optical signal coming from the waveguide as binding proceeds between tagged receptor protein and the binding molecular feature of the waveguide. This allows direct measurement of binding and dissociation rates between the receptor and the binding feature of the waveguide.

Abstract: A method and apparatus for measuring binding between a plurality of molecules of a first type and a plurality of molecules of a second type is presented. Apparatus utilizes a sensor possessing a waveguide to which have been attached in close proximity to its surface, features resembling molecules of said first type. Light is injected into said waveguide so as to produce an evanescent field at its surface. Molecules of said second type are tagged with a tag belonging to that class of chemicals which alters a characteristic of light, when said light passes through said chemical tag. Apparatus utilizes a rapid means of monitoring the change in optical signal coming from said waveguide as binding proceeds between tagged molecules of type 2 and the feature resembling molecules of type 1 on said waveguide. This allows direct measurement of binding and dissociation rates between the two types of molecules.

Abstract: Method for specific detection of one or more analytes in a sample. The method includes specifically associating any one or more analytes in the sample with a scattered-light detectable particle, illuminating any particle associated with the analytes with light under conditions which produce scattered light from the particle and in which light scattered from one or more particles can be detected by a human eye with less than 500 times magnification and without electronic amplification. The method also includes detecting the light scattered by any such particles under those conditions as a measure of the presence of the analytes.

Abstract: Methods for diagnosis, detection and prediction of preterm labor by detecting levels of nitric oxide in myometrium using non-invasive non-surgical methods for detection of nitric oxide in blood, urine, saliva, in biopsy samples or in other tissue samples. A non-invasive diagnostic procedure for detecting the onset of term labor using non-invasive or non-surgical methods.

Abstract: The invention relates in part to the use of independent assay controls (IACs) for the optical communication between an assay device and an instrument in monitoring and performing assays, preferably immunoassays.

Abstract: A method for diagnosing a congenital disease by determining a cell's response to activation of a membrane receptor using a physiological indicator is provided. The method of the invention uses fetal or adult cells in a non-invasive screen for congenital disorders.

Abstract: The present invention relates to a simple immunochemical semi-quantitative assay method according to chromatography, which comprises trapping a certain amount of an analyte in a sample with a predetermined amount of a fixed antibody for the analyte before qualitative analysis of the analyte, the certain amount corresponding to the amount of the fixed antibody, and thereby decreasing a concentration of the analyte to be subjected to subsequent immunochemical qualitative determination, and an apparatus therefor.

Abstract: There are provided methods for assaying biological specimens for one or more of leptin, prorenin or renin in order to provide predictive information about the likelihood of a woman carrying a Downs Syndrome affected fetus.

Abstract: An assay device for detection or determination of an analyte in a sample uses opposable components and is suitable for assay of human chorionic gonadotropin and other protein or glycoprotein hormones.

Abstract: A method and system for receiving, processing and responding to emergency medical calls for patients with pregnancy related medical problems is described. A consistent, standard and systematic process is provided which in combination with adequate training, supervision and quality assurance serves to provide a method for gathering emergency medical information regarding a patients pregnancy problems, categorizing such information into various determinant levels for appropriate response, and for giving qualified emergency medical information to callers thereby permitting "zero time" response by those at the scene. By using this invention properly a dispatcher is guided through the interrogation of callers concerned with pregnancy, childbirth or miscarriage medical problems, gathering critical information and giving the appropriate guidance to the caller.

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 includes a hollow rectangular outer casing and an assay material disposed within co-joined upper and lower sections of the casing. The outer casing includes a urine inlet port; a viewing window in the upper section; at least the upper section consisting of transparent material; and may also include at least one drainage vent spaced about the urine inlet port. The assay material is a sorptive material including: 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 a liquid sample between the urine sample application region and the analyte capture region. The flow of urine in the fluid path is observable through the transparent upper section for confirming a test is operative.

Abstract: This invention represents a significant advance in prenatal diagnosis by providing urinary screening to detect fetal aneuploidies. Herein disclosed are methods for prenatally assessing risks of a pregnancy being affected by Down syndrome and other aneuploidies by testing maternal urine samples for levels of .beta.-core-hCG. Levels of maternal urinary .beta.-core-hCG above normal indicate a risk that the pregnancy is affected with Down syndrome, and in general risks of other fetal aneuploidies are indicated by either lower than normal or higher than normal maternal urinary .beta.-core-hCG levels. Assessments can be made based on urinary .beta.-core-hCG levels alone or in conjunction with levels of other urinary and/or serum markers, ultrasound parameters and other factors, such as, maternal age.

Abstract: Dimeric inhibin concentration can be used in the determination of the risk of a women carrying an unborn child affected by chromosomal abnormalities, e.g. Downs Syndrome. A method for antenatal screening for chromosomal abnormalities is carried out by measuring body fluid taken from a pregnant woman for the level of at least one marker or precursor or metabolite of the marker together with the gestational age of the woman are compared with reference values taken from women carrying fetuses with chromosomal abnormalities and/or women carrying normal fetuses, using dimeric inhibin as a marker. A second marker is the free beta subunit of human chorion gonadotropin. An apparatus for carrying out the method described comprises a computer with a means for comparing the values described.

Abstract: A method for antenatal screening for chromosomal abnormalities in which maternal blood from a pregnant woman is measured for levels of free beta hCG and at least a second serum marker and/or precursors and metabolites of these markers and the measured levels of these markers together with the gestational age of the pregnant woman are compared to reference values at various gestational ages of the levels for free beta hCG and the second serum marker in (a) pregnant women carrying foetuses having the abnormalitie(s) subject to the screen and (b) pregnant women carrying normal foetuses, the comparison being indicative of the risk of the pregnant woman carrying a foetus with an abnormality subject to the screen characterised in that the second serum marker is pregnancy associated plasma protein A (PAPPA) and the screen is carried out by the end of the thirteenth (13th) completed week of pregnancy.

Abstract: A method of determining the probability of an in vitro fertilization (IVF) or embryo transfer (ET) method being successful is disclosed. Relaxin can be measured directly in the serum or indirectly by culturing granulosa lutein cells extracted from the patient as part of an IVF/ET procedure. A method of enhancing the rate of a successful pregnancy resulting from an IVF/ET procedure is also disclosed whereby relaxin is administered.

Abstract: An antibody specific for a target analyte is purified by affinity chromatography on a substrate bearing a low-affinity analogue of the target analyte. The antibody is displaced from the substrate by contact with a second analogue of intermediate affinity, which remains complexed with the antibody. This complex can be used in a conventional assay for the target analyte, which displaces the intermediate-affinity analogue. The complexed antibody is rendered more storage-stable because the second analogue protects the antibody binding reagion.

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: 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: A method of preventing false detection of signal due to splashing of reagent liquid used to produce such signal, when dispensing at least one such liquid from a metering tip into a second liquid, comprising the steps of: a) positioning the metering tip a predetermined distance above the upper level of the second liquid prior to dispensing the one liquid; andb) while maintaining the distance throughout the dispensing of the one liquid, dispensing the one liquid;wherein the predetermined distance is between about 1.0 mm and about 2.0 mm so that splashing during dispensing is reduced.

Abstract: Disclosed is an improvement to a sandwich type immunoassay in which there is immobilized to a solid support an antibody which is specific to an epitope of the analyte whose presence or concentration is being sought and a first labeled antibody which is specific to another epitope of the analyte. The improvement involves providing a second labeled antibody which is specific to the first labeled antibody to thereby form a chain of two or more labeled antibodies which results in amplification of the signal generated upon formation of the sandwich.

Abstract: A method of identifying highly fecund males in which an isotonic, buffered liquid test specimen of semen is layered on top of a barrier medium that inhibits net movement (migration) of less mobile sperm into the barrier medium. Differences in mobility of populations of sperm among test subjects have been found to predict whether a male will be highly fecund or not. Sperm migration into the barrier medium is quantitated, for example by analyzing the barrier medium in a spectrophotometer or a photometer after sperm migration is allowed to occur. Alternatively, a collection member coated with a sperm binding protein may be placed below the barrier medium, and the number of sperm that bind to the collection member quantitated after incubation. The invention also includes a device for incubating the barrier medium at a physiologic temperature for a sufficient period of time to allow the highly mobile sperm to migrate into the barrier medium.

Abstract: The present invention provides methods for detecting the presence of or determining the amount of a ligand in a fluid sample. The methods comprise providing a first reagent comprising a sol particle having a detectable physical property bound to the ligand or ligand analogue (in a competitive format) or a substance capable of specifically coupling with the ligand (in a sandwich format), providing a second reagent having a detectable physical property comprising a sol particle bound to a substance capable of specifically coupling with the ligand and/or ligand analogue, if present, combining the first reagent, second reagent and the fluid sample and detecting before, during or after the reaction, a change in the physical property of the sol particles, which provides a qualitative or quantitative indication of the ligand in the fluid sample.

Abstract: A glycoprotein having a molecular weight of 28,000 to 32,000 and an isoelectric point of 7.0 to 9.0, both as determined by two-dimensional SDS polyacrylamide gel electrophoresis, is synthesized and secreted specifically by stromal cells of endometriotic origin. Amino acid residues in the region of the N-terminus of the glycoprotein share amino acid sequence identity with a region of tissue inhibitor of metalloproteinases-1 (TIMP-1). A method of screening for endometriosis is disclosed by detection of lower levels of the protein or TIMP-1 in peritoneal fluid or serum samples of women.

Abstract: The present invention provides a more accurate risk assessment of antenatal screening results because the maternal age of the patient is considered in evaluating the results from various common screening markers, and especially the results from UE determinations.

Abstract: A method for antenatal screening for chromosomal and other abnormalities in an unborn child is determined by measuring the gestational age discrepancy of the pregnant mother. This data is determined (a) by reference to the last menstrual period, and (b) a biometric measurement of the fetus. The difference between the ages as determined using (a) and (b) is calculated. This calculated difference is then examined using reference data to determine fetal abnormalities. These data can also be used with assay of maternal fluids for various pregnancy markers.

Abstract: An antibody to the purified and isolated glycoprotein and functional analogs thereof characterized by being progesterone induced and estradiol inhibited secretory glycoprotein specifically from stromal cells of endometrial origin. The protein has the molecular weight of 70,000 daltons as determined by two-dimensional SDS-PAGE polyacrylamide gel electrophoresis and has an isoelectric point of 5.7.

Abstract: The present invention relates to a method and assay device for detecting small analytes. The results of the assay can be directly read from the device, which is a lateral flow device.