Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises (a) an upper support strip having a fluid receiving port and (b) a lower support strip having a color change viewing port and securely sandwiched therebetween (c) a spreading mesh screen for uniformly distributing the fluid, (d) a chemically treated separating layer for removing an undesirable element, e.g.

Abstract: A functional linker for a polypeptide in which two alpha or beta globin-like domains are genetically fused is determined by screening a library of genetically fused polypeptides, in which the linker region is varied, for the ability to participate in the formation of hemoglobin-like protein, as measured by the protein's response to carbon monoxide. In a preferred embodiment, cells expressing the protein turn red as a result of carbon monoxide pressure.

Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and an insertable test strip containing a reagent enabling detection of the analyte of interest.

Abstract: The invention provides a method of diagnosing hemochromatosis or a predisposition thereto by detecting an increase in erythrocyte parameters such as mean corpuscular volume or mean corpuscular hemoglobin compared to normal individuals unaffected by hemochromatosis.

Abstract: The present invention relates to a hemoglobin compositions stabilized against the formation of aggregates. The present invention further relates to methods of making such hemoglobin compositions.

Abstract: Formed constituents of a quiescent anticoagulated whole blood sample are optically or visually analyzed in a sample chamber which has a varying through plane thickness due to convergent opposing sample chamber walls. At least one of the convergent walls of the chamber is transparent so that the blood sample constituents can be observed. The chamber's varying thickness produces a first lesser thickness region in the chamber wherein a quiescent monolayer of red blood cells in the sample will reside after the sample is introduced into and fills the chamber. Larger formed constituents such as white blood cells in the sample are unable to enter the aforesaid lesser thickness region of the chamber. The red cells which reside in the greater thickness regions will agglomerate to form rouleaux and lacunea. The exact thickness of the chamber at any particular location in the chamber can be predetermined, or can be determined in situ as the sample is being analyzed.

Abstract: A blood analyzing instrument includes a single transducer for simultaneously measuring the DC volume, RF conductivity, light scattering and fluorescence characteristics of blood cells passing through a cell-interrogation zone. Preferably, the transducer includes an electro-optical flow cell which defines a cell-interrogation zone having a square transverse cross-section measuring approximately 50×50 microns, and having a length, measured in the direction of cell flow, of approximately 65 microns.

Abstract: Disclosed is an assay for an analyte in a fluid test sample such as urine which involves combining the fluid test sample with a reagent system comprising an apo-peroxidase, a redox dye, a peroxide and a metal porphyrin which is bound to an analyte/analyte specific binding partner which complex has a combined molecular weight of at least about 180 K Daltons. When this conjugate interacts with analyte in the fluid test sample, a portion of the specific binding partner is dissociated from the complex thereby enabling the metal porphyrin to reconstitute with the apo-peroxidase. The reconstituted peroxidase can interact with the peroxide and redox dye to provide a colored response to analyte in the fluid test sample.

Abstract: The present invention provides a process for the extraction of proteins from gastrointestinal tract samples taken from humans or other mammals wherein the sample is mixed with an excess amount of aqueous extraction medium comprising at least one dissociating, disaggregating and/or chelating agent, homogenised in a closed vessel, the solid and liquid materials of the dispersion are separated from each other and the clear liquid extract is recovered.

Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and at least one insertable test strip containing a reagent enabling detection of the analyte of interest.

Abstract: A device for sampling feces, by which an approximately constant amount of feces can be sampled in simple manner and it is possible to easily identify whether occult blood is present in the feces or not. The device comprises a main container for a liquid for suspending feces in it, a cap arranged at one end of said main container, a separating device for dividing inner spaces of the main container and the cap, a through-hole formed in the separating device, and a collecting stick having a device for collecting feces engaged and inserted in the through-hole, wherein the device for collecting feces is composed of a plurality of hairs and arranged at or near the forward end of the collecting stick, whereby feces collected by the device for collecting feces being composed of the plurality of hairs are passed into the through-hole of the separating device in order to sample an approximately constant amount of the feces.

Abstract: The invention concerns a method for the determination of an analyte in a sample containing free haemoglobin in which the determination is carried out by an optical measurement and the value measured for the analyte concentration is mathematically corrected. This method is in particular suitable for determining the parameters total protein, iron and albumin in a medical sample e.g. in a serum or plasma sample. The correction of the measured value for the analyte concentration is achieved by the steps (a) measuring the blank value of the sample to be analysed, (b) measuring the blank value of a haemoglobin-free reference sample, (c) measuring the uncorrected value for the analyte concentration and (d) correcting the value obtained in step (c) by correlation with the values obtained in step (a) and (b) in order to obtain the corrected value for the analyte concentration.

Abstract: A conduction assist member has conductive members disposed in some or all through holes which are formed in a large number in a sheet made of an insulating elastic material. The conduction member is a cut piece which is fixed to the sheet at one end thereof and has two or more blades formed by one, two or more cuts. In the conduction assist member, one or some of the two or more blades formed on each cut piece, are bent toward one of two opening portions of the through hole so that ends of the blades formed on the cut pieces protrude from the opening portion on the same surface of the sheet. The conduction assist member can be applied as a connector to both a flat conduction surface and a curved conduction surface, and as an integrated circuit socket which can easily cope with differences in sizes of connectors and sockets, which is superior in high speed performance and usable as an integrated circuit socket for mounting, and which can easily be assembled.

Abstract: Blood samples are stabilized for methemoglobin determination with a buffer composition containing (a) carbon monoxide-containing water; (b) sodium tetraborate or potassium tetraborate; and (c) KCN or NaCN. The buffer composition preferably may also have an erythrocytolysis agent. The buffer fixes the valence state of heme iron at a concentration representative of the blood at the time of collection, and maintains that fixed state for an extended period of time preventing further methemoglobin formation. The buffer also prevents reduction of existing target analyte, i.e., methemoglobin (ferric hemoglobin, Fe3+ hemoglobin) to normal reduced hemoglobin (ferrous hemoglobin, Fe2+ hemoglobin).

Abstract: A method for quantifying the concentration of hemoglobin in a cell, and indicia of anemia, comprises determining the wavelength of the longitudinal mode of a liquid in a laser microcavity; determining the wavelength of the fundamental transverse mode of a red blood cell in the liquid in the laser microcavity; and determining if the cell is anemic from the difference between the wavelength of the longitudinal mode and the fundamental transverse mode. In addition to measuring hemoglobin, the invention includes a method using intracavity laser spectroscopy to measure the change in spectra as a function of time for measuring the influx of water into a red blood cell and the cell's subsequent rupture.

Abstract: The present invention relates to a method for identification of defects in the clotting, fibrinolysis and complement system.

Abstract: For blood or other physiological fluid sample collection kits that use filter paper to collect the sample, the performance of the kit and associated analytical method can be improved by using a material having properties which are superior to those of standard filter paper or modified filter paper routinely used in standard biological assays. Certain materials currently available for uses other than blood collection, storage, or transport have properties that are advantageous as employed in assays of biological fluids, including the use of specific cellulose blotting materials for collecting blood samples for hemoglobin or hemoglobin A1c monitoring.

Abstract: The invention features a novel method of assaying glycated hemoglobin (GHb) in a sample using a capture molecule that binds GHb and hemoglobin (Hb), and detecting bound GHb with a molecule that distinguishes GHb from non-glycated hemoglobin (Hb). The molecule used to distinguish GHb from Hb may be an antibody. The assay and antibodies of the invention are useful for the evaluation of GHb in disease states such as diabetes.

Abstract: A control or calibration standard for use with instruments for the optical measurement of the hemoglobin content in blood samples, features scattering particles or beads dispersed in aqueous electrolyte solution. To prevent sedimentation of the beads during storage, they have a mean diameter of <0.6 &mgr;m, preferably about 0.3 &mgr;m, and a volume concentration of <1%, preferably <0.3%. To prevent long term agglomeration, a non-ionic surfactant with an added antioxidant can be included in the formulation.

Abstract: A glycated hemoglobin assay utilizes a simple procedure for the determination of standardized %GHb in whole blood samples correlated to the Diabetes Control and Complications Trial (DCCT). First, a lysed whole blood sample is incubated with a solid phase that is coupled with boronic acid or similar boronate compound through covalent linkage chemistries known in the art. Next, a labeled antibody to human hemoglobin is added and the resulting signal is directly proportional to the %GHb in the sample. The advantages of measuring %GHb using a single determination include high precision and, since the assay is easily automatable, high throughput. With automation, this assay can also be consolidated with other testing on one analyzer. The method according to the various embodiments of the invention thus eliminates the need for two measurements: one for GHb and another for total hemoglobin (THb).

Abstract: A method and apparatus for urine self testing wherein the apparatus is placed directly into the toilet after urination which avoids the direct placement and retention of an apparatus in the stream of urine as is common with urine testing devices. The apparatus detects the presence of certain chemicals in dilute urine such as the presence of human chorionic gonadotropin (hCG) in the urine of a pregnant woman. An opening in the apparatus is fitted with a fluid absorption device which acts to concentrate the diluted urine on an indicator strip which contains antibodies, enzymes and antibody blockers which will provide a reactive change, usually of color, when subjected to a predetermined chemical such as hCG. The apparatus functions in dilute urine when placed in a toilet after urination and is largely constructed of biodegradable materials so that it can be flushed into the sewage system or a septic tank.

Abstract: Multi-analyte reference solutions having a stable partial pressure of oxygen (pO.sub.2) in zero headspace packaging and methods for preparing such solutions are disclosed. The solutions have long shelf and use lives when stored at room temperature and are packaged in laminated foil containers having low or no oxygen reactivity. Access devices are also disclosed.

Abstract: The present invention is directed to a method of determining the ratio of the concentration or amounts of two or more chemical compounds and/or biopolymers, or of the relative amounts of sub-populations of closely structurally related compounds, in a multi-component mixture, extract, system, and the like using an analytical physicochemical process. The method is based on distribution of the components of the mixture (system, extract, etc.) between two or more immiscible phases and the subsequent determination of the total amounts (concentrations) of biopolymers (chemical compounds) or of the amounts (concentrations) of one or more component(s) or sub-populations of the system in the phases. The ratio between these concentrations is defined therein as the partition coefficient. The partition coefficient is used as a measure of the ratio of the amounts of two or more biopolymers (chemical compounds) or their sub-populations in a multi-component mixture (extract, system, etc.

Abstract: Apparatus for analyzing blood or the like has a centrifuge rotor (10) with a means for visibly holding a sample, and a scanning arm (32) which traverses the rotor and includes a means (38) for sending light to the sample to detect the sample component interfaces. A second light source (40) may be provided for colorimetric inspection of the sample.

Abstract: A method of and apparatus for determining stable and labile glycated compound levels in blood. Electromagnetic energy covering a multiplicity of wavelength bands within a wavelength range from 380 nm to 2500 nm is directed into a sample volume containing blood. Portions of the energy representative of both the source energy and energy after interacting with material within the sample volume are collected. The energy portions carry information relating to the source energy and the levels of labile and stable compounds within the sample volume, respectively. The portions are converted into electrical signals representative of the intensities of the respective portions in each of the multiplicity of wavelength bands.

Abstract: A reagent for measurement of the haemoglobin and determination of the leukocytes in a blood sample is provided. This reagent comprises at least one detergent of the cationic type; a compound of the glycoside type, and in particular a saponin; at least one inorganic salt and/or an osmotic and/or leukoprotective agent; and an organic and/or inorganic buffer which can adjust the pH of the agent selectively, either to a substantially neutral value, e.g. pH between 5 and 8, or to a basic value, e.g. pH between 8 and 12. The reagent can be used in haematological analyses in human and veterinary medicine.

Abstract: The invention provides a very fast and reliable method and reagent composition for determining reticulocyte and erythrocyte counts, identification and characterization, as well as platelet counts, in a whole blood sample using fully automated hematology analyzers. The reagent composition includes a zwitterionic surfactant as sphering agent for reticulocytes and erythrocytes, an organic cationic dye, e.g., Oxazine 750, for staining the reticulocytes, and buffer solution components for maintaining a reagent pH of about 7.2 to 7.8, and an osmolarity of about 292.+-.5. On the basis of the particular pH, ionic strength, and dye concentration, the reagent composition of the present method improves upon previous methods, thus allowing fully automated blood sample analyses to be completed in less than about 30 seconds, with only about a 20 second incubation of sample in the reagent solution before analysis.

Abstract: The present invention provides methods and compositions relating to synthetic test stains comprising isolated fibrin and/or fibrin precursors and blood plasma proteins. Kits for the preparation of synthetic test stains containing an isolated fibrin precursor and an initiator for converting the fibrin precursor to fibrin are also provided. In addition, methods for checking the efficiency of cleaning processes, and kits for carrying out these methods are provided.

Abstract: Assays are disclosed for evaluating the presence or amount of a heme protein in a sample. The assays are based on chemiluminescence. Assay solutions include the sample, a suitable substrate and an oxidizing agent. The substrate is selected to undergo a specific reaction with the proteins of interest to produce an intermediate that emits light. suitable heme proteins include hemoglobin and myeloperoxidase. Suitable substrates include cyclic hydrazides and acridan derivatives.

Abstract: Apparatus and method for determining at least one parameter, e. g., concentration, of at least one analyte, e. g., urea, of a biological sample, e.g, urine. A biological sample particularly suitable for the apparatus and method of this invention is urine. In general, spectroscopic measurements can be used to quantify the concentrations of one or more analytes in a biological sample. In order to obtain concentration values of certain analytes, such as hemoglobin and bilirubin, visible light absorption spectroscopy can be used. In order to obtain concentration values of other analytes, such as urea, creatinine, glucose, ketones, and protein, infrared light absorption spectroscopy can be used. The apparatus and method of this invention utilize one or more mathematical techniques to improve the accuracy of measurement of parameters of analytes in a biological sample.

Abstract: A method and apparatus for testing tissue samples is provided which includes an integrated specimen test card. The test card is especially useful in testing for the presence of blood in stool samples and includes a frangible ampule contained within a channel mounted on the test card, the ampule containing a developer and the test slide being impregnated with a chromatographic reagent. Upon crushing the ampule within the channel, the developer is directed along a canal to a test section of the slide where, upon diffusion of the developer through the slide and moistening of the test slide by the developer in the presence of blood, a chromatographic reaction occurs to indicate to the user the presence of blood. A discrete control section having a second slide impregnated with reagent and a control indicator, such as hemoglobin, may be provided so that developing liquid can be directed simultaneously both to the test section of the slide and the control section of the slide.

Abstract: The present invention involves an improvement to an assay for the activity of a metal chelate, such as copper II/creatinine, which activity is related to the concentration of the analyte in a fluid test sample. In carrying out the assay, there is combined the fluid test sample, the metal chelate or precursors thereof, a hydroperoxide, an oxidizable indicator and a pyrazole derivative which inhibits the ability of hemoglobin to oxidize the oxidizable dye.

Abstract: Disclosed is an improvement to the method of determining the concentration of a hemoglobin adduct in a blood sample by the steps of assaying the blood sample for the total amount of hemoglobin, assaying the blood sample for the hemoglobin adduct, and dividing the hemoglobin adduct concentration by the total hemoglobin concentration. The improvement involves normalizing the measurement of the hemoglobin adduct to the total amount of hemoglobin in the blood sample.

Abstract: An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises (a) an upper support strip having a fluid receiving port and (b) a lower support strip having a color change viewing port and securely sandwiched therebetween (c) a spreading mesh screen for uniformly distributing the fluid, (d) a chemically treated separating layer for removing an undesirable element, e.g.

Abstract: The present invention concerns a diagnostic test carrier for the determination of an analyte from whole blood with the aid of a reagent system contained in the carrier which includes a colour forming reagent with a test field which has a sample application side onto which the blood sample is applied and a detection side on which an optically detectable change takes place as a result of the reaction of analyte with the reagent system and which is constructed in such a way that erythrocytes present in the sample do not reach the detection side, which is characterized in that the test field comprises a transparent foil onto which a first and a second film layer are applied on top of one another and wherein the first layer located on the transparent foil scatters light considerably less in a wet state than the overlying second layer and wherein the side of the foil on which the first layer is applied which is opposite to the foil side is the detection side and the side of the second layer which is opposite to the

Abstract: A new hematological parameter, namely mean hemoglobin density in one liter of blood (MDHL), is based on the new index of mean cell density of hemoglobin, MCHD, or more particularly, MDHL is provided as an advantageous screening parameter to distinguish between Iron Deficiency Anemia (IDA) and Thalassemia Trait TT. The MDHL parameter showed superior sensitivity, specificity, predictive value and efficacy of as high as 100%. The new screening test also entails significantly lower costs involving the evaluation of patients with hypochromic microcytosis.

Abstract: A hemoglobin derivative-containing sample is treated with a treating reagent containing 2-butanol and then immunologically analyzed to determine the quantity of the hemoglobin derivative. By the treatment with 2-butanol, the immunological determination for the hemoglobin derivative, particularly HbA.sub.1c, can be attained with high sensitivity by a simple procedure. Since 2-butanol-containing treating reagent does not affect the enzymatic activity, the homogeneous enzyme immunoassay with high sensitivity is realized.

Abstract: A method for continuous separation and analysis of glycated and non-glycated proteins in a blood sample by HPLC using a phenylboronic acid resin and a polyol as eluant.

Abstract: The present invention relates to a hematology control product for automated hematology instruments containing an aqueous solution of at least one blood cell analog, an absorbance agent in an amount sufficient to simulate a hemoglobin concentration, and a stabilizing agent in an amount sufficient to stabilize the size of the blood cell analog when the control product is subjected to temperature ranging from -15.degree. C. to 45.degree. C. The control product does not require controlled temperature storage for product stability. In addition, a novel method of using a hematology control product is provided wherein the control product contains a single blood cell analog and is used to simulate both red blood cells and white blood cells on an automated hematology instrument.

Abstract: An improved method of detecting latent bloodstains using a thickened solution of fluorescin which is applied to a surface, activated by application of hydrogen peroxide and visualized as fluorescein under ultraviolet (UV) light is disclosed.

Abstract: A reagent for measurement of leukocytes and hemoglobin concentration in the blood includes a cationic surfactant in an amount sufficient to lyse erythrocytes and denature hemoglobin, at least one of the following hemoglobin stabilizers:(a) sulfosalicylic acid, or its salt, in an amount effective for promoting the conversion of hemoglobin into methemoglobin,(b) 0.2 to 10.0 g/L of a water-soluble chelating agent having a nitrogen atom and a carboxyl group, and(c) piperazine, or its salt, in an amount effective for promoting the conversion of hemoglobin into methemoglobin, anda buffer for maintaining pH at 4 to 6.

Abstract: A method of detecting and quantifying cyanide concentration in a patient, by monitoring photometric changes resulting from the transformation of methemoglobin to cyanomethemoglobin. The present invention provides for a means of cyanide poisoning assessment in patients using the affinity of methemoglobin for cyanide to assess the photometric changes resulting from methemoglobin converting to cyanomethemoglobin, as an indicator of cyanide concentration in a patient. Appropriate corrective action can then be promptly taken.

Abstract: An in vitro method of identifying or isolating fetal cells from a blood sample is described. Fetal nucleated erythrocytes or erythroblasts are identified by using an antibody or antibody fragment specific for embryonic hemoglobin or an embryonic hemoglobin chain. Once the fetal cells are identified, they can be treated to render the fetal nucleic acids or proteins available for identification or amplification. Detecting the occurrence or existence of selected fetal nucleic acids or proteins allows a quantitative or qualitative diagnostic or prenatal evaluation, including determining the sex of the fetus, determining chromosomal, single gene or protein abnormalities, and determining the presence or absence of particular genes, nucleic acid sequences or proteins.

Abstract: Cyanide-free reagents for the determination of hemoglobin and leukocytes present in a blood sample contain an aqueous solution of at least one quaternary ammonium salt, preferably selected from the group of alkyltrimethylammonium salts, alkyldimethylbenzylammonium salts or alkylpyridium salts consisting of tetradecyltrimethyl ammonium bromide (TTAB), dodecyltrimethyl ammonium chloride, cetyltrimethyl ammonium bromide, hexadecyltrimethyl ammonium bromide and benzalkonium chlorides, and hydroxylamine salts, especially hydrochloride, sulfate and phosphates and other acid salts. The method involves mixing the reagent with a diluent- diluted blood sample, presenting it to an absorbance spectrophotometer and measuring the resulting optical density as an indicator of hemoglobin concentration. This cyanide-free reagent could be used solely for hemoglobin determinations, or , it can also be used in leukocyte counting and sizing using hematology instrumentation.

Abstract: An apparatus for separating a blood component, e.g., fibrin monomer, from blood or plasma ?comprises! includes a container ?(110)! with a reaction chamber for receiving the plasma, where ?said! the reaction chamber is defined by an outer wall and ?comprises! includes means for supplying ?said! the reaction chamber with an agent for converting the fibrinogen content of the plasma into a non-cross-linked fibrin polymer. The apparatus ?comprises furthermore! also includes a device for centrifuging the reaction chamber with the plasma and ?said! the agent to a degree sufficient for separating the non-cross-linked fibrin polymer from the plasma, for depositing ?said! the polymer on the outer wall of the reaction chamber, and for expelling the remaining plasma from the reaction chamber. The container ?(110) comprises! includes means for supplying the reaction chamber with a solvent for dissolving ?said! the non-cross-linked fibrin polymer.

Abstract: Methods of preparing a boronate-antigen complex for immunization of animals, a monoclonal antibody specific for the same, an immunoassay method for detection of the complex and a method of calculating the amount of a target glycated protein within the sample useful in the diagnostic monitoring of diabetes are disclosed. An immunoassay kit based on this reagent is also disclosed.

Abstract: A method for evaluating constituents of a sample of substantially undiluted anti-coagulated whole blood is provided which includes the steps of a) providing a sample chamber; b) admixing a sensible colorant with the sample of whole blood; c) inserting the admixed sample into the sample chamber; d) quiescently holding the admixed sample for a period until rouleaux and lacunae form within the sample; and e) evaluating a target constituent disposed within the lacunae.

Abstract: A specimen testing device having first and second panels and a reagent sheet therebetween. The first panel has an aperture with a cover and the second cover has an aperture opposite the aperture in the first panel. The sheet in the first aperture has first and second portions disposed on opposite sides of a longitudinal axis of the panel and a fecal specimen is smeared on the sheet in the apertures so as to cover the first and second portions. The second panel is provided with a cover which overlies the first portion of the sheet and with a further cover which overlies the second portion of the sheet. The further cover is selectively moveable depending on the outcome of testing of the sample on the first portion through the respective aperture on the second panel.

Abstract: A sample containing hemoglobin A1c (HbA1c) is simultaneously brought in contact with a solid phase and anti-HbA1c antibody, the anti-HbA1c antibody bound to the adsorbed HbA1c on the solid phase and the anti-HbA1c antibody in solution are separated, and the anti-HbA1c antibody bound to the adsorbed HbA1c on the solid phase is detected. HbA1c % is determined by one-step immunoassay, and the time required for measurement is shortened in comparison with conventional immunoassay methods. Since the exposure time to the pretreatment solution present in the reaction solution during the immune reaction is shortened, formation of a precipitate in the sample as well as inactivation of the enzyme of the enzyme-labeled anti-HbA1c antibody, when used, is reduced.

Abstract: A process for the determination of H. pylori in a fecal specimen comprising (a) dispersing a fecal specimen suspected of carrying H. pylori in a sample diluent; (b) contacting the fecal specimen in the diluent with a first polyclonal antibody for H. pylori antigen to form a complex of the antibody and the antigen; (c) separating said specimen and said complex; (d) exposing the complex to a second polyclonal antibody for said antigen and a portion of the antibody reacting with said complex, one of said first and second antibody being bound to a solid carrier and the other being labeled with a detection agent; and (e) determining the amount of the labeled antibody and in turn determining the presence of H. pylori antigen in said fecal specimen.