Abstract: Test kit whereby the sponge portion of kit is used to swab saliva. The saliva is then extracted from sponge by either squeezing it out or through the use of a centrifuge. The sponge portion of the kit is attached to a collection container when used in the centrifuge. A filter can be placed between these two portions of the kit to filter out only substances of certain molecular weights and to clean saliva. When the saliva is collected by squeezing, the sponge is placed in soft walled vial that is squeezed to extract saliva. After extracted from the sponge, the collected saliva can be removed from kit by twisting off cap. This test kit can be used for, but not limited to, testing for HIV antibodies, hepatitis and drugs.

Abstract: An immunoassay device has a housing defining a first opening for receiving a solution and a second opening through which a liquid sample is deposited, a strip of sorbent material having a test site with immobilized antigen or antibody for the ligand to be tested, and a filter for filtering the sample. The filter is located at the second opening and directly above the test site. The sorbent material defines a horizontal flow path in the housing for the solution from the first opening to the test site. In use, the sample is first applied via the filter to the test site, and then, after the ligand has been captured, a buffer added through the first opening is used to cause a secondary specific binder conjugated to a marker to migrate horizontally by capillary action to the test site where it can bind to the already captured ligand. This immunoassay offer several advantages over the traditional chromatographic immunoassays.

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: The present invention relates generally to an assay for detecting and differentiating multiple analytes, if present, in a single fluid sample, including devices and methods therefore.

Abstract: An immunochemical assay device for determining the presence of NT-proBNP alone or conjunctively with Cardiac Troponin I comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (i) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.

Abstract: A system and an apparatus for use in detecting a target microorganism or agent is disclosed which involves a solid support carrying a binding partner specific for the particular microorganism or agent and the solid support being characterised in that it defines means for protecting the binding partner from being dislodged or scraped off the solid support by physical means. The provision of protection against the binding partner being dislodged from or scraped off the solid support improves the reliability of tests such as immunoassays being conducted with the solid support and also enables such tests to be automated. Modules and machines for use with the solid support, and the automated conduct of tests ate also disclosed.

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: Disclosed is a lateral flow quantitative assay method which can measure one or more analyte species at the same time, with high sensitivity. Also, the present invention relates to a strip which can measure one or more analyte species at the same time, with high sensitivity and a package in which the strip is integrated with a laser-induced surface fluorescence detector. The present invention can quantify multiple analytes with a minimum detection limit of pg/ml. Therefore, the present invention provides an advantage capable of quantifying a plurality of analytes at the same time using a simple lateral flow assay strip.

Abstract: Superparamagnetic (“SPM”) subunits of 1–30 nm average mean diameter (e.g. ferro fluid) subparticles are treated with a magnetically noninterfering substance capable of coating and covering them (e.g, BSA) and they spontaneously form agglomerates of about 100 nm to about 450 nm or higher average mean diameter and are then used to form complexes with target biological ligands such as viruses, contained in large volumes of liquid. The complexes are subjected to the gradient intensity of a strong magnetic field, and excess liquid is removed, where upon an immunochromatographic assay is conducted to determine the identity and/or amount of target ligand present, in which operation SPM particles that bonded to the ligand function as tags for ligand detection.

Abstract: The present invention provides charged separation media, kits comprising the separation media, and methods of using the same to bind and optionally isolate biological molecules. The charged separation media and methods utilize a polyion non-covalently bound to the separation media to bind the desired biological molecule to the separation media.

Abstract: The present invention provides methods, compositions, and kits for rapid detection of analytes in a sample. Surprisingly, it has been found that bulking materials having non-sugar sweeteners effectively enhance chromatographic detection methods by providing component stability and controlled release. Thus, the novel components and methods disclosed herein provide a completely new modality of chromatographic analyte detection.

Abstract: A microorganism culture device comprising a porous matrix layer having a basis weight of 40 to 100 g/m2 and an air permeability of 7 to 24 cm/sec, and at least one layer of a water-soluble polymer layer laminated with the matrix layer.

Abstract: A simple easy to manufacture analytical device capable of performing membrane based immunoassays on batch of samples within 3 to 10 minutes wherein the method permits focused application of samples, costly labeled immunoassay and signal amplification reagents, said device includes an antibody-immobilized micro porous membrane, breadth corner layer of which is directly attached to a semi-rigid liquid-impervious body with water insoluble adhesive; absorbent body is provided separately and is not attached to analytical device during manufacture, absorbent body is wetted and is placed proximal to the lower surface of the membrane thereby forming networks of capillary channels with the absorbent body; flow of samples or reagents is always kept downwards and focused without application of any force to the absorbent body and the use of disposable adsorbent body permits stepwise addition of signal amplification reagents for ultra sensitive detection of diagnostically important molecules by visual examination of the m

Abstract: The present invention recognizes that sample handling devices, particularly those used for testing for substances of abuse, do not allow for a separation of the bulk sample from a sample thereof to be tested. The present invention provides such a device and methods of use. The present invention includes but is not limited to a specimen collection device that includes a chamber such that the chamber is capable of collecting a specimen. The device also includes a reservoir such that the reservoir is capable of receiving a portion of the specimen from the chamber and optionally so that the reservoir is capable of receiving a test device. The device includes a valve including a valve body and a valve plunger functionally interposed between the chamber and the reservoir that is capable of transferring at least a portion of the specimen from the chamber to the reservoir such that the chamber and the reservoir are not in direct fluid communication.

Abstract: The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.

Abstract: The present invention provides methods, compositions, and kits for rapid detection of analytes in a sample. Surprisingly, it has been found that bulking materials having starch reagents effectively enhance chromatographic detection methods by providing component stability and controlled release. Thus, the novel components and methods disclosed herein provide a completely new modality of chromatographic analyte detection.

Abstract: A device for evaluating at least one analyte in a test sample. The device comprises a cassette having a hollow test chamber, a test strip disposed within the test chamber for receiving the test sample, and a temperature control member. The cassette has at least one aperture extending from an exterior of the cassette to the hollow test chamber. The test strip includes a reagent adapted to react with the at least one analyte to produce a reaction indicative of the presence of the analyte. The temperature control member is adapted to extend through the at least one aperture in the cassette and into the test chamber for controlling the temperature of the test chamber.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. A sample membrane is utilized having a collection region and a detection region, the collection region having a known saturation volume for the intended test sample. A barrier is defined between the collection region and the detection region. The collection region is saturated with the test sample having a volume of less than about 100 microliters so that a known volume of the test sample is contained in the collection region. The barrier is removed from between the collection region and detection region of the membrane and a diluent is supplied to the collection region of the membrane to facilitate flow of the test sample from the collection region to the detection region of the membrane.

Abstract: A method for conducting a receptor-ligand association reaction includes the steps of dipping a biochemical analysis unit including a substrate formed with a plurality of absorptive regions which contain receptors or ligands and are formed to be spaced apart from each other in a reaction solution containing a ligand or receptor labeled with a labeling substance, simultaneously inserting a plurality of electrodes into all of the plurality of absorptive regions containing the receptors or ligands and sequentially applying a positive voltage to one of the electrodes at a time while other electrodes are grounded, thereby conducting a receptor-ligand association reaction. According to the this method, it is possible to efficiently react a ligand or receptor with receptors or ligands fixed in the plurality of absorptive regions of the biochemical analysis unit and produce biochemical analysis data having an excellent quantitative characteristic with good repeatability.

Abstract: The present invention recognizes that sample handling devices, particularly those used for testing for substances of abuse, do not allow for a separation of the bulk sample from a sample thereof to be tested. The present invention provides such a device and methods of use. The present invention includes but is not limited to a specimen collection device that includes a chamber such that the chamber is capable of collecting a specimen. The device also includes a reservoir such that the reservoir is capable of receiving a portion of the specimen from the chamber and optionally so that the reservoir is capable of receiving a test device. The device includes a valve functionally interposed between the chamber and the reservoir that is capable of transferring at least a portion of the specimen from the chamber to the reservoir such that the chamber and the reservoir are not in direct fluid communication.

Abstract: Device (1) for assaying a particulate analyte, comprising (a) a receptacle (2) for receiving a suspension (5) of particulate analyte, and containing label (3) for the particulate analyte, and (b) a porous detection material (4) that is permeable to label (3) but is impermeable to particulate analyte, the detection material (4) being arranged within receptacle (2) such that introduction of suspension (5) of particulate analyte into receptacle (2) forms liquid communication between label (3) and detection material (4). After liquid sample (5) is introduced into the receptacle (2), capillary flow through the porous detection material (4) begins. Particulate analyte cannot flow through the detection material (4) and is captured at its surface. Addition of liquid sample (5) also releases the label (3) within the receptacle (2), which is then free to flow through the detection material (4). Label (3) encounters the captured analyte and gives a signal (7).

Abstract: The invention concerns a method for the detection of an analyte in a sample using analyte-specific conjugates which have at least one heterologous group for an analyte-independent binding to a control zone. The present invention additionally provides new conjugates and reagent kits.

Abstract: A wearable article equipped with a multi-level alert system detects and emits signals corresponding to various abnormal levels of a substance in a mammalian extract. By providing different signals corresponding to multiple abnormal levels of the substance, the wearer is simultaneously alerted to the existence of an abnormality, and informed of the level of severity.

Abstract: Methods, articles, and kits for obtaining elevated concentrations of a substance from a sample that has become bound, for example by providing a positive test result in an immunoassay or other binding assay. The concentrated substance is optionally subjected to further processing or analysis, for example to confirm the identity of the substance, such as a pathogenic organism in a food sample.

Abstract: A self-contained apparatus using a gravitationally encouraged, interrupted, downward, diffusive and programmed flow of fluid to provide for rapid confirmatory immunological testing (“RCIT”) in, for example, a clinical, point-of-care setting. A fluid specimen such as blood, saliva or urine is deposited into a first chamber carrying a source of conjugate having mobilizable binding members such as immunographic antigens or antibodies specific to the condition being tested conjugated to a detectable label such as colloidal gold. The specimen is premixed with a first measured, reactive mix buffer solution carried within an openable tank. The specimen and solution are temporarily held within an incubation reservoir formed behind a dam made from porous, diffusive material.

Abstract: A chromatographic assay device for the analysis of an analyte in a liquid sample has a proximal sample application zone and a distal test zone. The test zone contains a first ligand capable of binding with the analyte to form an analyte-ligand complex. The device also includes a spatially distinct reservoir containing a labeled reagent capable of binding to the analyte-ligand complex; an absorbent sink which is positioned to be capable of drawing the contents of the spatially distinct reservoir through the test zone; and structures for contacting the spatially distinct reservoir with the chromatographic medium so that the labeled reagent migrates from the reservoir to the absorbent sink, and thereby through the test zone to determine the presence or absence of the analyte. The device is used in a method for detecting analyte.

Abstract: An immunoassay cassette, apparatus, and method for detecting an analyte in a liquid body-fluid sample are disclosed. The cassette has a body and a support mounted on the body, for movement relative to the body to first and second transfer positions. Sample supplied to a sample well in the cassette body is transferred to a reagent reservoir on the cassette body, by moving the support to its first transfer position. Here the sample reacts with a first reagent composition in the reservoir effective to form a modified sample. The modified sample is then transferred to a reagent strip on the support by moving the support to its second transfer position. The reagent strip has a transfer zone at which sample material is transferred to the strip, a second reagent composition effective to react with the modified sample to form a detectable analyte-dependent product, and a detection zone located downstream at which the detectable product can be observed.

Abstract: The biochemical analysis unit has a base plate and absorptive regions. The absorptive regions are surrounded by the base plate formed of materials which shield a radioactive ray and a light. In the absorptive regions are applied and absorbed specific binding substances to be bound with substances derived from a living organism that are labeled with labeling substances for generating the radioactive ray or the light. The base plate prevents the specific binding substances from penetrating in the other absorptive regions. When an analysis of data of the radioactive ray and the light is carried out, an image of the radioactive ray and the light is generated without noises.

Abstract: An immunoassay cassette, apparatus, and method for detecting an analyte in a liquid body-fluid sample are disclosed. The cassette has a body and a support mounted on the body, for movement toward and away from a sample transfer position. Sample supplied to a sample well in the cassette body is taken up by a reagent reservoir containing a first reagent composition effective to form a modified sample. The support provides a reagent strip having a transfer zone that is brought into contact with the reservoir, when the support is in the transfer position, a detection zone located downstream of the transfer zone, and a second reagent composition effective to react with the modified sample to form a detectable analyte-dependent product. By controlling movement of the support, volume and rate of sample flow from the reservoir to the strip can be controlled to optimize and/or standardize sample-transfer conditions in the assay.

Abstract: An assay system has a chamber that receives a test strip onto which a sample comprising an analyte has been placed. The chamber is in gaseous communication with a piezoelectric material that generates an electrical signal in response to a pressure change in the chamber that is caused by a reaction between the analyte and a reagent.

Abstract: A method and apparatus for use in a flow through assay process is disclosed. The method is characterised by a “pre-incubation step” in which the sample which is to be analysed, (typically for the presence of a particular protein), and a detection analyte (typically an antibody bound to colloidal gold or a fluorescent tag) which is known to bind to the particular protein may bind together for a desired period of time. This pre incubation step occurs before the mixture of sample and detection analyte come into contact with a capture analyte bound to a membrane. The provision of the pre-incubation step has the effect of both improving the sensitivity of the assay and reducing the volume of sample required for an assay. An apparatus for carrying out the method is disclosed defining a pre-incubation chamber for receiving the sample and detection analyte having a base defined by a membrane and a second membrane to which a capture analyte is bound.

Abstract: The present invention provides methods for determining a ratio of an amount of a glycated form of a protein to a total amount of the protein in a sample containing the glycated protein, the glycosylated protein, or the glycoprotein. The method incorporates lateral flow test strip or vertical flow test strip devices having negatively charged carboxyl or carboxylate groups and hydroxyboryl groups immobilized and interspersed on a solid support matrix. The solid support matrix may include derivatives of cellulose (e.g., carboxy cellulose) derivatized with carboxylic acid (e.g., carboxylate, carboxyl) groups and hydroxyboryl compounds including phenylboronic acid (e.g., phenylborate), aminophenylboronic acid, boric acid (e.g., borate), or other boronic acid (e.g., boronate) compounds. The present invention is usefi.il for monitoring glycation or glycosylation of hemoglobin or albumin for monitoring glycemic control (e.g., glycemia in diabetes).

Abstract: Near infrared molecular assays can be used to detect small quantities of a molecule of interest in vivo or in vitro using laser dyes. A hand-held portable device is provided which can rapidly read small quantities of selected molecular tags in tissues of fish or other animals in the field. The device is composed of four components: (1) a light source, such as a laser diode; (2) a sample holder; (3) an optical system; and (4) a detector.

Abstract: An apparatus for culture is provided, which apparatus enables to increase the ratio of a culture medium solution to the number of cells while keeping the density of the cells at a high level and diminishing the absolute number of the cells. The apparatus comprises a container having at least one concave part and at least one member (x) selected from the group consisting of a gelatinous material, a sponge material, and a mesh material, wherein the member (x) is placed within the concave part of the container, has at least one hollow by which a part or parts of a surface of the container in the concave part is bared, and holds a solution containing culture medium components. Further, processes for preparing the apparatus, culturing methods that use the apparatus, a method for studying or observing an influence of a substance to be examined on cells or a piece of a tissue, a kit for making the apparatus, and a flat substrate for culture are provided.

Abstract: The systems of the invention include test cells with a first sorbent material defining a first flow path for a solution, a second sorbent material defining a second flow path distinct from the first flow path for a sample, and a test line or test site with immobilized antigens or antibodies or other ligand binding molecules such as aptamers, nucleic acids, etc. located at the junction of the first and second sorbent materials. The first and second sorbent strips touch each other at the test site location.

Abstract: Chromatographic strip is used in combination with a transmittance detecting system in a test to quantitate analytes in biological fluid. Chemical reagents or conjugate labels are simply absorbed on the passages' materials of the strip. The substrates, affinity reagents, or antibodies are immobilized on transparent beads in the detection cell of the strip. The biological fluid passes through the strip. The captured analytes are detected by transmittance detection for quantification. Uncaptured elements and interferences in the fluid are drained to the absorbent portion of the strip when the fluid passes the cell as a wash. This chromatographic strip with an analyte capture zone simplifies the procedures that a transmittance detecting system alone cannot overcome. Adjustable light path of the cells in the strip overcome the sensitivity limitation of reflectance detection.

Abstract: A method of sensing an environmental agent, comprising obtaining a sample from the environment and transferring the sample into the working fluid for dispensation to a detection module. The sample and working fluid mixture is filtered through a porous polymer Bragg grating. By comparing the refractive index of the grating with the mixture to the refractive index of a grating without the sample, a difference in the refractive index aids in the identification of a hazardous agent in the environment. The sensor also acts as a chemical filter by trapping specific target agents by a highly specific reaction with a conjugate molecule. Recirculation of the working fluid throughout the system provides a sensor that is “always on.

Abstract: An apparatus for separating and detecting motile spermatozoa in a liquid sample, comprises: a separation vessel including (i) an inlet port, (ii) an outlet port arranged to be opened, (iii) a separation medium into which motile spermatozoa in the sample can flow via the inlet port, and (iv) an actuator operable to open the outlet port for allowing the separation medium to flow out of the vessel through the outlet port; and a spermatozoa detection device including (i) an application zone in communication with the outlet port, (ii) a detection zone, in which presence of spermatozoa can be detected, and (iii) a reagent zone containing a reagent which is capable of reacting with spermatozoa to facilitate detection of the spermatozoa in the detection zone, with the application zone, the detection zone and the reagent zone being arranged to permit capillary flow of spermatozoa from the application zone to the detection zone.

Abstract: The present invention provides antibodies which specifically bind early conception factor, which can be found in body fluids of animals including but not limited to the cow, cat, dog, horse, human, sheep, and pig. The invention provides methods for detecting conception or the absence of conception in an animal, the latter being recognized by the absence of early conception factor in a suitable body fluid collected from the animal. Apparati for detecting early conception factor in a body fluid from an animal comprising the antibodies which specifically bind early conception factor are also provided.

Abstract: A microscale binding assay, analyte binding array, and kits are disclosed, which exploit the mass action law to harvest analyte from a liquid sample. This is achieved by fabrication of sorbent zones having up to ten times the binding capacity per unit area generally obtained on polystyrene microtiter plates. The resulting arrays substantially deplete the liquid solution of analyte during incubation. Accordingly, the assays respond to total mass of analyte in the sample, not analyte concentration. This approach, coupled with direct fluorescence detection in the NIR, yields maximal signal intensity and low background for optimal sensitivity.

Abstract: A reagent is suitable for measuring the concentration of an analyte in a hemoglobin-containing biological fluid, such as whole blood. The reagent comprises a flavin-dependent enzyme that has specificity for the analyte, a flavin cofactor if, and only if, a flavin is not bound to the enzyme, a tetrazolium dye precursor, an electron transfer agent, and a nitrite salt. The reagent causes dye formation that is a measure of the analyte concentration. The nitrite salt suppresses interfering dye formation caused non-enzymatically by the hemoglobin. Preferably, the reagent is used in a dry strip for measuring glucose in whole blood.

Abstract: This invention provides solid phase specific binding lateral flow assay methods, devices and kits for quantitating high and low molecular weight analytes. The methods and devices of the invention employ labelled reagents which are either analyte analogs or complementary specific binding pair members for the analyte and a novel arrangement of capture zones comprising immobilized specific binding substances for either the analyte or the labelled reagent to effect bound from unbound labelled reagent as a function of analyte concentration. The capture zones are disposed on a non-bibulous matrix defining a flow path from a sample receiving zone to the capture zone. The devices of this invention also include multilane flow paths and multiple capture zones to quantitate analyte.

Abstract: An immunochemical assay device for determining the presence of NT-proBNP alone or conjunctively with Cardiac Troponin I comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (i) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.

Abstract: Assay apparatus comprising: a moulded cartridge containing a lateral flow test strip which has a label pad containing an enzyme antibody or antigen conjugate having affinity for an analyte; a capture zone having a capture antibody or antigen having affinity for said analyte; a reagent storage blister; a means for removing sample and/or label pad from the lateral flow test strip; a meter in which the cartridge is inserted enabling the control for reagent release from the reagent storage blister and for the sample and/or label pad removal and a means of providing quantitative measurement of said analyte.

Abstract: A method for selectively combining multiple membranes for assembly into test strips (such as visual blood glucose test strips with side-by-side membranes). The method includes first measuring a plurality of color parameters (e.g., L*, a* and b*color parameters) associated with membrane samples from at least two membrane lots. Next, response characteristics (e.g., blood glucose response levels) are simulated for a speculative test strip that includes, for purposes of the simulation, combined multiple membranes tentatively selected from the at least two membrane lots. The simulated response characteristics are based on the measured plurality of color parameters of the tentative selection of combined multiple membranes. Optionally, the simulated response characteristics can also be based on simulated color parameters of the tentative selection of combined multiple membranes.

Abstract: This invention provides methods of retentate chromatography for resolving analytes in a sample. The methods involve adsorbing the analytes to a substrate under a plurality of different selectivity conditions, and detecting the analytes retained on the substrate by desorption spectrometry. The methods are useful in biology and medicine, including clinical diagnostics and drug discovery.

Abstract: A biosensor is provided with an area in which a reagent having bleaching action is carried in a state where it can be dissolved, at least in a part of a sample application area to which an inspection target solution is applied or the downstream of the sample application area in the direction of the inspection target solution permeating, in a development layer. In the so-constituted biosensor, a colored component in the inspection target solution can be faded by the bleaching reagent, so that the color in parts other than a reactive area is reduced in consequence, whereby a visual judgment is possible and a more accurate measurement result in which a reading error by a measuring device is extremely suppressed can be obtained.

Abstract: An analytical test device useful for example in pregnancy testing, comprises 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 mea

Abstract: An immunochemical assay device for determining the presence of NT-proBNP alone or conjunctively with Cardiac Troponin I comprising a base member, an array disposed on the base member, and at least one assay indicia zone. The array comprises (i) a reservoir pad to receive sample liquid, (ii) a wicking membrane, and (iii) at least one filter zone interposed between the wicking membrane and the reservoir pad. The filter zone being operable to permit passage of any specific immunocomplex to the wicking membrane while impeding passage of larger components.

Abstract: A biological fluid collection container comprising a cup member, a lid assembly removably mounted to the cup member comprising a housing with a downwardly extending cylindrical skirt, a luer lock with a throughgoing bore extending from one side of the lid housing. A hollow tube extends from the other side of the lid housing adjacent the luer lock and is axially aligned with the throughgoing bore of the luer lock. The hollow tube is provided with a plurality of throughgoing holes leading into its lumen along its surface to provide for a sampling along various liquid level layers of the biological fluid specimen collected in the cup member so that when the biological fluid specimen is removed from the cup member a representative sampling is obtained.