Abstract: The invention concerns a reagent system for the so-called on-board control of analytical elements, in particular test strips, containing an organic N-oxide or a nitroso compound. The invention also concerns analytical elements containing a reagent system for a detection reaction and a reagent system for an on-board control. Furthermore, the invention concerns a method for checking analytical elements in which a reagent system for an on-board control is examined optically or electrochemically with the aid of a measuring instrument for changes which could indicate a stress of the analytical element.

Abstract: Method for the automatic analysis of a blood sample in which: an analysis solution containing the blood sample, a diluent, and at least one compound to lyze the erythrocytes; at least one compound to stabilize the haemoglobin in the form of a chromogenic complex, is formed in a single dilution and analysis tank, the haemoglobin level is measured in this analysis solution by spectrophotometry in the tank after the lysis of the erythrocytes; and an appropriate quantity of this analysis solution is taken from the tank on which a leucocytic differentiation is carried out by an optical elements characterized in that the analysis solution also contains at least one compound to protect the leucocytes, allowing the distinguishing of at least four main leucocyte sub-populations. A haematological analysis apparatus for the implementation of such a method is disclosed.

Abstract: High resolution particle differentiation process and separation system that provides enhanced resolution of particles based upon selected particle characteristics. In particular, the system may include an enhanced resolution flow cytometer. In an embodiment, the invention can include at least one fluid source conduit (24) that introduces 0 fluid source stream (24) into an enhanced resolution nozzle (25) at an angle that enhances particle resolution by the cell sensing system (13).

Abstract: The fluidic system of the preferred embodiment includes a sheath pump to pump sheath fluid from a sheath container into an interrogation zone, a sheath volume measurement device to measure the fluid in the sheath container, a waste pump to pump the sheath fluid and a sample fluid as waste fluid from the interrogation zone into a waste container, and a waste volume measurement device to measure the fluid in the waste container. The system also includes a controller connected to the sheath pump, the waste pump, and the volume measurement devices. The sheath pump and/or the waste pump draw sample fluid from a sample container into the interrogation zone, which functions to provide a location for the fluidic system and an optical system of the flow cytometer to cooperatively facilitate the analysis of the sample fluid.

Abstract: This invention is a disposable cartridge for use at the patient side to perform traditional coagulation assays on fresh whole blood or blood derivative samples. The cartridge, in use with an electronic analyzer allows a fluid sample to be metered and quantitatively mixed with reagents which activate the coagulation cascade. An artificial substrate for thrombin, the enzyme whose action results in clot formation is also provided. Clot formation is subsequently detected using a microfabricated sensor also housed within the cartridge which detects electrochemically the product of the thrombin reaction upon the synthetic substrate.

Abstract: A particle analyzer in which tagged particles to be analyzed are drawn through a suspended capillary tube where a predetermined volume in the capillary tube is illuminated. The illumination scattered by said particles is detected by a detector to count all particles. The fluorescent illumination emitted by tagged particles is detected and the output signals from the fluorescent detectors and scatter detector are processed to provide an analysis of the particles.

Abstract: The invention is directed to methods of screening for HLA antibodies comprising detecting antibodies specific for native HLA antigens and denatured HLA antigens. The invention also provides for method of predicting whether a transplant recipient has an increased risk for rejecting the transplanted organ.

Abstract: An apparatus which enables characterization of particles suspended in a liquid includes a housing with a mixing chamber and a collection chamber separated by a wall containing an aperture for passage of particles between, the mixing chamber and the collection chamber, the mixing chamber further containing a mixing member, a first electrode in the mixing chamber and a second electrode in the collection chamber for conduction of an electrical current through the aperture, a processor that is adapted for controlling the measurement sequence of the apparatus and detecting possible blockage of the aperture by detecting extended duration of the electrical pulse caused by the blocking particle, and upon detection of a blockage, reversing the liquid flow while mixing in the mixing chamber for removal of the blocking particle, and restarting particle counting.

Abstract: A sample analyzer includes a loading section in which a measuring unit is removably set, the measuring unit being adapted to receive a sample; and a control section which analyzes a signal acquired from the sample received in the measuring unit set in the loading section to provide a result of analysis of the sample; wherein the control section judges whether or not the measuring unit is properly set in the loading section.

Abstract: An aggregometer for measuring and recording platelet aggregation with at least one measurement cuvette having two electrodes, with a device for moving the liquid to be examined and with measurement and evaluation electronics connected to the electrodes via contact elements, is characterized in that the measurement cuvette comprises two adjacently arranged, upwardly open partial spaces which are only connected to one another in the lower region, in that the electrodes are designed as metal spheres inserted in the bottom of the measurement cuvette and in that the device for moving the liquid is a pumping device which can be placed on one of the partial spaces in a substantially sealing manner and which periodically and alternately generates low and excess pressure.

Abstract: A method of assaying nucleotide receptor P2X7 pore activity in white blood cells contained within a mixed cell sample is provided comprising labeling white blood cells with a white blood cell-specific label; depolarizing the labeled white blood cells with an isotonic depolarizing solution; contacting the labeled white blood cells with dye and a P2X7 agonist in an amount sufficient to activate P2X7 pore activity; contacting the labeled white blood cells with a divalent cation in an amount sufficient to deactivate P2X7 pore activity; and analyzing dye uptake whereby P2X7 pore activity is quantified by the amount of dye taken up in labeled white blood cells treated with the P2X7 agonist relative to labeled white blood cells in the absence of said P2X7 agonist, said P2X7 pore activity being corrected for sample age and by subtraction of P2X7 pore activity contributed by nonviable white blood cells.

Abstract: A method for determining the hematocrit of a blood sample is provided that includes the steps of: 1) depositing the sample into an analysis chamber operable to quiescently hold the sample for analysis, the chamber defined by the interior surfaces of first and second panels and a height extending there between, wherein both panels are transparent, and the height is such that at least some of the red blood cells within the sample contact both interior surfaces of the panels and one or more lacunae within the quiescent sample extend between the interior surfaces; 2) imaging at least a portion of the quiescent sample, which sample portion contains the red blood cells and one or more lacunae to determine an optical density of the imaged portion of the sample on a per image unit basis; 3) selecting and averaging the optical density values of the image units aligned with the red blood cells contacting the interior surfaces, and assigning an upper boundary value of 100% to the average optical density value of those i

Abstract: The present invention provides a method for testing quickly and easily the manner in which an antithrombotic agent inhibits the acceleration of blood coagulation when a platelet agonist causes acceleration of blood coagulation. The invention is a test method wherein a system in which an anticoagulant is added to a portion of blood sampled from a patient being administered an antithrombotic agent (X system blood), and a system in which an anticoagulant and adenosine diphosphate or collagen are added to a portion of the abovementioned blood (Y system blood) are simultaneously measured by thromboelastograph; and the efficacy of the antithrombotic agent is assessed by comparing the R values of the X system blood and the Y system blood. If the R value of the Y system blood is not found to differ significantly from the R value of the X system blood, the drug is judged to be working. Adenosine diphosphate and collagen can be used as the anticoagulant.

Abstract: Bodily fluid is analyzed for the presence of drugs of a selected panel of drugs in a simultaneous assay in which sample of the fluid is incubated with additional amounts of all drugs of the panel, antibodies specific to each of the drugs of the panel, and microparticles, the microparticles being divided into subsets, one subset for each drug in the panel and each subset distinguishable from the others. The incubation is performed in a liquid medium in which competitive binding occurs, the drugs in the sample competing with those added to the assay medium for binding to the antibodies. In one procedure, the added drugs are pre-coupled to the microparticles while the antibodies are not, and the incubation is followed by further incubating the microparticles with labeled ligands that have affinity for the antibodies.

Abstract: An apparatus for determining the volume fractions of the phases in a suspension includes a body, a channel structure, which is formed in the body, and an inlet area and a blind channel, which is fluidically connected to and capable of being filled via the same. Furthermore, a drive for imparting the body with rotation, so that phase separation of the suspension in the blind channel takes place, is provided. The blind channel includes such a channel cross-section and/or such wetting properties that, when filling same via the inlet area, higher capillary forces act in a first cross-sectional area than in a second cross-sectional area, so that at first the first cross-sectional area fills in the direction from the inlet area toward the blind end of the blind channel and then the second cross-sectional area fills in the direction from the blind end toward the inlet area.

Abstract: A flow cytometry system and method for sorting a mixture of particles with a fluid delivery system delivering a fluid containing particles, a flow cytometry apparatus for receiving the fluid, forming the fluid into a stream and using flow cytometry to classify the particles according to certain characteristics; a sorting system for sorting the particles according to the classification and according to a sorting strategy to provide at least one population containing desired particles and; a control responsive to information received from the flow cytometry apparatus for controlling the sorting system to vary its sorting strategy or for controlling the fluid delivery system to vary the rate at which fluid is delivered as a function at least one of purity and quantity of the particles.

Abstract: Methods for reducing time to result in blood bank diagnostic testing with an agitation device and a low ionic strength solution are disclosed. Specifically provided are methods for reducing incubation time for antigen-antibody reactions in an immunohematologic assay by subjecting the assay reactants to incubation with agitation and optionally additionally a low ionic strength diluent.

Abstract: A blood analyzer configured to prevent an abnormal number of white blood cells caused by lipid particles or red blood cells of poor hemolysis from being output. The blood analyzer includes a system for obtaining a first white blood cell number and a system for obtaining a second white blood cell number. The analyzer also includes an output device for outputting the second white blood cell number, and a system for determining whether the second white blood cell number is abnormal. The output device is configured to output the first white blood cell number when the second white blood cell number has been determined to be abnormal.

Abstract: A hemostasis analyzer, such as the Thrombelastograph® (TEG®) hemostasis analyzer is utilized to measure continuously in real time, the hemostasis process from the initial fibrin formation, through platelet-fibrin interaction and lysis to generate blood hemostasis parameters. The measured blood hemostasis parameters permit preparation of an individualized assessment of ischemic event risk and individualized treatment of a subject.

Abstract: The present invention is to present a particle analyzer that is capable of classifying and counting particles contained in a sample more accurately. The blood analyzer 1 includes: measuring unit 2 for obtaining a plurality of characteristic information of each of particles contained in a sample by measuring a measurement sample prepared from the sample; data processing unit 3 for obtaining a particle number of a specific kind of particles and each particle number of a plural kinds of particles different from the specific kind of particles, and determining a target kind of particles, whose particle number is corrected, from the plural kinds of particles, based on information obtained by the measuring unit 2, and correcting a particle number of the target kind of particles by using the particle number of the specific kind of particles.

Abstract: This invention is a disposable cartridge for use at the patient side to perform traditional coagulation assays on fresh whole blood or blood derivative samples. The cartridge, in use with an electronic analyzer allows a fluid sample to be metered and quantitatively mixed with reagents which activate the coagulation cascade. An artificial substrate for thrombin, the enzyme whose action results in clot formation is also provided. Clot formation is subsequently detected using a microfabricated sensor also housed within the cartridge which detects electrochemically the product of the thrombin reaction upon the synthetic substrate.

Abstract: A tube and float system for use in separation and axial expansion of the buffy coat includes a transparent or semi-transparent, flexible sample tube and a rigid separator float having a specific gravity intermediate that of red blood cells and plasma. The float includes a main body portion of reduced diameter to provide a clearance gap between the inner wall of the sample tube and the float. One or more protrusions on the main body portion serve to support the flexible tube. During centrifugation, the centrifugal force causes the diameter of the flexible tube to expand and permit density-based axial movement of the float in the tube. The float further includes a pressure relief system to alleviate pressure build up in the trapped red blood cell blood fraction below the float, thereby preventing red blood cells from being forced into the annular gap containing the buffy coat layers.

Abstract: A method for investigating the thrombocyte function of the blood, and particularly of platelet aggregation, wherein the following steps are carried out: a) cross-flowing an aperture with blood or blood components; b) determining the active radius of the aperture depending on time and c) evaluating the time-dependent modification of the radius as a measure for blood cell and/or thrombocyte function.

Abstract: A fluid property measurement system for measuring free stream particulates includes a fluid movement device positioned within a fluid container which is configured to cause fluid flow within the fluid container along a fluid flow path when a fluid is present. A constricted region along the fluid flow path generates a region of concentrated streamlined flow within the constricted region and mixing of the fluid outside of the constricted region. A property measuring device is positioned with respect to the constricted region to measure fluid properties in the region of streamlined flow.

Abstract: An assay stick 7 includes a transparent reaction vessel or tube 14 having one or more microbeads 8 disposed therein. The microbeads 8 have a plurality of unique identification digital codes based on a diffraction grating 12 disposed therein that are detected when illuminated by incident light 24. The incident light 24 may be directed transversely onto the side or onto an end of the tube 14 with a narrow band (single wavelength) or multiple wavelength source, in which case the code is represented by a spatial distribution of light or a wavelength spectrum, respectively. The assay stick 7 may be reused or disposed upon completion of the assay. Alternatively, the beads may be attached to a strip or planar surface. The encoded beads can also provide traceability, quality-control, and authenticity of each bead 8 to its source and/or to the chemistry on each bead 8. Also, the low sample volume of the assay stick allows for faster reactions and better sensitivity.

Abstract: Elevated number of Circulating Endothelial Cells (CEC) have been implicated in disease conditions associated with the formation or destruction of blood vessels such as acute coronary syndrome, thrombocytopenic purpura, sickle cell disease, sepsis, lupus, nephrotic syndromes, rejection of organ transplants, surgical trauma and cancer. This invention provides a method for assessing the levels of CEC which vary between different studies using a sensitive enrichment, imaging, and enumberation analysis. CD146 is one of the most specific endothelium-associated cell-surface antigens which can be used in image cytometry. CEC analysis provides an essential tool in prognostic/diagnostic evaluation in the clinic.

Abstract: A cartridge device having a receiving portion for receiving a blood sample and a jack portion for receiving a plug; a stirring device for circulating the blood sample within the receiving portion; and an electrode holder having at least one incorporated electrode wire pair; wherein the electrode holder is attachable to the cell such that one end of the at least one electrode wire pair forms a sensor unit for measuring the electrical impedance between the two electrode wires of the at least one electrode wire pair within the blood sample and that the opposite end of the at least one electrode wire pair forms a plug portion being connectable directly to the plug for an electrical connection of the sensor unit to an analyser.

Abstract: This invention provides a device for determining the concentration of an analyte like glucose, cholesterol, free fatty acids, triglycerides, proteins, ketones, phenylalanine or enzymes, in a physiological or aqueous fluid like blood, serum, plasma, saliva, urine, interstitial and/or intra-cellular fluid, the device having an integrated calibration and quality control system suitable for dry reagent test strips with a very small sample volume of about 0.5 ?L based on to a new sample distribution system. The production of the inventive analyte test element involves only a small number of uncomplicated production steps enabling an inexpensive production of the strips.

Abstract: The invention relates to a microfluidic system comprising a microfluidic device having a first and a second opposite surfaces and an optical detector, the microfluidic device comprises a flow channel with a detection channel section having a length of at least about 1 mm, the microfluidic device comprises at least one aperture section comprising at least a part of said detection channel section and a transparent window into said detection channel section, the optical detector is arranged to be in optical communication with said aperture section to determining at least one optical property of said aperture section as a function of time. The flow channel may have capillary dimensions and/or it may wholly or fully be arranged to drive a fluid flow by applying external forces.

Abstract: Processes of storing sorted and unsorted spermatozoa, in the form of a sperm dispersion, having reduced motility relative to endogenous ejaculated sperm are disclosed. The immotile spermatozoa of the dispersion tend to have a greater capacity for enduring the rigors associated with storage, transportation, and fertilization procedures. Processes for providing such sperm dispersions, for inseminating a female mammal with such sperm dispersions, as well as compositions and combinations comprising the sperm dispersions, are also disclosed.

Abstract: A measuring method and a measuring apparatus which can classify and count myeloblast more precisely without influence of other component in a sample including platelet aggregation in measurement of a blood sample with a flowcytometry, wherein damage is given to a cell membrane of erythrocyte and mature leukocyte contained in a hematological sample, a hemocyte in which a cell membrane is damaged is constricted, and this is dyeing-treated with a fluorescent dye which can stain a nucleic acid to obtain a sample, the sample is measured with a flowcytometer, and a cell contained in a first cell group containing myeloblast, which is specified based on forward scattered light information and side scattered light information, and contained in a second cell group containing myeloblast, which is specified based on forward scattered light information and fluorescent information, is counted as myeloblast.

Abstract: A microfluidic passive device and a method for determining clotting time are described, of a fluid medium such as blood, of low production cost which can therefore be disposable. When optimised to determine blood clotting time, it requires a minimal whole blood sample (<5 ?L) and it is particularly suited to INR or PT determination, which can be used autonomously by patient without venipuncture. Monitoring, and processing means to interpret the results are comprised in an external coagulometer device. A production method for the manufacture of the microfluidic device is also provided.

Abstract: Disclosed are methods for detecting antibody in a sample, where the antibody targets an antigen expressed by red blood cells or red blood cell ghosts. Rather than detecting the binding events between a particular antigen antibody pair (as in traditional agglutination based assays) the methods herein allow for multiplexed detection of clinically important allo-immune antibodies to blood group antigens. Specifically the method involves generating fluorescently encoded red blood cells or red blood cell ghosts with known antigen presentation and using them to detect the presence of antibody in serum/plasma with a fluorescent sandwich type immunoassay. The assay results can be read using flow cytometric or fluorescent microscope based imaging techniques.

Abstract: Disclosed herein is a microparticle sorting apparatus, including: a discharge direction confirming section configured to confirm a discharge direction of a discharged liquid discharged from a discharge outlet of a flow path; opposite electrodes disposed downstream with respect to the discharge outlet; an opposite electrode position controlling section configured to control positions of the opposite electrodes in accordance with the discharge direction confirmed by the discharge direction confirming section; a droplet generating section configured to generate a droplet from the discharge outlet; and a charging section configured to electrically charge the droplet with electric charges.

Abstract: A chemiluminescence-based detection system and method for counting blood cells by capturing and isolating target blood cells flowing through a microfluidic chip and detecting light emitted by the captured target blood cells.

Abstract: A method and device for blood hemostasis analysis is disclosed. A blood sample is displaced to reach a resonant state. The resonant frequency of the blood sample is determined before, during and after a hemostasis process. The changes in the resonant frequency of the blood sample are indicative of the hemostasis characteristics of the blood sample.

Abstract: The present invention relates to methods and kits for diagnosing, ascertaining the clinical course a of myelodysplastic syndrome(MDS) and ascertaining response to a therapy regimen of myelodysplastic syndrome. Specifically the invention provides method and kits useful in the diagnosis and determination of clinical parameters associated with MDS based on surface markers unique to MDS.

Abstract: A method for the enumeration of micronucleated erythrocyte populations while distinguishing platelet and platelet-associated aggregates involves the use of a first fluorescent labeled antibody having binding specificity for a surface marker for reticulocytes, a second fluorescent labeled antibody having binding specificity for a surface marker for platelets, and a nucleic acid staining dye that stains DNA (micronuclei) in erythrocyte populations. Because the fluorescent emission spectra of the first and second fluorescent labeled antibodies do not substantially overlap with one another or with the emission spectra of the nucleic acid staining dye, upon excitation of the labels and dye it is possible to detect the fluorescent emission and light scatter produced by the erythrocyte populations and platelets, and count the number of cells from one or more erythrocyte populations in said sample.

Abstract: The invention relates to methods of isolating white blood cells (WBCs) from a sample, e.g., whole blood, using magnetic particles that specifically bind to WBCs and a series of specific steps and conditions. The methods can include one or more of decreasing the viscosity of the sample prior to WBC isolation, agitating the sample at specified frequencies, and/or using a sample container arranged such that all of the sample is placed in close proximity (e.g., within 5, 2, 1, or 0.5 mm) to the source of the magnetic field. The new methods provide for isolation of WBC preparations with high yield, purity, and viability. The methods are designed for compatibility with automation protocols for rapid processing of multiple samples.

Abstract: The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments, and debris. Analysis is performed with a number of platforms, including flow cytometry and the CellSpotter® fluorescent microscopy imaging system. Analyzing damaged cells has shown to be important. However, there are two sources of damage: in vivo and in vitro. Damage in vivo occurs by apoptosis, necrosis, or immune response. Damage in vitro occurs during sample acquisition, handling, transport, processing, or analysis. It is therefore desirable to confine, reduce, eliminate, or at least qualify in vitro damage to prevent it from interfering in analysis. Described herein are methods to diagnose, monitor, and screen disease based on circulating rare cells, including malignancy as determined by CTC, clusters, fragments, and debris. Also provided are kits for assaying biological specimens using these methods.

Abstract: Feed devices for liquid samples serve to convey liquid samples, for example to convey a liquid sample from waste water in a waste water treatment plant so as to monitor the treatment process. Known feed devices feed continuously at relatively low speeds. Films may accrete in the feed line that hinder the feeding and may react with the liquid sample. Therefore, the feed line must be cleaned frequently. In view of this, it is the object of the invention to improve the handling and the maintenance of a feed device for liquid samples. According to the invention, this object is solved by the fact that the feed pump (16) feeds in a pulse-like manner and the feed pump (16) as well as the feed line (18) are configured such that the expansion volume of the feed line (18) during the feed pulse is at most 50% of the pulse volume. Thereby, the feed line is cleaned and kept free of accretions.

Abstract: High resolution particle differentiation process and separation system that provides enhanced resolution of particles based upon selected particle characteristics. In particular, the system may include an enhanced resolution flow cytometer. In an embodiment, the invention can include at least one fluid source conduit (24) that introduces 0 fluid source stream (24) into an enhanced resolution nozzle (25) at an angle that enhances particle resolution by the cell sensing system (13).

Abstract: An analyzing tool (Y) has a liquid-introducing opening (61), one or more flow passages (51) through which a sample liquid introduced from the liquid-introducing opening (61) is moved, and a separation film (8) for filtrating the sample liquid supplied to the liquid-introducing opening (61) and then introducing the liquid filtrated to the one or more flow passages (51). The analyzing tool (Y) is structured such that a liquid sample is filtrated by being advanced in the thickness direction of the separation film (8). The flow passage (51) is structured such that the sample liquid is moved by, for example, a capillary phenomenon.

Abstract: An apparatus for analyzing biologic fluid is provided that includes a first planar member, a second planar member, and at least three separators. At least one of planar members is transparent. The separators are disposed between the members, and separate the members to form a chamber having a height. At least one of the members or separators is sufficiently flexible to permit the chamber height to approximate the mean size of the separators. During use, the biologic fluid to be analyzed is disposed within the chamber.

Abstract: A device for measuring blood coagulation time is formed from a first substrate; a second substrate; a spacer layer disposed between the first and second substrates, said spacer layer having an opening formed therein defining a sample receiving chamber, a vented sink chamber, and an elongated reservoir forming a conduit for liquid movement between the sample receiving chamber and the sink chamber; a first electrode disposed on the first substrate, said first electrode being exposed in the reservoir portion through a first opening in the spacer layer; and a second electrode disposed on the second substrate, said second electrode being exposed in the reservoir portion through a second opening in the spacer layer. The device of the invention is used in combination with an apparatus that is connected to the first and second electrodes for measuring current flow between the first and second electrodes.

Abstract: The present invention is to present a sample analyzer, including: a lamp member which includes a halogen lamp including an electrode and a filament connected to the electrode; a holding mechanism for holding the lamp member such that the filament of the halogen lamp is positioned above the electrode; a light receiver for receiving light irradiated from the halogen lamp through an analysis sample; and an analysis unit for analyzing a component contained in the analysis sample based on the light received by the light receiver.

Abstract: A sample carrier with a sample receiver for the sample liquid and with preferably several sample chambers which are connected thereto is proposed. In order to avoid refilling with sample liquid when it evaporates or is otherwise lost or used up, there is additionally a reservoir for sample liquid which is covered in the same way as the sample chambers and which has a connecting channel to the environment which can be closed by the sample liquid.

Abstract: The present invention relates a method for the enumeration of in vivo gene mutation. The method utilizes differential staining of GPI-anchor deficient erythrocyte populations to distinguish between wild-type and pig-a gene mutants. Quantitative analyses can be conducted on erythrocytes and/or reticulocytes, and is based upon fluorescent emission and light scatter following exposure to an excitatory light source. Counting of mutant erythrocytes or reticulcoytes relative to the number of total erythrocytes or reticulocytes can be used to assess the DNA-damaging potential of an exogenous chemical agent, the DNA-damaging potential of an exogenous physical agent, the effects of an exogenous agent which can modify endogenously-induced DNA damage, and the effects of an exogenous agent which can modify exogenously-induced DNA damage. Kits for practicing the invention are also disclosed.

Abstract: A blood crossmatching apparatus, kit and methods for testing the compatibility of mammals for blood transfusion. Particulate layers in the apparatus allow nonagglutinated red blood cells to permeate through, while agglutinated red blood cells cannot. The apparatus also has a density solution. The density solution separates white blood cells from red blood cells in the whole blood when centrifuged, without lysing the red blood cells. Thus, the apparatus can be used to test whole blood.

Abstract: A new device and method for detecting the presence of living microorganisms in test samples are described. The device includes a container having at least one section transparent to light with an incubation zone defined in the container, the incubation zone containing growth media in which the sample is cultured. A detection zone containing a matrix composed of a polymeric material which is substantially transparent to light, and at least one indicator reagent sensitive to carbon dioxide gas generated by the microorganisms in the incubation zone is located in the transparent section of the matrix. The matrix is configured to facilitate penetration of external light aimed at the transparent section of the container and interaction of the external light with the indicator reagent to yield interactive light that escapes through the transparent section of the container, said interactive light is being indicative of the presence and/or concentration of the microorganisms.