Abstract: Methods, compositions, systems, and devices are provided for performing and analyzing agglutination assays. In one aspect, methods for image analysis of agglutination assays are provided. In another aspects, methods for performing agglutination assays are provided. In one aspect, the methods may be used for the detection of various molecules, including viruses or antibodies against a virus. In another aspect, the methods can be used to determine effective immunization of a subject.

Abstract: Instrument for producing a sample of body liquid for analysis by piercing the skin with a lancing element having a skin piercing tip. The instrument has a housing and a lancing drive for driving a lancing element connected thereto in a puncturing movement. A pressure ring surrounds a skin contact opening and is adapted for pressing against the skin such that the skin bulges into the opening for promoting expression of body fluid. The skin contact opening has an opening area corresponding to a circle with a diameter of at least 3 mm and at most 8 mm, and the instrument comprises a pressing force control device for controlling the pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, to be at least 3 N and at most 8 N.

Abstract: A system is proposed for detection of at least one analyte in a body fluid, in particular for detection of blood glucose. The system is designed to generate a sample of the body fluid and to transfer at least some of the sample to at least one test element, in particular a test panel. The system is designed such that a time period between the generation of the sample and the application to the test element is less than 1 second, preferably less than 500 ms.

Abstract: An instrument for producing a sample of body fluid for analysis by piercing the skin with a lancing element having a piercing tip is disclosed. The instrument can comprise a housing and a lancing drive for driving a lancing element connected thereto in a puncturing movement. A pressure ring can surround a skin contact opening and can be adapted for pressing against the skin such that the skin can bulge into the skin contact opening for promoting expression of body fluid. The skin contact opening can have a circular opening with a diameter of at least about 3 mm and at most about 8 mm. The instrument can comprise a pressing force control device for controlling the pressing force between the pressure ring and the skin at the time of triggering the puncturing movement, to be at least about 3 N and at most about 8 N.

Abstract: Systems and methods for the expression of bodily fluid from an incision in the skin include devices which bear against the skin in a manner to retain the fluid adjacent the incision site and urge the fluid inwardly toward the incision. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

Abstract: Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, the device further comprising a fluid receiving means remotely spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.

Abstract: Systems and methods for the expression of bodily fluid from an incision in the skin include devices which bear against the skin in a manner to retain the fluid adjacent the incision site and urge the fluid inwardly toward the incision. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

Abstract: Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, the device further comprising a fluid receiving means remotely spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.

Abstract: Systems and methods for the expression of bodily fluid from an incision in the skin include devices which bear against the skin in a manner to retain the fluid adjacent the incision site and urge the fluid inwardly toward the incision. Systems utilize a constricting member, a bi-stable expression member, or a pressing member. The present invention further encompasses combinations of the foregoing expression systems with each other, as well as with other expression devices known in the art. Moreover, the invention includes the combination of the expression systems with incising, sampling and/or testing systems, particularly in a single, integrated device. The present invention also contemplates the associated methods for expressing bodily fluid from an incision, including in combination with methods for incising, sampling and/or testing of the bodily fluid.

Abstract: An integrated bodily fluid sampling device includes a lancet, a test strip attached to the lancet, and a flexible sheet extending from the test strip. The lancet and the flexible sheet form a gap sized to draw bodily fluid onto the test strip via capillary action. Further, a sampling end portion of the flexible sheet is shaped to enhance capillary action of the sheet. In one form, a removable film covers the lancet and forms a seal with the flexible sheet such that the seal surrounds a lancet tip. In another form, an insulating layer covers a portion of the lancet to prevent electrical interference between the lancet and an electrical testing system on the test strip and ensure an accurate analysis of the bodily fluid.

Abstract: An expression device includes an expressing cap that defines a lancet opening. The expression cap has a skin contacting surface that is generally flat and positioned to face tissue during expression of body fluid. The expression cap includes an elastomeric ring extending around the lancet opening from the skin contacting surface. The elastomeric ring is made from elastomeric material. The expression cap has a beveled surface between the lancet opening and the elastomeric ring to enhance expression of the body fluid when the expression cap is pressed around an incision site. It was discovered that when the beveled was angled at about 20°, expression of the body fluid was significantly enhanced.

Abstract: An integrated bodily fluid sampling device includes a lancet, a test strip attached to the lancet, and a flexible sheet extending from the test strip. The lancet and the flexible sheet form a gap sized to draw bodily fluid onto the test strip via capillary action. Further, a sampling end portion of the flexible sheet is shaped to enhance capillary action of the sheet. In one form, a removable film covers the lancet and forms a seal with the flexible sheet such that the seal surrounds a lancet tip. In another form, an insulating layer covers a portion of the lancet to prevent electrical interference between the lancet and an electrical testing system on the test strip and ensure an accurate analysis of the bodily fluid.

Abstract: A bodily fluid sampling device is operable to rupture the skin surface at normal and oblique angles utilizing a flat lancet of specified thickness and at least one cutting surface inclined less than eighty degrees (80°) from the longitudinal axis of the flat lancet. The flat lancet thickness and cutting surface geometry minimize pain while maximizing the amount of emerged bodily fluid. The device limits the depth to which the flat lancet penetrates the skin to further minimize pain and may urge the bodily fluid from the rupture site. The bodily fluid emerging from the rupture site is transported to a test device that tests the bodily fluid for particular properties and characteristics.

Abstract: An efficient design for an expanded dynamic range in a lateral flow one step assay for the detection of an analyte in a biological sample is disclosed. The device comprises a multiple strip design, each constructed of four zones; a sample receiving zone, a sample treatment zone, a labeling zone, and a capture zone. The sample containing analyte is accepted in the sample receiving zone in the form of blood, serum, plasma, or urine. It is then carried into the sample treatment zone where it is rendered compatible with the chemistries of the assay strip. The treated sample then flows into the labeling zone where it interacts with visible particles that are coupled to analyte specific binding proteins. The flow continues, carrying the labeled analyte into the capture zone where it is immobilized in specific regions with analyte specific binding proteins. Excess flow is absorbed in an absorbent zone that is in contact with the capture zone.

Abstract: An apparatus includes a rotatable chuck for supporting a substrate and a splash guard. The splash guard surrounds the chuck and surrounds a substrate mounted on the chuck. The splash guard has a portion that deflects fluid being flung off the substrate by centrifugal action in a manner so as to not splash back onto the substrate. The splash guard is moveable between a process position in which the upper annular edge of the splash guard extends above the chuck and a substrate on the chuck, and a load/unload position in which the splash guard is tilted so that one side of the upper annular edge is below an upper edge of the chuck. The movement of the splash guard facilitates loading and unloading of a substrate.

Abstract: A substrate processing system has a first substrate cleaner and a second substrate cleaner. The first substrate cleaner comprises a forward portion and a rear portion. The forward portion includes a rotatable substrate support. The rear portion is vertically thicker than the forward portion. The rear portion includes a device for rotating the support. The second substrate cleaner includes the elements included in the first substrate cleaner. The second substrate cleaner is stacked above the first substrate cleaner with the forward portions being vertically aligned and the rear portions being vertically aligned. A space is formed between the forward portions to permit access to the forward portion of the first substrate cleaner and to permit ample gas flow into the area between the forward portions of the first and the second substrate cleaners.

Abstract: Systems and methods for the expression of bodily fluid from an incision in the skin include devices which bear against the skin in a manner to retain the fluid adjacent the incision site and urge the fluid inwardly toward the incision. One system utilizes a constricting member which engages the skin at initial, outer positions, and moves to draw the skin into an inner position forming a bulged, pinch of skin containing the incision site. The constricting member comprises flexible or non-flexible components, and is formed as a single, continuous member or as a plurality of discrete elements. A second system includes a bi-stable expression member including a skin-engaging portion having a first, outwardly bulged condition, and a second, inverted condition the skin is drawn into and retained within the member. The exterior surface of the expression member is optionally configured or treated to enhance the grasping of the skin.