Abstract: A sample collection apparatus for fluid handling of small amounts of sample fluid and loading of a syringe. The present sample collection apparatus can be utilized as a precise dispense device within an accompanying instrument, such as an input to an analytical instrument, point-of-care device, or automated analyzer. The present apparatus can also be used for preparing whole blood samples and for separating plasma from the cellular components of whole blood without centrifugation, as well as for providing filtered samples of biological materials.

Abstract: Described is a lateral flow high throughput assay device analyzer for preparing and analyzing a plurality of lateral flow assay samples. The analyzer comprises a cartridge stage for supporting an assay cartridge, an elevation adjustment mechanism, and a translation adjustment mechanism for aligning the cartridge stage and assay cartridge relative to a vertical support structure, fluid metering device, and detection device for high throughput lateral flow assay analysis.

Abstract: A flow assay cartridge for housing and protecting a flow assay membrane or lateral flow test strip which can be vertically stacked and is adapted for high-throughput automated lateral flow assay testing and analysis. The flow assay cartridge comprises a base and lid for receiving the flow assay membrane, and top and bottom engagement features such that two or more flow assay cartridges can be releasably adjoined in a vertical orientation such that they can be easily handled by an automated assay apparatus.

Abstract: A method for localizing a test region of interest on an assay membrane to determine the contours of the test region and enable calibration of the location of the test region such that the same region can be localized to image an analyte of interest after an assay run. Pre-localization of the test region limits the contours of the detection area to only the test region with a reasonable margin such that background noise received by the detector can be minimized. By limiting the region of detection to a pre-localized test region improved accuracy can be achieved in flow assay membrane tests, in particular in automated analyzer systems.

Abstract: A method and apparatus for assay sample volume normalization for a fluid sample applied to a diagnostic assay membrane to confirm the application of the sample fluid. The method can be used in manual, semi-automated, and automated analyser systems by applying a volume of a fluid sample having a fluorescence disruptor to a sample addition area of a membrane of an assay device having a fluorescent reporter and quantifying the change in fluorescence. Confirmation of sample fluid deposit and sample fluid volume calculation can be done by imaging the sample addition area to detect the disruption to fluorescence in the deposit area prior to running an assay.

Abstract: Described is a lateral flow high throughput assay device analyzer for preparing and analyzing a plurality of lateral flow assay samples. The analyzer comprises a cartridge stage for supporting an assay cartridge, an elevation adjustment mechanism, and a translation adjustment mechanism for aligning the cartridge stage and assay cartridge relative to a vertical support structure, fluid metering device, and detection device for high throughput lateral flow assay analysis.

Abstract: A device for collection of interstitial fluid that can perform needle assembly actuation, skin piercing, needle assembly repositioning, and secondary skin piercing. Also described is a method for extraction of ISF that results in a significant volume of extracted ISF. The presently described device and method can be used for interstitial fluid extraction and collection in the medical diagnostics field.