Abstract: An electrochemical-based analytical test strip (EBATS) for the determination of an analyte (such as glucose) in a bodily fluid sample (for example, a whole blood sample) includes an electrically insulating base layer (110), a patterned electrically conductive layer (120) disposed on the electrically insulating base layer, an enzymatic reagent layer (140) disposed on the patterned electrically conductor layer, a patterned spacer layer (150), a top layer (170) having an underside surface, and a soluble acidic material coating (160) on the underside surface of the top layer. The patterned spacer layer and top layer define a sample-receiving chamber (180) within the EBATS and the soluble acidic material coating is disposed on the underside surface of the top layer within the sample-receiving chamber. In addition, the soluble acidic material coating is operably dissolvable in the bodily fluid sample such that a pH of the bodily fluid sample in the sample-receiving chamber is reduced during use of the EBATS.

Abstract: In accordance with the present invention a measuring device compares the current generated by two working sensor active areas and gives an error indication if they are too dissimilar, i.e., the current at one sensor active area differs too greatly from what would be expected from considering the current at the other. Not only can this method detect when one of the sensor parts has not been properly covered with sample liquid, but it can also detect if there is a manufacturing defect in either sensor part or if either has been damaged after manufacture, since even with complete coverage of the working sensor parts, an anomalous current will be generated at the affected sensor part under such circumstances.

Abstract: A cap for use with a dermal tissue lancing device (that includes a housing and a lancet movable with respect to the housing) includes a proximal end for engaging with the housing, a distal end for engaging with dermal tissue and an opening for a portion of the lancet to pass through. The distal end of the cap includes portions for engaging dermal tissue. These portions are resiliently deformable such that, when the cap contacts and is urged towards dermal tissue, the portions deform resiliently, engaging the dermal tissue and approaching theretogether. A process for the collection of a fluid sample (e.g., blood) from dermal tissue includes providing a dermal tissue lancing device with a housing, a cap and a lancet that is moveable with respect to the housing and the cap. The cap includes a proximal end for engaging with the housing, a distal end for engaging with dermal tissue, and an opening for a portion of the lancet to pass through.

Abstract: An electrochemical glucose sensor comprising a base substrate, a conductive layer disposed on said base substrate, where said conductive layer comprises a reference electrode and at least two working electrodes; an insulation layer disposed on a part of said conductive layer, a reagent layer disposed on said working electrodes and on at least a part of said reference electrode, an adhesive layer disposed on a portion of said reagent layer and conductive layer wherein said adhesive layer substantially defines an area of said reference electrode which can be wetted by a liquid sample and said insulation layer substantially defines an area of said working electrodes which can be wetted by a liquid sample.