Abstract: Microfluidic devices having a diffusion-aided system for loading samples into the microfluidic device are provided. Methods of gas-venting a microfluidic device through a non-porous, gas permeable material sealing cover layer, for example, during liquid sample loading, are also provided. The non-porous, gas-permeable material can be, for example, a polysiloxane, for example, polydimethylsiloxane.

Abstract: An inverted microplate for conducting a thermocycled amplification reaction of polynucleotide. The microplate can comprise a main body having a first and second surfaces and a plurality of wells disposed in the first surface. Each of the plurality of wells can comprise a well opening and a well bottom and be sized to receive an assay. A sealing cover can be operably coupled to the first surface of the main body to seal the well openings of the plurality of wells when the main body is inverted so that the assay is in contact with the sealing covering cover.

Abstract: Methods for normalizing output from an instrument employing a reference standard or non-fluorescing substance disposed within at least one of a plurality of reaction chambers. The method comprises collecting and analyzing a signal associated with the reference standard or non-fluorescing substance to determine a normalizing bias. The normalizing bias is then applied to the data signal collected from a remainder of the plurality of reaction chambers.

Abstract: A method of conducting amplification comprising loading a liquid polynucleotide sample into a well of a microplate and covering the well of the microplate with a cover, such that the cover fluidly seals the liquid polynucleotide sample within the well. The method then comprises inverting the microplate such that the liquid polynucleotide sample contacts the cover; and thermocycling the microplate to promote amplification of polynucleotides in the liquid polynucleotide sample.

Abstract: An apparatus for normalizing a PCR instrument, can comprise a microplate comprising at least 6,000 wells and a system of dyes at known concentrations in a plurality of the at least 6,000 wells. A method for normalizing a system can comprise (a) providing a microplate comprising at least 6,000 wells and a system of dyes; (b) exciting at least one dye; (c) detecting an emission output for the at least one dye; (d) determining if the emission output is in an acceptable range; and (e) adjusting the system so that the emission output is in the acceptable range.

Abstract: A filling apparatus for filling a microplate. The microplate having a plurality of wells each sized to receive an assay. The filling apparatus can comprise an assay input layer having a first surface and an opposing second surface. The assay input layer can comprise an assay input port extending from the first surface to the second surface, a venting manifold formed in the second surface, and a vent hole in fluid communication with the venting manifold and atmosphere. An output layer can comprise a plurality of staging capillaries each having an inlet and an outlet. A venting layer can be disposed between the assay input layer and the output layer. The venting layer can comprise a plurality of microfluidic channels, a flow aperture being in fluid communication with the assay input port and the plurality of microfluidic channels, and a plurality of vent apertures each in fluid communication with at least one of the plurality of staging capillaries.

Abstract: Measurement of the series track resistance of a working and counter electrode pair in an electrochemical test strip provide error detection for multiple variations in the quality of the test strip, as well as the operation of strip in the test meter. In particular, a single measurement of series resistance can be used to detect and generate an error message when an incorrect reading is likely to result due to (1) damaged electrode tracks, (2) fouled electrode surfaces, (3) dirty strip contacts, or (4) short circuit between the electrodes.

Abstract: Determination of an analyte with increased accuracy is achieved by electrochemically determining an initial analyte concentration, performing a plurality of amperometric/potentiometric switching cycles, observing a characteristic of the signal during each of the plurality of switching cycles, determining an averaged value for the characteristic of the signal, and correcting the initial measurement value to arrive at a final measurement value of analyte concentration or rejecting the initial measurement value depending on the averaged value of the characteristic of the signal. The characteristic of the signal that is observed is not per se indicative of the amount of analyte present in a sample. Rather, it is a characteristic of the signal that reflects the quality of the electrodes, the extent of fill of the electrochemical cell or characteristics of the sample other than analyte concentration such as oxygen levels or hematocrit.

Abstract: Detection of abnormal signal traces in electrochemical measurements generated using an electrochemical test strip to which a potential is applied allows for an indication of an erroneous analyte determination. The current trace has an expected shape in which a peak current is observed a time tpeak after which there is a decrease in current. To detect abnormal signal traces, the time tpeak is determined experimentally and compared with an expected value, t?peak, and if the difference between the two values to over a predetermined threshold, an error message is provided to the user instead of a test result. The value of t?peak is determined as a function of a mobility term that is determined during a potentiometry phase following the amperometric measurements.

Abstract: Determination of an analyte such as glucose in a sample is done making use of a plurality of electron transfer reagents, for example two electron transfer reagents, that work together to transfer electrons between the enzyme and the electrodes. The first electron transfer agent is a mediator that interacts with the enzyme after it has acted on the analyte to regenerate enzyme in its active form. The second electron transfer agent is a shuttle that interacts with the electrodes and optionally the mediator. The oxidation and reduction of the shuttle serves as the major source of current that is measured as an indication of analyte.

Abstract: A method of conducting amplification comprising loading a liquid polynucleotide sample into a well of a microplate and covering the well of the microplate with a cover, such that the cover fluidly seals the liquid polynucleotide sample within the well. The method then comprises inverting the microplate such that the liquid polynucleotide sample contacts the cover; and thermocycling the microplate to promote amplification of polynucleotides in the liquid polynucleotide sample.

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: A diagnostic test strip vial has a container, a lid, and a plurality of diagnostic test strips. The container has a generally annular wall that terminates at a base and at an open mouth at an end that is opposite the base. The annular wall is cut at an oblique angle creating a wall that has a high side and a low side at the open mouth. The low side of the annular wall of the container is shorter in length than a diagnostic test strip that enclosed in the vial when the lid is closed with the container.

Abstract: Systems and methods for multiple analyte detection include a system for distribution of a biological sample that includes a substrate, wherein the substrate includes a plurality of sample chambers, a sample introduction channel for each sample chamber, and a venting channel for each sample chamber. The system may further include a preloaded reagent contained in each sample chamber and configured for nucleic acid analysis of a biological sample that enters the substrate and a sealing instrument configured to be placed in contact with the substrate to seal each sample chamber so as to substantially prevent sample contained in each sample chamber from flowing out of each sample chamber. The substrate can be constructed of detection-compatible and assay-compatible materials.

Abstract: A filling apparatus for filling a microplate. The microplate having a plurality of wells each sized to receive an assay. The filling apparatus can comprise an assay input layer having a first surface and an opposing second surface. The assay input layer can comprise an assay input port extending from the first surface to the second surface and at least one pressure nodule extending from the second surface. An output layer can comprise a plurality of staging capillaries each having an inlet and an outlet. A intermediate layer can be disposed between the assay input layer and the output layer. The intermediate layer can be flexible and comprise a plurality of microfluidic channels and a flow aperture being in fluid communication with the assay input port and the plurality of microfluidic channels.

Abstract: A pipette tip and system for aspiration of a biological sample, distribution to a plurality of sample chambers, and thermal cycling in the pipette tip.

Abstract: A thin-walled structure (e.g., an end cone insulator (12) and/or a mounting mat) (12) comprising insulating material suitable for insulating portions (e.g., an end cone) of a pollution control device (16) and/or mounting material suitable for mounting a pollution control element in a pollution control device (16) (e.g., a catalytic element in a catalytic converter, a filter element in a diesel or gasoline engine exhaust filter, etc.). The thin-walled structure can comprise an insulating material and/or mounting material in the form, for example, of a sheet, mat (12) or three-dimensional thin walled structure (e.g., a single piece or multiple piece three dimensional end cone insulator). (12) An intermediate adhesive (18) (e.g., a heat activated adhesive, hot melt adhesive and/or adhesive-like thermoplastic material) is bonded to at least one major surface of the thin-walled structure so as to coat and penetrate into the at least one major surface.

Abstract: The presence of oxygen or red blood cells in a sample applied to an electrochemical test strip that makes use of a reduced mediator is corrected for by an additive correction factor that is determined as a function of the temperature of the sample and a measurement that reflects the oxygen carrying capacity of the sample. The measured oxygen carrying capacity can also be used to determine hematocrit and to distinguish between blood samples and control solutions applied to a test strip.

Abstract: Partial fill of an electrochemical test strip is determined by making a DC determination of double layer capacitance from charging or discharging charge on a test strip containing sample, for example a blood sample to be tested for glucose. The measured double layer capacitance is compared to a reference value. The double layer capacitance may be determined as an integral or differential capacitance. Double layer capacitance may also be used for quality control to monitor the quality of electrode formation, particularly in strips using screen printed electrodes.

Abstract: Abstract of the Disclosure A test strip and analytical apparatus have pin connections permitting the definition of geographic regions or of particular customers. A test strip made for use in a particular region or for a particular customer will have pin connections matching features of the apparatus made for use in that region or by that customer. Insertion of the strip into the apparatus does not merely turn on the apparatus, but provides the regional or customer coding. Analog switches within the apparatus allow coding of a larger number of distinct regions or customers than would otherwise be possible, all without degrading the quality of the measurements made of the fluid being tested. Conductive paths in the strips permit testing the strips during manufacture so as to detect quality lapses regarding the printing or deposition of the paths.