Abstract: The present disclosure is drawn to loop-mediated isothermal amplification (LAMP) reaction assemblies including a substantially hygroscopic agent free LAMP reagent mixture in combination with a solid-phase reaction medium. The present disclosure also includes systems for a chromatic LAMP analysis including a substantially non-reactive solid phase reaction medium, and a non-interfering reagent mixture. The present disclosure also includes solid phase LAMP reaction mediums comprising a substrate, an adhesive layer disposed on the substrate, a reaction layer disposed on the adhesive layer, and a spreading layer disposed on the reaction layer. The present disclosure also includes methods of testing for a presence of a target nucleotide sequence including providing a biological sample, and dispensing the sample into a test environment having a solid phase reaction medium in combination with a LAMP reagent mixture and a pH sensitive dye.

Abstract: The present disclosure is drawn to loop-mediated isothermal amplification (LAMP) reaction assemblies including a substantially hygroscopic agent free LAMP reagent mixture in combination with a solid-phase reaction medium. The present disclosure also includes systems for a chromatic LAMP analysis including a substantially non-reactive solid phase reaction medium, and a non-interfering reagent mixture. The present disclosure also includes solid phase LAMP reaction mediums comprising a substrate, an adhesive layer disposed on the substrate, a reaction layer disposed on the adhesive layer, and a spreading layer disposed on the reaction layer. The present disclosure also includes methods of testing for a presence of a target nucleotide sequence including providing a biological sample, and dispensing the sample into a test environment having a solid phase reaction medium in combination with a LAMP reagent mixture and a pH sensitive dye.

Abstract: The present disclosure is drawn to loop-mediated isothermal amplification (LAMP) reaction assemblies including a substantially hygroscopic agent free LAMP reagent mixture in combination with a solid-phase reaction medium. The present disclosure also includes systems for a chromatic LAMP analysis including a substantially non-reactive solid phase reaction medium, and a non-interfering reagent mixture. The present disclosure also includes solid phase LAMP reaction mediums comprising a substrate, an adhesive layer disposed on the substrate, a reaction layer disposed on the adhesive layer, and a spreading layer disposed on the reaction layer. The present disclosure also includes methods of testing for a presence of a target nucleotide sequence including providing a biological sample, and dispensing the sample into a test environment having a solid phase reaction medium in combination with a LAMP reagent mixture and a pH sensitive dye.

Abstract: A technology is described for a system for identifying a colorimetric test result from a pathogen test performed on a solid phase substrate. The system can comprise a sensor configured to detect a spectrum of color wavelengths. The system can comprise one or more processors. The one or more processors can be configured to: receive color wavelength data; determine a wavelength threshold for providing a pathogen positive test result; identify whether the color wavelength data meets or exceeds the wavelength threshold for providing a pathogen positive test result; and generate a result indicator indicating either a pathogen positive or pathogen negative test result.

Abstract: The present disclosure is drawn to loop-mediated isothermal amplification (LAMP) reaction assemblies including a substantially hygroscopic agent free LAMP reagent mixture in combination with a solid-phase reaction medium. The present disclosure also includes systems for a chromatic LAMP analysis including a substantially non-reactive solid phase reaction medium, and a non-interfering reagent mixture. The present disclosure also includes solid phase LAMP reaction mediums comprising a substrate, an adhesive layer disposed on the substrate, a reaction layer disposed on the adhesive layer, and a spreading layer disposed on the reaction layer. The present disclosure also includes methods of testing for a presence of a target nucleotide sequence including providing a biological sample, and dispensing the sample into a test environment having a solid phase reaction medium in combination with a LAMP reagent mixture and a pH sensitive dye.

Abstract: A heating device for testing a biological sample is disclosed. The heating device can include a heat source operable to generate heat. In addition, the heating device can include a controller in communication with the heat source and operable to control heat generation by the heat source to heat a biological sample at less than or equal to about 2 degrees C./s. Furthermore, a heating device for testing a biological sample is disclosed that can include a heat source operable to generate heat to heat a biological sample. The biological sample can be at least partially contained within a removable enclosure distinct from the heating device. Additionally, the heating device can include an enclosure interface associated with the heat source. The enclosure interface can be configured to interface with the enclosure such that heat is transferred from the heat source to the enclosure by conduction.

Abstract: A liquid biological sample test cartridge is disclosed. The cartridge can include a tray. The cartridge can also include a chemical reaction pad supported by the tray. The cartridge can further include a chemical reaction pad cover disposed over the chemical reaction pad and coupled to the tray. The chemical reaction pad cover can have a sample opening to facilitate depositing a liquid biological sample at a predetermined location on the chemical reaction pad. In addition, the cartridge can include an outer cover operable to at least partially form an enclosure about the chemical reaction pad.

Abstract: A prothrombin time reagent for determination of low molecular weight heparin in fresh whole blood and in anti-coagulant treated blood is provided. The reagent is composed of recombinant animal tissue factor, and a mixture of synthetic phospholipids, which mixture includes a phosphatidylalcohol. A formulation buffer which includes a sensitivity adjuster is used in formulating the reagent. The recombinant animal tissue factor includes rabbit brain. The synthetic phospholipids of the mixture include palmitoyloleoylphosphatidylcholine (POPC), palmitoyloleoyl-phosphatidylserine (POPS), and a phosphatidylalcohol. The phosphatidyl alcohol includes dioleoylphosphatidylethanol, dioleoylphosphatidylmethanol, dioleoylphosphatidylpropanol, dioleoylphosphatidylbutanol, and dioleoylphosphatidylinositol. The sensitivity adjuster included in the formulation buffer is ?-Cyclodextrin. The formulated reagent is air-dried and remains stable for at least 3 weeks at 37° C.

Abstract: A prothrombin time reagent for determination of low molecular weight heparin in fresh whole blood and in anti-coagulant treated blood is provided. The reagent is composed of recombinant animal tissue factor, and a mixture of synthetic phospholipids, which mixture includes a phosphatidylalcohol. A formulation buffer which includes a sensitivity adjuster is used in formulating the reagent. The recombinant animal tissue factor includes rabbit brain. The synthetic phospholipids of the mixture include palmitoyloleoylphosphatidylcholine (POPC), palmitoyloleoyl-phosphatidylserine (POPS), and a phosphatidylalcohol. The phosphatidyl alcohol includes dioleoylphosphatidylethanol, dioleoylphosphatidylmethanol, dioleoylphosphatidylpropanol, dioleoylphosphatidylbutanol, and dioleoylphosphatidylinositol. The sensitivity adjuster included in the formulation buffer is ?-Cyclodextrin. The formulated reagent is air-dried and remains stable for at least 3 weeks at 37° C.

Abstract: A prothrombin time reagent for determination of low molecular weight heparin in frsh whole blood and in anti-coagulant treated blood is provided. The reagent is composed of recombinant animal tissue factor, and a mixture of synthetic phospholipids, which mixture includes a phosphatidylalcohol. A formulation buffer which includes a sensitivity adjuster is used in formulating the reagent. The recombinant animal tissue factor includes rabbit brain. The synthetic phospholipids of the mixture include palmitoyloleoylphosphatidylcholine (POPC), palmitoyloleoyl-phosphatidylserine (POPS), and a phosphatidylalcohol. The phosphatidyl alcohol includes dioleoylphosphatidylethanol, dioleoylphosphatidylmethanol, dioleoylphosphatidylpropanol, dioleoylphosphatidylbutanol, and dioleoylphosphatidylinositol. The sensitivity adjuster included in the formulation buffer is ?-Cyclodextrin. The formulated reagent is air-dried and remains stable for at least 3 weeks at 37° C.

Abstract: A prothrombin time reagent for determination of low molecular weight heparin in fresh whole blood and in anti-coagulant treated blood is provided. The reagent is composed of recombinant animal tissue factor, and a mixture of synthetic phospholipids, which mixture includes a phosphatidylalcohol. A formulation buffer which includes a sensitivity adjuster is used in formulating the reagent. The recombinant animal tissue factor includes rabbit brain. The synthetic phospholipids of the mixture include palmitoyloleoylphosphatidylcholine (POPC), palmitoyloleoyl-phosphatidylserine (POPS), and a phosphatidylalcohol. The phosphatidyl alcohol includes dioleoylphosphatidylethanol, dioleoylphosphatidylmethanol, dioleoylphosphatidylpropanol, dioleoylphosphatidylbutanol, and dioleoylphosphatidylinositol. The sensitivity adjuster included in the formulation buffer is &ggr;-Cyclodextrin. The formulated reagent is air-dried and remains stable for at least 3 weeks at 37° C.

Abstract: A cocktail reagent preparation for the rapid production of serum contains thrombin, snake venom, and protamine sulfate. The preparation employs very small quantities of clot promoting substances which behave in a synergistic manner such that rapid clotting of highly heparinized blood is achieved without altering the chemical analysis of the blood enzymes, proteins, sugars, or electrolytes. Thus, clinicians who rely upon the results of such tests can more closely monitor organ and tissue function and adjust patient therapies accordingly.

Abstract: The present invention is an apparatus and method for performing a coagulation time test on a sample of blood wherein the blood is deposited in a fluid reservoir and disposable cuvette. Within the cuvette is formed a capillary conduit have at least one restricted region. The cuvette is inserted into a testing machine which engages the cuvette and draws blood from the fluid reservoir into the capillary conduit. The blood is then caused to reciprocally move within the capillary conduit whereby the blood is forced to traverse the restricted region. The testing machine measures the time required each time the blood is caused to traverse the restrict region. When a measured time is a predetermined percentage longer than an immediately preceding time, coagulation is considered to have occured and the overall coagulation time is displayed to the operator.

Abstract: A standard whole blood composition is disclosed, which is useful as a pooled human hemostasis reference standard in blood coagulation assays including Activated Clotting Time (ACT), Whole Blood Prothrombin Time (WBPT), Whole Blood Activated Partial Thromboplastin Time (WBAPTT) and Whole Blood Thrombin time (WBTT). Also disclosed are methods for determining the human standardized potency of heparin and protamine.

Abstract: An apparatus and method for performing a coagulation time test on a sample of blood wherein the blood is deposited in a fluid reservoir and disposable cuvette. Within the cuvette is formed a capillary conduit have at least one restricted region. The cuvette is inserted into a testing machine which engages the cuvette and draws blood from the fluid reservoir into the capillary conduit. The blood is then caused to reciprocally move within the capillary conduit whereby the blood is forced to traverse the restricted region. The testing machine measures the time required each time the blood is caused to traverse the restricted region. When a measured time is a predetermined percentage longer than an immediately preceding time, coagulation is considered to have occurred and the overall coagulation time is displayed to the operator.