Abstract: A dry test strip assembly includes: a carrier base having a test port and a well adapted for receiving a dry test strip element, and a cover having a sample opening. The cover can be snapped onto the base with the sample opening aligned over the test port and with a test strip element compressed between the base and cover. A maximum dry test strip compression stop controls the maximum compression on the dry test strip, and a minimum dry test strip compression stop controls the minimum compression on the dry test strip. A rib between two test ports prevents fluid flow in the dry test strip element from one side of the rib to another, thereby separating the test strip element into a plurality of separate fluid compartments. A manufacturing system efficiently assembles the dry test strip assembly without handling by humans.

Abstract: A dry-phase triglycerides test strip that can be stored at room or elevated temperatures for several months without significant degradation in its effectiveness. The test strip includes a test membrane which receives plasma and forms a colored response in proportion to concentration of triglycerides in the plasma. The test membrane is impregnated with an aqueous solution containing lipoprotein lipase (LPL) and 4-aminoantipyrine (4AAP). The inventors have found that by reducing the pH of the impregnating solution to less than that of the recommended pH range for one of the key components (viz., less than pH 6.0), overall stability of the test strips was dramatically improved. The improvement in storage capability of these triglycerides test strips represents not just a difference in degree, but a difference in kind.

Abstract: Apparatus for determining concentration of creatinine in whole blood or plasma using a 1-methylhydantoinase (NMHase) catalyzed reaction, wherein the invention uses commercially available NMHase and thus eliminates prior art stabilization procedures for NMHase. Conveniently, known Trinder reagents and oxidative couplers are used for the indicator system. It has been found that by judiciously selecting the reagents used for the indicator system and/or varying the amount of enzyme NMHase that is loaded into the assay, the effect of the blank reaction can be minimized in the dynamic range of interest such that concentration of creatinine in normal and pathological levels can be measured directly without having to adjust for a blank reaction caused by bound N-methylhydantoin (NMH).

Abstract: A multilayer test strip and method of using the test strip for determining concentration of HDL cholesterol in a whole blood sample. The inventive test strip includes a two-stage blood separation mechanism, including a first glass fiber matrix which separates most of the blood cells and an adjacent, second matrix preferably also containing glass fibers that separates the remainder of the blood cells. The second layer also precipates and retains non-HDL cholesterol, thereby providing plasma that is substantially free of red blood cells and substantially free of non-HDL cholesterol to a reaction layer. Precipitation and retention on non-HDLs takes place by a vertical or dead-end filtration in a single layer. The reaction layer produces a color, the intensity of which is proportional to the concentration of HDL cholesterol in the blood sample which is applied to the test strip.

Abstract: A method for determining concentration of creatinine in whole blood or plasma using a 1-methylhydantoinase (NMHase) catalyzed reaction, wherein the invention uses commercially available NMHase and thus eliminates prior art stabilization procedures for NMHase. Conveniently, known Trinder reagents and oxidative couplers are used for the indicator system. It has been found that by judiciously selecting the reagents used for the indicator system and/or varying the amount of enzyme NMHase that is loaded into the assay; the effect of the blank reaction can be minimized in the dynamic range of interest such that concentration of creatinine in normal and pathological levels can be measured directly without having to adjust for a blank reaction caused by bound N-methylhydantoin(NMH).

Abstract: A bodily fluid analyzer including a dry test strip impregnated with a reagent providing a non-precipitating reaction to exclude non-desired analytes. The reagent complexes the non-desired analytes so they remain in solution but cannot participate in the test reaction. Red blood cells are removed from the detection area by slowing their vertical movement and stopping flow when the detection membrane is saturated.

Abstract: A bodily fluid analyzer including a test strip holder comprising a base and a snap-on cover which completely enclose the test strip except for a sample port in the cover and a sensor port in the base. The test strip is compressed between the base and cover in a sample container having a well-defined sample volume. The test strip comprises a woven dispersement layer, a depth filter containing a reagent, an asymmetrical membrane containing additional reagent, and a colorimetric detection membrane in a vertical stack. The red blood cells are removed from the colorimetric detection area by slowing their vertical movement and stopping flow when the detection membrane is saturated. A minimum value of the reflectance in a color range is used to determine a characteristic of the bodily fluid.

Abstract: There is a dry test strip holder having a test port and a retainer defining a well about the test port, and a sheet of test strip material. A test element that is 50% or less greater than the size of the test port is cut from the sheet using a die and punch. The punch drives the test element through a channel in the die while the cone-shaped outer surface of the die spreads the retainer, allowing the test element to drop into the well. A cap is snapped over the retainer to capture the test element.

Abstract: A test apparatus having a base which performs a plurality of tests for different analytes in body fluids. A portable tester, such as a glucose meter, is detachably mounted to the base and provides a convenient and ergonomic hand-held instrument which a diabetic may carry to frequently monitor blood glucose levels. When mounted or docked to the base, the portable tester is data linked to the base. The invention provides a communications network among the base, the portable tester and another device such as a PC. The portable tester can therefore be kept small and inexpensive since advanced computing and data storage capabilities are provided in the base or a PC.

Abstract: A multilayer test strip that measures concentrations of multiple analytes from a single whole blood sample. The test strip includes a test matrix of several layers held together in constant contact by a test strip holder. The invention is characterized in that it has no moving parts, which is made possible by the novel use of an elongate disbursement layer that spreads blood throughout its entire length, despite having layers with known wicking properties adjacent to and in contact with it. Since the invention relies primarily on a vertical flow format, the test strip is advantageously quite compact. With a single 35 microliter sample of blood applied thereto, the novel test strip can provide readings of total cholesterol, HDL cholesterol and triglycerides. From these, LDL can be calculated, thereby providing a full “lipid panel.” Other analytes such as glucose and ketones may be included in the test strip in addition to or in lieu of one or more of the other analytes.