Polymer Technology Systems, Inc.

Sunil G Anaokar

Emanuel Paul Crabtree

Michele Jeanne Crispino

Gena Lynn Antonopoulos

Alexandra N Muchnik

Patrick Cunningham

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 30-50 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.

Method for determining concentration of multiple analytes in a single fluid sample

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.

Test strip for determining concentration of multiple analytes in a single fluid sample

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.

Test strip for determining concentration of triglycerides

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. Advantageously, the inventive test strip is a vertical flow device, which can be made more compact and operates more efficiently than a lateral flow device.

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Indianapolis, IN, United States of America

Sunil G Anaokar