Systems and methods for point-of-care hdl and ldl particle assay

Patent metadata

Field	Value
Publication number	US-2017176472-A1
Application number	US-201615382367-A
Country	US
Kind code	A1
Filing date	Dec 16, 2016
Priority date	Dec 17, 2015
Publication date	Jun 22, 2017
Grant date	—

Abstract

A system for testing for LDL-Particles (LDL-P) and HDL-Particles (HDL-P) includes a first lateral flow test strip and a second lateral flow test strip; and a dosing area, the dosing area interconnected with the first and second lateral flow test strips. The system further includes a collector for collecting a sample; and a first mixer for receiving the sample from the collector, the mixer including buffers for mixing with the sample, the first mixer for dosing the sample pad, wherein the first lateral flow test strip provides for the detection of HDL-P and the second lateral flow test strip provides for the detection of LDL-P.

First claim

What is claimed as new and desired to be protected by Letters Patent of the United States is:

1 . A system for testing for LDL-P and HDL-P, the system comprising:
a first lateral flow test strip and a second lateral flow test strip; a dosing area, the dosing area interconnected with the first and second lateral flow test strips; a collector for collecting a sample; and a first mixer for receiving the sample from the collector, the mixer including buffers for mixing with the sample, the first mixer for dosing the sample pad, wherein the first lateral flow test strip provides for the detection of HDL-P and the second lateral flow test strip provides for the detection of LDL-P.

2 . The system of claim 1 , wherein the first lateral flow test strip includes a first stripe of colored particles coated with anti Apo A-1 antibody and a second stripe of Apo A antigen.

3 . The system of claim 1 , wherein the second lateral flow test strip includes a first stripe of colored particles coated with anti Apo B-100 antibody and a second stripe of Apo B-100 antigen.

4 . The system of claim 1 , wherein the first and second lateral flow test strips include conjugate, nitrocellulose, and nylon membranes.

5 . The system of claim 1 , further comprising an optical meter for reading the first and second lateral flow test strips, the meter configured to receive the first and second lateral flow test strips.

6 . A method of testing for LDL-P and HDL-P, the method comprising:
providing a meter; a first lateral flow test strip; a second lateral flow test strip; a dosing area, the dosing area interconnected with the first and second lateral flow test strips; a collector for collecting a sample; and a first mixer; collecting a sample with the collector; mixing the sample with the mixer; dosing the sample on the dosing area; laterally flowing the sample across the first and second lateral flow test strips; reading the first lateral flow test strip to determine a concentration of HDL-P in the sample; and reading the second lateral flow test strip to determine a concentration of LDL-P in the sample.

7 . The method of claim 6 , wherein the first lateral flow test strip includes a first stripe of colored particles coated with anti Apo A-1 antibody and a second stripe of Apo A antigen.

8 . The method of claim 6 , wherein the second lateral flow test strip includes a first stripe of colored particles coated with anti Apo B-100 antibody and a second stripe of Apo B-100 antigen.

9 . The method of claim 6 , wherein the first and second lateral flow test strips include conjugate, nitrocellulose, and nylon membranes.

10 . The method of claim 6 , further comprising calibrating the meter by comparing a color produced to a known standard for a plurality of concentrations.

11 . The method of claim 10 , wherein the known standard is the Liposcience (LabCorp.'s) NMR® method.

12 . The method of claim 10 , wherein the known standard is the Roche's “Tina-quant Apo lipoprotein A-1 for HDL and B-100 for LDL ver. 2®” assay.

13 . A system for testing for LDL-P and HDL-P, the system comprising:
a first lateral flow test strip and a second lateral flow test strip; a collector for collecting a sample; and a first mixer for receiving the sample from the collector, the mixer including buffers for mixing with the sample, the first mixer for dosing the first and second lateral flow test strips, wherein the first lateral flow test strip provides for the detection of HDL-P and the second lateral flow test strip provides for the detection of LDL-P.

14 . The system of claim 13 , wherein the first lateral flow test strip includes a first stripe of colored particles coated with anti Apo A-1 antibody and a second stripe of Apo A antigen.

15 . The system of claim 13 , wherein the second lateral flow test strip includes a first stripe of colored particles coated with anti Apo B-100 antibody and a second stripe of Apo B-100 antigen.

16 . The system of claim 13 , wherein the first and second lateral flow test strips include conjugate, nitrocellulose, and nylon membranes.

17 . The system of claim 13 , further comprising an optical meter for reading the first and second lateral flow test strips, the meter configured to receive the first and second lateral flow test strips.

Assignees

• Polymer Technology Systems Inc

Inventors

• Patwardhan Aniruddha
• Hughes Gary L

Classifications

• G01N2333/775

  Apolipopeptides · CPC title

• G01N2800/50

  Determining the risk of developing a disease · CPC title

• G01N33/92 Primary

  involving lipids, e.g. cholesterol {, lipoproteins, or their receptors (steroid hormones G01N33/743)} · CPC title

• G01N2800/32

  Cardiovascular disorders · CPC title

• G01N33/54389

  with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones · CPC title