Systems and methods for point-of-care determination of ldl-c and ldl-p

Patent metadata

Field	Value
Publication number	US-2017089894-A1
Application number	US-201615277510-A
Country	US
Kind code	A1
Filing date	Sep 27, 2016
Priority date	Sep 29, 2015
Publication date	Mar 30, 2017
Grant date	—

Abstract

A system for testing for LDL-C and LDL-P includes a first lateral flow test strip, 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 a first time. The first lateral flow test strip provides for the detection of LDL-C, 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-C and LDL-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 a first time, wherein the first lateral flow test strip provides for the detection of LDL-C and the second lateral flow test strip provides for the detection of LDL-P.

2 . The system of claim 1 , further comprising:
a second mixer, the second mixer containing an enzyme formulation, the enzyme formulation for dosing the sample pad.

3 . The system of claim 1 , wherein the first lateral flow test strip includes an antibody-antigen stripe and an antigen stripe.

4 . The system of claim 3 , wherein the antibody-antigen stripe is an anti Apo B Ab-latex conjugate.

5 . The system of claim 3 , wherein the antibody-antigen stripe includes blue particles connected to the anti Apo B-100 antibody.

6 . The system of claim 4 , wherein the antigen stripe is an Apo B-100 antigen stripe, located in a direction of flow distal from the dosing area on the first lateral flow test strip.

7 . The system of claim 6 , wherein the second lateral flow test strip includes an anti Apo B-100 antibody stripe.

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

9 . A method of testing for LDL-C and LDL-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; and reading the first lateral flow test strip to determine a concentration of LDL-P in the sample.

10 . The method of claim 9 , further comprising:
providing a sampler, the sampler containing an enzyme formula; dosing the dosing area with the enzyme formula; and reading the second lateral flow test strip with the meter to determine a concentration of LDL-C in the sample.

11 . The method of claim 10 , wherein the first lateral flow test strip includes an antibody-antigen stripe and an antigen stripe.

12 . The method of claim 11 , wherein the antibody-antigen stripe is an anti Apo B Ab-latex conjugate.

13 . The method of claim 11 , wherein the antibody-antigen stripe includes blue particles connected to the anti Apo B-100 antibody.

14 . The method of claim 12 , wherein the antigen stripe is an Apo B-100 antigen stripe, located in a direction of flow distal from the dosing area on the first lateral flow test strip.

15 . The method of claim 14 , wherein the second lateral flow test strip includes an anti Apo B-100 antibody stripe.

16 . The method of claim 15 , wherein the first and second lateral flow test strips include conjugate, nitrocellulose, and nylon membranes.

17 . The method of claim 15 , further comprising, after the dosing of the sample:
flowing the sample to the antibody-antigen stripe of the first lateral flow test strip; binding the anti Apo B-100 antibody to the LDL-P in the sample; flowing the sample to the antigen stripe of the first lateral flow test strip; and capturing unbound portions of the anti Apo B-100 antibody to the antigen stripe.

18 . The method of claim 17 , further comprising, after the dosing of the sample:
flowing the sample to the anti Apo B-100 antibody stripe of the second lateral flow test strip; and binding LDL to the anti Apo B-100 antibody stripe of the second lateral flow test strip.

19 . The method of claim 18 , further comprising, after the dosing with the enzyme formula:
flowing the enzyme formula to bound LDL, the bound LDL being a result of binding LDL to the anti Apo B-100 antibody stripe; and reacting the enzyme formula with the bound LDL.

20 . The method of claim 19 , wherein the reading of the first lateral flow test strip and reading of the second lateral flow test strip include reading an optical property with the meter for each reading.

Assignees

• Polymer Technology Systems Inc

Inventors

• Patwardhan Aniruddha
• Hughes Gary L

Classifications

• G01N33/558 Primary

  using diffusion or migration of antigen or antibody {(immunochromatographic test strips G01N33/54387)} · CPC title

• G01N33/92

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

• G01N33/54389 Primary

  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