Systems and methods for interference correction from hemoglobin variants

Patent metadata

Field	Value
Publication number	US-10670615-B2
Application number	US-201615369340-A
Country	US
Kind code	B2
Filing date	Dec 5, 2016
Priority date	Dec 4, 2015
Publication date	Jun 2, 2020
Grant date	Jun 2, 2020

Abstract

A system for determining a concentration of hemoglobin A1C includes a first lateral flow test strip, the first lateral flow test strip providing for a percent of HbA1C concentration; a second lateral flow test strip, the second lateral flow test strip providing for the total amount of hemoglobin; an antibody-microparticle stripe on each of the first and second lateral flow test strips; a conjugate stripe on each of the first and second lateral flow test strips; and a sample treatment buffer. The sample treatment buffer is strongly denaturing, and antibodies in the antibody-microparticle strip are covalently bound to microparticles.

First claim

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

1. A system for determining a concentration of hemoglobin A1C, the system comprising:
a first lateral flow test strip, the first lateral flow test strip providing for a percent of HbA1C concentration and providing for the total amount of hemoglobin, an antibody-microparticle stripe on the first lateral flow test strip;
a conjugate stripe on the first lateral flow test strip; and
a sample treatment buffer, wherein the sample treatment buffer is denaturing, antibodies in the antibody-microparticle strip are covalently bound to microparticles, the microparticles include an aldehyde group, and the sample treatment buffer includes sodium perchlorate as an oxidizing agent.

2. The system of claim 1 , wherein the sample treatment buffer includes 50 mM Imidazole, pH 7.0, 1M LiSCN, 0.5M GuSCN, 1% Polyoxyethyleneglycol Dodecyl Ether, and 500 mM NaClO 4 .

3. The system of claim 1 , wherein the sample treatment buffer includes 50 mM Imidazole, pH 7.0, 1M LiSCN, 0.5M GuSCN, 1% Polyoxyethyleneglycol Dodecyl Ether and lithium perchlorate.

4. The system of claim 1 , wherein the sample treatment buffer includes 50 mM Imidazole, pH 7.0, 1M LiSCN, 0.5M GuSCN, 1% Polyoxyethyleneglycol Dodecyl Ether and sodium nitrite.

5. The system of claim 1 , wherein the sample treatment buffer includes 50 mM Imidazole, pH 7.0, 1M LiSCN, 0.5M GuSCN, 1% Polyoxyethyleneglycol Dodecyl Ether, and 2.0925 g/L K 3 Fe(CN) 6 .

6. The system of claim 1 , wherein the sample treatment buffer includes 50 mM Imidazole, pH 7.0, 1.5M NaSCN, 0.5M GuSCN, 1% Polyoxyethyleneglycol Dodecyl Ether, and 2.0925 g/L K 3 Fe(CN) 6 .

7. The system of claim 1 , wherein the sample treatment buffer includes 50 mM Imidazole, pH 7.0, 0.75M LiSCN, 0.75M NaSCN, 0.5M GuSCN, 1% Polyoxyethyleneglycol Dodecyl Ether, and 2.0925 g/L KFeCN.

8. The system of claim 1 , further comprising:
a second lateral flow test strip, the second lateral flow test strip providing for a percent of HbA1C concentration and providing for the total amount of hemoglobin, an antibody-microparticle stripe on the second lateral flow test strip.

9. A system for determining a concentration of hemoglobin A1C, the system comprising:
a first lateral flow test strip, the first lateral flow test strip providing for a percent of HbA1C concentration and providing for the total amount of hemoglobin;
an antibody-microparticle stripe on the first lateral flow test strip;
a conjugate stripe on the first lateral flow test strip; and
a sample treatment buffer, wherein the sample treatment buffer is denaturing, and antibodies in the antibody-microparticle stripe are covalently bound to microparticles, and wherein the sample treatment buffer includes sodium perchlorate as an oxidizing agent.

10. The system of claim 9 , wherein the microparticles include an aldehyde group.

11. The system of claim 9 , wherein the sample treatment buffer includes 50 mM Imidazole, pH 7.0, 1M LiSCN, 0.5M GuSCN, 1% Polyoxyethyleneglycol Dodecyl Ether, and 500 mM NaClO 4 .

12. The system of claim 9 , wherein the antibody is monoclonal.

Assignees

• Polymer Technology Systems Inc

Inventors

• Xie Charles Z
• Kyung Jane
• Nguyen Tu-Anh
• Mendoza Annie V
• Moskowitz Keith

Classifications

• G01N2333/805

  Haemoglobins; Myoglobins · CPC title

• G01N33/726

  Devices · CPC title

• G01N33/723 Primary

  Glycosylated haemoglobin · CPC title

• G01N33/54313

  the carrier being characterised by its particulate form · CPC title

• G01N33/558

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