Assay for Troponin I using magnetic labels

• US 9,720,003 B2
• Filed: 12/15/2009
• Issued: 08/01/2017
• Est. Priority Date: 12/22/2008
• Status: Active Grant

• Current Assignee: Siemens Healthineers Nederland BV (Siemens AG)
• Original Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Inventors: Vissers, Joost Lambert Max, Martens, Michael Franciscus Wilhelmus Cornelis, Dekkers, David Walterus Cornelis, Dittmer, Wendy Uyen, Evers, Toon Hendrik, De Kievit, Peggy, Kamps, Ricky
• Primary Examiner(s): Brown, Melanie Y
• Assistant Examiner(s): MOERSCHELL, RICHARD P
• Application Number:
  US13/141,439
• Publication Number:
  US 20110256640A1
• Time in Patent Office: 2,786 Days
• CPC Class Codes: G01N 2800/324 Coronary artery diseases, e.g. angina pectoris, myocardial infarction
• CPC Class Codes: G01N 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
• CPC Class Codes: G01N 33/6887 from muscle, cartilage or connective tissue

Abstract

The present invention relates to a method for measuring Troponin I in a sample comprising the steps of providing a sample, contacting the sample with a monoclonal anti-Troponin I antibody coupled to a magnetic label, contacting the sample with a polyclonal anti-Troponin I antibody coupled to a sensor surface and detecting the magnetic label on the sensor surface. The invention further relates to a device and a cartridge for measuring Troponin I in a sample.

Claims

1. A method for measuring Troponin I in a sample with 1 pM limit of detection, comprising at least the following steps:

a. providing a sample comprising Troponin I to be measured;

b. contacting the sample with three monoclonal anti-Troponin I antibodies coupled to a labeled polymer coated iron oxide particle having a size of from 200 to 1000 nm;

c. applying a first magnetic field in the direction of a sensor surface, thereby contacting the particles with a polyclonal anti-Troponin I antibody coupled to the sensor surface, thereby causing at least some of the particles to be bound to the sensor surface, wherein the polyclonal anti-Troponin I antibody binds to Troponin I at the same time as the monoclonal anti-Troponin I antibody;

d. applying pulsed actuation by discontinuing the first magnetic field, thereby allowing unbound particles to move over the sensor surface, reapplying the first magnetic field, and discontinuing the first magnetic field, thereby increasing the number of particles bound to the sensor surface, and alternating the application of pulsed actuation with the application of magnetic pulses causing translational and rotational movement of the particles over the sensor surface, wherein the pulsed actuation and magnetic pulses are applied for less than five minutes; and

e. applying a second magnetic field in a direction away from the sensor surface to remove unbound particles, and thereafter detecting the labeled polymer coated iron oxide particles on the sensor surface;

wherein the three monoclonal anti-Troponin I antibodies are clones A34500, 267, and 560.

2. The method according to claim 1, wherein the polyclonal anti-Troponin I antibody used is a goat polyclonal antibody.

3. The method according to claim 1, wherein the labeled polymer coated iron oxide particle is optically detected by Frustrated Total Internal Reflection (FTIR).

4. The method according to claim 1 wherein the labeled polymer coated iron oxide particle is magnetically detected.

5. The method according to claim 1, wherein the sample is from a patient suspected of myocardial infarction.