Methods and devices for rapid assessment of severity of injury

• US 9,927,446 B2
• Filed: 07/17/2015
• Issued: 03/27/2018
• Est. Priority Date: 05/30/2006
• Status: Active Grant

• Current Assignee: AntibodyShop A/S
• Original Assignee: Antibosyshop A/S
• Inventors: Bangert, Kristian, Uttenthal, Lars Otto
• Primary Examiner(s): FOSTER, CHRISTINE E
• Application Number:
  US14/802,023
• Publication Number:
  US 20150323552A1
• Time in Patent Office: 984 Days
• Field of Search: None
• CPC Class Codes: G01N 2333/475 Assays involving growth factors
• CPC Class Codes: G01N 2800/40 Disorders due to exposure to physical agents, e.g. heat disorders, motion sickness, radiation injuries, altitude sickness, decompression illness
• CPC Class Codes: G01N 2800/42 Poisoning, e.g. from bites or stings
• CPC Class Codes: G01N 2800/56 Staging of a disease; Further complications associated with the disease
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors

Abstract

Methods and devices for rapid assessment of the severity of injury not due to a natural disease based upon measurement of neutrophil gelatinase-associated lipocalin (NGAL) are provided.

Claims

1. A method for diagnosing and treating radiation injury in a human subject who has been exposed to radiation likely to cause injury of the epithelium of the gastrointestinal tract and/or lungs, said method comprising the steps of

(a) obtaining a plasma sample from the human subject within 12 hours after the human subject has been exposed to ionizing radiation;

(b) measuring a level of neutrophil gelatinase-associated lipocalin (NGAL) in the plasma sample by applying antibodies capable of binding to NGAL to the plasma sample;

(c) comparing the measured level of NGAL to a selected cutoff value;

(d) diagnosing the human subject as having radiation injury of the epithelium of the gastrointestinal tract and/or lungs based on the measured level of NGAL exceeding the selected cutoff value, wherein the higher the level of NGAL in the plasma sample, the more severely the epithelium is likely to be injured; and

(e) administering an effective amount of radiation protection drugs to the human subject diagnosed with radiation injury wherein the radiation protection drugs are free-radical scavenging agents.

2. The method of claim 1, wherein the measurement of NGAL gives rise to a quantitative or qualitative signal that is read by visual inspection or by means of a portable reading device that is carried to wherever an injured subject may be encountered.

3. The method of claim 1, wherein NGAL is measured by an automated method.

4. The method of claim 1, wherein the plasma sample is obtained within 6 hours after the human subject has been exposed to the radiation.

5. The method of claim 1, wherein the plasma sample is obtained within 2 hours after the human subject has been exposed to the radiation.

6. The method of claim 1, wherein the plasma sample is obtained within 1 hour after the human subject has been exposed to the radiation.

7. The method of claim 1, wherein the cutoff value is between 80 ng/ml and 110 ng/ml.