Method for preparing a sample

Patent metadata

Field	Value
Publication number	US-12405279-B2
Application number	US-202217710329-A
Country	US
Kind code	B2
Filing date	Mar 31, 2022
Priority date	Sep 13, 2017
Publication date	Sep 2, 2025
Grant date	Sep 2, 2025

Abstract

The invention relates to a method for determining, diagnosis, prognosis, treatment guidance, treatment monitoring, risk assessment and/or risk stratification of patients with abnormal platelet levels comprising providing a sample of said patient, determining a level of proadrenomedullin (proADM) or fragment(s) thereof in said sample, wherein said level of proADM or fragment(s) thereof correlates with the abnormal platelet levels in said patient. In embodiments of the invention, a level of proADM or fragment(s) thereof of high severity indicates low platelet levels in the subject and subsequent initiating or modifying a treatment of the patient to improve said condition. In some embodiments of the invention the method comprises determining a level of one or more additional markers in a sample isolated from the patient, such as the level of platelets, the level of PCT or fragment(s) thereof, one or more markers of thrombocytopenia and/or one or more markers of an inflammatory response.

First claim

The invention claimed is:

1. A method comprising:
preparing a sample comprising bodily fluid from a patient, and an antibody which binds to proADM or fragment(s) thereof,
wherein the patient has platelet levels below 150,000 platelets per microliter of
blood and/or thrombocytopenia and/or disseminated intravascular coagulation (DIC), and
wherein the level of detectable proADM or fragment(s) in the sample is equal to or greater than 6.5 nmol/l±20%.

2. The method according to claim 1 , wherein the bodily fluid from the patient is selected from the group consisting of a blood, a blood plasma, a blood serum and a urine sample.

3. The method according to claim 1 , wherein the sample of said patient is a first sample isolated before, at or after a time point of a diagnosis and a treatment initiation, and wherein the method further comprises,
a. providing a second sample, wherein said second sample has been isolated after the first sample and after the time point of treatment initiation, and
b. wherein the level of proADM or fragment(s) thereof in the second sample is different than the level of proADM or fragment(s) thereof in the first sample.

4. The method according to claim 1 , wherein the patient has been diagnosed with an infectious disease and/or one or more existing organ failure(s), or has been diagnosed as suffering from sepsis, severe sepsis or septic shock.

5. The method according to claim 1 , wherein patient has been diagnosed with one or more existing organ failure(s) and/or is a posttraumatic or postsurgical patient.

6. The method according to claim 1 , wherein the antibody to proADM or fragment(s) thereof binds mid-regional (MR)-proADM in the sample.

7. The method according to claim 1 , wherein the sample further comprises an antibody to at least one additional marker, selected from the group consisting of PCT, lactate and C-reactive protein, sCD14-ST, prothrombinase, antithrombin, cationic protein 18 (CAP18), von Willebrand factor (vWF)-cleaving proteases, lipoproteins in combination with CRP, fibrinogen, fibrin, B2GP1, GPIIb-IIIa, non-denatured D-dimer of fibrin, platelet factor 4 and one or more histones.

8. The method according to claim 1 , wherein the level of proADM or fragments thereof is equal to or greater than 7.7 nmol/l±20%.

9. The method according to claim 1 , wherein the level of proADM or fragments thereof is equal to or greater than 9.5 nmol/l±20%.

10. The method according to claim 1 , wherein the level of proADM or fragments thereof is equal to or greater than 10.9 nmol/l±20%.

11. A method, comprising:
preparing a sample comprising bodily fluid from a patient, and an antibody which binds to proADM or fragment(s) thereof,
wherein the patient has platelet levels below 150,000 platelets per microliter of blood and/or thrombocytopenia and/or disseminated intravascular coagulation (DIC), and
wherein the level of detectable procalcitonin (PCT) or fragment(s) thereof is equal to or greater than 0.5 ng/ml, and wherein the level of detectable proADM or fragment(s) thereof is equal to or greater than 6.5 nmol/l.

12. The method according to claim 11 , wherein the sample further comprises at least one additional labeled marker which have been labeled with a luminescence molecule,
wherein the at least one additional labeled marker is selected from the group consisting of lactate and C-reactive protein, sCD14-ST, prothrombinase, antithrombin, cationic protein 18 (CAP18), von Willebrand factor (vWF)-cleaving proteases, lipoproteins in combination with CRP, fibrinogen, fibrin, B2GP1, GPIIb-IIIa, non-denatured D-dimer of fibrin, platelet factor 4 and one or more histones.

13. A sample comprising:
a bodily fluid from a patient, an antibody bound to procalcitonin (PCT) or fragment(s), and an antibody bound to proADM or fragment(s) thereof,
wherein the patient has platelet levels below 150,000 platelets per microliter of blood and/or thrombocytopenia and/or disseminated intravascular coagulation (DIC), and
wherein the level of detectable proADM or fragment(s) thereof is equal to or greater than 6.5 nmol/l±20%,
or
a bodily fluid from a patient, an antibody bound to procalcitonin (PCT) or fragment(s), and an antibody bound to proADM or fragment(s) thereof,

wherein the patient has platelet levels below 150,000 platelets per microliter of
blood and/or thrombocytopenia and/or disseminated intravascular coagulation (DIC),
wherein the level of detectable procalcitonin (PCT) or fragment(s) thereof is equal to or greater than 0.5 ng/ml, and wherein the level of proADM or fragment(s) thereof is equal to or greater than 6.5 nmol/l.

14. The sample according to claim 13 , wherein the bodily fluid is selected from the group consisting of blood, a blood plasma, blood serum and urine.

15. The sample according to claim 13 , wherein the level of proADM or fragments thereof is equal to or greater than 7.7 nmol/l±20%.

16. The sample according to claim 13 , wherein the level of proADM or fragments thereof is equal to or greater than 10.9 nmol/l±20%.

17. The sample according to claim 13 , wherein the level of proADM or fragments thereof is equal to or greater than 9.5 nmol/l±20%.

Assignees

• Brahms Gmbh

Inventors

• Pehla Aline
• Kirsch Stefan
• Wilson Darius

Classifications

• G01N2800/52

  Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis · CPC title

• G01N2800/50

  Determining the risk of developing a disease · CPC title

• G01N2800/222

  Platelet disorders · CPC title

• G01N33/86 Primary

  involving blood coagulating time {or factors, or their receptors} · CPC title

• A61P7/00

  Drugs for disorders of the blood or the extracellular fluid · CPC title