# US 7,745,224 B2 · Procedure for the standardization of coagulation tests

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- Number: US 7,745,224 B2
- Document ID: US7745224B2
- Status: Granted
- Kind: B2
- Application number: 11/452,966
- Filed: 2006-06-15
- Published: 2007-01-25
- Granted: 2010-06-29
- Earliest claimed: 2005-06-16
- Assignees: Siemens Healthcare Diagnostics Products GmbH
- Inventors: Norbert Zander; Matthias Wilkens
- Web page: https://patentgrep.com/patent/US7745224B2

## CPC

- G01N 33/86: involving blood coagulating time {or factors, or their receptors}
- G01N 33/96: involving blood or serum control standard
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present invention lies in the field of coagulation diagnosis and relates to a procedure for the standardization of coagulation tests, where calibrators are used to which a discrete standard coagulation time is assigned. The procedure is particularly suitable for the standardization of prothrombin time, activated partial thromboplastin time, thrombin time, ecarin time or batroxobin time.

## Claims

### Claim 1

A method for the determination of a standardized coagulation time of a sample, comprising
a) measuring the coagulation time of a sample in a test system:
b) measuring the coagulation times of at least two calibrators, for which discrete standard coagulation times have been predetermined, in the same test system as used in step a);
c) forming a calibration curve that plots the predetermined standard coagulation times of the calibrators versus the coagulation times of the calibrators measured in step b); and
d) converting the coagulation time of the sample measured in step a) to a standardized coagulation time using the calibration curve formed in step c).

### Claim 2 (depends on 1)

The method as claimed in claim 1 for the determination of a standardized coagulation time wherein the coagulation time is chosen from prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (U), batroxobin time (BT) and ecarin time (ECT).

### Claim 3 (depends on 1)

The method as claimed in claim 1, wherein the sample is a plasma sample.

### Claim 4 (depends on 1)

The method as claimed in claim 1, wherein the calibrators are plasma-based.

### Claim 5 (depends on 1)

The method as claimed in claim 1, wherein the calibrators are plasma pool-based.

### Claim 6 (depends on 1)

The method as claimed in claim 1, wherein the sample contains a substance which influences the coagulability of the sample.

### Claim 7 (depends on 6)

The method as claimed in claim 6, wherein the substance which influences the coagulability of the sample is an anticoagulatory substance.

### Claim 8 (depends on 7)

The method as claimed in claim 7, wherein the anticoagulatory substance is chosen from heparin, heparinoids, hirudin, argatroban, melagatran and natural or synthetic factor Xa inhibitors.

### Claim 9 (depends on 7)

The method as claimed in claim 7, wherein at least one calibrator contains a defined amount of an anticoagulatory substance.

### Claim 10 (depends on 9)

The method as claimed in claim 9, wherein the anticoagulatory substance contained by at least one calibrator is heparin at a concentration of 0.1 to 1.0 IU per ml.

### Claim 11 (depends on 1)

The method as claimed in claim 1, wherein the calibration curve is plotted with the aid of an interpolation or extrapolation procedure.