Device and method for measuring prothrombin time and hematocrit by analyzing change in reactance in a sample

• US 8,828,322 B2
• Filed: 06/09/2011
• Issued: 09/09/2014
• Est. Priority Date: 06/09/2010
• Status: Active Grant

• Current Assignee: Apex Biotechnology Corporation
• Original Assignee: Apex Biotechnology Corporation
• Inventors: Chen, Sz-Hau, Lin, Yueh-Hui, Chu, Ching-Yuan, Cheng, Chu-Ming, Shen, Thomas Y.S., Chen, Guan-Ting, Lu, Yi-Chen
• Primary Examiner(s): Sines, Brian J
• Application Number:
  US13/156,693
• Publication Number:
  US 20110303556A1
• Time in Patent Office: 1,188 Days
• Field of Search: 422/50, 422/68.1, 422/502, 422/503, 422/82.01, 436/43, 436/63, 436/66
• US Class Current: 422/82.01
• CPC Class Codes: G01N 27/447 using electrophoresis
• CPC Class Codes: G01N 2800/224 Haemostasis or coagulation
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

Devices and methods for measuring prothrombin time (PT) and hematocrit (HCT) by analyzing the change in reactance in a sample are presented. A diagnostic device for measuring HCT and PT of a fluid includes a relative electrode-type sensor device and a blood test card assembly including one or more pairs of electrodes, wherein alternating current (AC) provided by the sensor device is used to measure and calculate HCT and PT of blood test using the reactance analysis.

Claims

1. A diagnostic device for measuring hematocrit (HCT) or prothrombin time (PT) of a sample, comprising:

a sensor device; and

a test card assembly including one or more pairs of electrodes,

wherein the sensor device comprises

a test card receiving unit for accommodating the test card assembly;

a power source for providing an AC test signal at a constant frequency to electrodes of the test card assembly;

a signal retrieving unit coupled to the test card assembly;

a microprocessor in the sensor device programmed for (i) performing a reactance analysis of a sample provided on the test card assembly by comparing the AC test signal and a response signal from the test card assembly in response to the AC test signal, calculating a change in phase of the AC test signal, and calculating a reactance from the change in phase of the AC test signal, and (ii) determining PT or HCT of the sample; and

,

a display for displaying the PT or HCT of the sample.

2. The diagnostic device as claimed in claim 1, wherein the reactance analysis further comprises:

calculating a reactance due to a change in capacitance, and

transforming the change in capacitance with algorithms and correcting to the prothrombin time by reference of the HCT.

3. The diagnostic device as claimed in claim 1, the reactance analysis further comprises correcting the PT with an international normalized ratio.

4. The diagnostic device as claimed in claim 1, wherein the test card assembly comprises one or more pairs of the noble metal electrodes, set on the same plane.

5. The diagnostic device as claimed in claim 1, wherein the test card assembly comprises one or more pairs of the electrodes, set on different planes.

6. The diagnostic device as claimed in claim 1, wherein the test card assembly comprises a base plate comprising a porous material that includes holes, voids or cavities thereon.

7. The diagnostic device as claimed in claim 6, wherein the base plate of the test card assembly comprises pores such as holes, voids or cavities thereon, with diameters approximately in a range of about 0.1 μ

m to about 10 μ

m.

8. The diagnostic device as claimed in claim 7, wherein the microprocessor further transforms the capacitance with algorithms, corrects to the PT by reference of the HCT;

and calculates the PT with an international normalized ratio.