Portable test apparatus and associated method of performing a blood coagulation test

• US 5,504,011 A
• Filed: 10/21/1994
• Issued: 04/02/1996
• Est. Priority Date: 10/21/1994
• Status: Expired due to Term

• Current Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Original Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Inventors: Huang, Ming, Mawhirt, James A., Gavin, Michael, Cimini, Catherine M., Kuklo, Anthony Jr., Marcelino, Eduardo, Simone, Albert
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): CARRILLO, BIBI SHARIDAN
• Application Number:
  US08/327,320
• Time in Patent Office: 529 Days
• Field of Search: 422/73, 436/69, 436/165, 435/13, 128/760, 128/763, 128/765, 606/181
• US Class Current: 436/69
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/56
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

A portable device for performing coagulation tests on a patient'"'"'s blood. Blood is first drawn from a patient using a lancet. The blood is then supplied to a disposable cuvette placed within the testing device. The blood is drawn into multiple conduits within the cuvette. Each of the conduits contains a dried or lyophilized activation reagent that is rehydrated by the blood. The blood in each of the conduits is then reciprocally moved across a restricted region until a predetermined degree of coagulation occurs. Since the coagulation time is being monitored in multiple conduits, a representation coagulation time for a given sample can be determined. In at least one of the conduits a normalizing control agent is present. The normalizing control agent counteracts any effects of anticoagulants present in the blood sample, thereby allowing the blood sample to have generally normal coagulation characteristics. The normalized blood is tested simultaneously with the untreated blood to provide a reference value against which the functionality of the test system and the quality of the sample can be judged.

Claims

1. A method of performing a prothrombin time test on a blood sample that contains an anticoagulant, comprising the steps of:

providing a plurality of conduits that extend from a first end to a second end, wherein at least one restriction is disposed between said first end and second end in each of said conduits, said plurality of conduits including at least one test conduit and at least one control conduit;

providing a normalizing agent in said at least one control conduit, wherein said normalizing agent is capable of counteracting effects of the anticoagulant in the blood sample;

drawing a predetermined volume of blood into each of said plurality of conduits;

simultaneously moving the blood in each of said plurality of conduits back and forth through said at least one restriction from a first position to a second position, wherein said normalizing agent in said control conduit mixes with the blood and creates a normalized blood sample;

timing how long it takes the blood in each of said test conduits to move from said first position to said second position, until a predetermined degree of coagulation occurs;

analyzing the coagulation times occurring in said test conduit, to obtain a representative prothrombin time for the blood sample; and

using the normalized blood sample in the control conduit as a quality control sample to quantify the reliability of the prothrombin time test for the blood sample.

2. The method according to claim 1, further including the step of mixing the blood in each of said plurality of conduits with a prothrombin time reagent.

3. The method according to claim 2, wherein said prothrombin time reagent is selected from a group including thromboplastin extract and tissue factor.

4. The method according to claim 1, further including steps of:

mixing the blood in one of said plurality of conduits with an anticoagulant, thereby creating an abnormal blood sample with abnormal coagulation characteristics;

using the abnormal blood sample in the prothrombin time test as a quality control sample to quantify the reliability of the prothrombin time test for the blood sample.

5. The method according to claim 1, wherein said normalizing agent includes Vitamin K dependent clotting factor concentrate and barium citrate eluate.

6. The method according to claim 5, wherein said normalizing agent also includes gluconic acid, trehalose, malto dextrin and barbital buffered saline.

7. The method according to claim 1, wherein each of said plurality of conduits are disposed within a common cuvette.

8. The method according to claim 7, further including the steps of:

pricking the finger of a patient with a lancet to draw blood;

discarding a first droplet of blood formed on the finger;

transferring a second droplet of blood formed on the finger to the cuvette,

wherein the second droplet of blood can be drawn into the plurality of conduits.

9. The method according to claim 7, further including the steps of:

drawing blood from a patient with a lancet;

placing a sample of the drawn blood in a reservoir device;

coupling the reservoir device to the cuvette, wherein the blood can be drawn into the plurality of conduits from the reservoir.

10. The method according to claim 9, wherein said reservoir device is coupled to said lancet and said step of coupling the reservoir device to the cuvette includes bringing the lancet in contact with the cuvette.

11. The method according to claim 1, wherein said normalizing agent includes Vitamin K dependent clotting factor concentrate, barium citrate eluate, trehalose, malto dextrin and barbital buffered saline.

12. The method according to claim 11, wherein said normalizing agent further includes gluconic acid.

13. The method according to claim 11, wherein said normalizing agent further includes heparin.

14. The method according to claim 11, wherein said normalizing agent includes 1.0μ

/ml-3.5μ

/ml Vitamin K dependent clotting factor concentrate, 0.009μ

/ml-0.05μ

/ml barium citrate eluate, 0.008M-0.03M gluconic acid, 3.0%-8.0% trehalose and 2.0%-6.0% malto dextrin.

20. The method according to claim 5, wherein said normalizing agent also includes gluconic acid, trehalose, malto dextrin and barbital buffered saline.

15. A method of performing a prothrombin time test on a blood sample, comprising the steps of:

providing a plurality of conduits that extend from a first end to a second end, wherein at least one restriction is disposed between said first end and second end in each of said conduits, said plurality of conduits including at least one test conduit and at least one control conduit;

providing an anticoagulant in said at least one control conduit, wherein said anticoagulant is capable of producing an abnormal blood sample with abnormal coagulation characteristic when mixed with the blood sample;

drawing a predetermined volume of blood into each of said plurality of conduits;

simultaneously moving the blood in each of said plurality of conduits back and forth through said at least one restriction from a first position to a second position, wherein said anticoagulant in said control conduit mixes with the blood and creates said abnormal blood sample;

timing how long it takes the blood in each of said test conduits to move from said first position to said second position, until a predetermined degree of coagulation occurs;

analyzing the coagulation times occurring said test conduit, to obtain a representative prothrombin time for the blood sample; and

using the abnormal blood sample in the control conduit as a quality control sample to quantify the reliability of the prothrombin time test for the blood sample.

16. The method according to claim 15, further including the step of mixing the blood in each of said plurality conduits with a prothrombin time reagent.

17. The method according to claim 16, wherein said prothrombin time reagent is selected from a group including tissue thromboplastin, extract and tissue factor.

18. The method according to claim 15, further including the steps of:

mixing the blood in one of said conduits with a normalizing agent that counteracts the effects of an anticoagulant in the blood sample, thereby creating a normalized blood sample with generally normal coagulation characteristics;

using the normalizing blood sample in the prothrombin time test as a quality control sample to quantify the reliability of the prothrombin time test for the blood sample.

19. The method according to claim 18, wherein said normalizing agent includes Vitamin K dependent clotting factor concentrate and barium citrate eluate.

21. The method according to claim 15, wherein each of said plurality of conduits are disposed within a common cuvette.

22. The method according to claim 21, further including the steps of:

pricking the finger of a patient with a lancet to draw blood;

discarding a first droplet of blood formed on the finger;

transferring a second droplet of blood formed on the finger to the cuvette, wherein the second droplet of blood can be drawn into the plurality of conduits.

23. The method according to claim 21, further including the steps of:

drawing blood from a patient with a lancet;

placing a sample of the drawn blood in a reservoir device;

coupling the reservoir device to the cuvette, wherein the transferring a second droplet of blood formed on the finger to the cuvette, wherein the blood can be drawn into the plurality of conduits from the reservoir.

24. The method according to claim 23, wherein said reservoir device is coupled to said lancet and said step of coupling the reservoir device to the cuvette includes bringing the lancet in contact with the cuvette.