Portable prothrombin time test apparatus and associated method of performing a prothrombin time test

• US 5,591,403 A
• Filed: 03/18/1996
• Issued: 01/07/1997
• 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): Warden, Jill
• Assistant Examiner(s): CARRILLO, BIBI SHARIDAN
• Application Number:
  US08/617,296
• Time in Patent Office: 295 Days
• Field of Search: 422/73, 436/69, 436/165, 436/8, 435/13, 128/760, 128/763, 128/765, 606/181
• US Class Current: 422/73
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• 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 cuvette used in performing a test on a blood sample, comprising:

a generally transparent member having a plurality of conduits contained therein;

a channel, common to all of said plurality of conduits through which a predetermined volume of a blood sample can be drawn into each of said conduits;

a normalizing control agent contained within a first one of said conduits, wherein said normalizing control agent reacts with a blood sample delivered to said first one of said conduits to counteract the effect of an anticoagulant in the blood sample thereby creating a normalized control blood sample; and

an anticoagulant contained within a second one of said conduits, wherein said anticoagulant reacts with the blood sample delivered to said second one of said conduits to produce a blood control sample having abnormal clotting characteristics.

2. The cuvette according to claim 1, wherein a prothrombin time reagent is disposed in each of said conduits.

3. The cuvette according to claim 2, wherein said normalizing control agent includes Vitamin K dependent clotting factor concentrate, and barium citrate eluate.

4. The cuvette according to claim 3, wherein said normalizing control agent further includes gluconic acid, trehalose, malto dextrin and barbital buffered saline.

5. The cuvette according to claim 2, wherein said normalizing control agent includes between 1.0 u/ml and 3.5 u/ml of Vitamin K dependent clotting factor concentrate, between 0.009 u/ml and 0.035 u/ml of barium citrate eluate, between 0.008M and 0.03M of gluconic acid, between 3.0% and 8.0% of trehalose, and between 2% and 6% of malto dextrin.

6. The cuvette according to claim 1, wherein said anticoagulant includes heparin.

7. The cuvette according to claim 1, wherein said anticogulant further includes Vitamin K dependent clotting factor concentrate, barium citrate eluate, trehalose, malto dextrin and barbital buffered saline.

8. The cuvette according to claim 2, wherein said prothrombin time reagent is selected from a group that includes tissue thromboplastin extract and tissue factor.

9. The cuvette according to claim 1, wherein each of said conduits has a first end, a second end and a restricted area disposed in between said first end and said second end.

10. The cuvette according to claim 1, further comprising a reservoir, selectively coupled to said channel for receiving a blood sample containing an anticoagulant from a patient, wherein said channel enables the sample to flow from said reservoir to said plurality of conduits.

11. The cuvette according to claim 10, wherein said reservoir is biased into a first position not in contact with said channel, whereby pressure from applying the blood sample to the reservoir moves the reservoir to a second position in contact with the channel, thereby enabling the sample to flow from the reservoir into the channel.

12. The cuvette according to claim 9, wherein said reservoir is selectively removable from said cuvette, thereby enabling the reservoir to be filled with the blood sample at a remote location and selectively returned to the cuvette.

13. The cuvette according to claim 12, wherein said reservoir is contained as pan of a lancet assembly.