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HelpTest Code BIVAL Bivalirudin, Ecarin, Plasma
Ordering Guidance
This test is not indicated for monitoring low molecular weight heparin, unfractionated heparin, or oral direct anti-Xa inhibitors (eg, apixaban, rivaroxaban). For monitoring oral direct anti-Xa inhibitors, see APIXA / Apixaban, Anti-Xa, Plasma or RIVAR / Rivaroxaban, Anti-Xa, Plasma.
Necessary Information
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Specimen Type: Platelet-poor plasma
Collection Container/Tube: Light-blue top (3.2% sodium citrate)
Submission Container/Tube: Plastic vial (polypropylene preferred)
Specimen Volume: 1 mL
Collection Instructions:
1. Specimen should be collected 2 hours after initiation of continuous infusion of bivalirudin.
2. For complete instructions, see Coagulation Guidelines for Specimen Handling and Processing.
3. Centrifuge, transfer all plasma into a plastic vial, and centrifuge plasma again.
4. Aliquot plasma into a plastic vial leaving 0.25 mL in the bottom of centrifuged vial.
5. Freeze plasma immediately (no longer than 4 hours after collection) at -20° C or, ideally, below -40° C.
Additional Information:
1. Double-centrifuged specimen is critical for accurate results as platelet contamination may cause spurious results.
2. Each coagulation assay requested should have its own vial.
Useful For
Monitoring of bivalirudin therapy for patients with prolonged baseline activated partial thromboplastin time
Special Instructions
Method Name
Chromogenic
Reporting Name
Bivalirudin, Ecarin, PSpecimen Type
Plasma Na CitSpecimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma Na Cit | Frozen | 42 days |
Reject Due To
| Thawing | Cold Reject; Warm reject |
Clinical Information
Bivalirudin, is a parenteral anticoagulant that directly inhibits thrombin (direct thrombin inhibitor), factor IIa. It is indicated for use in patients with unstable angina undergoing percutaneous coronary intervention (PCI), in those undergoing PCI with provisional use of glycoprotein IIb/IIIa inhibitor (GPI), or in those with, or at risk of, heparin- induced thrombocytopenia (HIT) or HIT and thrombosis syndrome (HITTS) undergoing PCI. In these indications, it is intended for use with aspirin.
Frequently, bivalirudin is used for prevention of treatment of thrombosis in patients with HIT with or without thrombosis and with kidney and/or hepatic dysfunction.
Bivalirudin is administered via continuous intravenous infusion, is removed by a combination of proteolytic cleavage by thrombin and renal clearance mechanisms and can inhibit both soluble and clot-bound thrombin.
Bivalirudin's effect is typically monitored using the activated partial thromboplastin time (aPTT) test with a target aPTT ratio of 1.5 to 2.5 times the patient's baseline value. However, in instances where patients have a prolonged baseline aPTT (eg, lupus anticoagulants and factor XII deficiency), aPTT monitoring of bivalirudin is not reliable, and direct measurement of the effect of bivalirudin on factor IIa may be more reliable. For HIT, monitoring every 2 to 4 hours until in range and then once daily; for PCI, monitoring is unnecessary unless kidney failure is present.
Internal laboratory validation demonstrates that plasma concentrations of bivalirudin from 0.25 to 2.00 mcg/mL correspond to an aPTT ratio of 1.5 to 3.0. Correlation of bivalirudin drug concentrations with aPTT ratios may vary with different aPTT reagents.
Reference Values
<0.10 mcg/mL
Interpretation
Therapeutic reference ranges have not been established. See Clinical Information for activated partial thromboplastin time correlative information.
Cautions
The recommended monitoring per product guidelines is with the activated partial thromboplastin time ratio; routine monitoring of bivalirudin drug levels is not indicated.
Bivalirudin concentration may be affected by drug interactions, liver, and kidney disease.
Marked presence of hemolysis or bilirubin in the sample could falsely decrease bivalirudin levels. Marked presence of lipemia in the sample could falsely increase bivalirudin levels.
Method Description
The bivalirudin, ecarin chromogenic assay is performed on the Instrumentation Laboratory ACL TOP Family using the Diagnostica Stago ECA II kit. The STA ECA II kit is a chromogenic assay based on the cleavage of prothrombin by ecarin to meizothrombin, which then enzymatically cleaves the para-nitroaniline (pNA) from the chromogenic substrate resulting in a measurable colorimetric change.(Package insert: STA-ECA II. Diagnostica Stago S.A.S; Revision 09/2015)
Day(s) Performed
Monday through Friday
Report Available
1 to 3 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
80299
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| BIVAL | Bivalirudin, Ecarin, P | 104690-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| BIVA1 | Bivalirudin, Ecarin, P | 104690-3 |
| BIVA2 | Interpretation | 69049-5 |
| BIVA3 | Cautions | 62364-5 |