Test Overview
Test Methodology

Anti-IIa clottable assay

Test Usage

Used for monitoring Bivalirudin therapy.

Reference Range *

The concentration in a normal individual is zero. Bivalirudin exhibits linear pharmacokinetics following IV administration to patients undergoing percutaneous transluminal coronary angioplasty(PTCA). In these patients, a mean steady state Bivalirudin concentration of 12.3 +/- 1.7 mcg/mL is achieved following a IV bolus of 1 mg/kg, and a 4 - hour 2.5 mg/kg/hr IV infusion.

For anticoagulation outside of PTCA, the dosing is lower. For ECMO, it is usually started at 0.1 - 0.2 mg/kg/hr up to 0.5 mg/kg/hr with levels of 1.23 - 2.46 mcg/mL.

This test was developed and its performance characteristics were determined by Michigan Medicine. It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Details
Days Set Up
Daily, 24 hours
Analytic Time

2 hours

Soft Order Code
BIVAL
MiChart Code
Bivalirudin Level, Anit-IIa Inhibitor Assay
Laboratory
Hematopathology
Section
Coagulation
STAT Availability

STAT requests for this test will be performed on a STAT basis (supervisory staff approval is not required).

Specimen Requirements
Collection Instructions

Collect specimen in a blue top (citrate 3.2%) tube. Mix by inversion. Specimen should arrive at lab within 4 hours of collection; transport at room temperature. Alternatively, centrifuge, aliquot plasma into a plastic vial, and freeze the specimen within 4 hours of collection. Transport frozen specimen on dry ice. Collection of the blood through lines that have been previously flushed with heparin should be avoided. If the blood must be drawn through a VAD (vascular access device), the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes of the VAD discarded.

Rejection Criteria
Specimens will be rejected if not properly filled, clotted, grossly hemolyzed, contaminated with heparin or received outside acceptable time limits.
Contraindications
Not to be used for patients on Argatroban or Dabigatran therapy.
Blue Top Tube
Normal Volume
Full 2.7mL tube or 1mL plasma aliquot
Minimum Volume
Full 1.8mL tube or 1mL plasma aliquot
Storage Temperature
Room temperature for whole blood or frozen aliquot of citrated plasma.
Additional Information

Bivalirudin is a direct thrombin inhibitor used for patients:
-Undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor(GPI).
-With, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI.
-With unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).

Bivalirudin is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin. The safety and effectiveness of Bivalirudin has not been established in patients with acute coronary syndromes (ACS) who are not undergoing PCI or PTCA

Billing
CPT Code
85130
Fee Code
BA019
NY State Approved
No
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