Test Details
Methodology
One stage clot detection
Result Turnaround Time
7 - 10 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This assay is intended for the evaluation of plasma emicizumab levels (µg/mL) in patients receiving emicizumab therapy.
Limitations
Patients receiving factor VIII replacement therapy in addition to emicizumab may show falsely elevated results, as will patients with significant native factor VIII levels (greater than 25% native factor VIII activity). If factor VIII inhibitor levels are required while the patient is on emicizumab, this can be ordered by using Factor VIII Chromogenic Bethesda Profile, for Patients on Emicizumab [504722].
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Specimen Requirements
Specimen
Citrated plasma, frozen
Volume
1 mL
Minimum Volume
0.5 mL (Note: This volume does not allow for repeat testing.)
Container
Light blue-top (3.2% sodium citrate) collection tube
Collection Instructions
Separate plasma from cells by centrifugation. Centrifuge separated plasma to yield platelet-poor plasma. Transfer plasma to a plastic transport tube before freezing.
Storage Instructions
Freeze. Stable at room temperature for 6 hours, and for 3 additional freeze/thaw Instructions cycles.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 505715 | Emicizumab Activity | 505716 | Emicizumab Activity | ug/mL | 99614-0 | |
| Order Code | 505715 | |||||
| Order Code Name | Emicizumab Activity | |||||
| Order Loinc | ||||||
| Result Code | 505716 | |||||
| Result Code Name | Emicizumab Activity | |||||
| UofM | ug/mL | |||||
| Result LOINC | 99614-0 |