Test Code RAVMP Ravulizumab Monitoring Panel, Serum
Additional Codes
Torrance Memorial Laboratories Test Code: 4644217791
Ordering Guidance
To measure only serum concentration of ravulizumab, order RAVU / Ravulizumab, Serum.
Specimen Required
Patient Preparation:
1. Fasting: 8 hours, preferred but not required
2. Suggest discontinuing natalizumab at least 4 weeks before specimen collection for ravulizumab testing. Patient should consult the healthcare professional who prescribed this drug to determine if discontinuation is an option. If not, it is okay to proceed with testing while taking natalizumab.
Supplies: Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Red top (serum gel/SST are not acceptable)
Submission Container/Tube: 2 Plastic vials
Specimen Volume: 2 mL Serum in 2 plastic vials, each vial containing 1 mL
Collection Instructions:
1. Draw blood immediately before next scheduled dose.
2. Immediately after specimen collection, place the tube on wet ice and allow specimen to clot.
3. Centrifuge at 4° C and aliquot serum into two 5 mL plastic vials.
4. Freeze serum within 30 minutes of centrifugation. Serum must be placed on dry ice if not frozen immediately.
NOTE: If a refrigerated centrifuge is not available, it is acceptable to use a room temperature centrifuge, provided the sample is kept on ice before centrifugation, and immediately afterward, the serum is aliquoted and frozen.
Useful For
Monitoring of complement blockage by ravulizumab
Assessing the response to ravulizumab therapy
Assessing the need for dose escalation
Evaluating the potential for dose deescalation or discontinuation of therapy in remission states
Monitoring patients who need to be above a certain ravulizumab concentration in order to improve the odds of a clinical response for therapy optimization
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| RAVU | Ravulizumab, S | Yes | Yes |
| RAVUM | Ravulizumab Complement Blockage, S | No | Yes |
| RAVIN | Ravulizumab Interpretation, S | No | Yes |
Method Name
RAVU: Liquid Chromatography Tandem Mass Spectrometry, High Resolution Accurate Mass (LC-MS/MS HRAM)
RAVUM: Enzyme-Linked Immunosorbent Assay (ELISA)
RAVIN: Technical Interpretation
Reporting Name
Ravulizumab Monitoring Panel, SSpecimen Type
SerumSerum Red
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Frozen | 14 days |
| Serum Red | Frozen | 14 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | OK |
Reference Values
RAVULIZUMAB:
Lower limit of quantitation =5.0 mcg/mL
>175 mcg/mL: Therapeutic concentration for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome
RAVULIZUMAB COMPLEMENT BLOCKAGE:
≥46% Normal
Day(s) Performed
Varies
Report Available
3 to 10 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
86161
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| RAVMP | Ravulizumab Monitoring Panel, S | 101923-1 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 609500 | Ravulizumab Complement Blockage, S | 74520-8 |
| 609420 | Ravulizumab, S | 97184-6 |
| 619952 | Ravulizumab Interpretation | 59462-2 |
Forms
If not ordering electronically, complete, print, and send a Coagulation Test Request (T753) with the specimen.