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Test ID RAVU Ravulizumab, Serum


Advisory Information


To screen test complement abnormalities in the alternative pathway, order RAVUM / Ravulizumab Complement Blockage Monitoring, Serum.



Specimen Required


Patient Preparation: Natalizumab or eculizumab must be discontinued at least 4 weeks prior to testing for ravulizumab quantitation in serum.

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 2.5 mL

Collection Instructions:

1. Draw blood immediately before next scheduled dose.

2. Centrifuge within 2 hours of collection.


Useful For

Assessing the response to ravulizumab therapy

 

Assessing the need for dose escalation

 

Evaluating the potential for dose de-escalation 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

 

This test is not useful as the sole basis for a diagnosis or treatment decisions.

Highlights

Therapeutic drug monitoring of ravulizumab may be useful when assessing response to therapy is difficult or when patients need to be above a certain therapeutic monoclonal antibody concentration in order to improve the odds of a clinical response for therapy optimization, including potential dose de-escalation or discontinuation of therapy in remission states.

Method Name

Liquid Chromatography-Tandem Mass Spectrometry, High Resolution Accurate Mass (LC-MS/MS HRAM)

Reporting Name

Ravulizumab, S

Specimen Type

Serum

Specimen Minimum Volume

1.1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
  Ambient  28 days
  Frozen  28 days

Reference Values

Lower limit of quantitation=5.0 mcg/mL

 

>175 mcg/mL-Therapeutic concentration for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome

Performing 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. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

80299

LOINC Code Information

Test ID Test Order Name Order LOINC Value
RAVU Ravulizumab, S In Process

 

Result ID Test Result Name Result LOINC Value
609420 Ravulizumab, S In Process

NY State Approved

Yes