26609 Agalsidase beta (Fabrazyme) IgG Antibody, Serum (504770)

​​Agalsidase beta IgG antibodies; Fabrazyme IgG antibodies; Anti-Fabrazyme IgG antibodies; Fabry disease immunogenicity testing, anti-drug antibody 

​**The Sanofi program no longer will pay for this service and will no longer be of charge to patients. Labcorp has market access and reimbursement support services that will continue to offer as needed. 

A collection timing of at least 3 days after infusion or prior to subsequent infusion is recommended.  If reflex test is performed, additional charges/CPT code(s) may apply.​  

Collect prior to enzyme infusion OR At least 3 days after infusion.  

Two (2) frozen specimens are required for this assay.  

Centrifuge tubes and split serum into two screw-capped polypropylene transport tubes (not "pop-top" or "snap-cap"), and FREEZE.        

(SANOFI GENZYME RARE DISEASE PROGRAM) LabCorp needs to be called to arrange a special courier. Call (855) 522-2677 before 10 am for same-day pickup. Calls after 10 am will be scheduled for pick up the following business day. Tell them the account number (48021400) and number of specimens. State that they need to call (715) 221-6200 when they arrive, and we will bring sample(s) out to them (near dumpsters). Note the confirmation number in comments.   

**REGIONAL CENTERS: All specimens should be sent to the main Marshfield Clinic lab for handling after collection.​

Un​spun Red Top Tube specimens, specimens with visible hemolysis, specimens not collected prior to enzyme infusion or are collected less than 3 days after the infusion are not acceptable.

​This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.  This test should not serve as the sole basis for patient- specific clinical decision making.  

There are no established reference ranges.  Results are reported as micrograms/mL 

​Positives are confirmed by radioimmunoprecipitation assay (RIPA).  Titers are reported for positive results as the reciprocal of the highest serum dilution for which ELISA is positive.  Please refer to prescribing information and/or Sanofi Genzyme Medical Information for additional information.  Adverse events suspected to be associated with agalsidase beta should be reported directly to Sanofi Genzyme Pharmacovigilance.​