AAV5 Detect CDxTM -AAV5 Total Antibody Assay for ROCTAVIAN (valoctocogene roxaparvovec-rvox) Eligibility in Hemophilia A
Also known as: AAV5 TAB
Companion Diagnostic
AAV5 Detect CDxTM -AAV5 Total Antibody Assay for ROCTAVIAN (valoctocogene roxaparvovec-rvox) Eligibility in Hemophilia A is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
The AAV5 Total Antibody Assay is indicated as an aid in the selection of adult hemophilia A patients for whom valoctocogene roxaparvovec treatment is being considered. This test helps identify patients who are eligible for ROCTAVIAN therapy by determining the presence or absence of antibodies against adeno-associated virus serotype 5 (AAV5). Specifically, patients with detected anti-AAV5 antibodies are not eligible for treatment, while those without detected antibodies are eligible.
Special Instructions
The test is available at no cost for evaluating eligibility under an FDA-approved indication for ROCTAVIAN treatment. It should be ordered using the ARUP test requisition form or through ARUP's web-based ordering system available to existing ARUP clients. The full name of the ordering physician must be included on the form to ensure timely processing. Specimen shipment to ARUP needs adherence to frozen storage requirements.
Limitations
This assay is validated for male patients only. Samples exceeding a 7.3% sodium citrate concentration, hemolyzed, or lipemic specimens are not acceptable. Stability is not evaluated in tube types other than ARUP transport tube (polypropylene). Test performance has not been validated for any other context beyond identifying eligibility for ROCTAVIAN in hemophilia A patients.
FDA ApprovedNew York ApprovedCompanion Diagnostic
Methodology
Immunoassay (ECLIA)
Biomarkers
Result Turnaround Time
8-10 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
1 mL
Minimum Volume
0.5 mL
Container
polypropylene transport tube
Collection Instructions
Collect the patient's whole blood in a 3.2% sodium citrate tube. Centrifuge the specimen and separate the plasma within 72 hours of collection. Transfer 1 mL (minimum: 0.5 mL) of plasma into a polypropylene pour-off (transport) tube. Label the transport tube with the patient's first and last name, date of birth, and sex.
Storage Instructions
Freeze plasma specimen at -10C or below. Ship frozen plasma specimens to ARUP as soon as possible.
Causes for Rejection
Hemolyzed specimens, lipemic specimens, and samples exceeding 7.3% sodium citrate cannot be evaluated.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Unacceptable |
| Refrigerated | Unacceptable |
| Frozen | Acceptable |