This information is for providers outside of the U.S. ONLY.

AAV5 Total Antibody Assay for Valoctocogene Roxaparvovec Eligibility in Hemophilia A

The AAV5 DetectCDx® for valoctocogene roxaparvovec eligibility in Hemophilia A is a qualitative in vitro diagnostic test by electrochemiluminescence intended for detection of antibodies in human plasma collected in 3.2% sodium citrate that bind to the adeno-associated virus serotype 5 (AAV5). The AAV5 DetectCDx is indicated as an aid in the selection of adult hemophilia A patients for whom valoctocogene roxaparvovec treatment is being considered. Patients that are anti-AAV5 antibody positive (result of detected) are not eligible for treatment with valoctocogene roxaparvovec; patients that are anti-AAV5 antibody negative (result of not detected) are eligible for treatment with valoctocogene roxaparvovec. This assay is for professional use only.

Instructions for Use: AAV5 DetectCDx Kit IVDD

Download and view the AAV5 DetectCDx Kit Instructions for Use.

Instructions for Use: AAV5 DetectCDx Specimen Shipping Kit

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How to Order

If you are interested in ordering, please visit aav5detectcdx.com for more information.