Ordering Recommendation

The AAV5 Total Antibody Assay for ROCTAVIAN (valoctocogene roxaparvovec-rvox) Eligibility in Hemophilia A ("AAV5 TAb Assay") or AAV5 DetectCDx 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 TAb Assay is indicated as an aid in the selection of adult hemophilia A patients for whom ROCTAVIAN treatment is being considered. Patients that are anti-AAV5 antibody positive (result of Detected) are not eligible for treatment with ROCTAVIAN; patients that are anti-AAV5 antibody negative (result of Not Detected) are eligible for treatment with ROCTAVIAN. This assay is for professional use and is a single-site assay performed at ARUP Laboratories.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

3.2% sodium citrate

Specimen Preparation

Separate from cells ASAP or within 72 hours of collection. Transfer 1 mL plasma to an ARUP standard transport tube. (Min: 0.5 mL)

Storage/Transport Temperature

Critical frozen

Unacceptable Conditions

Hemolyzed specimens and lipemic specimens

Remarks

Ship frozen specimens to ARUP as soon as possible. Collection Instructions: Collect the patient's whole blood in a 3.2% sodium citrate tube. Samples that exceed 7.3% sodium citrate cannot be evaluated and may require patient redraw. NOTE: When drawing blood for the AAV5 DetectCDx test, universal precautions for bloodborne pathogens should be observed. Centrifuge the specimen and separate the plasma within 72 hours of collection. Refer to your manufacturer's manual for recommended centrifuge speed and duration. Transfer 1 mL (minimum: 0.5 mL) of plasma into a polypropylene pour-off (transport) tube. Sample stability for the AAV5 DetectCDx has not been evaluated in tube types other than the ARUP transport tube (polypropylene). Failure to provide sufficient volume may result in the need for patient redraw. Label the transport tube with the patients first and last name, date of birth, and sex. Freeze plasma specimen at -10C or below. Ship frozen plasma specimens to ARUP as soon as possible. NOTE: Plasma specimens must be frozen before they are shipped to ARUP Laboratories.

Stability

Frozen (-10 C or colder): Acceptable, Refrigerated: Unacceptable, Ambient: Unacceptable

Methodology

Qualitative Electrochemiluminescent Immunoassay (ECLIA)

Performed

Mon-Fri

Reported

8-10 days

Reference Interval

Interpretive Data

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. Patients who have a result of Detected are not eligible for treatment with valoctocogene roxaparvovec; patients who have a result of Not Detected are eligible for treatment with valoctocogene roxaparvovec.

Compliance Category

FDA

Note

Test validated for male patients only.
1.  AAV5 DetectCDx is offered at no cost to evaluate eligibility for an FDA-approved indication. While the assay is provided at no cost, any other expenses, charges, services, costs, materials, or lab work that are not provided by ARUP are not covered under this program. No patient, private health plan, government health program, or any other individual or entity shall be billed for this serotype test and no reimbursement will be sought for any tests or materials provided at no cost in connection with such test. Access to the test at no cost is not contingent upon the recommendation, ordering, prescription, or purchase of any other product or service.
2. The test should be ordered using the ARUP test requisition form or via ARUP's web-based ordering interface (available only to existing ARUP clients). The full name of the ordering physician must be included on the ARUP form to ensure timely testing of the specimen. Specimens submitted with incomplete information may delay specimen testing.
3. To send a specimen to ARUP, contact your local hospital/reference lab to determine if they are an ARUP client and can send the specimen. If they cannot send the specimens to ARUP, contact ARUP Client Services at 800-522-2787 to be directed to an alternative ordering mechanism.

Hotline History

N/A

Components

Component Test Code* Component Chart Name LOINC
3000965 AAV5 Tab Interp
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

AAV5 Detect CDxTM -AAV5 Total Antibody Assay for ROCTAVIAN (valoctocogene roxaparvovec-rvox) Eligibility in Hemophilia A