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Lab Test Dictionary

AAV5 Detect CDxTM -AAV5 Total Antibody for ROCTAVIAN (3000959)

Methodology

Qualitative Electrochemiluminescent Immunoassay (ECLIA)


Specimen Type

Plasma

Performing Lab

ARUP


Epic ID

Other Reference Test

Lab Test Days

Monday-Friday

Standard TAT

8-10 Days


Collection Information

Specimen Required

(one) 1.8 mL or 2.7 mL Blood

Container Type

Sodium Citrate (Blue-Top) Tube


Processing Information - Lab Use Only

Transport Temperature

Frozen-Only

Specimen Stability

Room Temp: Unacceptable; Refrigerated: Unacceptable; Frozen: Undetermined

Rejection Criteria

Hemolyzed; Lipemic specimens

Test Volume Required

1 mL Plasma

Minimum Test Volume

0.5 mL Plasma

Processing Instructions

Separate from cells ASAP or within 72 hours of collection. Complete an ARUP requisition form and submit sample frozen with daily Apollo courier pick up.


Comments

Test validated for male patients only. 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.


CPT Codes

no cpt, no price @ this time, awaiting FDA approval - cas 12/12/23


Revised

1/4/24

Initials

SA