AAV9 Antibody Test

• Test Details
• Technical Information
• CPT Coding
• Specimen Requirements
• Shipping Considerations

Test Details

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Test code:	1181
Type of disorder:	Genetic Diseases
Disease(s) tested for:	Anti-drug Antibody

Technical Information

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Clinical Significance:	Adeno-associated viruses (AAVs) are commonly used in gene therapy due to the ease of genome manipulation, ease of purification and safety (1). However, many AAV serotypes commonly infect humans resulting in pre-existing immunity which may reduce the efficiency of gene therapy that utilizes these serotypes (1,2,3). The AAV9 ELISA detects antibodies against AAV9 which may inhibit the efficacy of gene therapies (1,2). References: 1. Naso et al. (2017) Adeno-Associated Virus (AAV) as a Vector for Gene Therapy. BioDrugs. 31(4): 317-334.   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5548848/ 2. Mingozzi and High. (2013) Immune Response to AAV vectors: overcoming barriers to successful gene therapy. Blood. 122(1): 23-26. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3701904/   3.  Boutin et al. (2010). Prevalence of serum IgG and neutralizing factors against adeno-associated virus (AAV) types 1, 2, 5, 6, 8, and 9 in the healthy population: implications for gene therapy using AAV vectors.  Hum Gene Ther. 21(6): 704-712. https://www.ncbi.nlm.nih.gov/pubmed/20095819
Methodology:	Enzyme Linked Immunosorbent Assay
Reference Range:	<1:25

CPT Coding

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The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

CPT:

86790(1)

Specimen Requirements

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Please label each specimen tube with two forms of patient identification. These forms of identification must also appear on the requisition form.

Specimen Type:	Serum
Specimen Stability:	Room temperature: 72 hours, Refrigerated: 14 days, Frozen: 14 days
Specimen Requirements:	2 mL (0.5 mL minimum) serum in a Red-top tube or Serum Separator Tube (SST)
Instructions:	If using SST, separate serum from whole blood by centrifugation at a speed of 900 to 1200 RCF for 8 minutes within 48 hours of venipuncture. If using red top tube (no additives), ship whole blood immediately for next day delivery OR Separate serum from whole blood by centrifugation at 900 to 1200 RCF for 8 minutes within 48 hours of venipuncture. Transfer the serum to a properly identified capped vial.

Shipping Considerations

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Transport Temperature:	Refrigerated
Reject Criteria:	Turbid and/or any suggestion of bacterial contamination
Set-up/Analytic Time:	2-4 days