Quest Diagnostics AAVrh74 Antibody ELISA CDx

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors

PMA Number

P250002 ↗

FDA Product Code

QWQ

Device Class

Class III

Advisory Committee

Hematology

FDA Decision

APPR Approved

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• What is the primary purpose of the Quest Diagnostics AAVrh74 Antibody ELISA CDx in clinical decision-making?

  The Quest Diagnostics AAVrh74 Antibody ELISA CDx is designed to semi-quantitatively detect IgG antibodies to AAVrh74 capsid in human serum, providing a measured antibody titer. Its key role is to determine patient eligibility for AAVrh74 vector-based gene therapy by distinguishing between titers below 1:400 (potentially eligible) and those at or above 1:400 (ineligible). This aids clinicians in assessing immune status before treatment, ensuring safer administration of gene therapy.

• Where and by whom must this test be performed, and is it reusable?

  This test is exclusively performed at Quest Diagnostics Nichols Institute in San Juan Capistrano, CA, by trained operators. It is supplied as a single-use in vitro diagnostic device, meaning each assay kit is intended for one-time use only with a human serum sample. Reuse is not permitted, as it could compromise accuracy and reliability.

• How does the test interpret results, and what does a titer of 1:400 or higher indicate?

  The assay reports a semi-quantitative antibody titer and interprets results based on this value. A titer below 1:400 is classified as 'not elevated,' suggesting the patient may be eligible for AAVrh74 vector-based gene therapy. Conversely, a titer of 1:400 or higher is marked as 'elevated,' indicating the patient is likely ineligible due to pre-existing immunity, which could interfere with treatment efficacy.

• Is this device compatible with any imaging modalities like MRI, or does it require special handling beyond standard laboratory procedures?

  No, this ELISA-based assay does not involve MRI or any imaging modality. It is purely a laboratory test requiring human serum samples and standard in vitro diagnostic handling. Storage and handling conditions are detailed in the instructions for use to ensure proper performance, but no additional imaging compatibility considerations apply.

• What regulatory pathway does this device follow, and what does that mean for its use?

  The Quest Diagnostics AAVrh74 Antibody ELISA CDx is authorized under an FDA Premarket Approval (PMA) with PMA number P250002, classifying it as a Class III medical device. This means it undergoes rigorous review to ensure safety and effectiveness, and its use is strictly regulated to prescription-only settings. The PMA approval ensures the assay meets high standards for detecting AAVrh74 antibodies, supporting clinical decisions in gene therapy workflows.