Recombx® Hu Autoantibody Test

Test Code

94610

CPT Codes
83520<br>Restricted Client Code

Physician Attestation of Informed Consent

This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.

Preferred Specimen

2 mL serum

Minimum Volume

0.5 mL

Other Acceptable Specimens

2 mL CSF collected in a sterile leak-proof container

Instructions

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

Serum must be separated from cells within 48 hours of collection.

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 72 hours
Refrigerated: 28 days
Frozen: 28 days

Methodology
Automated Nanoliter Scale Immunoassay

FDA Status
This test was developed and its analytical performance characteristics have been determined by Athena Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Mon-Fri; Report available: 3-5 days

Reference Range

Serum <1:100
CSF <1:1

Clinical Significance

Anti-Hu (ANNA1) antibody is found in 5-10% of patients with small cell carcinoma of the lung and are associated with paraneoplastic encephalomyelitis and sensory neuropathy. This semi-quantitative assay may be useful in monitoring therapeutic responses in select cases.

The CPT Codes provided in this document 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 payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.