Co-GM1 Quattro™ Autoantibody Test

Test Code
92314


CPT Codes
83520 (x4)<br /> Limited Access 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


Instructions
Note: 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: 21 days
Frozen: 4 months


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Hemolysis; Icteric; Lipemia


Methodology
Enzyme-Linked Immunosorbent Assay (ELISA)

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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Mon, Wed; Report available: 7-10 days


Reference Range
See Laboratory Report


Clinical Significance
Anti-GM1, anti-GD1a, anti-asialo-GM1 and anti-GD1b antibodies are found in patients with a distal motor neuropathy.




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.