SMA Plus

Test Code

92951

CPT Codes
81329 (x2), 81336<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.

Includes

Sequencing is performed reflexively when a single copy of SMN1 is found.

Please note CPT: Step 1: 81329; Steps 1 & 2: 81329, 81336

Preferred Specimen

4 mL whole blood collected in an EDTA (lavender-top) tube, or
Pediatric (0-3 years): 2 mL collected in a pediatric (3.0 mL recommended) EDTA (lavender-top) tube

Minimum Volume

2 mL • 1 mL pediatric

Instructions

This test requires physician attestation that patient consent has been received.

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

Higher blood volumes ensure adequate DNA quantity, which varies with WBC, specimen condition, and need for confirmatory testing. Patients, 0-3 years have higher WBC, yielding more DNA per mL of blood.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 10 days
Refrigerated: 10 days
Frozen: Unacceptable

Methodology
Quantitative Real-Time Polymerase Chain Reaction • Sanger Sequencing

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: Varies; Report available: 14-21 days

Reference Range

See Laboratory Report

Clinical Significance

Detects copy number (dosage) of the SMN1 and SMN2 genes. Sequencing is performed reflexively when a single copy of SMN1 is found.

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.