Sars COV-2 Variants

Message

This is a lab ordered test.

Test Code

SARS-COV-2 VARIANT PAN,MULTIPLEX PCR(WH)

Preferred Specimen

Nasal swab

Other Acceptable Specimens

Nasopharyngeal swab

Transport Temperature

Refrigerated <=3 Days; Frozen >3 Days.

Specimen Stability

Refrigerated <=3 Days; Frozen >3 Days.

Methodology
The MassARRAY SARS-CoV-2 Panel v3 (Agena Bioscience) is a
multiplex PCR assay which detects 36 genetic markers and 15 variants of the
SARS-CoV-2 (SC2) virus. The panel is designed to detect the Delta
(B.1.617.2), Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Iota (B.1.526),
Epsilon (B.1.427/B.1.429), Zeta (P.2) variants, as well as several other
variants and mutations. The assay only detects these specific variants and
mutations and does not identify all possible lineages.
The assay requires an initial RNA extraction step, followed by reverse transcription polymerase chain reaction, then automated transfer to a chip array and detection with the MassARRAY analyzer. The MassARRAY identifies PCR products based on their mass and charge using an integrated mass spectrometer. Invalid results may be obtained if the viral load in the original patient specimen is too low for the assay.
The specimen will be reflexed to whole genome sequencing if the assay result is indeterminate, if only the D614G mutation is detected, or if the assay is unable to distinguish between two or more variants. Most variants detected by the panel are or have been classified by the CDC as variants of concern or variants of interest. Please consult the CDC website for the latest classifications and their clinical impact
(https://www.cdc.gov/coronavirus/2019-ncov/ variants/variant-info.html).

Clinical Significance

Performing Laboratory
VA Connecticut Virology Reference Lab
Contact Danielle Plant 203-937-5711 x3503

Last Updated: October 6, 2021

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.