Chromosomal Microarray, POC FFPE, ClariSure® Oligo-SNP

Test Code
39029


CPT Codes
81229

Preferred Specimen
5x5 mm POC formalin-fixed, paraffin-embedded tissue block


Minimum Volume
2x3 mm


Other Acceptable Specimens
5 unstained, positively (+) charged slides prepared from formalin-fixed, paraffin-embedded tissue


Instructions

Pathology report must be supplied with sample.
⁠⁠⁠⁠⁠⁠⁠
Formalin-fixed paraffin-embedded tissue or charged/+slides from formalin-fixed paraffin-embedded tissue. Specimen must be fixed in 10% neutral buffered formalin. Cold ischemic time of less than 1 hour and fixation between 6 and 72 hours is recommended.

Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.



Transport Temperature
Room temperature


Specimen Stability
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable


Methodology
Oligo-SNP Array

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest 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: Daily; Report available: 13-16 days


Reference Range
See Laboratory Report


Clinical Significance
This Oligo/SNP array assay of products of conception is used to detect genomic alterations that may be associated with fetal miscarriage and should be used in conjunction with conventional cytogenetics testing and clinical evaluation of the miscarriage.


Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042



Last Updated: November 6, 2024


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.