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

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.

Pathology report must be supplied with sample. Ship at room temperature. Do not freeze.

Send specimen to testing lab for viability determination. Do not reject

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 5 years
Refrigerated: 5 years
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 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

Monday-Sunday Evening Report available: 12 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.

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.