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Chromosomal Microarray, POC FFPE, ClariSure® Oligo-SNP
Test Code39029
CPT Codes
81229
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
5x5 mm POC formalin-fixed, paraffin-embedded tissue
Minimum Volume
2x3 mm
Other Acceptable Specimens
5 unstained (+) charged slides, prepared from formalin-fixed, paraffin-embedded tissue
Instructions
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.
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.
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
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 12-15 days
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.
