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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
BRCAvantage™ with Reflex to Breast Plus Panel
Test CodeCPT Codes
81162<br /> Restricted Client Code
Includes
Positive for a known Pathogenic Mutation;
Positive for a likely Pathogenic Mutation;
Positive for a likely Pathogenic Mutation and a variant with unknown significance, then TP53, PTEN, CDH1, STK11, and PALB2 will be performed at an additional charge (add CPT code(s) 81307, 81321, 81323, 81351, 81404, 81405, 81406, 81479).
Preferred Specimen
Patient Preparation
Saliva: Do NOT eat, drink, smoke or chew gum for 30 minutes before collection.
Buccal Swab: Please refer to user instructions provided with kit. Ensure the sponge tip does NOT come into contact with any surface prior to collection. Do NOT eat, drink, smoke, or chew gum for 30 minutes before collection. Do not touch swab tips or allow contact with any other object.
Minimum Volume
Other Acceptable Specimens
Instructions
Do not hold specimen. Forward to laboratory when specimen arrives.
Whole blood (preferred): Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.
Saliva: 2 mL saliva collected in the Oragene-Dx collection kit up to the "fill to" line (OGD-500/OGD-600, OGD-510/OGD-610). Do NOT remove the plastic film from the funnel lid.
For fibroblasts and skin fibroblasts, call 1-866-GENEINFO (1-866-436-3463) prior to collecting and ordering.
Transport Temperature
Specimen Stability
Whole blood
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Saliva or buccal swab
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 14 days
Fibroblasts and skin fibroblasts
Room temperature: 48 hours
Refrigerated: Unacceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Methodology
Next Generation Sequencing, Multiplex Ligation-dependent Probe Amplification, Exon Capture
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
Reference Range
Clinical Significance