PTEN Sequencing and Deletion/Duplication
Test code
CPT code(s)*
CPT coding may differ dependent on payer rules which may impact prior authorization testing.
Please direct any questions regarding CPT coding to the payer being billed.
Test resources
Details
Methodology
DNA Bait Capture • Long Range Polymerase Chain Reaction • Next Generation Sequencing • Microarray
Assay category
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.
Specimen requirements | |
|---|---|
| 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. |
| Preferred specimen(s) | 5 mL whole blood collected in an EDTA (lavender-top) tube or ACD (yellow-top) tube |
| Alternative specimen(s) | 2 mL saliva to "fill to" line collected in OGD-500, Oragene-Dx Collection Kit or 1 buccal swab submitted in OCD-100A buccal kit (ORAcollect-Dx Collection Kit) or 10 mg skin fibroblasts collected in sterile plastic container or 2 flasks skin fibroblasts collected in each of two separate sterile T25 culture flasks or equivalent with 80-100% confluent growth |
| Minimum volume | 2 mL whole blood • 2 mL saliva • 1 buccal swab • 10 mg skin fibroblasts • 2 flasks 75% confluent |
| Collection instructions | Do not hold specimen. Forward to laboratory when specimen arrives. Whole blood: 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 container | EDTA (lavender-top) tube or ACD (yellow-top) tube |
| Transport temperature | Room 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 | Do not reject. Forward to performing laboratory for evaluation of sample. |
Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.
*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.
This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.
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