Signatera & Altera (Sendout)
General Information
- Lab Name
- Signatera and Altera, Inhouse collection
- Lab Code
- RSIALT
- Epic Ordering
- Signatera and Altera Panel (O374177)
- External Test Id
- Signatera™ and Altera™
- Description
Test Information: Signatera™ is a mPCR-NGS assay for detection and quantification of circulating tumor DNA (ctDNA) in the plasma of patients previously diagnosed with cancer. Individual-specific mutation signatures are identified by upfront tissue and matched normal whole exome sequencing. Altera™ offers a whole exome and transcriptome based approach for Comprehensive Genomic Profiling (CGP) with boosted >500X coverage for 440 medically important genes.
Ordering Requirements: A Natera Signatera and Altera™ kit is required for testing. Providers should arrange with Natera to obtain kits and have the patient bring the kit to Phlebotomy for collection.
- Synonyms
- Altera Genomic Profile, Natera, Signatera ctDNA
- Components
-
Code Name RSIASP Signatera and Altera Collection
Interpretation
- Method
NGS
- Reference Range
- See individual components
Ordering & Collection
- Specimen Type
- Blood
- Collection
-
Collect 2 x 10 mL Streck Cell-Free DNA BCT® tubes (mottled black and tan) and 1 x 6 mL LAVENDER TOP (EDTA) tube from Natera Signatera and Altera™ kit. Natera will not accept other tubes.
Additional Instructions:
- Fill all tubes completely and mix by gently inverting 8-10 times. Do not shake vigrorously.
- Walk samples to the laboratory after collection. Do not transport via pneumatic tube system, as this may compromise the Streck collection tubes.
- When delivering samples to the lab, include the kit and the Natera requisition that prints from Epic.
- Clinics should not rely on DLMP to provide kits due to unknown volume of orders.
- Handling Instructions
Outside Laboratories: Test available to UW Medicine patients only.
- Quantity
-
requested: 20 mL whole blood in Streck tubes and 6 mL EDTA whole blood in Natera Signatera and Altera™ kit
minimum: 20 mL whole blood in Streck tubes and 6 mL EDTA whole blood inNatera Signatera and Altera™ kit
Processing
- Processing
Store and transport whole blood samples at room temperature.
- HMC and UW-NW: Forward samples and kit to UW-MT for sendout.
- Fred Hutch: Send samples to Natera using provided kit. Close the order after sendout by entering NATSO for the pending RSIATR (Signatera and Altera Sample Tracking) test.
UW-MT Sendouts:
- Package samples along with the Natera requisition (printed from Epic) and ship at room temperature using the provided kit.
- Samples may be shipped on Friday for Saturday delivery.
Stability:
- Lavender Tubes: Ambient (required): 14 days; Refrigerated: Unacceptable; Frozen: Unacceptable.
- Streck Tubes: Ambient (required): 9 days; Refrigerated: Unacceptable; Frozen: Unacceptable.
CAST:
- Print a pending UNATSO worksheet.
- Use Sunquest 'Audit Trail' to confirm that the sample has been sent out.
- Close the RSIALT order by entering NATSO for the pending RSIATR (Signatera and Altera Sample Tracking) component.
- Results will file directly from Natera to Epic via interface.
Performance
- LIS Dept Code
- Sendouts (SO)
- Performing Location(s)
-
Sendout Natera 201 Industrial Road
San Carlos, CA 94070Phone Numbers:
- 650-273-4468 (Organ Health)
- 844-778-4700 (Women's Health)
- 650-489-9050 (Oncology)
- Other Locations/Notes
-
Signatera & Altera Clinical Support:
- Phone: 650.489.9050
- Email: signateracc@natera.com
- Frequency
- Turnaround Times: Signatera: 3 - 4 weeks; Altera: 2-3 weeks.
- Available STAT?
- No
Billing & Coding
- CPT codes
- Billing Comments
No institutional billing. Patient self-pay or direct insurance billing only.
- LOINC
- 30896-5