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Overview
ข้อมูลทั่วไป Specimen
ข้อมูลสิ่งส่งตรวจ Performance
ข้อมูลการทดสอบ Clinical & Interpretation
ข้อมูลทางคลินิก
 
Test Code (รหัสการทดสอบ):
090-71-3419
Order Name (ชื่อการทดสอบ):
SigNatera initial test, Tissue (FFPE) + Blood **
 
Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):
FFPE Tissue 6-10 Slide/or tissue block + H&E slide
+ Blood (SigNatera Kit) - Two 10mL Streck tubes + 6mL EDTA tube

Document Required
- Filled Requisition Form & Sign Consent 
 
Turnaround Time (ระยะเวลารอผล):
Received specimen to reported within 5 weeks (Slide received to report)
 
Useful For (ประโยชน์การทดสอบ):
Detect circulating tumor DNA (ctDNA) for molecular residual disease (MRD) assessment and recurrence monitoring for patients previously diagnosed with cancer.
 
Methodology (วิธีการทดสอบ):
Detect ctDNA by tracking 16, tumor-specific clonal variants based on WES + PCR + NGS
 
 
 
Test Code (รหัสการทดสอบ):
090-71-3419
Order Name (ชื่อการทดสอบ):
SigNatera initial test, Tissue (FFPE) + Blood **
 
Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):
FFPE Tissue 6-10 Slide/or tissue block + H&E slide
+ Blood (SigNatera Kit) - Two 10mL Streck tubes + 6mL EDTA tube

Document Required
- Filled Requisition Form & Sign Consent 
 
Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):
FFPE Tissue 6-10 Slide/or tissue block + H&E slide
+ Whole blood 10mL Streck x 2 tubes + 6mL EDTA tube
 
Sub Mission Container (ภาชนะส่งตรวจ):
SigNatera tissue collection Kit  +  SigNatera blood collection Kit
 
 
Specimen Stabillity (ความคงตัวของสิ่งส่งตรวจ):
Specimen Type Temperature Time
Whole blood Ambient temperature 7 days *
* Sent to USA
 
 
 
Test Code (รหัสการทดสอบ):
090-71-3419
Order Name (ชื่อการทดสอบ):
SigNatera initial test, Tissue (FFPE) + Blood **
 
Method detail (วิธีการทดสอบ):
Detect ctDNA by tracking 16, tumor-specific clonal variants based on WES + PCR + NGS
 
Schedule (ตารางการทดสอบ):
N/A **Sent out to Natera, Inc., USA
 
 
Turnaround Time (ระยะเวลารอผล):
Received specimen to reported within 5 weeks (Slide received to report)
 
Performing Location (หน่วยงานที่ทำการทดสอบ):
Natera, Inc.
Referral Lab Services, Laboratory Department 14160-2
 
 
 
Test Code (รหัสการทดสอบ):
090-71-3419
Order Name (ชื่อการทดสอบ):
SigNatera initial test, Tissue (FFPE) + Blood **
 
 
Clinical Information (ข้อมูลทางคลินิก):
“Signatera Test” means Natera’s individual-specific screening test for detecting and monitoring circulating tumor DNA in the plasma of patients previously diagnosed with cancer. Individual-specific mutation signatures are identified by upfront FFPE tissue and matched-normal whole exome sequencing.

Signatera Setup consists of whole exome sequencing of tissue and matched-normal in order to determine the individual-specific mutation signature, to be measured with the Initial Plasma Test and monitored with Subsequent Plasma Tests.
 
Clinical Reference (เอกสารอ้างอิง):
www.natera.com/oncology/signatera-clinicians (Retrieved: 22 Jul 2020)