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Test Code (รหัสการทดสอบ):
090-71-3433

Order Name (ชื่อการทดสอบ):
SPOT-MAS, Blood **

 
Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):
Whole blood sample (10ml streck tube) / Gene Solution's Collection kit

Document required:
ใบประวัติ/consent (อยู่ในกล่องชุดตรวจ) ต้องมีลายเซ็นต์คนไข้ + แพทย์
 
Turnaround Time (ระยะเวลารอผล):
30 days
 
Useful For (ประโยชน์การทดสอบ):
Testing for cancer-asscociated gene methylation: Early cancer detection of 5 frequent types of cancer (liver, breast, lung, colorectal and stomach)
 
Methodology (วิธีการทดสอบ):
1. Circulating tumor DNA (ctDNA) with unique SPOT-MAS technology
2. Next-generation sequencing
 
AliasesName (ชื่อเรียกอื่นๆ) :
SPOT-MAS ( K-DETEK)
 
 
 
Test Code (รหัสการทดสอบ):
090-71-3433

Order Name (ชื่อการทดสอบ):
SPOT-MAS, Blood **

 
Patient Preparation (การเตรียมตัวผู้ป่วย):
The test should NOT perform for these following subjects with one of these
following signs suspected for cancer:
• Unexplained weight loss (6 kg within 6 months)
• Pain in the upper right quadrant or epigastrium does not help with medication
• Bleeding, abnormal discharge in the nipple
• Prolonged cough and taking medicine does not help
• Disorders of bowel movements: Diarrhea, constipation, bloody stools

The test could NOT perform for these following subjects:
1. Has been diagnosed with cancer and is undergoing cancer treatment within 5 years (attach results of pathology)
2. Has suspected signs of cancer (Part C) and has not been examined by a doctor
3. Has tumor/lesion with imaging results suspected of cancer (BIRADS ≥ 5 for breast lesion, TIRADS ≥ 5 for thyroid lesion…)
4. Has tumor/lesion that could interfere with ctDNA signals: breast or uterine fibroma, breast or uterine fibroadenoma, colorectal polyp or gallbladder polyp with size ≥ 1 cm
5. Pregnant woman
6. People with a history of bone marrow transplant or blood transfusion within 3 months
 
Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):
Whole blood sample (10ml streck tube) / Gene Solution's Collection kit

Document required:
ใบประวัติ/consent (อยู่ในกล่องชุดตรวจ) ต้องมีลายเซ็นต์คนไข้ + แพทย์
 
Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):
Whole blood sample (10ml streck tube)
 
Sub Mission Container (ภาชนะส่งตรวจ):
Original tube 
 
 
 
Test Code (รหัสการทดสอบ):
090-71-3433

Order Name (ชื่อการทดสอบ):
SPOT-MAS, Blood **

 
Schedule (ตารางการทดสอบ):
N/A **Sent Out to Gene Solutions (Thailand) Co., Ltd
 
Turnaround Time (ระยะเวลารอผล):
30 days
 
Performing Location (หน่วยงานที่ทำการทดสอบ):
Gene Solutions (Thailand) Co., Ltd (Gene Solution, Vietnam)
Referral Lab Services, Laboratory Department 14160-2
 
 
 
Test Code (รหัสการทดสอบ):
090-71-3433

Order Name (ชื่อการทดสอบ):
SPOT-MAS, Blood **

 
 
Clinical Information (ข้อมูลทางคลินิก):
SPOT-MAS TECHNOLOGY
SPOT-MAS (Screening for Presence of Tumor by Methylation and Size of cfDNA) is a liquid biopsy test applied in early cancer screening based on its ability to detect extracellular DNA released by the tumor into the blood stream (circulating tumor DNA, ctDNA). The SPOT-MAS test process consists of 5 main steps:
Step 1: Extraction of cell free DNA (cfDNA) from 10ml of patient using the MagMax magnetic bead-based technology on the automated system KingFisher (Thermo Fisher, USA).
Step 2: Processing cfDNA treatment with bisulfite using the Zymo EZ DNA Gold kit (Zymo Research, USA) and creating a sequencing library using the kit xGen™ Methylation DNA Library Preparation Kit (IDTDNA, USA).
Step 3: Hybridization capture 450 regions of interest containing 18,000 CpG sites carrying specific methylation
alteration with specific probes of xGen Lockdown (IDTDNA, USA) kit and recover the remaining cfDNA library segment after hybridization-capture (flow through segment)
Step 4: Sequencing region of interest within the library segments and flow through using next-generation sequencing technology by nanoball (DNA nanoball Sequencing) on NDBSEQ system (MGI Tech Co.)
Step 5: Using a combination of Stacking ensemble machine learning models and Deep Neutral Network (DNN) to detect ctDNA in the blood and determine the origin of tumors based on a database of alteration in methylation pattern, variations on copy number and size of DNA fragments at 450 regions of interest and on global genome.

LIMITATIONS OF THE TEST 
- A negative result does not completely rule out the possibility that the test participant has cancer that is out of the scope of investigation or because the tumor is too small and located in a difficult site to release ctDNA into the bloodstream.
- Some special conditions such as pregnant women or patients whose tumors have disappeared due to the action of the immune system can create interference signals.
- Cannot rule out the possibility that the test can detect some rare cancers that release ctDNA with similar features to the 5 types of cancers in the scope of the investigation.


This test is a screening test, not a diagnostic test. Please consult your doctor to advise on you to do the next steps for cancer confirmation. 

Positive SPOT MAS result – next steps for biopsy confirmation;
- Breast cancer -> Ultrasound + Mammogram
- Liver cancer -> CT scan
- Lung cancer -> LD CT scan
- Colorectal cancer -> Colonoscopy
- Stomuch cancer -> Upper endoscopy
 
 
Interpretation (การแปลผล):
An interpretive report will be provided.