Genetic mutation test kit TG-QCY-0037

for genetic testingoncologyfor PDGFRA gene mutations

Product overview
This kit is a real-time qualitative in vitro diagnostic (IVD) assay for detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue from patients with gastrointestinal mesenchymal stromal tumors (GIST).

Intended use / Application
This kit is intended to detect somatic mutations in the PDGFRA gene to support diagnosis of tumor types associated with specific PDGFRA mutations, such as certain gastrointestinal mesenchymal stromal tumors.

Composition of the kit

• Reaction mixture
• Positive control
• Taq DNA polymerase
• No template control
• Sample diluent

Safety information
Handle all reagents according to standard laboratory safety procedures. Wear a lab coat, disposable gloves and protective goggles. Consult the safety data sheets (SDS) for detailed information.

Precautions
The assay is validated for formalin-fixed, paraffin-embedded (FFPE) specimens.

• All chemicals and biological materials may be hazardous.
• Specimens and extracted samples may be infectious; treat as biohazardous.
• Follow local regulations for disposal of specimens and test waste.
• Do not use expired or improperly stored components.

Storage and shipping
Shipping: Ship on dry ice.
Storage: Store refrigerated at -30 to -15°C; protect from light.

Product Details (table)
Product Name: Gastrointestinal mesenchymal stromal tumors (GIST) PDGFRA Test Kit
Catalog No.: TG-QCY-0037
Description: Real-time qualitative IVD assay for detection of the D842V somatic mutation in PDGFRA using genomic DNA from FFPE tumor tissue.
Certification: FDA
Application: Detect somatic mutations in the PDGFRA gene to aid diagnosis of tumor types associated with specific gene mutations.
Target Disease: Gastrointestinal mesenchymal stromal tumors (GIST)
Detection Target: PDGFRA
Specifications: 24T
Assay Type: PCR
Samples: Genomic DNA extracted from tumor tissue
Composition of the Kit: Reaction mixture; Positive control; Taq DNA polymerase; No template control; Sample diluent.
Safety information: Wear appropriate protective equipment; consult SDS.
Precautions: For FFPE specimens; handle specimens as biohazardous; follow local disposal procedures; do not use expired or improperly stored components.
Storage and Shipping: Ship on dry ice; store at -30 to -15°C; protect from light.

Technical specifications

• Catalog number: TG-QCY-0037
• Target gene: PDGFRA (detects D842V somatic mutation)
• Intended sample type: Genomic DNA extracted from FFPE tumor tissue
• Assay format: Real-time qualitative PCR (IVD)
• Kit size / specification: 24T
• Kit components: reaction mixture, positive control, Taq DNA polymerase, no template control, sample diluent
• Certification: FDA
• Shipping: on dry ice
• Storage: refrigerated at -30 to -15°C; protect from light