Sentosa SQ Thyroid Cancer Panel (RUO)

Detect sequence variants in thyroid cancer samples

RELEVANCE

Sentosa SQ Thyroid Cancer Panel is a ready-to-use kit for automated PCR-based next generation sequencing library preparation using the Sentosa® SX101 instrument for the detection of mutations associated with thyroid cancer. This kit contains four sets of reagents and solutions; each set allows for the preparation, purification and normalization of eight libraries per run. In addition, Sentosa® SQ Thyroid Cancer Panel contains Thyroid Cancer SC (Thyroid Cancer System Control), which functions as an extraction control, a positive control and a no template control. The primer mix provided in this kit is designed for the specific amplification of target genes containing potential mutations as well as the system control fragment.

PURPOSE

The Sentosa SQ Thyroid Cancer Panel is a next generation sequencing-based test that simultaneously detects hot spot mutations in 10 genes from formalin-fixed paraffin-embedded (FFPE) samples for research use only. This panel is intended to be used on the Sentosa® SX101 with the Sentosa SX FFPE II gDNA Kit in conjunction with the Sentosa ST401 and Sentosa SQ301 instruments.

TARGET GENES

Target GenesNumber of AmpliconsNumber of Target MutationsAmplicon Locations in Exon(s)
BRAF 2 15 11, 15
CTNNB1 1 5 2
EGFR 4 10 18, 19, 20, 21
FGFR3 3 9 7, 9, 14
KRAS 3 22 2, 3, 4
NRAS 3 19 2, 3, 4
PTEN 3 3 5, 7
PIK3CA 2 14 11, 22
RET1 1 1 16
TP53 3 7 4, 6, 7
Total 25 105  

FEATURES AND BENEFITS

Supporting Research Use

  • Minimal sample input - 10μm section of FFPE tissue or 5 ng DNA per library
  • Automated and user-friendly data analysis and results reporting with Sentosa SQ Reporter

Providing Laboratory Efficiency

  • From clinical sample to result in 2 days
  • Reproducibility of 99.89% with detection of up to 5% variant frequency
  • Seamless sample traceability and IT connectivity with Sentosa Link

WORKFLOW

SPECIFICATIONS

AttributeValue
Sample Input 10 μm section of FFPE tissue (on glass slide or scroll)
Target Amplicons 25 targets and 1 control
Target Mutations 105
Min. Coverage / Target Mutation > 1,000 x
Analytical Sensitivity ≥ 5 ng DNA input; 5% variant frequency for mutation detection
Clinical Sensitivity 100% (95% CI: 95.07% to 100%)
Clinical Specificity 100% (95% CI: 95.42% to 100%)
Reproducibility ≥ 99.89% (95% CI: 99.82% to 99.93%)

ORDERING INFORMATION

ProductPack SizeItem Number
Sentosa SQ Thyroid Cancer Panel 4x8 tests 690035
Sentosa SX FFPE II gDNA Kit 4x8 tests 300231
Sentosa SQ 318 Chip Kit 8 runs 300301
Sentosa SQ Sequencing Kit 8 runs 690005
Sentosa ST Template Kit 8 runs 690007
Sentosa SX101 1 400089
Sentosa ST401 1 690027
Sentosa SQ301 (120 VAC) 1 690026

For availability in your country, please contact your Vela Diagnostics sales representative. Availability is subject to country's regulatory approval.