- Qualitative analysis designed to identify by massive sequencing point mutations and small insertions and deletions in the coding regions, splicing, promoter region [5’UTR] of the TP53, as well as in the non-coding regions present in exon 1 and 2 .
- This assay does not allow detection of large deletions and/or insertions.
- Optimized for the detection of germline and somatic variants in DNA from both peripheral blood and tumor tissue.
- Target regions with 500X – 1000X coverage.
- Sensitivity and specificity > 99.9%.
- Detection limit 2.5%
- It complies with the quality requirements specified by ISO 13485 and ISO 14001 in relation to the materials used in its manufacturing process.
- For in vitro diagnostic use.
Due to the high frequency with which mutated TP53 appears in different tumors, TP53 OncoKitDx is optimized to detect germline and somatic mutations in DNA from both peripheral blood and tumor tissue. All this through multiplexed PCRs and subsequent sequencing with NGS platforms, high-throughput massive sequencing technology.
|Compatible sequencers||Illumina iSeq, Illumina MiSeq, Illumina NextSeq500, Illumina NextSeq2000, Illumina HiSeq, Illumina NovaSeq|
|Amount of DNA needed||40 ng of gDNA|
|Type of sample||DNA from peripheral blood, paraffin-embedded tissues, fresh or frozen tissue|
|Optimal readings per sample||≥20,000 PF clusters|
|Number of samples per run||Illumina Miseq Micro (300 cycles): 48
Illumina Miseq V2 (300 cycles): 160
|sequencing||Paired-end (2 x 150 cycles)|
|manual work time||1 hour|