TERT Promoter Mutation Detection Kit

[REF] UBP-T01348G

[Packing specification] 48Tests/Kit

[Intended use]

UltraDx TERT Promoter Mutation Detection Kit (Real-time PCR) is used to qualitatively detect two mutations in the TERT gene promoter region (1 295 228C> T and 1 295 250 C> T) in neutral formaldehyde-fixed, paraffin-embedded glioma tissue samples from glioma patients, providing a reference for pathological typing of glioma patients.


Glioma is a general term for neuroepithelial tumors with neuroepidermal features of glial cell phenotypes, and is the most common primary intracranial tumor, accounting for 27% of all primary CNS tumors and 80% of CNS malignancies.” WHO central nervous system tumor classification (blue book)” plays an important role in the diagnosis and treatment of glioma, for classification and classification system of 2016 revised blue book subversive changed the traditional glioma classification method, and for the first time to molecular classification as the core basis of tumor classification, genotype increased the accuracy of diagnosis.

Telomerase (telomerase) is a ribonucleoprotein complex composed of RNA and proteins. It belongs to reverse transcriptase and is closely related to the regulation mechanism of telomeres, and plays a key role in maintaining cell immortalization and carcinogenesis.

Telomerase reverse Transcriptase (TERT) is the catalytic center of the telomerase complex.The TERT gene is located in human chromosome 5pl5.33, and the promoter region in glioma contains two mutations: 1 295 228C> T and 1 295 250 C> T (called C228T and C250T, respectively, occurring independently of each other, its one mutation was tested positive, the sample is TERT mutant). It has been demonstrated to enhance the TERT promoter transcriptional activity. TERT promoter region mutations (hereinafter referred to as TERT mutations) mainly show genetic changes specific to ma lignant somatic cells, with characteristic telomeres in a variety of tumors led by gliomas, which is the key cause of the occurrence and development of tumors.

The test results provided in this kit are only used for auxiliary clinical diagnosis, and the prognostic judgment function has not been verified in clinical research and cannot be used as the sole basis for disease diagnosis; the determination or modification requires the clinical history, drug indications , Treatment response, pathological diagnosis and disease progression.

[Test Principles]

UltraDx TERT Promoter Mutation Detection Kit is based on amplification-refractory mutation system (ARMS) technology and Taqman probe. ARMS is a reliable method for detecting any mutation involving single base changes or small deletions, which is based on the use of sequence-specific PCR primers that allow amplification of test DNA only when the target allele is contained within the sample and will not amplify the no ntarget allele. The product of PCR is detected by fluorescent probes labeled with FAM.

UltraDx TERT Promoter Mutation Detection Kit contains internal control genes for measuring the quality of sample DNA, and Uracil-DNA Glycosylase (UDG) for preventing PCR amplification carryover contamination.

  • High sensitivity: Accurate detection of mutations as low as 10 copies/uL.
  • Strong Specificity: The specificity can be reached 99.5% by using PCR technology.
  • Easy operation: results in 90 mins.
  • Reliable: Internal and External controls are included.
[Acceptable Specimens]

Applicable sample type: FFPE tumor tissue


[Applicable Equipment]

Applied Biosystems™ Real time PCR system 7500, ABI QuantStudio™5 Real-time PCR system, LightCycler® 480 PCR system, Bio-Rad CFX96 real-time PCR instrument. Ultrassay eQ9600 Real Time qPCR System etc.