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Biocartis Idylla™ NRAS-BRAF Mutation test pack (6 tests/pack), CE-IVD

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Tootekood A0030/6

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For professional/laboratory use only.

The Idylla™ NRAS-BRAF Mutation Test, performed on the Biocartis Idylla™ system, is an in vitro diagnostic Test for the qualitative detection of 18 mutations in codons 12, 13, 59, 61, 117, 146 of the NRAS gene and 5 mutations in codon 600 of the BRAF gene.

The Idylla™ NRAS-BRAF Mutation Test, from sample-to-result, starts with formalin-fixed paraffin-embedded (FFPE) human tissue from metastatic colorectal cancers to liberate DNA for subsequent real-time PCR amplification and detection. The fully automated IdyllaTM NRAS-BRAF Mutation Test covers 18 mutations in NRAS exons 2,3 and 4 as well as 5 mutations in BRAF codon 600 showing an excellent concordance to reference methods of >99%.

· 18 mutations in NRAS exons 2, 3 and 4 & 5 mutations in BRAF codon 600
· 120 minutes assay turnaround time
· <2 minutes hands-on time
· Only 1 slice of FFPE tissue required
· Highly sensitive & standardized
· Suitable for any lab

Spetsifikatsioonid

Spetsifikatsioonid
Pack Size

6 tests/pack

Sample Type

FFPE tissue sections (5 to 10 µm)

Tissue Area

50-600 mm² (5 µm) 25-300 mm² (10 µm)

Analytical sensitivity

LOD < 5% for most prevalent NRAS and BRAF mutations

Total turnaround time

120 minutes

Dokumendid

Idylla_NRAS-BRAF-IVD_Tech-Sheet.pdf

Idylla NRAS-BRAF IVD Technical Sheet

EN | 135,097 KB

Download

Specimen_Req.pdf

Specimen Requirements

EN | 115,054 KB

Download

Idylla-Brochure.pdf

Idylla Oncology Brochure

EN | 3,128 MB

Download

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