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

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SKU A0010/6

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For professional/laboratory use only.

The fully automated IdyllaTM BRAF Mutation Test covers BRAF V600E, E2, D, K, R and M mutation with a sensitivity of 1% of mutant in wild type background in FFPE samples with an excellent concordance to reference methods of >95%.

The Idylla™ BRAF Mutation Test, performed on the Biocartis Idylla™ System, is an in vitro diagnostic Test for the qualitative detection of V600E/E2/D and V600K/R/M mutations in codon 600 of the BRAF gene. The Idylla™ BRAF Mutation Test, from sample-to-result, starts with formalin-fixed paraffin-embedded (FFPE) human tissue from metastatic melanoma to liberate DNA for subsequent real-time PCR amplification and detection.

· 7 BRAF mutations in codon 600
· 90 minutes assay turnaround time
· <2 minutes hands-on time
· Only 1 slice of FFPE tissue required
· Highly sensitive & standardized
· Suitable for any lab

Specifications

Specifications
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

1% mutant in wild type background

Total turnaround time

90 minutes

Documents

Idylla_BRAF-IVD_Tech-Sheet.pdf

Technical Sheet

EN | 119.807 KB

Download

Specimen_Req.pdf

Idylla Specimen Requirements Sheet

EN | 115.054 KB

Download

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