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

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Tootekood A0020/6

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For professional/laboratory use only.

The Idylla™ KRAS Mutation Test, performed on the Biocartis Idylla™ system, is an in vitro diagnostic Test for the qualitative detection of 21 mutations in codons 12, 13, 59, 61, 117 and 146 of the KRAS gene. The Idylla™ KRAS 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 KRAS Mutation Test covers 21 KRAS mutations in exons 2,3 and 4 showing an excellent concordance to reference methods of >95%. Comparison with various other KRAS detecting technologies revealed a superior performance of the IdyllaTM KRAS Mutation Test in terms of ease of use, turnaround time, and hands-on time while demonstrating superior levels of sensitivity.

· 21 KRAS mutations in exons 2, 3 and 4
· 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 all KRAS mutations

Total turnaround time

120 minutes

Dokumendid

Idylla_KRAS-IVD_Tech-Sheet.pdf

Idylla KRAS IVD Technical Sheet

EN | 145,928 KB

Download

Specimen_Req.pdf

Specimen Requirements

EN | 115,054 KB

Download

Idylla-Brochure_2024-10-10-153145_qozz.pdf

EN | 3,128 MB

Download

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