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Mimix™ Quantitative Multiplex, FFPE Reference Standard IVD

Mimix™ Quantitative Multiplex FFPE Reference Standard is a highly characterized, biologically-relevant quality control material used to assess the performance of NGS and PCR assays that detect somatic mutations.

For In Vitro Diagnostic use. This product is only available where licensed in accordance with law. Please contact your local representative for availability.

Mimix quantitative multiplex control is a cell line-derived pan-cancer reference standard, featuring 11 variants across 6 key cancer genes. These variants range from 0.9-24.5% allelic frequency (AF), to aid in the limit of detection (LOD) determination of your assay. Each batch of Mimix quantitative multiplex controls include 11 variants confirmed by ddPCR, along with a batch-specific whole exome sequencing (WES) variant allelic frequency (VAF) file at 500x coverage performed by Revvity Omics using the Agilent CREV3 kit on an Illumina or Aviti platform. This provides an accurate and reliable truth set for monitoring your workflow and assay's performance.

 

Technical Product Information

Format: FFPE

Fixation method: 4% PFA

Section size: 15µm

Cell density: 3 x 108 cells per block. Approx. 3.5 x 105 cells per section

Expected DNA yield: > 400 ng

Genes covered: BRAF, KIT, EGFR, KRAS, NRAS, PIK3CA

Allelic frequencies: 0.9-24.5%

 

Chromosome Gene Variant Expected Allelic Frequency, %

7q34

BRAF

V600E

10.70%

4q11-q12

cKIT

D816V

10.00%

7p12

EGFR

ΔE746 - A750

1.90%

7p12

EGFR

L858R

2.80%

7p12

EGFR

T790M

0.90%

7p12

EGFR

G719S

24.50%

12p12.1

KRAS

G13D

15.00%

12p12.1

KRAS

G12D

6.30%

1p13.2

NRAS

Q61K

12.50%

3q26.3

PIK3CA

H1047R

17.50%

3q26.3

PIK3CA

E545K

8.80%

 

General information

Storage: 4°C

Shipping: Ambient

Expiration: See all product shelf life information

Intended Use:
The Mimix™ quantitative multiplex FFPE reference standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from human cancer cell lines, containing 11 variants across 6 cancer genes. It is intended for qualitative and/or quantitative monitoring next-generation sequencing (NGS) or droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations in genomic DNA (gDNA) from human samples for in vitro diagnostic use.

The gDNA obtained from the Mimix quantitative multiplex FFPE reference standard can be used to monitor NGS or ddPCR workflow, test performance, assay variation, and helps identify increases in random or systematic errors. This product is for professional laboratory use only.

 

Quality control

Allelic frequency: Droplet Digital™ PCR

Quantification: Quantifluor™

DNA Integrity: Agarose gel electrophoresis