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EC CERTIFICATE

EC Declaration of Conformity Annex (List B)

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CERTIFICATE ISO 13485

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AmpliSens
AmpliSens Pyroscreen BRCA-screen
Cat.: PMQ-005-50-F-CE
Name: AmpliSens Pyroscreen BRCA-screen
Number of tests: 55
Detection Method: Pyrosequencing
Packaging arrangement (PA): Kit with reagents only for amplification step
Content: All reagents are in individual vials (no PCR-tubes)
Shelf life: 9 months

AmpliSens Pyroscreen BRCA-screen kit Instruction Manual (version 26.02.2018, update: )


AmpliSens Pyroscreen BRCA-screen kit is an in vitro nucleic acid amplification test based on pyrosequencing technology for genotyping the single-nucleotide mutations.

AmpliSens Pyroscreen BRCA-screen kit is intended for the detection of mutations in BRCA1 and BRCA2 genes associated with higher risk of breast and/or ovarian cancer.

Mutations for analysis

Locus

Product

Mutation

rs

Sequence to Analyze

Analysis

Risk allele

BRCA1

Breast cancer gene 1

185delAG

rs80357713

T[CT]AAGATTTTCTGC

reverse

delAG

BRCA1

Breast cancer gene 1

300T>G (C61G)

rs28897672

T/GGTCCTTTATGTA

forward

G

BRCA1

Breast cancer gene 1

2080delA

rs80357522

[T]CTTTATCTCT

reverse

delA

BRCA1

Breast cancer gene 1

4153delA

rs80357711

GA[A]GAAAGAGGA

forward

delA

BRCA1

Breast cancer gene 1

5382insC

rs80357906

[G]ATTCTCTTG

reverse

insC

BRCA2

Breast cancer gene 2

6174delT

rs80359550

[A]CTTGCTGTG

reverse

delT


Recommended extraction kits:RIBO-prep(K2-9-Et-100-CE),DNA-sorb-B(K1-2-100-CE). It is possible to use other nucleic acid extraction protocols.

Nesessary reagent kit for sample preparationPEERO-prep(K15-1611-40-CE).

NOTICE: This kit is compatible only with PyroMark Gold Q24 or PyroMark Gold Q96 MD instrument (QIAGEN, Germany).


 
Attention!!! Number of tests includes controls and calibrators (for quantitative tests).

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