Hellenic Accreditation System

Annex G1/3 to the Certificate No. 990-2
SCOPE of ACCREDITATION
of the
Clinical Laboratory
of
“EUROGENETICA Μ.S.A”
Materials/Products tested / Types of test/Properties measured / Applied methods/Techniques used /
Μοριακή Γενετική
1. Peripheral blood, Amniotic Fluid, Chorionic Villi /
1. Detection of 32 mutations of the CFTR (cystic fibrosis transmembrane conductance regulator) gene
/ Manufacturer’s kit Cystic Fibrosis Genotyping Assay (Abbott Molecular)* by Multiplex-PCR and OLA, in the PCR Biorad DNA Engine followed by fragment analysis on ABI 3100 Genetic Analyzer (Applied Biosystems) *
2. Detection and identification of mutations by scanning of exons 3, 4, 7, 10, 11, 13, 14b, 17b, 19, 20, 21 (legacy names) of the CFTR (cystic fibrosis transmembrane conductance regulator) gene /
In house method (Protocol P.01)
1. Scanning of exons with DGGE method after PCR in the PCR Biorad DNA Engine*
If an unknown variant is detected by DGGE, DNA sequencing is performed on ABI 3100 Genetic Analyzer (Applied Biosystems) *
2.Peripheral blood, Amniotic Fluid, Chorionic Villi, Product of Conception and samples of abortuses /
1. Rapid aneuploidy detection for chromosomes 13, 18, 21, X, Y and detection of the ΔF508 mutation of the CFTR gene
/
In house method (Protocol P.02) by QF-PCR using the PCR Biorad DNA Engine and fragment analysis on ABI 3100 Genetic Analyser (Applied Biosystems) *
Cytogenetics
1. Peripheral Blood / 1. Chromosomal analysis and karyotyping /Detection of chromosomal abnormalities / In-house methods (Π.03, Π.04) Cell culturing, cell collection (harvest), chromosome preparation and banding, karyotyping (Chromosome analysis).
2. Amniotic fluid
3. Chorionic villi (CV)
4. Products of conception

* Commercial names mentioned are reffering to specific analytical method and laboratory work protocol.

Site of assessment: Permanent laboratory premises, Andrianoupoleos 7, 55133 Kalamaria, Thessaloniki

Approved signatories: Papadakis M, Vittas S, Oikonomidou E, Efstathiou G, Darmani E, Malamaki C, Tsezou A.

This Scope of Accreditation replaces the previous one dated 01.03.2016

The Accreditation Certificate No. 990-2, to ELOT EN ISO 15189:2012, is valid until 14.07.2019.

Athens, June 24th, 2016

Ioannis Sitaras

Director of the Laboratories Accreditation Division

Page 1 of 2 Annex G1/3 to the Certificate ESYD No 990-2 24.06.2016