Download ΕΘΝΙΚΟ ΣΥΣΤΗΜΑ ΔΙΑΠΙΣΤΕΥΣΗΣ

Hellenic Accreditation System
Annex G1/6 to the Certificate No. 776-4
SCOPE of ACCREDITATION
of the
Laboratory of Radiation Protection,
Health Physics, Radiobiology & Cytogenetics
of the
Institute of Nuclear & Radiological Sciences & Technology,
Energy & Safety
of
NCSR «Demokritos»
Materials / Products
tested
Types of test / Properties measured
Applied methods / Techniques used
Cytogenetics
1. Peripheral blood
1. Karyotype / detection of
congenital chromosomal
abnormalities (ΜΔ-01)
Karyotype analysis (ΜΔ-01, ΜΔ-02) based on «ECA
Cytogenetic Guidelines and Quality Assurance,
Version 1.2»:
2. Bone marrow,
Peripheral blood
1. Karyotype / detection of aquired
chromosomal abnormalities (ΜΔ02)
- Cell culturing
- GTG banding
- Microscopic analysis
- Karyotyping using Ikaros System (MetaSystems,
GmBH)*
Molecular Cytogenetics
1. Bone marrow,
Peripheral blood
1. Detection of sex and autosomal
chromosome aneuploids (ΜΔ-03)
2. Detection of fusion genes
[BCR-ABL, ETO-AML1,
PML-RARA, IGH-CCND1
(BCL1), IGH-BCL2, TEL-AML1,
FIPL1-PDGFRA] (ΜΔ-04)
3. Detection of gene
rearrangements [MLL, CBFΒ, IGH,
RARA, PDGFRB, EVI1, C-MYC]
(ΜΔ-05)
Pages 1 of 2
Fluorescence in situ hybridization (FISH) analysis
(ΜΔ-03, ΜΔ-04, ΜΔ-05, ΜΔ-06) based on «ECA
Cytogenetic Guidelines and Quality Assurance,
Version 1.1»
 Fluorescence in situ hybridization (FISH) with
DNA probes (Abbot Molecular, CE-IVD)*, using
the Vysis HYBrite System (Abbot Molecular, CE
Marked)* for the localisation of unique or
repetitive sequences on interphase and metaphase
cells.
 Fluorescence microscopy and imaging using the
Isis System (Metasystems, GmBH)*
Annex G1/6 to the Certificate ESYD No. 776-4
17.05.2016
Materials / Products
tested
Bone marrow,
Peripheral blood
(continued)
Types of test / Properties measured
Applied methods / Techniques used
4. Detection of chromosome / gene
losses [-5/del(5q),
-7/del(7q), 13q14.3/13q34,
-20/del(20q), 17p13.1 (TP53),
del (9p), 11q22.3 (ATM)] (ΜΔ-06)
Biodosimetry
1. Peripheral Blood
1. Absorbed dose and risk
estimation following accidental or
overexposure to ionizing radiation
by means of chromosomal
aberration analysis in lymphocytes
(ΜΔ-07)
Biodosimetry method (ΜΔ-07) based on the
International Atomic Energy Agency «Cytogenetic
Analysis for Radiation Doses Assessment: A
Manual», Technical Reports Series No 405, IAEA,
Vienna, 2001.
 Cell culturing
 Microscopic analysis
 Karyotyping using the Ikaros System
(MetaSystems, GmBH)*
*Commercial names of analyzers / products correspond to certain analytical method and work protocol.
Site of assessment: Laboratory Permanent premises, NCSR «Demokritos», 15341 Aghia Paraskevi,
Athens, Greece.
Approved signatories: G. Pantelias, C. Sambani, G. Terzoudi, K. Manola.
This scope of Accreditation replaces the previous one dated 26.04.2016.
The Accreditation Certificate No. 776-4, to ELOT EN ISO 15189:2012, is valid until 04.12.2019.
Athens, May 17, 2016
Ioannis Sitaras
Director of the Laboratories Accreditation Division
Pages 2 of 2
Annex G1/6 to the Certificate ESYD No. 776-4
17.05.2016