Hellenic Accreditation System
Annex G1/5 to the Certificate No.715-2
SCOPE of ACCREDITATION
of the
Clinical Laboratory
of
“ΑΛΦΑ LAB” private diagnostic laboratory, Medical S.A.
Tested materials/ products
Types of test/ Properties to be
measured
Applied Standards/ Techniques to be
used
Cytogenetics
1. Bone Marrow , Peripheral
Blood , Lymphatic tissue
1. Karyotype /Detection of acquired
chromosome abnormalities
2. Peripheral Blood
1. Karyotype /Detection of
chromosome abnormalities
3. Amniotic fluid
4. Chorion villus sample
(CVS)
In-house methods (Π.Κ.01, Π.Κ.02,
Π.Κ.03, Π.Κ.04, Π.Κ.05) Cells
culturing, cell collection (harvest) and
karyotyping (Chromosome analysis)
based on ACC and ECA Cytogenetic
Guidelines and Quality Assurance, 2005
and ISCN, 2009
5. Products of conception and
samples of abortuses
Molecular Genetics
1. Amniotic fluid, Chorion
1. QF PCR and detection of F508del
villus sample (CVS), Products mutation of the cystic fibrosis gene
of conception and samples of
abortuses
In-house method (Π.M.04) Polymerase
Chain Reaction (PCR) (MJReasearch)
with the use of STRs on specific sites of
chromosomes 13, 18, 21, Χ and Υ.
Fragment analysis in genetic analyser
ABI 3130XL and quantitative estimate
of the PCR products with the use of
analysis program GeneMapper ID
2. Peripheral Blood, Amniotic 1. Detection of 36 mutations of the
fluid, Chorion villus sample
cystic fibrosis gene (CFTR)
(CVS)
INNO-LiPA CFTR19 and INNO-LiPA
CFTR17 INNOGENETICS*
Polymerase Chain Reaction (PCR) and
reverse dot blot (MJ Research)
3. Peripheral Blood
In-house method (Π.Μ.22) DNA
Sequencing with the use of Big Dye
Terminator kit v.1.1 (ABI) and analysis
of the results in genetic analyser ABI
3130XL
Page 1 of 3
1.Mutation detection in Breast Cancer
susceptibility gene 1 and 2 (BRCA1 &
BRCA2) (full coding sequence, splice
sites and flanking intronic sequences)
Annex G1/5 to the Certificate ESYD No. 715-2
26.11.2014
Tested materials/ products
4. Paraffin-embedded tissues
Types of test/ Properties to be
measured
1.Mutation detection in KRAS gene
(exons 1,2)
2. Mutation detection in NRAS gene
(exons 2,3,4)
3.Mutation detection in BRAF gene
(exons 11,15)
4. Mutation detection in EGFR gene
(exons 18,19,20,21)
Applied Standards/ Techniques to be
used
In-house method (Π.Μ.11) DNA
Sequencing with the use of Big Dye
Terminator kit v.1.1 (ABI) and analysis
of the results in genetic analyser ABI
3130XL
In-house method (Π.Μ.26) DNA
Sequencing with the use of Big Dye
Terminator kit v.1.1 (ABI) and analysis
of the results in genetic analyser ABI
3130XL
In-house method (Π.Μ.27) DNA
Sequencing with the use of Big Dye
Terminator kit v.1.1 (ABI) and analysis
of the results in genetic analyser ABI
3130XL
In-house method (Π.Μ.18) DNA
Sequencing with the use of Big Dye
Terminator kit v.1.1 (ABI) and analysis
of the results in genetic analyser ABI
3130XL
Molecular microbiology
1. Paraffin-embedded tissues,
tissue sample from biopsy,
cellular swab
Detection and genotyping of Human
Papilloma Virus (HPV)- 28 genotypes
(6, 11, 16, 18, 26, 31, 33, 35, 39, 40,
43, 44, 45, 51, 52, 53, 54, 56, 58, 59,
66, 68, 69/ 71, 70, 73, 74, 82)
PCR and Reverse dot blot hybridization
with the manufacturer’s kit INNO-LiPA
HPV Genotyping Extra,
INNOGENETICS*. Use of RFLP
method (restriction fragment length
polymorphism).
Molecular Cytogenetics
1. Bone marrow, Peripheral
Blood, Paraffin-embedded
tissues (section), surgical
biopsy
Florescent In Situ Hybridization
(FISH), with DNA probes for the
detection of:
1. Chromosome aneuploidies
In-house method (Π.K.10) In Situ
Hybridization with DNA probes for
specific or repeated sequences
2. Fusion genes (BCR-ABL, ETOAML1, TEL-AML1, PML-RARA,
IgH-CCND1, IgH-FGFR3, IgHBCL2, IgH-MAF, CBFβ/MYH11,
FIP1L1/ PDGFRA)
3. Gene rearrangements (IgH, MLL,
AML1, PDGFRB, TCRa/d, ALK, cMYC, IGL, IGK)
4. Chromosome / Gene deletions
(5/5q, 7/7q, P16(9p21),
D13S319(13q14.3), 13q34,
P53(17p13.1), ATM(11q22.3),
MYB(6q23), 1p36)
5. Gene amplifications (1q21)
* Reference to the commercial name of a specific kit, refers to a specific analytical method and protocol
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Annex G1/5 to the Certificate ESYD No. 715-2
26.11.2014
Site of assessment: Laboratory permanent premises: 11 Anastasiou str., GR-115 24, Athens, Greece.
Approved signatories: L. Florentin, P. Velissariou, F. Sachinidi, C. Bili, A. Hatzaki, E. Gali,
Th. Varvouni, A. Maravelaki, E. Panou, E. Manisali, J. Donoghue-Nadali, M. Karkaletsi,
S. Christopoulou, P. Pitta, C. Gouedard, A. Katseli.
This Scope of Accreditation replaces the previous one dated 10.07.2014.
The Accreditation Certificate No.715-2, to ELOT EN ISO 15189:2007, is valid until 08.11.2018.
Athens, November 26, 2014
Ioannis Sitaras
Director of the Laboratories Accreditation Division
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Annex G1/5 to the Certificate ESYD No. 715-2
26.11.2014