Hellenic Accreditation System
Annex G1/10 to the Certificate No. 350-4
SCOPE of ACCREDITATION
of the
Clinical Laboratory
of
"BioAnalytica-GenoΤype"
Private Diagnostic Laboratory for Molecular and Cytogenetic Analysis M. S.A.
Tested materials/ products
Types of test/ Properties to be measured
Applied Standards/ Techniques to be
used
Cytogenetics
1. Peripheral Blood
1. Karyotype /Detection of congenital
chromosome abnormalities
2. Bone Marrow, Peripheral
Blood , Surgical Biopsy
1. Karyotype /Detection of acquired
chromosome abnormalities
Cell Cultures, Karyotyping/
Chromosome analysis (ECA General
Guidelines and Quality Assurance
for Cytogenetics 2012, for Acquired
Cytogenetics, 2013 και for
Cytogenetic Investigations in
Tumours, 2014)* with CytoVision
(Applied Imaging)
Molecular Genetics
1. Bone Marrow and
Peripheral Blood
1. Detection of fusion gene transcripts:
BCR/ABL, PML/RaRa
Nested RT-PCR with the Invivoscribe
kit* in the GeneAmp PCR System 9700
(Applied Biosystems)* or TC-512
(Techne)*
2. Detection of point mutation V617F in
JAK 2 gene
In house Amplification Refractory
Mutation System (ARMS-PCR) in the
GeneAmp PCR System 9700 (Applied
Biosystems)* or TC-512 (Techne)*
3. Detection of ITD and D835 mutations PCR and restriction endonuclease
in FLT3 gene
digestion with the Invivoscribe kit* in
the GeneAmp PCR System 9700
(Applied Biosystems)* or TC-512
(Techne)*
2. Bone Marrow , Peripheral
Page 1 of 2
1. Rearrangements of genomic sequences PCR with the Invivoscribe kit* in the
Annex G1/10 to the Certificate ESYD No. 350-4
10.07.2015
Tested materials/ products
Blood , Surgical Biopsy
Types of test/ Properties to be measured
IgH, TCR, IgH/BCL2
Applied Standards/ Techniques to be
used
GeneAmp PCR System 9700 (Applied
Biosystems) or TC-512 (Techne)
2. Quantitative measurement of
Real-Time PCR with the Ipsogen kits
transcripts: BCR-ABL-p210, BCR-ABL- (BCR-ABL Mbcr, BCR-ABL mbcr,
p190, PML/RaRa, TEL-AML1, WT1
PML/RaRa, TEL-AML1,
WT1FusionQuant Kits)* in the Light
Cycler 2.0 (Roche) and Rotorgene
3. PCR products, plasmids
1. DNA Sequencing
Dye terminator cycle sequencing with
the CEQ 8000 Genetic Analyzer
(Beckman Coulter)*
4. Paraffin-embedded tissues
(section), Surgical Biopsy
1. Mutation detection G719S/C/A (exon DNA Pyrosequencing with QIAGEN
18), Gene deletions (exon 19), T790M & kits* in PyroMark Q24 (QIAGEN)
S768I (exon 20), L858R & L861Q/R
(exon 21) in EGFR gene and in codons
12 and 13 (exon 2) of K-RAS and ΝRAS genes
5. Surgical Biopsy,
Cervicovaginal smears
1. Human papillomas virus (HPV)
detection and genotyping [49 types: 6,
11, 16, 18, 26, 31, 33, 34, 35, 39, 40, 42,
43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61,
62, 64, 66, 67, 68, 69, 70, 71, 72, 73, 74,
81, 82, 83, 84, 85, 86, 87, 89, 97, 101,
102, 103, 106, 150, 151]
PCR, hybridisation and DNA
microarrays with Genomica kit* in PCR
GeneAmp 9700 (ABI) or PCR TC-512
(Techne), Themomixer (Eppendorf) and
Clinical Array Reader (Genomica)
Molecular Cytogenetics
1. Bone Marrow and
Peripheral Blood
1. Detection of sex and autosomal
chromosome aneuploidies
2. Bone Marrow, Peripheral
Blood, Plasma Cells, Bone
Marrow Biopsy
1. Fusion genes/specific translocations
[BCR-ABL, ETO(CBFA2T1)AML1(RUNX1 or CBFA2), IgHCCND1(BCL1), IgH-FGFR3(MMSET),
IgH-c-maf, IgH-BCL2, API2/MALT1]
3. Peripheral Blood, Bone
Marrow, Surgical Biopsy,
Plasma Cells, Bone Marrow
Biopsy, Formalin Fixed
Paraffin Embedded tissue
sections.
1. Gene rearrangements/translocations
with variant partners [IgH, MLL, RARa,
CBFb, ALK, EWSR1, FKHR, CHOP,
SYT, ETV6(TEL), FIP1+PDGFRA, CMYC]
Fluorescence in situ hybridization with
DNA probes of unique or repetitive
sequences (ECA General Guidelines
and Quality Assurance for
Cytogenetics 2012, for Acquired
Cytogenetics 2013 και for
Cytogenetic Investigations in
Tumours 2014)* for localization of
nucleic acid sequences in
interphase/metaphase cells with the
CytoVision (Applied Imaging)* and the
Vysis HYBrite (Abbott Diagnostics)*
2. Chromosome deletions/Gene losses
[5/5q, 7/7q, 13q14.3, 13q14.3/13q34,
20q12, P53]
4. Surgical Biopsy, Formalin 1. Gene amplification [Her-2 neu
Fixed Paraffin Embedded
(ΕRΒΒ2), EGFR, N-MYC, 1q21
tissue sections, Bone Marrow
5. Urine
1. Aneuploidies of chromosomes 3, 7,17
and deletion of 9p21
*Reference to the commercial name of a specific analyzer/kit, refers to a specific analytical method and protocol
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Annex G1/10 to the Certificate ESYD No. 350-4
10.07.2015
Site of assessment: Laboratory permanent premises: 3-5 Ilision str., GR-115 28, Athens, Greece.
Approved signatories: V. Alexiadis, S. Ventis, E. Gourgouveli, D. Iakovaki, Ζ . Kosmaidou – Aravidou,
P. Konstantoulakis, T. Tranga, G. Bardi.
This Scope of Accreditation replaces the previous one dated 21.04.2015.
The Accreditation Certificate No. 350-4, to ELOT EN ISO 15189:2012, is valid until 10.05.2019.
Athens, July 10, 2015
Ioannis Sitaras
Director of the Laboratories Accreditation Division
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Annex G1/10 to the Certificate ESYD No. 350-4
10.07.2015