Υπουργείο Ανάπτυξης

Hellenic Accreditation System
Annex G1/11 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, Acquired
Cytogenetics 2013 and
Cytogenetic Investigations in
Tumours 2014)* with CytoVision
(Applied Imaging) or Lucia
Cytogenetics (LUCIA)*
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 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
GeneAmp PCR System 9700
(Applied Biosystems)* or TC-512
(Techne)*
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Annex G1/11 to the Certificate ESYD No. 350-4
21.07.2016
Tested materials/ products
2. Bone Marrow , Peripheral
Blood , Surgical Biopsy
Types of test/ Properties to be measured
Applied Standards/ Techniques to be
used
1. Rearrangements of genomic sequences PCR with the Invivoscribe kit* in the
IGH, TCR, IGH/BCL2
GeneAmp PCR System 9700
(Applied Biosystems) or TC-512
(Techne)
2. Quantitative measurement of
transcripts: BCR-ABL-p210, BCR-ABLp190, PML/RARa, ETV6(TEL)/
AML1(RUNX1 or CBFA2), WT1
Real-Time PCR with the Ipsogen kits
(BCR-ABL Mbcr, BCR-ABL mbcr,
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)
6. Peripheral Blood, Blood
plasma
1. Detection and quantitative
determination of viral Hepatitis B DNA
Real Time PCR with GeneProof HBV
CE-IVD* kit in RotorGene Q-5Plex
2. Detection and quantitative
determination of viral Hepatitis C RNA
Real Time RT-PCR with Artus HCV
RG RT-PCR CE-IVD* (QIAGEN) in
RotorGene Q-5Plex
7. Cell Suspension, Urine
1. Detection of DNA of Chlamydiaceae
spp
GeneSig Chlamydiaceae kit*in Light
Cycler 2.0 Roche and RotorGene Q5Plex
8. Peripheral Blood
1. Mutation detection of Factor V (VLeiden), Prothrombin (Factor IIG20210A), MTHFR (C677T) genes,
predisposing to thrombophilia
Vienna Labs FV-PTH- MTHFR CEIVD* in PCR GeneAmp 9700 (ABI)
or PCR TC-512 (Techne) and Auto
Lipa (Inna Genetics)
2. Mutation detection of ΒRCA 1 and
BRCA 2 genes (breast and/or ovarian
cancer predisposition)
Multiplicom BRCA MASTR-Dx CEIVD* in PCR GeneAmp 9700 (ABI)
or PCR TC-512 (Techne) and Next
Generation sequencer (NGS) MiSeq
(Illumina)
9. Peripheral Blood, Amniotic 1.Mutation detection of CFTR gene
fluid, Cell Suspension
(Cystic Fibrosis)
Page 2 of 3
Multiplicom CFTR MASTR-Dx CEIVD* in PCR GeneAmp 9700 (ABI)
or PCR TC-512 (Techne) and Next
Generation Sequencer (NGS) MiSeq
(Illumina)
Annex G1/11 to the Certificate ESYD No. 350-4
21.07.2016
Tested materials/ products
Types of test/ Properties to be measured
10. Surgical Biopsy, Paraffin- 1. Detection of somatic mutations of
embedded tissues (section),
KRAS, NRAS, BRAF, EGFR, ΚΙΤ and
Cell Suspension
PDGFRA genes
Applied Standards/ Techniques to be
used
Multiplicom SOMATIC 1 MASTR
Plus Dx CE-IVD kit*, EGFR 18-21
MASTR, GIST MASTR* in PCR
GeneAmp 9700 (ABI) or PCR TC512 (Techne) and Next Generation
Sequencer (NGS) MiSeq (Illumina)
Molecular Cytogenetics
1. Bone Marrow and
Peripheral Blood
2. Bone Marrow, Peripheral
Blood, Plasma Cells, Bone
Marrow Biopsy
3. Peripheral Blood, Bone
Marrow, Surgical Biopsy,
Plasma Cells, Bone Marrow
Biopsy, Formalin Fixed
Paraffin Embedded tissue
sections.
1. Detection of sex and autosomal
chromosome aneuploidies
Fluorescence in situ hybridization
with DNA probes of unique or
repetitive sequences (ECA General
1. Fusion genes/specific translocations
Guidelines and Quality Assurance for
[BCR-ABL, ETO(CBFA2T1)Cytogenetics 2012, Acquired
AML1(RUNX1 or CBFA2), IGHCCND1(BCL1), IGH-FGFR3(MMSET), Cytogenetics 2013 and Cytogenetic
IGH-C-MAF, IGH-MAF-B,IGH-BCL2, Investigations in Tumours 2014)* for
localization of nucleic acid sequences
API2/MALT1, COL1A1-PDGFB]
in interphase/metaphase cells with
1. Gene rearrangements/translocations
Vysis HYBrite (Abbott Diagnostics),
with variant partners [IGH, MLL, RARa, CytoVision (Applied Imaging) or
BCL6, EGFR1, FGFR1, CBFb, ALK,
Lucia Cytogenetics (LUCIA)*.
EWSR1, FKHR, CHOP, SYT,
ETV6(TEL), ROS1, RET,
FIP1+PDGFRA, PDGFRB, C-MYC]
2. Chromosome deletions/Gene losses
[1p/19q, 5/5q, 6/6q, 7/7q, 9/9p(p16),
11q(ATM), 13q, 17p(P53), 20q]
4. Surgical Biopsy, Formalin 1. Gene amplification [Her-2 neu
Fixed Paraffin Embedded
(ΕRΒΒ2), EGFR, FGFR1, MET, Ntissue sections, Bone Marrow, MYC, 1q21]
Plasma Cells
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
Site of assessment: Laboratory permanent premises: 3-5 Ilision str., GR-115 28, Athens, Greece.
Approved signatories: V. Alexiadis, S. Ventis, S. Samara, D. Tsakalia, A. Kouskouti, P. Konstantoulakis,
P. Pollakis, D. Iakovaki, E. Gourgouveli, G. Bardi.
This Scope of Accreditation replaces the previous one dated 10.07.2015.
The Accreditation Certificate No. 350-4, to ELOT EN ISO 15189:2012, is valid until 10.05.2019.
Athens, July 21, 2016
Ioannis Sitaras
Director of the Laboratories Accreditation Division
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Annex G1/11 to the Certificate ESYD No. 350-4
21.07.2016