Hellenic Accreditation System
Annex G1/2 to the Certificate No. 973 SCOPE of ACCREDITATION of the Clinical Laboratory of KARYO Ltd
Materials/Products tested Types of test/Properties measured Applied methods/Techniques used
Molecular Genetics
1. Sections from formalin- 1. Qualitative detection and identification of Multiplex PCR with the fixed paraffin-embedded mutations in exons 18, 19, 20 and 21 of the COBAS EGFR Mutation Test (FFPET) human non-small epidermal growth factor receptor (EGFR) gene CE-IVD kit* (Roche cell lung cancer (NSCLC) Diagnostics GmbH) using the tumor tissue Real Time PCR instrument COBAS z 480 Roche* 2. Sections from formalin- 1. Qualitative detection of the BRAF V600 Real Time PCR with the fixed paraffin-embedded (T1799A) mutations COBAS BRAF V600 Mutation (FFPET) human Test CE-IVD kit* (Roche melanoma tissue Diagnostics GmbH) using the Real Time PCR instrument COBAS z 480 Roche* 3. Sections from formalin- 1. Qualitative detection of mutations in exon 2 of HRM-PCR and LightMix kit fixed paraffin-embedded the Kras gene with HRM-PCR, retesting and 12/13 with use of LightCycler (FFPET) human tissue confirmation of the mutated samples with the 480 II instrument. Multiplex Lightmix kit 12/13 TIB MolBiol. Real Time PCR for the rest of the exons with use of the Cobas 2. Qualitative detection and identification of z 480 instrument mutations in exons 3,4 of the Kras gene with the LightMix kit TIB MolBiol.
4. Sections from formalin- 1.Qualitative detection of mutations in exons 2.3.4 Multiplex PCR with use of the fixed paraffin-embedded of the Nras gene with the LightMix kit TIB MolBiol Real Time PCR instrument (FFPET) human tissue Cobas z 480
5. Sections from formalin- 1.Detection of DNA Microsatellite Instability (MSI) PCR with use of the Real Time fixed paraffin-embedded from FFPET with HRM PCR instrument Cobas z 480 (FFPET) human tissue and peripheral blood
Page 1 of 2 Annex G1/2 to the Certificate ESYD No. 973 03.07.2017 Materials/Products tested Types of test/Properties measured Applied methods/Techniques used 6. Peripheral blood 1.Molecular genetic testing of mutations: (G1691A) PCR for detection of mutations FV gene & (G20210A) FII gene in FV, FII genes using T100 Biorad thermocycler and analyzing pcr products in agarose gel 7. Peripheral blood 1.Molecular genetic testing of the polymorphisms HRM-PCR with use of the C677T and A1298C of the MTHFR gene using Lightcycler 480 II instrument HRM-PCR
8. Peripheral blood 1.Molecular genetic testing of the polymorphism Real time PCR with use of the 4G/5G of the PAI-1 gene with the Light Mix Kit Lightcycler 480 II instrument
Cytogenetics
1. Bone Marrow, 1.Karyotyping / detection of acquired chromosomal Cell Culture peripheral blood abnormalities GTG banding Microscopic analysis Karyotyping (Q- capture Imaging system, VideoTest Karyo 3.1 analysis of karyotype)
* Reference to the commercial name of a specific analyzer/ kit, refers to a specific analytical method and protocol.
Site of assessment : Permanent laboratory premises, 51 Ermou srt., GR-54623, Thessaloniki, Greece. Approved signatories: Th. Papadopoulos, G. Timologos, K. Tara.
This Scope of Accreditation replaces the previous one dated 02.04.2015. The Accreditation Certificate No. 973, to ELOT EN ISO 15189:2012, is valid until 01.04.2019.
Athens, July 03, 2017
Ioannis Sitaras Director of the Laboratories Accreditation Division
Page 2 of 2 Annex G1/2 to the Certificate ESYD No. 973 03.07.2017