Hellenic Accreditation System
Annex G1/Α2 to the Certificate No. 913
SCOPE of ACCREDITATION
of the
Microbiology Department
of the
Laboratories Division
of
“Sotiria” Chest Diseases General Hospital of Athens
Tested materials/ products
Types of test/ Properties to be
measured
Applied Standards/ Techniques to be used
Molecular Microbiological Tests
Direct testing to: Sputum,
Bronchial Secretions and
Washings, Brushings, Urine,
Body Fluids (Gastric, Pleural,
Ascetic, Synovial, Pericardial,
Biopsies etc.) and Wound
Specimens
1. Direct qualitative detection
and identification of
Mycobacterium tuberculosis
complex rRNA
TMA-HPA method with manufacturer’s
kit Amplified MTD (GenProbe)*
Direct testing to: Sputum,
Bronchial Secretions and
Washings, Brushings, Urine,
Body Fluids (Gastric, Pleural,
Ascetic, Cerebrospinal,
Synovial, Pericardial, Biopsies
etc.) and Wound Specimens
2. Direct qualitative detection
of Mycobacterium tuberculosis
complex DNA and detection of
rifampicin resistance
Real-time PCR method with
manufacturer’s kit Gene Xpert MTB/RIF
(Cepheid)*
- Direct testing to: Sputum,
Bronchial Secretions and
Washings, Brushings, Urine,
Body Fluids (Gastric, Pleural,
Ascetic, Cerebrospinal,
Synovial, Pericardial, Biopsies
etc.) and Wound Specimens
3. Mycobacterium tuberculosis
complex DNA identification
and detection of resistance to
rifampicin and isoniazid
Qualitative Multiplex-PCR and strip
reverse hybridization method with
manufacturer’s kit Genotype MTBDRplus
v.2 (Hain Lifescience)*
- Mycobacterium tuberculosis
complex cultures
Page 1 of 4
Annexes G1/A2 and B2 to the Certificate ESYD No. 913
17.11.2014
Tested materials/ products
Types of test/ Properties to be
measured
Applied Standards/ Techniques to be used
- Direct testing to: Sputum,
Bronchial Secretions and
Washings, Brushings, Urine,
Body Fluids (Gastric, Pleural,
Ascetic, Cerebrospinal,
Synovial, Pericardial, Biopsies
etc.) and Wound Specimens
4. Mycobacterium tuberculosis
complex DNA identification
and detection of resistance to
reserve drugs(
Fluoroquinolones, Ethambutol
and injectables [Amikacin,
Caperomycin, Kanamycin])
Qualitative Multiplex-PCR and strip
reverse hybridization method with
manufacturer’s kit for the identification of
Mycobacterium tuberculosis complex
Genotype MTBDRsl (Hain Lifescience)*
Mycobacterium tuberculosis
complex cultures
5. Identification of
Mycobacterium tuberculosis
complex sub-species DNA (Μ.
tuberculosis / canettii, M.
africanum, M. microti, M.
bovis ssp. bovis,BCG, M. bovis
ssp. caprae)
Qualitative Multiplex-PCR and strip
reverse hybridization method with
manufacturer’s kit Genotype MTBC (Hain
Lifescience)*
Non-tuberculous Mycobacteria
cultures
6. Non-tuberculous
Mycobacteria Species DNA
Identification (CM: common
species, AS: additional
species)
Qualitative Multiplex-PCR and strip
reverse hybridization method with
manufacturer’s kit Genotype CM/AS
(Hain Lifescience)*
- Mycobacterium tuberculosis
complex cultures
*Reference to the commercial name of a specific analyzer/kit, refers to a specific analytical method and protocol
Site of assessment: Permanent laboratory premises, 152 Mesogeion ave., GR-11527, Athens, Greece.
Approved signatories: D. Papaventsis, P. Ioannidis, E. Vogiatzakis.
This Scope of Accreditation replaces the previous one dated 28.04.2014.
The Accreditation Certificate No. 913, to ELOT EN ISO 15189:2007, is valid until 27.04.2018.
Athens, November 17, 2014
Ioannis Sitaras
Director of the Laboratories Accreditation Division
Page 2 of 4
Annexes G1/A2 and B2 to the Certificate ESYD No. 913
17.11.2014
Hellenic Accreditation System
Annex G1/B2 to the Certificate No. 913
SCOPE of ACCREDITATION
of the
Biochemistry Department
of the
Laboratories Division
of
“Sotiria” Chest Diseases General Hospital of Athens
Tested materials/ products
Types of test/ Properties to be
measured
Applied Standards/ Techniques to be used
Biochemical Tests
Determination of 27 parameters
Automated Biochemical Analyzer ADVIA 2400
SIEMENS*
Blood serum, plasma, CSF
1. Glucose
Enzymatic method hexokinase
Blood serum, plasma, urine
2. Urea
Urease enzymatic reaction with GLDH
Blood serum, plasma, urine
3. Creatinine
JAFFE Method
Blood serum, urine
4. Potassium
Potentiometric ISE
Blood serum, urine
5. Sodium
Potentiometric ISE
Blood serum, urine
6. Chloride
Potentiometric ISE
Blood serum, plasma
7. Aspartate aminotransferase
(AST/GOT)
Modified IFCC** without P-S-P
Blood serum, plasma
8. Glutamic-pyruvate
transaminase
Modified IFCC** without P-S-P
(GPT/ALT)
Blood serum, plasma
9. Creatinine Kinase (CK)
IFCC**, NAC ativated
Blood serum, plasma
10.Creatinine Kinase-MB (CKMB)
Enzymatic Μ-subgroup immuno-inhibition
Blood serum, plasma
11.Total Bilirubin
Oxidation of vanadium
Blood serum, plasma
12.Direct Bilirubin
Oxidation of vanadium
Blood serum
13. Gamma-glutamyl trasferase
(γ-GT)
IFCC**
Blood serum, plasma
14.Alkaline phosphatase (ALP)
IFCC**
Page 3 of 4
Annexes G1/A2 and B2 to the Certificate ESYD No. 913
17.11.2014
Tested materials/ products
Types of test/ Properties to be
measured
Applied Standards/ Techniques to be used
Blood serum, plasma
15.Lactate dehydrogenase (LDH)
IFCC** (L -> P)
Blood serum, plasma
16.Total Protein
BIURET Method
Blood serum, plasma
17.Albumin
Colorimetric BROMOCRESOL GREEN
Blood serum, plasma
18.Amylase
Enzymatic colorimetric with substrate pNPG7
blocked with ethylidene
Blood serum, plasma, urine
19.Calcium
ARSENAZO Method
Blood serum, urine
20.Inorganic Phosphorus
MOLYBDATE UV
Blood serum, plasma, urine
21.Magnesium
XYLIDYL BLUE
Blood serum, plasma, urine
22.Uric acid
Enzymatic colorimetric reaction with
uricase/peroxidase
Blood serum, plasma
23.Iron
FERROZINE Method
Blood serum, plasma
24.Cholesterol
Enzymatic CHOD-POD
Blood serum, plasma
25.Triglycerides
Enzymatic kinetic GPO-POD
Blood serum, plasma
26.HDL-cholesterol
Immuno-inhibition
Blood serum, plasma
27.LDL-cholesterol
Calculated
*Reference to the commercial name of a specific analyzer/kit, refers to a specific analytical method and protocol
**IFCC: International Federation of Clinical Chemistry
Site of assessment: Permanent laboratory premises, 152 Mesogeion ave., GR-11527, Athens, Greece.
Approved signatories: Ch. Kantza, A. Ramantani, E. Vlachogianni, C. Kanelopoulou, P. Ioannidis,
Β. Margariti, Μ. Logotheti, D. Kazi, Ol. Papadopoulou, E. Vogiatzakis.
This Scope of Accreditation replaces the previous one dated 28.04.2014.
The Accreditation Certificate No. 913, to ELOT EN ISO 15189:2007, is valid until 27.04.2018.
Athens, November 17, 2014
Ioannis Sitaras
Director of the Laboratories Accreditation Division
Page 4 of 4
Annexes G1/A2 and B2 to the Certificate ESYD No. 913
17.11.2014