Hellenic Accreditation System
Annex G1/Α15 to the Certificate No. 356-5
SCOPE of ACCREDITATION
of the
Clinical Laboratory
of
BIOMED S.A.
(Athens)
Materials/Products
tested
Types of test/Properties measured
Applied methods/Techniques used
Biochemical Tests
Blood serum
Page 1 of 13
Determination of 41 parameters
Automated Analyzer Cobas 8000,
Roche*
1. Glucose
Enzymatic reaction GOD-PAP
2. Triglycerides
Enzymatic reaction GPO – PAP
3. Total Cholesterol
Enzymatic reaction CHOD – PAP
4. Uric acid
Enzymatic cοloremetric reaction
uricase/peroxidase
5.Urea (blood, urine 24h)
Kinetic Enzymatic / UV
6.Creatinine
JAFFE METHOD
7. Total Bilirubin
DPD
8.Calcium
Colorimetric assay
9.Phosphorus
Colorimetric PHOSPHOMOLYBDADE
10.Iron
Colorimetric FERROZINE
11.Total Protein
Colorimetric assay
12.Albumin
Colorimetric BROMOCRESOL GREEN
13.Potassium
Potentiometric ISE
14.Sodium
Potentiometric ISE
15.Serum glutamic-oxaloacetic transaminase
(SGOT)
Colorimetric UV μέθοδος IFCC** χωρίς
P-S-P
16. Serum glutamic-pyruvic transaminase
(SGPT)
Colorimetric UV μέθοδος IFCC** χωρίς
P-S-P
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Blood serum
(continued)
Types of test/Properties measured
Applied methods/Techniques used
17.Gamma-glutamyl trasferase (γ-GT)
Enzymatic Colorimetric method GCNA Liquid
stand SZASZ
18.Alkaline phosphatase (ALP)
Colorimetri method liquid acc to IFCC**
19.Creatinine kinase (CK)
Colorimetri method liquid acc to IFCC**
20.Lactate dehydrogenase (LDH)
Colorimetri method UV optimized
(DGKC***)
21. Amylase
Enzymatic colorimetric method liquid acc
to IFCC
22. Cholesterol HDL
Homogenous, Enzymatic colorimetric
23. Cholesterol LDL
Calculated
24.Bilirubin Direct
Colorimetric
25.Very Low Density Lipoptrotein (VLDL)
Calculated
26. Magnesium
27. Creatinine kinase-MB (CK-MB)
28. Acid Phosphatase
29. Total Iron-binding Capacity
(TIBC)
30. Apolipoprotein Α1 (APO A1)
31, Apolipoprotein Β (APO B)
32. Lipoprotein-a (LP-a)
33. Cholinesterase
Colorometric
Immunological UV/Cobas 8000
Colorimetric
34.Complement C3
Immunoturbimetric method
35.Complement C4
Immunoturbimetric method
36.Iron Transferrin (TRF)
Immunoturbimetric method
37.Anti-streptolysin O (ASTO)
Immunoturbimetric method
38.C-reactive protein (CRP)
Immunoturbimetric method
39.Immunoglobulin G ( IgG)
Immunoturbimetric method
40.Immunoglobulin M ( IgM)
41.Immunoglobulin A ( IgA)
Determination of 3 parameters
1. Lactate
2. Lipase
3. Bicarbonates
Immunoturbimetric method
Immunoturbimetric method
Automated Analyzer Integra 400 plus
Roche*
Colorimetric
Enzymatic
Colorimetric
Determination of 2 parameters
Electrolyte Analyzer AVL 9181*
1.Ionized calcium
Direct Potentiometry
2. Lithium
Direct Potentiometry
Automated Analyzer Integra 400 plus
Roche*
Kinetic interaction of microparticles in a
solution
Urine
Determination of 9 Parameters
1.Amphatemines
2.Barbiturates
Colorimetric/
Immunoturbimetric method
Immunoturbimetric method
Immunoturbimetric method
Colorimetric
3.Benzodiapines
Page 2 of 13
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Types of test/Properties measured
Applied methods/Techniques used
4.Cannabis
5.Cocaine
6.Methadone
7. Opiates
8.Phenyciclidine
9.Propoxyphene
Urine
Blood serum
1. Osmolality
Freeze-point suppression /Osmometer
Vapor Pressure 552*
1.Serum Protein Electrophoresis
Capyllari Electrophoresis Sebia
1. A1- globulins
2. A2-globulins
3. Βeta globulins
4. Gamma globulins
5. Albumin/Globulins ratio
6. Total protein* Colorimetric
Hematology Tests
Total blood
(EDTA)
Page 3 of 13
Determination of 2 parameters
Automated Analyzer Cobas Integra 800
Roche* (Α 06190 & Α 06138)
1.Determination of glycated hemoglobin A1c
( HbA1C )
Immunoturbimetric method
2. Determination of hemoglobins A2/F
Chromatographic HPLC VARIANT II
Bio-Rad*
Full Blood count Determination of 8
parameters
Automated analyzers SYSMEX XE
2100-1, SYSMEX XE 2100-2, SYSMEX
XE-2100-3*
1. White Blood Cells (WBC)
Flow Cytometry method (which employs a
semiconductor laser)
2. Red Blood Cells (RBC)
Hydrodynamic Focusing (DC Detection)
3. Hemoglobin (HGB)
Photometry
4. Hematocrit (HCT)
Hydrodynamic Focusing (DC Detection)
5. Mean Cell Volume (ΜCV)
Calculated based on specific equation (DC
Detection)
6. Mean Cell Hemoglobin
Calculated based on specific equation (DC
Detection)
7. Mean corpuscular hemoglobin
concentration
Calculated based on specific equation (DC
Detection)
8. Platelets (PLTs)
Hydrodynamic Focusing (DC Detection)
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Types of test/Properties measured
Applied methods/Techniques used
White Blood Cell Automated Differential
Count Determination 5 parameters
Automated analyzers SYSMEX XE
2100-1, SYSMEX XE 2100-2, SYSMEX
XE-2100-3*
1.Neutrophil (number and %)
Flow cytometry with fluorescence
2.Lymphocyte (number and %)
3.Monocyte (number and %)
4.Eosinophil (number and %)
5.Basophil (number and %)
Coagulation Tests
Blood plasma
(Citrate)
Determination of 9 Parameters
Analyzers BCS XP-1 Siemens (Α 06125),
BCS XP-2 Siemens (Α 06196)*
Coagulation Method Automated
1.Prothrombin time
2.Fibrinogen activity (FIB)
3.Activated partial prothrombine time (APPT)
Coagulation Method Automated
Coagulation Method Automated
Coagulation Method Automated
4.Protein –S activity
5.Free Protein S Antigen
6.Von Willebrant (vWF) Factor Activity
Coagulation Method Automated
Coagulation Method Automated
Turbidimetric method
7.D-Dimers
8.Antithrombin ΙΙΙ Activity
Chromogenic
9.Protein –C Activity
Chromogenic
Immunchemical Tests
Blood serum
Determination of 6 Therapeutic Drugs
Monitoring parameters
Automated Immunochemical analyzer
Modular P 800, Roche*
1. Digoxin
Kinetic interaction of mikroparticles in a
solution
2. Carbamazepine
Fluorescence polarization
3. Valproic Acid
Fluorescence polarization
4. Gentamicin
Kinetic interaction of microparticles in a
solution
Kinetic interaction of microparticles in a
solution
Kinetic interaction of microparticles in a
solution
5. Phenytoin
6. Phenobarbital
Determination of 38 Parameters
1. Ferritin
2. A-Fetoprotein (AFP)
Page 4 of 13
Automated Analyzer Modular E 170
Roche*
ElectroChemiluminescense (ECLIA)
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Blood serum
(continued)
Types of test/Properties measured
Applied methods/Techniques used
3. Estradiol (E2)
4. Testosterone
5. β-Human Chorionic Gonadotropin (βΗCG)
6. Cortisol
7. Dehydroepiandrosterone sulfate (DHEAS)
8. Carcinoembryonic antigen (CEA)
9. Cancer antigen CA 125
10. Cancer antigen CA 15-3
11. Cancer antigen CA 19-9
12. Cancer antigen CA 72-4
13. Prostate Specific Antigen (PSA)
14. Free Prostate Specific Antigen (FreePSA)
15. Sex Hormone Binding Globulin (SHBG)
16. Parathyroid Hormone (PTH)
17. Vitamin B12
18. Folate
19. Prolactin (PRL)
20. Progesterone (PRG)
21. Follicle Stimulating Hormone (FSH)
22. Luteinizing Hormone (LH)
23. Insulin
24. C-Peptide
25. Calcitonin (CT)
26. Neuronal specific enolase (NSE)
27. 25 OH Vitamin D (Total)
28. Protein PAPP-A
29. Free B-HCG
30. Growth Hormon (GH)
31. Thyrotropin Hormone (TSH)
32. Free Thyroxin (Free-T4)
33. Thyroxin total (Τ4)
34. Free Triidothyronine (Free T3)
35. Triidothyronine total (T3)
36. Thyroglobulin (Tg)
37. Thyroid Autoantibodies Against
Microsomal Antibodies (ATPO)
38. Antithyroglobulin Antibodies (ATG)
Page 5 of 13
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Blood serum
(continued)
Types of test/Properties measured
Determination of 2 Parameters
Applied methods/Techniques used
Automated Analyzer Liaison
Diasorin*
Chemiluminescence
1. Renin
2. Tissue Polypeptide Antigen (TPA)
Automated Analyzer Abbot Architect I
2000SR
Determination of 2 Parameters
1. Beta Natriuretic Peptide (BNP)
2. Index Carcinoma Squamous Types (SCC)
Determination of 3 Parameters
1. Androstenedione (Δ4)
2. Gastrin
3. Free Estriol (UE3)
Chemiluminescense
Automated Analyzer Immulite 2000,
XPI Siemens
Chemiluminescense
Determination of 1 Parameter
Automated Analyzer Elecsys 2010,
Roche
1. Troponin T High Sensitivity
ElectroChemiluminescense (ΕCLIA)
Determination of 13 Parameter
1. Total antibodies to Hepatitis A virus
Automated Analyzer Modular E-170
Roche
ElectroChemiluminescense (ΕCLIA)
2. Antibody to hepatitis C virus
3. Hepatitis B surface antigen
4. Antibodies to Hepatitis B core antigen
5. Antibody to hepatitis B surface antigen
6. Toxoplasma IgG antibodies (TOXO IgG)
7. Toxoplasma IgM antibidies (TOXO IgM)
8. Cytomegalovirus IgG antibodies (CMV
IgG)
9. Cytomegalovirus IgM antibodies (CMV
IgM)
10. Antibodies to the herpes simplex virus
(HSV-1 and HSV-2 IgG Ab)
11. Antibodies to Rubella virus IgG Ab
12. Antibodies to Rubella virus IgM Ab
13. Antibodies to Human Immunodeficiency
Virus (HIV Ag (p24) / HIV 1&2 Ab)
Serum Blood
Determination of 4 Parameters
1. Cardiolipin Antibodies IGG
Automated Analyzer Liaison Diasorin
Chemiluminescense
2. Cardiolipin Antibodies IGMIGM
Page 6 of 13
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Types of test/Properties measured
Applied methods/Techniques used
3. Antibodies against Extracable Nuclear
Antigens, anti-ENA (SSA, SSB, RNP/Sm,
SCL-70, Jo1, CENP-B)
4. Antibodies against double stranded DNA
(ds-DNA)
Automated Immunoassay Analyzer PhD
Blood serum
Blood serum
Determination of 1 Parameter
Module, BIORAD
1. Antinuclear Antibodies (ΑΝΑ)
Immunofluorescence (IFA) method,
substrate HEP-2
Automated Immunoassay Analyzer BN
Determination of 2 Parameter
1. Immunoglobulin E (IGE)
2. Ra-test
Determination of 14 Direct Physicochemical
Parameters
1. Total vitamin D (D2/D3)
2. Cholecalciferol [25-OH-D3]
3. Ergocalciferol [25-OH-D2]
Urine
4. Vanillyl mandelic acid (VMA)
5. 5-Hydroxyindoleacetic acid
6. Homovanillic acid
7. Urinary Catecholamines
8. Epinephrine [Adrenaline]
9. Norepinephrine [Noradrenaline]
10. Dopamine
11. Metanephrines
12. Metanephrine
13. Normetanephrine
14. 3-Methoxytyramine (3-MT)
Blood serum
Determination of 189 Allergens
Quantitative measurment of allergen-specific
IgE
II Siemens
Nephelometric
High Pressure Liquid
Chromatographywith Qualitative &
Quantitative determination detector
coupled to Mass
(LC-MSMS)
High Pressure Liquid Chromatography
with Electrochemical detection
(HPLC-EC detection)
Specific IgE Universal Kit, Immulite
2000 Siemens*
Chemiluminescense (CLIA)
1.PENICILLOYL G (c1) Specific IGE,
2.PENICILLOYL V (c2) Specific IGE,
3.AMPICILLOYL (c5) Specific IGE,
4.AMOXICILLOYL (c6) Specific IGE,
5.DERMATOPHAGOIDES
PTERONYSSINUS Specific IGE,
6.DERMATOPHAGOIDES FARINAE
Specific IGE,
7.DERMATOPHAGOIDES MICROCERAS
Specific IGE,
8.ACARUS SIRO Specific IGE,
9.LEPIDOGLYPHUS DESTRUCTOR
Specific IGE,
10.TYROPHAGUS PUTRESCENTIAE
Specific IGE,
Page 7 of 13
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Types of test/Properties measured
Applied methods/Techniques used
11.GLYCOPHAGUS DOMESTICUS
Specific IGE,
12.EUROGLYPHUS MAYNEL Specific IGE,
13.CAT EPITHELIUM Specific IGE,
14..DOG EPITHELIUM Specific IGE,
15.CANARY BIRD FEATHERS Specific
IGE,
16. PIGEON FEATHERS Specific IGE,
17. HORSE DANDER Specific IGE,
18.DOG DANDER Specific IGE,
19.PIGEON DROPPINGS Specific IGE,
20.GOOSE FEATHERS Specific IGE,
21.MOUSE EPITEHL Specific IGE,
22..BUDGERIGAR FEATHERS Specific
IGE,
23.BUDGERICAR PROTEIN SERUM
Specific IGE,
24.GOAT EPITHELIUM Specific IGE,
25.CHICKEN FEATHERS Specific IGE,
26.DUCK FEATHERS Specific IGE,
27.GOOSE-CHICKEN-DUCK AND
TURKEY FEATHERS Specific IGE,
28.EGG WHITE (f1) Specific IGE,
29. SESAME SEED (f10) Specific IGE,
30.CHOCOLATE Specific IGE
31.GREEN PEA (f12) Specific IGE,
32.PEANUT (f13) Specific IGE,
33.SOYA BEEN (f14) Specific IGE,
34.WHITE BEAN (f15) Specific IGE,
35.HAZELNUT (f17) Specific IGE,
36.BRAZIL NUT (f18) Specific IGE,
37.COW MILK (f2) Specific IGE,
38.ALMOND (f20) Specific IGE,
39.CASHEW NUT (f202) Specific IGE,
40..PISTACHIO (f203) Specific IGE,
41.LEMON (f208) Specific IGE,
42.MUSHROOM Specific IGE,
43.LETTUCE Specific IGE,
44.CABBAGE Specific IGE,
45.COFFEE (f221) Specific IGE,
46.PUMPKIN (f225) Specific IGE,
47.CRAB (f23) Specific IGE,
48.LENTIL (f235) Specific IGE,
49.APRICOT (f237) Specific IGE,
50.SHRIMP (f24) Specific IGE,
51.CHERRY (f242) Specific IGE,
52.EGG (FULL) (f245) Specific IGE,
53.TOMATO (f25) Specific IGE,
54.WALNUT (f256) Specific IGE,
55.SQUID (f258) Specific IGE,
56.GRAPE (f259) Specific IGE,
57.PORK (f26) Specific IGE,
58. BROCCOLI Specific IGE,
Page 8 of 13
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Types of test/Properties measured
59.BEEF (f27) Specific IGE,
60.BLACK PEPPER (f280) Specific IGE,
61.TURKEY MEAT Specific IGE,
62..CAULIFLOWER (f291) Specific IGE,
C 63.CHESTNUT (f299) Specific IGE,
64. CODFISH (f3) Specific IGE,
65.CARROT (f31) Specific IGE,
66.ORANGE (f33) Specific IGE
67.POTATO (f35) Specific IGE,
68.COCONUT (f36) Specific IGE,
69.BLUE MUSSEL (f37) Specific IGE,
70.WHEAT(f4) Specific IGE,
71.TUNA (f40) Specific IGE,
72.SALMON (f41) Specific IGE,
73.STRAWBERRY (f44) Specific IGE,
74.YEAST (f45) Specific IGE,
75.APPLE (f49) Specific IGE,
76.RYE (f5) Specific IGE,
77.OKTOPUS (f59) Specific IGE,
78.BARLEY (F6) Specific IGE,
79.Sardine (F61) Specific IGE,
80.PERCH (F65) Specific IGE,
81.OAT (f7) Specific IGE,
82.EGG YOLK (f75) Specific IGE,
83.ALPHA LACTALBUMIN (f76) Specific
IGE,
84.BETA LACTOGLOBULIN (f77) Specific
IGE,
85.CASEIN (f78) Specific IGE,
86.GLUTEIN (79) Specific IGE,
87.CORN (f8) Specific IGE,
88.LOBSTER (f80) Specific IGE,
89.CHEESE, CHEDDAR TYPE (f81)
Specific IGE,
90.CHEESE, MOLD TYPE (f82) Specific
IGE,
91.CHICKEN MEAT (f83) Specific IGE,
92.KIWI FRUIT (f84) Specific IGE,
93.CELERY (f85) Specific IGE,
94.PARSLEY Specific IGE,
95.MELON (f87) Specific IGE,
96..LAMB (MUTTON) (f88) Specific IGE,
97.RICE (f9) Specific IGE,
98.BANANA (f92) Specific IGE,
99.CACAO (f93) Specific IGE,
100.PEAR (f94) Specific IGE,
101.PEACH (f95) Specific IGE,
102.SWEET VERNAL GRASS (g1) Specific
IGE,
103.JOHNSON GRASS Specific IGE,
104.BROME GRASS Specific IGE,
105.CULTIVATED RYE Specific IGE,
106.CULTIVATED OAT Specific IGE,
Page 9 of 13
Applied methods/Techniques used
Chemiluminescense (CLIA)
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Types of test/Properties measured
Applied methods/Techniques used
107.CULTIVATED WHEAT Specific IGE,
108.MEADOW FOXTAIL GRASS Specific
IGE,
109.BAHIA GRASS Specific IGE,
110.BERMUDA GRASS (g2) Specific IGE,
111.ZEA MAYS (CORN) Specific IGE,
112.COCKSFOOT (DAKTYLIS) (g3)
Specific IGE,
113.MEADOW FESCUE (g4) Specific IGE,
114.LOLIUM PERENNE (g5) Specific IGE,
115.TIMOTHY GRASS (g6) Specific IGE,
116.COMMON REED GRASS Specific IGE,
117.KENTUCKY BLUE (g8) Specific IGE,
118.BENT GRASS (g9) Specific IGE,
119.GREER LABS. Specific IGE,
120.HOLLISTER-STIER LABS. Specific IGE
121.HONEY BEE Specific IGE
122.WHITE-FACED HORNET Specific IGE,
123.YELLOW JACKET Specific IGE,
124.PAPER WASP Specific IGE,
125.YELLOW HORNET Specific IGE,
126.COCKROACH Specific IGE,
127.MOSQUITO Specific IGE,
128.EUROPEAN HORNET Specific IGE,
129.MOTH Specific IGE,
130.ISOCYANATE TDI Specific IGE,
131.FORMALDEHYDE / FORMALIN
Specific IGE,
132.LATEX Specific IGE,
133.SUNFLOWER SEED (k84) Specific IGE,
134.PENICILLIUM MOTATUM Specific
IGE,
135.AUREOBASIDIUM PULLULANS
Specific IGE,
136.CLADOSPORIUM HERBARUM
Specific IGE,
137.ASPERGILLUS FUMIGATUS Specific
Chemiluminescense (CLIA)
IGE,
138.MUCOR RACEMOSUS Specific IGE,
139.CANDIDA ALBICANS Specific IGE,
140.ALTERNARIA TENUIS Specific IGE,
141.BOTRYTIS CINEREA Specific IGE,
142.PITYROSPORUM ORBICULARE
Specific IGE,
143.HELMINTHOSPORIUM HALODES
Specific IGE,
144.FUSARIUM MONILIFORME Specific
IGE,
145.COTTON (CRUDE FIBERS) (o1)
Specific IGE,
146.BOX-ELDER Specific IGE,
147.WALNUT Specific IGE,
148.SYCAMORE Specific IGE,
Page 10 of 13
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Types of test/Properties measured
149.WILLOW Specific IGE,
150.COTTONWOOD Specific IGE,
151.WHITE ASH Specific IGE,
152.WHITE PINE Specific IGE,
153.JAPANESE CEDAR Specific IGE,
154.EYCALYPTUS Specific IGE,
155.ACACIA Specific IGE,
156.ΕLDER Specific IGE,
157.MESQUITE Specific IGE,
158.PECAN Specific IGE,
159.ITALIAN CYPRESS Specific IGE,
160.COMMON SILVER BIRCH Specific
IGE,
161.HAZEL Specific IGE,
162.BEECH Specific IGE,
163 MOUNTAIN JUNIPER Specific IGE,
164.OAK Specific IGE,
165.MULBERRY Specific IGE,
166.ELM Specific IGE,
167.OLIVE Specific IGE,
168.AMBROSIA ELATIOR Specific IGE,
169.GOOSEFOOT Specific IGE,
170.SALTWORT Specific IGE,
171.GOLDENROD Specific IGE,
172.ROUGH PIGWEED Specific IGE,
173.ROUGH MARSH ELDER Specific IGE,
174.PARIETARIA OFFICINALIS Specific
IGE,
175.AMBROSIA PSILOSTACHYA Specific
IGE,
176.NETTLE Specific IGE,
177.PARIETARIA JUDAICA Specific IGE,
178.RABBIT BUSH W36 Specific IGE,
179.MUGWORT W6 Specific IGE,
180.MARGUERITE W7 Specific IGE,
181.DANDELION W8 Specific IGE,
182.PLANTAIN Specific IGE,
Mixtures of allergens
183.EX1(e70, e85, e86, e89) Specific IGE,
184.FP1 (f13, f17, f18, f20, f36) Specific IGE,
185.GX1( g3, g4, g5, g6, g8) Specific IGE,
186.GX2( g2, g5, g6, g8,g10, g17) Specific
IGE,
187. ΗΧ1(H1, D1, D2, I6) Specific IGE,
188.MΧ1 (m1, m2, m3, m5, m6) Specific
IGE,
189.WX3(w6, w9, w10, w12, w20) Specific
IGE,
Page 11 of 13
Applied methods/Techniques used
Chemiluminescense (CLIA)
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Materials/Products
tested
Types of test/Properties measured
Applied methods/Techniques used
Genetic Testing
1. Total blood in
heparin, Amniotic
fluid, Chorion
villus sample
46 chromosome analysis using G-banding
technique in order to reveal abnormal banding
pattern or abnormal number of chromosomes
Optical microscopy with Giemsa stain
Molecular Testing
1. Blood plasma
(EDTA)
1. Quantification of Hepatitis B Virus DNA
(HBV-DNA)
Manufacturer's methodology AmpliPrep
COBAS®/ TAQMAN HBV Test v2.0*
with Real-time qPCR
Methodology COBAS®
AmpliPrep/COBAS® TAQMAN HCV
Quantitative Test v2.0* with Real time
PCR
2. Blood plasma
(EDTA), total
blood (EDTA)
1. Quantification of Hepatitis C Virus RNA
(HCV-RNA)
3. Blood serum,
Blood plasma
(EDTA)
1. Hepatitis C Genotyping
Methodology VERSANT HCV Genotype
2.0 LiPA, Siemens* with hybridization in
strips after RT-PCR
4. Total blood
(EDTA)
1. Detection 50 mutations of cystic fibrosis
transmembrane conductance regulator (CFTR)
gene
Manufacturer methodology Elucigene CF
EU2v1: Fluorescent ARMS PCR - allele
specific amplification technology Amplified sequences are separated by
capillary electrophoresis using genetic
analyzer AΒΙ3130*
5. Vaginal,
cervical swab
sample
Detection and genotyping of Human
Papilloma Virus (HPV)- 37 genotypes {11,
16, 18, 26, 31, 33, 35, 39, 40, 42, 45, 51, 52,
53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68,
69, 70, 71, 72, 73 (MM9), 81, 82 (MM4), 83
(MM7), 84 (MM8), IS39, CP6108}
Manufacturer’s methodology using
LINEAR ARRAY HPV Genotyping Test
(ROCHE) * PCR amplification on ABI
9700 followed by hybridization of the
amplified products to oligonucleotide
probes and detection of the probe bound
amplified products by colomeric
determination.
Cytological tests
Biological
Specimens and
Fluids of
conventional
cytology
1. Gynecological
specimens
(cervicovaginal
smears,
endometrial
specimens)
Determination of parameters (which refer
to all specimens and fluids)
Technique / Equipment (Automatic
staining machine, Centrifuge machine)
Morphologic test – (Qualitative –
Semiquantitative method)/
1. Specimen adequacy
2. Presence of normal cells
3. Inflammatory cell lesions
4. Specific inflammation (typing)
5. Precancerous lesions
6. Primary and secondary neoplastic diseases
1. Fixation
2. Papanicolaou stain (Automatic staining
machine, Shandon Varistain 24-4)
3. Microscopy (Nikon Eclipse E 400,
Nikon Eclipse 50i, Zeiss 473011, Olympus
BX 40, Olympus X 31).
*Reference to the commercial name of a specific analyzer/kit, refers to a specific analytical method and protocol
IFCC: International Federation of Clinical Chemistry
DGKC: Deutsche Geselschaft fur Klinische Chemie
Page 12 of 13
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015
Site of assessment : Laboratory permanent premises, 132 Kifisias av. and Papadas str., 11526 Athens,
Greece.
Approved signatories : J. Kourea-Kremastinou, G. Arsenis, K. Sidoni.
This scope of Accreditation replaces the previous one dated 29.07.2015.
The Accreditation Certificate No. 356-5, to ELOT EN ISO 15189:2012, is valid until 30.05.2019.
Athens, September 17, 2015
Ioannis Sitaras
Director of the Laboratories Accreditation Division
Page 13 of 13
Annex G1/Α15 to the Certificate ESYD No.356-5
17.09.2015