CYPRUS ORGANIΖATION FOR THE PROMOTION OF QUALITY
CYPRUS ACCREDITATION BODY
ACCREDITATION CERTIFICATE no.
L072
The Board of Governors
of the Cyprus Organization for the Promotion of Quality,
the National Accreditation Body,
in accordance with the Article 7 of the Law 156(Ι)/2002
GRANTS ACCREDITATION to
CLINICAL LABORATORY M.P.N Unilab Ltd
in Nicosia
The above Laboratory was assessed according to the Accreditation Criteria for
Medical Laboratories, as defined in the Standard
CYS EN ISO 15189:2012
and was found technically competent to carry out the Tests included in the Scope of
Accreditation which is described in the Annex to this Certificate as an integrated part
of it. The Scope of Accreditation can change only after approval from the Cyprus
Accreditation Body.
The current Accreditation Certificate, no.
valid until the 8th June 2019.
L072,
is issued on 9th June 2015 and is
Accreditation was awarded for the first time on the 9th June 2015.
Antonis Ioannou
Director
Date: 9th June 2015
This laboratory is accredited in accordance with the recognised International Standard ISO
15189:2012. This accreditation demonstrates technical competence for a defined scope and
the operation of a laboratory quality management System ( ISO-ILAC-IAF Communiqué,
January 2015).
Annex
to the Accreditation Certificate no. L072
SCOPE OF ACCREDITATION
for the
CLINICAL LABORATORY M.P.N
Unilab Ltd
Valid as from the 9th June 2015 till the 8th June 2019
Materials
/Products
tested
Types of test/
Properties measured
Applied methods/
Techniques used
BIOCHEMISTRY TESTS
Determination of 30 parameters
Serum/ Plasma
Cobas Integra 400 Plus
1. Alanine Aminotranserase (ALT/SGPT)
1. IFCC/ Without Pyridoxal phsospate activation
2. Aspartate Aminotransferase (AST/SGOT)
2. IFCC / Without Pyridoxal phsospate activation
3. γ-Glutamyl-transferase (GGT)
3. IFCC/ Szasz method
4. Lactate Dehydrogenase (LDH)
4. IFCC/ UV (L→P)
5. Total Bilirubin (T-bili)
5. Diazo Method
6. Cholesterol (Chol)
6. Enzymatic reaction GPO-PAP
7. Creatinine Kinase (CPK)
7. IFCC/ DGKC, SCE, SFBC
8. Iron (Fe)
8. Ferrozine colorimetric method
9. Triglycerides (Tri)
9. Enzymatic reaction GPO-PAP
10. High Density Lipoproteins (HDL)
10. Enzymatic-Colorimetric
11. Direct Bilirubin (BIL-D)
11. Diazo Method
12. Total Iron Binding Capacity UIBC
12. Ferrozine
(TIBC)
13. C-Reactive Protein (CRP)
13. Particle enhanced turbidimetric assay
14. Rheumatoid Factor (Rf)
14. Immunoturbidimetric assay
Materials
/Products
tested
Types of test/
Properties measured
15. Cholinesterase (Che)
Applied methods/
Techniques used
15.Butyrylthiochlorine
p .1/4
Serum
Serum/ Plasma/
Urine
16. Alkaline Phosphatase (ALP)
16. IFCC/ Colorimetric method
17. Lithium (Li)
17. ISE direct
18. Albumin (Alb)
18. Colorimetric Bromocresol Green
19. Calcium (Ca)
19. o-cresolphthalein colorimetric method
20. Creatinine (Creat)
20. Jaffe buffered kinetic compensated
21. Magnesium (Mg)
21. Colorimetric
22. Phosphorus (Phos)
22. Colorimetric
23. Uric Acid (UA)
23. Enzymatric colorimetric reaction
24. Urea (BUN)
24. Urease method
25. Amylase (AMS)
25. IFCC –Enzymatric Colorimetric
26. Sodium (Na)
26. Indirect and direct potensiometry/ ion selective
electrode
27. Potassium (K)
27. Indirect and direct potensiometry/ ion selective
electrode
28. Chloride (Cl)
28. Indirect and direct potensiometry/ ion selective
electrode
Serum/ Plasma/
Urine/ ENY
29. Glucose (Glu)
29. Enzynmatic reaction HK/G6PDH
30. Total Protein (TP)
30. Colorimetric biuret
HAEMATOLOGY TESTS
Determination of 14 parameters
Pentra 80
1. White Blood Cells (WBC)
1. Electronic Impedance Variation
2. Red Blood Cells (RBC)
2. Electronic Impedance Variation
3. Haemoglobin (HGB)
3. Cyanmethemoglobin method-Photometry
4. Haematocrit (HCT)
4. Computation from stroted data directly measured
for these parameters
5. Mean Corpuscular (Erythrocyte) Volume
5. Automatic calculation from HCT and RBC
(MCV)
Blood
6. Mean Corpuscular Haemoglobin (MCH)
6. Automatic calculation from HGB and RBC
7. Mean Corpuscular Haemoglobin
7. Automatic calculation from HGB and HCT
Concentartion (MCΗC)
Materials
/Products
tested
Types of test/
Properties measured
Applied methods/
Techniques used
8. Mean Platelet Volume (MPV)
8. Automatic calculation from PCT and PLT
9. Red Blood Cell Distribution Width
9. Electronic Intergration
p .2/4
(RDW-cv)
10. Plateletcrit (PCT)
10. Automatic calculation from MPV and PLT
11.Platelet Distribution Width (PDW)
11. Automatic calculation from PLT’s histogram
12. Platelets (PLT)
12. Electronic impedance variation
13. Neutrophils, Lymphocytes, Monocytes,
13. Impedance and light scattering
Eosinophils, Basophils %, Atypical
Lymnphosites (ALY) and Large
Immature Cells (LIC)
14. Erythrocytes Sedimentation Rate (ESR)
14. Westergren
IMMUNOASSAY TESTS
Determination of 18 parameters
Serum/ Plasma
Elecsys 2010
1. Luteinising Hormone (LH)
1. Sandwich method
2. Tumor Marker CA-125 (Ca-125)
2. Sandwich method
3. Follicle Stimulating Hormone (FSH)
3. Sandwich method
4. Thyrotropin Hormone (TSH)
4. Sandwich method
5. Free Triidothyronine (FT3)
5. Competition method
6. Free Thyroxine (FT4)
6. Competition method
7. Total Prostatic Specific Antigen (tPSA)
7. Sandwich method
8. Estradiol (E2)
8. Competition method
9. Prolactin (PRL)
9. Sandwich method
10. Ferritin
10. Sandwich method
11. Tumor Marker CA 15-3 (Ca 15-3)
11. Sandwich method
12. Carcinoembryonic Antigen (CEA)
12. Sandwich method
13. Free Prostatic Specific Antigen (PSA)
13. ECLIA Sandwich principle
14. Insulin
14. ECLIA Sandwich principle
15. Testosterone (Testo)
15. ECLIA Sandwich principle
16. Anti-Human Immunodefficiency Virus
16. ECLIA Sandwich principle
1&2 (HIV)
17. Hepatitis B Surface antigen (HbsAg)
17. ECLIA Sandwich principle
18. Anti HCV (Hepatitis C)
18. ECLIA Sandwich principle
p. 3/4
All report should be signed by Mrs Pavlina Lena and Mrs Mariella Kasapi
Comments
This Annex refers only to tests carried out in the premises of the Laboratory, Address:
19 Themistokli Dervi (aptm 31), 1066, Nicosia
Antonis Ioannou
Director
Date: 9th June 2015
p. 4/4