HAA je potpisnica multilateralnog sporazuma s Europskom ... AKREDITIRANIH PRETRAGA...HAA je...
Transcript of HAA je potpisnica multilateralnog sporazuma s Europskom ... AKREDITIRANIH PRETRAGA...HAA je...
HAA je potpisnica multilateralnog sporazuma s Europskom organizacijom za akreditaciju (EA) HAA is a signatory of the European co-operation for Accreditation (EA) Multilateral Agreement
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 1 od/of 16
PRILOG POTVRDI O AKREDITACIJI br: 7130 Annex to Accreditation Certificate Number:
Klasa/Ref. No.: 383-02/12-35/006 Urbroj/Id. No.: 569-02/02-16-24 Datum izdanja priloga /Annex Issued on: 2016-02-25
Zamjenjuje prilog/Replaces Annex: Klasa/Ref. No.: 383-02/12-35/006 Urbroj/Id. No.: 569-02/02-15-20 Datum izdanja priloga /Annex Issued on: 2015-11-09
Norma: HRN EN ISO 15189:2012
Standard: (ISO 15189:2012; EN ISO 15189:2012)
Akreditacija istječe: 2017-12-30
Accreditation expiry:
Prva akreditacija: 2007-12-31
Initial accreditation:
Akreditirani medicinski laboratorij
Accredited medical laboratory
KLINIČKA BOLNICA MERKUR
KLINIČKI ZAVOD ZA MEDICINSKU BIOKEMIJU I LABORATORIJSKU
MEDICINU
Zajčeva 19, HR-10000 Zagreb
Područje akreditacije:
Scope of accreditation:
Medicinska biokemija - ispitivanja u području kliničke kemije,
laboratorijske hematologije i koagulacije, laboratorijske imunologije-imunofenotipizacije
stanica i molekularne dijagnostike
Medical Biochemistry – Testing in the field of Clinical Chemistry, Laboratory Hematology
and Coagulation, Laboratory Immunology-Immunophenotyping and Molecular Diagnostics
Važeće izdanje Priloga dostupno je na web adresi: www.akreditacija.hr / Valid issue of the Annex is available at the web address: www.akreditacija.hr
Ravnatelj: Director General:
Tihomir Babić, dipl. ing.
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 2 od/of 16
PODRUČJE AKREDITACIJE / SCOPE OF ACCREDITATION
Klinička kemija/Clinical Chemistry
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
1.
Pregled mokraće – kemijski
(test-traka) Urinalysis by test strip
KZMBLM-SOP30/4
Refraktometrija Refractometry
mokraća
urine
2.
Pregled mokraće –
mikroskopski (sediment) Urine sediment analysis
KZMBLM-SOP31/4
Svjetlosna mikroskopija Bright field microscopy
3. C-reaktivni protein (CRP)
C-reactive protein
KZMBLM-
SOP32/4
Imunoturbidimetrija Immunoturbidimetry
serum serum
4. Imunoglobulin A (IgA)
Immunoglobulin A KZMBLM-SOP33/5
5. Imunoglobulin G (IgG)
Immunoglobulin G
KZMBLM-
SOP34/4
6. Imunoglobulin M (IgM)
Immunoglobulin M KZMBLM-SOP35/5
7. Mioglobin
Myoglobin
KZMBLM-
SOP36/4
8.
Transferin - topljivi receptori (TfR)
Soluble transferin receptors
KZMBLM-SOP37/3
9. Digoksin
Digoxin
KZMBLM-
SOP38/3
10. Bilirubin-ukupni Total bilirubin
KZMBLM-SOP39/4
Fotometrijska metoda s 3,5-diklorfenil-diazonium-
tetrafluoroboratom (DPD) Photometric colour test
(DPD method)
11. Glukoza Glucose
KZMBLM- SOP40/3
Fotometrijska enzimska UV metoda s heksokinazom
Enzymatic UV test
(hexokinase method)
12. Laktat
Lactate
KZMBLM-
SOP42/5
Fotometrijska enzimska metoda
Enzymatic colour test
plazma
plasma
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 3 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
13.
Urati
Urates
KZMBLM-
SOP43/4
Fotometrijska enzimska metoda s urikazom i askorbat-oksidazom
Enzymatic colour test with uricase and ascorbate
oxidase
serum serum
14. Ureja Urea
KZMBLM-SOP44/5
Fotometrijska UV metoda Kinetic UV test
15. Alanin-aminotransferaza
(ALT) (EC 2.6.1.2) Alanine aminotransferase
KZMBLM-SOP45/5
Fotometrijska UV metoda s piridoksal- fosfatom
( IFCC metoda) Kinetic UV test with
pyridoxal phosphate (IFCC method)
16. -amilaza (AMS) (EC
3.2.1.1)
α-amylase
KZMBLM-SOP46/5
Fotometrijska metoda
(IFCC metoda) Kinetic colour test
(IFCC method)
17.
Aspartat-aminotransferaza (AST)
(EC 2.6.1.1) Aspartate aminotransferase
KZMBLM-
SOP47/5
Fotometrijska UV metoda s
piridoksal- fosfatom ( IFCC metoda)
Kinetic UV test with pyridoxal phosphate (IFCC
method)
18. -glutamiltransferaza (GGT)
(EC 2.3.2.2) Gamma-glutamyltransferase
KZMBLM-SOP48/5
Fotometrijska metoda
(IFCC metoda) Kinetic colour test
(IFCC method)
19.
Kolinesteraza (CHE) (EC 3.1.1.8)
Cholinesterase
KZMBLM-SOP49/4
Fotometrijska metoda s butiriltiokolinom, (GSCC) Kinetic colour test (GSCC
method)
20. Kreatin-kinaza (CK)
(EC 2.7.3.2)
Creatine kinase
KZMBLM-
SOP50/5
Fotometrijska UV metoda (IFCC metoda)
Kinetic UV test (IFCC method)
Fotometrijska UV metoda (IFCC metoda)
Kinetic UV test (IFCC
method)
21.
Laktat-dehidrogenaza (LD) (EC 1.1.1.27)
Lactate dehydrogenase
KZMBLM-SOP51/4
22. Fosfati-anorganski
Inorganic phosphorous
KZMBLM-
SOP52/4
Fotometrijska UV metoda s amonij-molibdatom
Photometric UV-test with ammoniummolybdate
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 4 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
23.
Kalcij-ukupni
Total calcium
KZMBLM-SOP53/4
Fotometrijska metoda s
o-krezolftaleinom Photometric colour test
(o-cresolphthalein method)
serum
serum
24.
Željezo Iron
KZMBLM-SOP54/5
Fotometrijska metoda s
2,4,6-tri (2-piridil)-5-triazinom (TPTZ)
Photometric colour test (TPTZ method)
25.
Željezo-nezasićeni kapacitet
vezanja željeza (UIBC) Unsaturated iron binding
capacity
KZMBLM-SOP55/4
Fotometrijska metoda s 2-nitrozo-5-(N-propil-N-
sulfopropilamino) fenolom (nitrozo-PSAP)
Photometric colour test (nitrozo-PSAP method)
26. Albumin
Albumin
KZMBLM-
SOP56/4
Fotometrijska metoda s bromkrezol-zelenilom
Photometric colour test (BCG method)
27. Ukupni proteini
Total protein
KZMBLM-
SOP57/4
Fotometrijska metoda
Photometric colour test
28. Kolesterol-HDL HDL-cholesterol
KZMBLM-SOP58/4
Fotometrijska enzimska metoda Enzymatic colour test
29. Kolesterol-ukupni
Total cholesterol
KZMBLM-
SOP59/4
Fotometrijska metoda
Photometric colour test
30. Trigliceridi
Triglyceride
KZMBLM-
SOP60/5
Fotometrijska enzimska metoda
Enzymatic colour test
31. Etanol
Ethanol
KZMBLM-
SOP61/4
Fotometrijska UV metoda s alkohol-dehidrogenazom
Photometric UV test with alcohol dehydrogenase
32. Kalij
Potassium
KZMBLM-
SOP62/4 Indirektna potenciometrija
Indirect potentiometry
33. Kloridi
Chloride KZMBLM-SOP63/4
34. Natrij
Sodium KZMBLM-SOP64/4
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 5 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
35. Magnezij- ionizirani Ionized magnesium
KZMBLM-SOP65/4
Direktna potenciometrija
Direct potentiometry
serum, plazma, puna krv
serum, plasma,
whole blood
36. Kalij-ionizirani
Ionized potassium
KZMBLM-
SOP66/4
Direktna potenciometrija
Direct potentiometry
serum,
plazma, puna krv serum,
plasma, whole
blood
37. Natrij-ionizirani Ionized sodium
KZMBLM-SOP67/4
38. Kloridi-ionizirani
Ionized chloride
KZMBLM-
SOP68/4
39. Kalcij-ionizirani Ionized calcium
KZMBLM-SOP69/4
40. Parcijalni tlak kisika (pO2)
Oxygen partial pressue
KZMBLM-
SOP70/5 Elektrokemijske metode kalibrirane s tekućim
kalibratorima Electrochemical methods calibrated with all –liquid
Calibrator Cartridge
arterijska
i kapilarna
krv arterial
and
capillary blood
41.
Parcijalni tlak ugljičnog dioksida (pCO2)
Carbon dioxide partial pressue
KZMBLM-
SOP71/5
42. pH KZMBLM-SOP72/5
43. CA-125
Cancer Antigen 125 KZMBLM-SOP73/4
Elektrokemiluminiscencija
(ECLIA) Electrochemiluminescence
serum serum
44.
-1-fetoprotein
(AFP)
1-fetoprotein
KZMBLM-
SOP74/4
45.
Karcinoembrionalni antigen
(CEA) Carcinoembrionic antigen
KZMBLM-SOP75/4
46.
Prostata-specifični antigen-
ukupni (PSA) Total-prostate-specific
antigen
KZMBLM-SOP76/5
47.
Prostata-specifični antigen-
slobodni (fPSA) Free prostate-specific antigen
KZMBLM-SOP77/5
48. CA 19-9
Carbohydrate Antigen 19-9
KZMBLM-
SOP78/4
49.
Ukupni korionski gonadotropin (hCG + hCG
beta) Chorionic gonadotropin
KZMBLM-
SOP79/4
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 6 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
50. Feritin
Ferritin KZMBLM-SOP80/4
Elektrokemiluminiscencija (ECLIA)
Electrochemiluminescence
serum serum
51. Ciklosporin
Cyclosporine KZMBLM-SOP81/7
Kemiluminiscentno
imunokemijsko određivanje pomoću magnetskih mikročestica(CMIA)
Chemiluminescent magnetic micriparticle immunoassay
(CMIA) technology
puna krv
whole blood
52. Takrolimus
Tacrolimus
KZMBLM-
SOP82/6
53. Amonijak Ammonia
KZMBLM-SOP84/3
Fotometrijska UV metoda Kinetic UV test
plazma plasma
54. Vankomicin
Vancomycin
KZMBLM –
SOP95/3
Kemiluminiscentno imunokemijsko određivanje
pomoću magnetskih
mikročestica(CMIA)
Chemiluminescent magnetic
micro particle immunoassay (CMIA) technology
serum
serum
55. Alkalna fosfataza (ALP)
Alkaline phosphatase KZMBLM-SOP97/3
Fotometrija metoda
(IFCC metoda) Photometric colour test
(IFCC method)
serum serum
56. β-2-mikroglobulin β-2-microglobulin
KZMBLM-SOP98/3
Imunoturbidimetrija Immunoturbidimetry
57. Konjugirani bilirubin
Conjugated bilirubin
KZMBLM-
SOP99/3
Fotometrija s 3,5-diklorfenil-
diazonium-tetrafluoroboratom (DPD)
Photometric colour test (DPD method)
58. Glukoza Glucose
KZMBLM-
SOP100/3
Fotometrijska enzimska UV
metoda s heksokinazom Enzymatic UV test
(hexokinase method)
mokraća
urine
59. Kreatinin
Creatinine
KZMBLM-
SOP101/3
Kontinuirana fotometrijska metoda (Jaffe-ova metoda)
Kinetic colour test (Jaffe method)
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 7 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
60. Urati
Urates
KZMBLM- SOP102/4
Fotometrijska enzimska metoda s urikazom i askorbat-oksidazom
Enzymatic colour test with uricase and ascorbate
oxidase
mokraća urine
61. Ureja
Urea
KZMBLM- SOP103/3
Fotometrijska UV metoda Kinetic UV test
62. Ukupni proteini Total protein
KZMBLM- SOP104/3
Fotometrija s pirogalol crvenilom
Photometric colour test
(Pyrogallol red)
mokraća,
likvor urine,
cerebrospinal fluid
63.
-amilaza (AMS) (EC
3.2.1.1) α-amylase
KZMBLM- SOP105/4
Fotometrijska metoda (IFCC metoda)
Kinetic colour test
(IFCC method)
mokraća,
pleuralni izljev,
ascites,
dren urine, pleural
effusion, ascites,
secretion from
drains
64. Fosfati-anorganski
Inorganic phosphorous
KZMBLM- SOP106/4
Fotometrijska UV metoda s
amonij-molibdatom Photometric UV-test with
ammoniummolybdate
mokraća
urine
65. Kalij
Potassium KZMBLM- SOP107/3
Indirektna potenciometrija Indirect potentiometry
mokraća urine
66. Kloridi
Chloride KZMBLM- SOP108/3
Indirektna potenciometrija Indirect potentiometry
mokraća urine
67. Natrij
Sodium
KZMBLM- SOP109/3
Indirektna potenciometrija Indirect potentiometry
mokraća urine
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 8 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
68.
Moždani natriuretički peptid (BNP)
Human B-type natriuretic
peptide (BNP)
KZMBLM-
SOP118/3
Kemiluminiscentno imunokemijsko određivanje
pomoću magnetskih
mikročestica (CMIA)
Chemiluminescent magnetic
micro particle immunoassay (CMIA) technology
plazma
plasma
69.
Plazmatski protein A
povezan s trudnoćom
(PAPP-A) Pregnancy-associated
plasma protein-A (PAPP-A)
KZMBLM- SOP132/4
Elektrokemiluminiscencija (ECLIA)
EIectrochemiluminiscen
ceimmunoassay(ECLIA)
serum serum
70.
Slobodna ß-hCG
podjedinica (slobodna ß-hCG)
Free ß-subunit of human
chorionic gonadotropin (free ß-hCG)
KZMBLM- SOP133/4
Elektrokemiluminiscencija (ECLIA)
EIectrochemiluminiscen
ceimmunoassay(ECLIA)
serum serum
71.
Ugljikohidratni antigen (CA
15-3) Cancer antigen 15-3
KZMBLM-
SOP135/2
Elektrokemiluminiscencija (ECLIA)
EIectrochemiluminiscen
ceimmunoassay(ECLIA)
serum
serum
72.
Lipokalin udružen s
neutrofilnom gelatinazom u urinu (NGAL)
Urinary neutrophil
gelatinase- associated lipocalin (NGAL)
KZMBLM-
SOP116/2
Kemiluminiscentno
imunokemijsko određivanje pomoću magnetskih
mikročestica(CMIA)
Chemiluminescent magnetic
micro particle immunoassay (CMIA) technology
mokraća urine
73. Standardizirani kreatinin
Standardized creatinine
KZMBLM-
SOP139/2
Enzimska metoda Enzymatic method serum
serum 74.
Standardizirani kreatinin
Standardized creatinine
KZMBLM-
SOP140/2
Kompenzirani Jaffe Compensated Jaffe
75. Analiza sedimenta mokraće
Urine sediment analysis
KZMBLM-
SOP145/2
Automatizirana
mikroskopija sedimenta
mokraće Automated urine sediment
microscopy
mokraća
urine
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 9 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
76. Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c)
KZMBLM- SOP500/2
Imunoturbidimetrija Immunoturbidimetry
puna krv
whole blood
77. Slobodni trijodtironin (fT3)
Free triiodthyronine KZMBLM- SOP503/3
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminiscent immunoassay (CLIA)
serum serum
78. Slobodni tiroksin (fT4)
Free Thyroxine
KZMBLM-
SOP504/3
79. Ukupni trijodtironin (T3)
Total triiodthyronine KZMBLM- SOP505/3
80. Ukupni tiroksin (T4)
Total Thyroxine
KZMBLM-
SOP506/3
81.
Tireoidni stimulirajući hormon-tireotropin (TSH)
Thyrotropin
KZMBLM- SOP507/3
82.
Inzulin
Insulin
KZMBLM-
SOP510/3
83.
Albumin-u mokraći (mikroalbumin)
Urinary albumin (microalbumin)
KZMBLM-
SOP512/3
Imunoturbidimetrija
Immunoturbidimetry
mokraća
urine
84. Osmolalnost Osmolality
KZMBLM- SOP520/2
Krioskopija Crioscopy
serum,
mokraća serum, urine
85.
Parcijalni tlak kisika (pO2)
Oxygen partial pressue
KZMBLM- SOP530/3
Elektrokemijske metode
kalibrirane s komprimiranim pinovima
Electrochemical methods calibrated with compressed
gas cartridges
ed gas cartridges
arterijska i
kapilarna krv
arterial
and capillary
blood
86.
Parcijalni tlak ugljičnog
dioksida (pCO2) Carbon dioxide partial
pressue
KZMBLM- SOP531/3
87. pH KZMBLM-
SOP532/3
Elektrokemijska metoda
sljediva do NIST SRM 186 referentnog materijala
Electrochemical method traceable to NIST SRM 186
reference materials
88. Fruktoza
Fructose
KZMBLM-
SOP533/3
Spektrofotometrija (fosfo-
glukoza-izomeraza/heksokinaza)
Spectrophotometry (phospho-glucose-
isomerase/hexokinase)
sjemena tekućina
seminal fluid
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 10 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
89. Kortizol
Cortisol
KZMBLM-
SOP502/3
Kemiluminiscentna imuno-
analiza (CLIA) Chemiluminiscent
immunoassay (CLIA)
serum, mokraća serum,
urine
90. PTH
PTH
KZMBLM-
SOP509/3
plazma
plasma
91. Anti TPO Anti TPO
KZMBLM-SOP513/3
serum serum
92. Anti TG Anti TG
KZMBLM-SOP514/3
93. APO A1 APO A1
KZMBLM-SOP523/2
Imunoturbidimetrija
Immunoturbidimetry 94.
APO B
APO B
KZMBLM-
SOP524/2
95. Lp(a) Lp(a)
KZMBLM-SOP525/2
96. Ukupni kalcij Total calcium
KZMBLM-SOP529/2
Spektrofotometrija s kromogenom arsenazo III Spectrophotometry with
arsenazo III chromogen
serum,
mokraća serum,
urine
97.
Dehidroepiandrosteron
-sulfat (DHEAS) Dehydroepiandrosterone
-sulfate (DHEAS)
KZMBLM-SOP537/2
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminiscent immunoassay (CLIA)
serum
serum
98. Estradiol
Estradiol KZMBLM-SOP538/2
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminiscent
immunoassay (CLIA)
serum serum
99. Folitropin (FSH)
Follitropin (FSH)
KZMBLM-
SOP539/3
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminiscent immunoassay (CLIA)
serum
serum
100. Lutropin (LH)
Lutropin (LH) KZMBLM-SOP540/3
Kemiluminiscentna imuno-
analiza (CLIA) Chemiluminiscent
immunoassay (CLIA)
serum
serum
101. Progesteron
Progesterone KZMBLM-SOP541/3
Kemiluminiscentna imuno-
analiza (CLIA) Chemiluminiscent
immunoassay (CLIA)
serum serum
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 11 od/of 16
Br.
No. Pretraga
Examination
Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
102. Prolaktin
Prolactin KZMBLM-
SOP542/3
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminiscent immunoassay (CLIA)
serum serum
103.
Globulin koji veže spolne
hormone (SHBG) Sex hormone - binding
globulin (SHBG)
KZMBLM-SOP543/2
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminiscent immunoassay (CLIA)
serum serum
104. Testosteron
Testosterone KZMBLM-
SOP544/3
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminescent immunoassay (CLIA)
serum
serum
105.
Ukupni korionski gonadotropin (hCG + hCG
beta) Human chorionic
gonadotropin (hCG)
KZMBLM-
SOP545/3
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminescent immunoassay (CLIA)
serum
serum
106. Kalcij-ukupni Total calcium
KZMBLM-SOP147/2
Fotometrijska metoda s o-krezolftaleinom
Photometric colour test
(o-cresolphthalein method)
mokraća urine
107.
Ukupni
korionskigonadotropin (hCG + hCG beta)
Chorionic gonadotropin
KZMBLM-SOP148/2
Kemiluminiscentno
imunokemijsko Određivanje pomoću
magnetskih
mikročestica (CMIA) Chemiluminescent
magnetic micriparticle
immunoassay (CMIA)
technology
serum serum
108. C-peptid C-peptide
KZMBLM-SOP556/2
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminiscent immunoassay (CLIA
serum
serum 109.
Adrenokortikotropni hormon-kortikotropin
(ACTH)
Adrenocorticotropic hormone (ACTH)
KZMBLM-
SOP557/2
110. Hormon rasta (hGH)
Growth hormone (hGH)
KZMBLM-
SOP558/2
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 12 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
111. Anti-Mϋllerov hormon
(AMH)
Anti-Müllerian hormone
KZMBLM-SOP559/2
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminiscent
immunoassay (CLIA
serum serum
112. Homocistein
Homocysteine
KZMBLM-
SOP560/2
Kemiluminiscentna imuno-analiza (CLIA)
Chemiluminiscent immunoassay (CLIA
plazma plasma
113.
Elektroforeza proteina u serumu
Serum protein electrophoresis
KZMBLM-
SOP150/2
Elektroforeza na agarozi
Agarose electrophoresis serum
serum
114. Bakar
Copper KZMBLM-SOP151/1
Atomska apsorpcijska
spektrometrija Atomic Absorption
Spectroscopy
115. Ciklosporin
Cyclosporine
KZMBLM-SOP153/1
Tekućinska kromatografija
s dvojnom spektrometrijom masa
Liquid chromatography-
tandem mass spectrometry
puna krv
whole blood
116. Takrolimus Tacrolimus
KZMBLM-
SOP154/1
117. Sirolimus Sirolimus
KZMBLM-SOP155/1
118. Everolimus Everolimus
KZMBLM-SOP156/1
119. Mikofenolna kiselina
Mycophenolic acid
KZMBLM-
SOP157/1
Tekućinska kromatografija visoke učinkovitosti s UV
detektorom
High performance liquid chromatography with UV
detector
plazma
plasma
120. Fruktozamin
Fructosamine
KZMBLM-SOP561/1
NBT kolorimetrija NBT colorimetric
serum serum
121. Visoko osjetljivi troponin I
High-sensitivity Troponin I
KZMBLM-SOP152/2
Kemiluminiscentna
imunokemijska metoda na mikročesticama (CMIA)
Chemiluminescent microparticle immunoassay
(CMIA)
EDTA-plazma
EDTA-plasma
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 13 od/of 16
Laboratorijska hematologija i koagulacija/ Laboratory Haematology and coagulation
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
1. Krvna slika na brojaču
Haematology parameters on
automated analyzer
KZMBLM-SOP1/7
Protočna citometrija s
poluvo-dičkim laserom,
hidrodinamičko fokusiranje,
spektrofotome-trijsko
određivanje hemoglobina
Flow cytometry method using se-miconductor
laser,hydro dynamic focusing,
spectrophotometric SLS-haemoglobin
method
puna krv
whole blood
2. Fibrinogen
Fibrinogen KZMBLM-SOP2/8
Koagulometrija
Coagulometry
plazma plasma
3. Protrombinsko vrijeme
Prothrombin time KZMBLM-SOP3/8
4.
Aktivirano parcijalno
tromboplastinsko vrijeme
Activated partial
thromboplastin time
KZMBLM-SOP4/8
5. D-dimer D-dimer
KZMBLM-SOP134/5
Imunoturbidimetrija Immunoturbidimetry
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 14 od/of 16
Laboratorijska imunologija-imunofenotipizacija stanica
Cell Immunology - Imunophenotyping
Br.
No.
Pretraga
Examination
Postupak/izdanje
Procedure/revision
Vrsta ispitivanja
Type of examination
Uzorak
Sample
1. CD3+T limfociti
CD3+T lymphocyte KZMBLM-
SOP5/6
Protočna citometrija
Flow Cytometry
puna krv
whole blood
2.
Pomoćnički T limfociti
(CD4+T limfociti) Helper T lymphocyte
(CD4+T lymphocyte)
KZMBLM-
SOP6/6
3.
Citotoksično-supresijski T
limfociti CD8+T limfociti)
Cytotoxic-suppressor T lymphocyte
(CD8+T lymphocyte)
KZMBLM-
SOP7/6
4. B limfociti (CD19)
B lymphocyte (CD19)
KZMBLM
SOP8/6
5.
NK stanice (CD16+CD56+CD3-
NK cells (CD16+CD56+CD3-)
KZMBLM-
SOP9/6
6. Leukociti (CD45)
Leukocytes (CD45)
KZMBLM-
SOP10/6
7. Matične stanice (CD34)
Stem cells (CD34) KZMBLM-
SOP11/6
puna krv, limfni čvor,
koštana srž whole blood, lymph node
aspirates, bone
marrow
8. CD2+ stanice CD2+ cells
KZMBLM-SOP12/6
9. CD3+ stanice CD3+ cells
KZMBLM-SOP13/6
10. CD4+ stanice CD4+ cells
KZMBLM-SOP14/6
11. CD5+ stanice
CD5+ cells
KZMBLM-
SOP15/6
12. CD7+ stanice CD7+ cells
KZMBLM-SOP16/6
13. CD8+ stanice
CD8+ cells
KZMBLM-
SOP17/6
14. CD13+ stanice CD13+ cells
KZMBLM-SOP18/6
15. CD14+ stanice
CD14+ cells
KZMBLM-
SOP19/6
16. CD19+ stanice CD19+ cells
KZMBLM-SOP20/6
17. CD33+ stanice
CD33+ cells
KZMBLM-
SOP21/6
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 15 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
18. CD34+ stanice CD34+ cells
KZMBLM-SOP22/6
Protočna citometrija
Flow Cytometry
puna krv,
limfni čvor, koštana srž
whole blood,
lymph node aspirates,
bone marrow
19. HLA D/DR+ stanice HLA D/DR+ cells
KZMBLM-SOP23/6
20.
KAPPA laki lanac+ B
limfociti KAPPA light chain+ B lymphocytes
(KAPPA+CD19+)
KZMBLM-SOP24/6
21.
LAMBDA laki lanac+B limfociti
(LAMBDA+CD19+) LAMBDA light chain+B
lymphocytes
(LAMBDA+CD19+)
KZMBLM-SOP25/6
22.
Antitijela protiv stanične jezgre (ANA)
Antinucler antibodies
(ANA)
KZMBLM-SOP555/3
Indirektna imunoflorescencija
Indirect
immunofluorescence
serum serum
Molekularna dijagnostika – Molecular Diagnostics
Br.
No.
Pretraga
Examination
Postupak/izdanje
Procedure/revision
Vrsta ispitivanja
Type of examination
Uzorak
Sample
1.
IgH preuredba (BIOMED-2)
IgH rearrangement (BIOMED-2)
KZMBLM-
SOP29/7
Lančana reakcija
polimerazom (PCR) Polymerase chain reaction
(PCR)
puna krv, limfni čvor,
koštana srž, tkivo
whole blood,
lymph node aspirates,
bone marrow,
tissue
2.
TCR preuredba (BIOMED-
2) TCR rearrangement
(BIOMED-2)
KZMBLM-SOP89/7
3.
TCR preuredba (GAMMA)
TCR rearrangement (GAMMA)
KZMBLM-SOP90/5
4. JAK 2 (V617F) JAK 2 (V617F)
KZMBLM-SOP91/5
puna krv,
koštana srž whole blood,
bone marrow
5. Nasljedna hemokromatoza
(HFE) Hemocromatosis (HFE)
KZMBLM-SOP92/6
puna krv, whole blood
Prilog potvrdi o akreditaciji Annex to the Accreditation Certificate
7130
Datum izdanja priloga/ Annex Issued on 2016-02-25
Zamjenjuje pri log od/Replaces Annex dated: 2015-11-09
HAA-Ob-7/7-2/8 /Izdanje/Issue:4 stranica/page 16 od/of 16
Br.
No. Pretraga
Examination Postupak/izdanje
Procedure/revision Vrsta ispitivanja
Type of examination Uzorak
Sample
6. t(9;22); prijepis BCR-ABL
t(9;22); transcript BCR-ABL
KZMBLM-SOP85/7
Reverzna transkripcija-
lančana reakcija polimerazom (RT-PCR) Reverse transcription-
polymerase chain reaction (RT-PCR)
venska krv, koštana srž,
pročišćene matične stanice
(produkt citofereze)
venous blood, bone
marrow,
buffy coat
7.
t(8;21); prijepis AML1-
ETO t(8;21); transcript AML1-
ETO
KZMBLM-SOP86/6
8.
t(15;17); prijepis PML-
RAR
t(15;17); transcript PML-
RAR
KZMBLM-
SOP87/6
9.
inv16; prijepis CBF-
MYH11
inv16; transcript CBF-
MYH11
KZMBLM-SOP88/7
10.
Paraoksonaza 1 – polimorfizam
Paraoxonase 1 - polymorphism
KZMBLM-
SOP117/5
Lančana reakcija polimerazom –
polimorfizam duljine restrikcijskih fragmenata
(PCR-RFLP) Polymerase chain reaction
– restriction fragment
lenght polymorphism (PCR-RFLP)
puna krv
whole blood
11.
Fms-slična tirozin
kinaza 3 (FLT3/ITD)
FMS-like tyrosine kinase 3
KZMBLM- SOP125/7
Reverzna transkripcija-
lančana reakcija polimerazom (RT-PCR) Reverse transcription-
polymerase chain reaction (RT-PCR)
puna krv koštana srž whole blood
bone marrow