Područje akreditacije: Scope of accreditation:
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2 PRILOG POTVRDI O AKREDITACIJI br: Annex to Accreditation Certificate Number: Klasa/Ref. No.: /07-35/01 Urbroj/Id. No.: / Datum izdanja priloga /Annex Issued on: Zamjenjuje prilog/replaces Annex: Klasa/Ref. No.: /07-35/001 Urbroj/Id. No.: / Datum/Date: Norma: HRN EN ISO 15189:2008 Standard: (ISO 15189:2007; EN ISO 15189:2007) Akreditacija istječe: Accreditation expiry: Prva akreditacija: Initial accreditation: Akreditirani laboratorij Accredited laboratory KLINIČKI BOLNIČKI CENTAR SESTRE MILOSRDNICE KLINIČKI ZAVOD ZA KEMIJU Klinička jedinica za prijem bolesnika i distribuciju uzoraka Klinička jedinica za medicinsku biokemiju s analitičkom toksikologijom Klinička jedinica za laboratorijsku hematologiju i koagulaciju Klinička jedinica za specijalnu medicinsku biokemiju Klinička jedinica za molekularnu dijagnostiku Vinogradska 29, HR Zagreb Područje akreditacije: Scope of accreditation: Medicinska biokemija - ispitivanja u području kliničke kemije, laboratorijske hematologije i koagulacije, laboratorijske imunologije, toksikologije i molekularne dijagnostike Medical Biochemistry Testing in the field of Clinical Chemistry, Laboratory Hematology and Coagulation, Laboratory Immunology, Toxicology and Molecular Diagnostics Važeće izdanje Priloga dostupno je na web adresi: / Valid issue of the Annex is available at the web address: Ravnateljica: Director General: mr. sc. Biserka Bajzek Brezak, dipl. ing. HAA-Ob-7/7-2/18/Izdanje 2 stranica/page 1 od/of 15
3 PODRUČJE AKREDITACIJE / SCOPE OF ACCREDITATION Klinička kemija/ Clinical chemistry br Imunoglobulin G (IgG) Immunoglobulin G (IgG) Imunoglobulin G (IgG) Immunoglobulin G (IgG) Imunoglobulin M (IgM) Immunoglobulin M (IgM) Imunoglobulin A (IgA) Immunoglobulin A (IgA) Lagani lanci imunoglobulina kapa tipa (Ig/L-kapa) Light immunoglobulin chains kappa type (Ig/L-kappa) Lagani lanci imunoglobulina lambda tipa (Ig/L-lambda) Light immunoglobulin chains lambda type (Ig/L-lambda) Albumin (Alb) Albumin (Alb) Albumin (Alb) Albumin (Alb) Albumin (Alb) Albumin (Alb) Ceruloplazmin (Cp) Ceruloplasmin (Cp) Haptoglobin (Hp) Haptoglobin (Hp) MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /2 Imunonefelometrija Immunonephelometry Cerebrospinalna tekućina Cerebrospinal fluid Cerebrospinalna tekućina Cerebrospinal fluid 12. Transferin (Tf) Transferrin (Tf) MP /1 Imunoturbidimetrija Immunoturbidimetry 13. Imunoglobulin A (IgA) Immunoglobulin A (IgA) MP /1 HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 2 od/of 15
4 br Imunoglobulin G (IgG) Immunoglobulin G (IgG Imunoglobulin M (IgM) Immunoglobulin M (IgM) Komplement - komponenta C3 (C3) Complement - component C3 (C3) Komplement - komponenta C4 (C4) Complement - component C4 (C4) MP /1 MP /1 MP /1 MP /1 Imunoturbidimetrija Immunoturbidimetry α-1-antitripsin (AAT) α-1-antitrypsin (AAT) Apolipoprotein A I (Apo A I) Apolipoprotein A I (Apo A I) Apolipoprotein B (Apo B) Apolipoprotein B (Apo B) Troponin T (Tn T) Troponin T (Tn T) Vitamin B12 Vitamin B12 Folna kiselina Folic acid Mioglobin (Mb) Myoglobin (Mb) Mioglobin (Mb) Myoglobin (Mb) Osteokalcin Osteocalcin C-terminalni crosslinking telopeptid kolagena tip I (CTX) C-terminal crosslinking collagen telopeptide type I (CTX) Kalij Potassium Kalij Potassium Kalij Potassium Kalij Potassium MP /2 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Imunonefelometrija Immunonephelometry Elektrokemiluminiscencija Electrochemiluminescence Potenciometrija Potentiometry, plazma, plasma, plazma, plasma Plazma Plasma Cerebrospinalna tekućina Cerebrospinal fluid HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 3 od/of 15
5 br Natrij Sodium Natrij Sodium Natrij Sodium Kloridi Chloride Kloridi Chloride Kloridi Chloride Alanin-aminotransferaza (ALT) Alanine-aminotransferase (ALT) Albumin (Alb) Albumin (Alb) Alkalna fosfataza (ALP) Alkaline phosphatase (ALP) α-amilaza (AMS) α-amylase (AMS) α-amilaza (AMS) α-amylase (AMS) α-amilaza (AMS) α-amylase (AMS) Angiotenzin-konvertaza (ACE) Angiotensin-converting enzyme (ACE) Aspartataminotransferaza (AST) Aspartateaminotransferase (AST) Bilirubin - konjugirani Bilirubin - conjugated Bilirubin - ukupni Bilirubin - total Kalcij - ukupni Calcium - total Kalcij - ukupni Calcium - total MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Potenciometrija Potentiometry Spektrofotometrija Spectrophotometry Cerebrospinalna tekućina Cerebrospinal fluid Cerebrospinalna tekućina Cerebrospinal fluid, plazma,, plasma, Punktati Puncture, plazma, plasma, plazma,, plasma,, plazma, plasma HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 4 od/of 15
6 br Karboksihemoglobin (COHb) Carboxyhemoglobin (COHb) Kolesterol - ukupni Cholesterol - total Kolesterol - HDL Cholesterol - HDL Kolesterol - LDL Cholesterol - LDL Kreatin-kinaza (CK) Creatine-kinase (CK) Izoenzim kreatin-kinaze MB (CK-MB) Creatin- kinase MB izoenzyme (CK-MB) Kreatinin Creatinine Kreatinin Creatinine γ-glutamiltransferaza (GGT) γ-glutamyltransferase (GGT) Glukoza Glucose Glukoza Glucose Glukoza Glucose Glukoza Glucose Fosfati - anorganski Phosphates - inorganic Fosfati - anorganski Phosphates - inorganic Željezo Iron MP /1 MP /1 MP /1 MP /1 MP /1 MP /2 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Spektrofotometrija Spectrophotometry Puna krv, plazma Whole blood, plasma, plazma,, plasma,, plazma, plasma, amnijska tekućina, amniotic fluid, plazma,, plasma,, plazma, plasma urine Cerebrospinalna tekućina Cerebrospinal fluid Punktati Puncture, plazma, plasma, plazma,, plasma, HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 5 od/of 15
7 br Laktat-dehidrogenaza (LD) Lactate-dehydrogenase (LD) Laktat-dehidrogenaza (LD) Lactate-dehydrogenase (LD) Lipaza (LPS) Lipase (LPS) Magnezij - ukupni Magnesium - total Magnezij - ukupni Magnesium - total Methemoglobin (MetHb) Methemoglobin (MetHb) Porfirini - ukupni Porphyrins - total Ukupni proteini Total proteins Ukupni proteini Total proteins Ukupni proteini Total proteins Ukupni proteini Total proteins Trigliceridi Triglycerides Željezo - nezasićeni kapacitet vezanja željeza (UIBC) Iron - unsaturated iron binding capacity (UIBC) Urea Urea Urea Urea Urati Uric acid Urati Uric acid 5'-nukleotidaza 5 -nucleotidase MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /2 MP /2 MP /1 MP /2 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Spektrofotometrija Spectrophotometry Punktati Puncture, plazma, plasma, plazma,, plasma,, plazma, plasma Puna krv, plazma Whole blood, plasma, plazma, plasma Punktati Puncture Cerebrospinalna tekućina Cerebrospinal fluid, plazma,, plasma,, plazma, plasma, plazma, plasma HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 6 od/of 15
8 br. 84. Ukupne žučne kiseline Total bile acids, MP /2 Spektrofotometrija Spectrophotometry Hemoglobin - slobodni Hemoglobin - free Hemoglobin - fetalni (HbF) Hemoglobin fetal (HbF) Kolesterol - LDL Cholesterol - LDL Bilirubin - nekonjugirani Bilirubin - unconjugated Saturacija željeza Fe saturation Željezo - ukupni kapacitet vezanja željeza (TIBC) Iron - total iron binding capacity (TIBC) MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Spektrofotometrija Spectrophotometry Računski Calculating Plazma Plasma Hemolizat Hemolysate, plazma,, plasma, Molekularna dijagnostika / Molecular diagnostics Enzimi metabolizma lijekova (CYP2C9) - genotipizacija alela *2 i *3 CYP2C9 - genotyping of alelles *2 and *3 Enzimi metabolizma lijekova (CYP2C19) - genotipizacija alela *2 i *3 CYP2C19 - genotyping of alelles *2 and *3 Nasljedna hemokromatoza (HFE) - genotipizacija polimorfizma H63D, S65C, C282Y Hereditary hemochromatosis (HFE) - genotyping of H63D, S65C, C282Y polymorphism MP /1 MP /1 MP /1 Analiza krivulje taljenja Melting curve analysis DNK DNA HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 7 od/of 15
9 Alfa-1-antitripsin (AAT) genotipizacija alela PiZ (Glu342Lys) i PiS (Glu264Val) Alfa-1-antitrypsin (AAT) genotyping of alelles PiZ (Glu342Lys) and PiS (Glu264Val) Angiotenzin konvertirajući enzim (ACE) - genotipizacija polimorfizma I/D Angiotensine converting enzime (ACE) - genotyping of I/D polymorphism UDP glukuronil transferaza (UGT1A1, Gilbertov sindrom) - genotipizacija alela *28 (TA6/7) UDP glucuronyl transferase (UGT1A1, Gilbert syndrome) - genotyping of alelle *28 (TA6/7) MP /1 MP /1 MP /1 Analiza krivulje taljenja Melting curve analysis Lančana reakcija polimeraze (PCR) Polimerase chain reaction (PCR) DNK DNA DNK DNA Laboratorijska imunologija / Laboratory Immunology Antitijela na dvostruku uzvojnicu DNA (dsdna) Autoantibodies to doublestranded DNA (dsdna) Antikardiolipinska antitijela IgG (acl) Anti-cardiolipin IgG (acl) Antikardiolipinska antitijela IgM (acl) Anti-cardiolipin IgM (acl) Antitijela na proteinazu 3 (Pr-3) Anti-proteinase 3 (Anti- PR3) MP /1 MP /1 MP /1 MP /1 Enzimski imunotest (ELISA) Enzyme-linked immunosorbent assay (ELISA), plazma, plasma HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 8 od/of 15
10 Antitijela na mijeloperoksidazu (MPO) Anti-Myeloperoxidase (Anti-MPO) Antitijela na humanu transglutaminazu IgA (ttg-iga) Anti-tissue transglutaminase IgA (ttg-iga) Antitijela na cikličke citrulinirane peptide (anti-ccp) Anti-cyclic citrullinated peptides (Anti-CCP) Antitijela na SS-A (Ro) Antibodies against SS-A Antitijela na SS-B (La) Antibodies against SS-B Antitijela na Sm Antibodies against Sm Antitijela na RNP/Sm kompleks a Antibodies against nrnp/sm complex Antitijela na Scl-70 Antibodies against Scl-70 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Enzimski imunotest (ELISA) Enzyme-linked immunosorbent assay (ELISA), plazma, plasma 109. Antitijela na Jo1 Antibodies against Jo-1 MP / Antimitohondrijalna antitijela (AMA) - M2 Antibodies against AMA- M2 MP /1 Imunoblot Immunoblot, plazma, plasma 111. Antitijela na histone Antibodies against histones MP /1 HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 9 od/of 15
11 Antitijela na mikrosome jetre i bubrega (LKM) - LKM-1 Antibodies against LKM- 1 Antitijela na Jo1 (kvalitativno) Antibodies against Jo-1 (qualitative) Antitijela na RNP/Sm kompleks a (kvalitativno) Antibodies against nrnp/sm complex (qualitative) Antitijela na Sm (kvalitativno) Antibodies against Sm (qualitative) Antitijela na SS-A (Ro) (kvalitativno) Antibodies against SS-A (qualitative) Antitijela na SS-B (La) (kvalitativno) Antibodies against SS-B (qualitative) MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Imunoblot Immunoblot, plazma, plasma 118. Antitijela na Scl-70 (kvalitativno) Antitijela na Scl-70 (qualitative) MP / Antinuklearna antitijela (ANA) Antinuclear antibodies (ANA) Antimitohondrijalna antitijela (AMA) Antibodies against mitochondria (AMA) Antitijela na glatku muskulaturu (AGLM) Antibodies against smooth muscles (ASMA) Antitijela na mikrosome jetre i bubrega (LKM) Antiobodies against liverkidney microsomes (LKM) MP /1 MP /1 MP /1 MP /1 Indirektna imunofluorescencija Indirect immunofluorescence, plazma, plasma HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 10 od/of 15
12 Indirektna imunofluorescencija Indirect immunofluorescence 123. ANCA screening Antibodies against cytoplasm of granulocytes (ANCA) MP /1, plazma, plasma Laboratorijska koagulacija / Laboratory coagulation D dimeri D- dimers Fibrinogen Fibrinogen Protrombinsko vrijeme (PV) - % Prothrombin time (PT) - % Protrombinsko vrijeme INR (PV INR) Prothrombin time INR (PT INR) Aktivirano parcijalno tromboplastinsko vrijeme (APTV) sekunde Activated partial thromboplastin time - seconds Aktivirano parcijalno tromboplastinsko vrijeme (APTV) omjer Activated partial thromboplastin time - ratio MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Imunoturidimetrija Immunoturbidimetry Koagulometrija Coagulometric test Plazma Plasma HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 11 od/of 15
13 Trombinsko vrijeme (TV) Thrombin time (TT) Put proteina C Protein C pathway APC rezistencija (APCR) Activated protein C resistance (APCR) Faktor II (FII) - % Factor II (FII) - % Faktor V (FV) - % Factor V (FV) - % Faktor VII (FVII) - % Factor VII (FVII) - % Faktor VIII (FVIII) - % Factor VIII (FVIII) - % Faktor IX (FIX) - % Factor IX (FIX) - % Faktor X (FX) - % Factor X (FX) - % Faktor XI (FXI) - % Factor XI (FXI) - % Faktor XII (FXII) - % Factor XII (FXII) - % Lupus antikoagulant (LAC) omjer Lupus anticoagulant (LAC) - ratio Inhibitor faktora II Factor II inhibitor Inhibitor faktora V Factor V inhibitor Inhibitor faktora VII Factor VII inhibitor MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Koagulometrija Coagulometric test Plazma Plasma HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 12 od/of 15
14 Inhibitor faktora VIII Factor VIII inhibitor Inhibitor faktora IX Factor IX inhibitor Inhibitor faktora X Factor X inhibitor Inhibitor faktora XI Factor XI inhibitor Inhibitor faktora XII Factor XII inhibitor APTV(s) test miješanja uz LAC APTT(s) mixing test for LAC Antitrombin (AT) - % Antithrombin (AT) - % Protein C (PC) - % Protein C (PC) - % Faktor XIII (FXIII) - % Factor XIII (FXIII) - % Inhibitor faktora XIII Factor XIII inhibitor Plazminogen - % Plasminogen - % MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Koagulometrija Coagulometric test Kromogena Chromogenic method Plazma Plasma 156. Razgradni produkti fibrinogena/fibrina (FDP) Fibrinogen/fibrin degradation products (FDP) MP /1 Lateks aglutinacija Latex agglutination Protrombinsko vrijeme INR (PV INR) Prothrombin time INR (PT INR) von Willebrandov faktor (vwf Ri:Co) - % Von Willebrand Factor (vwf Ri:Co) - % MP /1 MP /1 Reflektantna fotometrija Reflectance photometry Turbidimetrija Turbidimetry Puna krv Whole blood Plazma Plasma HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 13 od/of 15
15 Laboratorijska hematologija / Laboratory hematology Osmotska rezistencija eritrocita Osmotic resistance of erythrocytes Sedimentacija eritrocita - modifikacija metode po Westergrenu Erythrocyte sedimentation rate (ESR) - modified Westergren method - manual Krvne stanice u ascitesu Blood cells in ascites Krvne stanice u dijalizatu/ma Blood cells in dialyzed and speciments Kompletna krvna slika Differential blood count MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 MP /1 Kolorimetrija Colorimetric method modifikacija metode po Westergrenu ručna i automatska modified Westergren method manual and automated Optička metoda Optic count Optička metoda Optic count Impedancija /Impedantion Impedancija i optička metoda Impedantion and optical count Metoda po Pappenheimu Pappenheim method Protočna citometrija Flow citometry Računski Calculatimg Spektrofotometrija Spectrofotometry VCS (volumetrija, provodljivost, raspršenje) VCS (volumetry, scattering, conductivity) Puna krv Whole blood Ascites Ascites Dijalizat, Dialyzed and speciments Puna krv Whole blood HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 14 od/of 15
16 Toksikologija / Toxicology Digoksin Digoxin Fenobarbiton Phenobarbital Karbamazepin Carbamazepine Valproična kiselina Valproic acid Teofilin Theophylline Litij Lithium Etilni alkohol Ethanol MP /2 MP /2 MP /2 MP /2 MP /2 MP /1 MP /1 MEIA (enzimski imunotest na mikročesticama) MEIA (mocroparticle enzyme immunoassay) Imunofluorecsentna polarizacija Immunofluorescent polarizacion Kolorimetrijska Cholorimetric method, plazma, plasma HAA-Ob-7/7-2/8 / Izdanje 2 stranica/page 15 od/of 15
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