CORMAY CONTROL SERUM HN CORMAY CONTROL SERUM HP

Transcription

1 CORMAY CONTROL SERUM HN CORMAY CONTROL SERUM HP CONTROL SERUM (LYOPHILISED) CORMAY SERUM HN 4 x 5 ml Cat. No CORMAY SERUM HP 4 x 5 ml Cat. No CORMAY SERUM HN / CORMAY SERUM HP is lyophilised serum of human origin designed for routine quality control of inorganic, organic and enzymatic constituents being generally within normal range (CORMAY SERUM HN) or pathological range (CORMAY SERUM HP). The calculated target values are results of tests performed by automated analysers as well as manual methods. Maximum permissible deviation range (RANGE) corresponds with mean assigned value (ASSIGNED VALUE) + 2 SD (standard deviation). RECONSTITUTION Open the vial carefully and add exactly 5 ml of distilled water at C, close bottle and let stand out of bright light for 30 min. Dissolve contents completely by swirling gently, avoiding the formation of foam. Do not shake! Use only after complete reconstitution. STABILITY AND STORAGE 1. Lyophilised serum remains stable when stored at 2-8 C until expiry date given on the product label. 2. The constituents in reconstituted control serum are stable for (except of parameters mentioned in notes): Temp C Temp. 2-8 C Temp. -20 C 24 hours 7 days 30 days NOTES 1. When used for the quality control of alanine aminotransferase (ALT, ALAT, GPT) and/or aspartate aminotransferase (AST, ASAT, GOT) activity determination, CORMAY SERUM HN/HP can be stored up to 24 hours at C, up to 3 days at 2-8 C or up to 30 days at -20 C after reconstitution. 2. Bilirubin as well as other organic compounds are light sensitive and it is recommended that the serum be stored in the dark. Stored in the dark bilirubin is stable for 8 hours at 2-8 C. 3. The activity of alkaline phosphatase in reconstituted serum will rise over the stability period. It is recommended that the reconstituted serum be allowed to stand for 1 hour at C before measurement. 4. For total and prostatic acid phosphatase the material should be stabilized by adding 1 drop of 0,7 M acetic acid solution to 1 ml of serum. After stabilization total and prostatic acid phosphatase is stable for 2 hours at C, 2 days at 2-8 C or 30 days at -20 C. 5. This serum has been tested for the HIV antibody, HbsAg and HCV and found to be non-reactive. However this material should be handled as thought capable of transmitting infectious disease. WASTE MANAGEMENT Please refer to local legal requirements. Date of issue: MANUFACTURER P.Z. CORMAY ul. Rapackiego 19, Lublin, POLAND P.O. Box 122, Lublin 2 tel.: +48 (0) fax: +48 (0) AUTHORISED REPRESENTATIVE Europe Contact Steinäcker 20, D Aichwald, GERMANY tel.: +49 (0) fax: +49 (0) EuropeContact@t-online.de 01/05/09/04

2 CORMAY SERUM HN Nr kat/cat. No Seria / Lot: E Data wa6n. / Exp.: ALBUMINA ALBUMIN BILIRUBINA CA:KOWITA BILIRUBIN TOTAL BILIRUBINA BEZPO7REDNIA BILIRUBIN DIRECT BIA:KO CA:KOWITE CHOLESTEROL CA:KOWITY CHOLESTEROL TOTAL CHOLESTEROL HDL GLUKOZA GLUCOSE KREATYNINA CREATININE KWAS MOCZOWY URIC ACID MOCZNIK UREA TRIGLICERYDY TRIGLYCERIDES TOTAL PROTEIN WARTO78 7RODKOWA ASSIGNED VALUE ZieleG bromokrezolowa 41,0 g/l 33,6 48,3 Bromocresol green (BCG) 4,10 g/dl 3,36 4,83 Purpura bromokrezolowa 42,0 g/l 34,4 49,5 Bromocresol purple (BCP) 4,20 g/dl 3,44 4,95 41,3 g/l 33,8 48,7 Dry chemistry 4,13 g/dl 3,38 4,87 31,9 µmol/l 25,2 38,6 1,87 mg/dl 1,47 2,26 Malloy-Evelyn (Liquick Cor-BIL TOTAL) 31,9 µmol/l 25,2 38,6 1,87 mg/dl 1,47 2,26 24,9 µmol/l 19,7 30,2 Dry chemistry 1,46 mg/dl 1,15 1,77 18,4 µmol/l 14,6 22,3 1,08 mg/dl 0,85 1,31 Malloy-Evelyn (Liquick Cor-BIL DIRECT) 18,4 µmol/l 14,6 22,3 1,08 mg/dl 0,85 1,31 16,0 µmol/l 12,7 19,4 Dry chemistry 0,94 mg/dl 0,74 1,13 Kolorymetryczna z odczynnikiem biuretowym, punktu kogcowego 61,0 g/l 55,5 66,5 Biuret reaction (end-point) 6,10 g/dl 5,55 6,65 60,9 g/l 55,4 66,4 Dry chemistry 6,09 g/dl 5,54 6,64 Enzymatyczna esteraza/oksydaza cholesterolu (CHOD/PAP) 3,94 mmol/l 3,23 4,65 Cholesterol esterase/oxidase (CHOD/PAP) 152 mg/dl ,90 mmol/l 3,20 4,60 Dry chemistry 151 mg/dl Metoda bezpojrednia oparta na selektywnej inhibicji 1,21 mmol/l 1,00 1,42 Direct method (selective inhibition) 46,7 mg/dl 38,6 54,8 Enzymatyczna z oksydazl glukozy (GOD/PAP) 6,16 mmol/l 5,24 7,08 Glucose oxidase (GOD/PAP) 111 mg/dl 94,4-128 Enzymatyczna z heksokinazl 6,04 mmol/l 5,13 6,95 Hexokinase 109 mg/dl 92, ,89 mmol/l 5,01 6,77 Dry chemistry 106 mg/dl 90,3-122 Kinetyczna Jaffe, bez odbiamczania 117 µmol/l Kinetic Jaffe without deproteinization (CORMAY CREATININE) 1,33 mg/dl 1,09 1,57 Kinetyczna Jaffe, bez odbiamczania 128 µmol/l Kinetic Jaffe without deproteinization (Liquick Cor-CREATININE) 1,45 mg/dl 1,19 1, µmol/l 99,5-143 Dry chemistry 1,37 mg/dl 1,12 1,62 Enzymatyczna, kolorymetryczna z urikazl 381 µmol/l Enzymatic, colorimetric with uricase 6,40 mg/dl 5,31 7, µmol/l Dry chemistry 5,88 mg/dl 4,87 6,89 7,73 mmol/l 5,87 9,59 Kinetyczna z ureazl (UV) 46,5 mg/dl Kinetic with urease (UV) 35,3 57,6 Dry chemistry 21,7 mg BUN/dl 16,5 26,9 7,29 mmol/l 5,54 9,04 43,8 mg/dl 33,3 54,3 20,5 mg BUN/dl 15,6 25,4 Lipaza - kinaza glicerolowa (GPO-PAP), bez korekcji glicerolu 1,13 mmol/l 0,89 1,37 Lipase - glycerol kinase (GPO-PAP) without glycerol correction 100 mg/dl 78, ,23 mmol/l 0,97 1,49 Dry chemistry 109 mg/dl 85,8-132 ISE (metoda bezpojrednia) / ISE (direct method) 97,9 mmol/l 92,0-104 CHLORKI CHLORIDE ISE (metoda pojrednia) / ISE (indirect method) 97,4 mmol/l 91,6-103 / Dry chemistry 98,0 mmol/l 92,1-104 CYNK 22,8 µmol/l 18,2 27,5 ZINC Atomic absorption 149 µg/dl LIT LITHIUM ISE 0,96 mmol/l 0,84 1,08 FOSFOR (nieorganiczny) PHOSPHORUS (inorganic) MAGNEZ MAGNESIUM MIED> COPPER Kolorymetryczna z molibdenianem amonowym 1,48 mmol/l 1,26 1,70 Phosphomolybdate UV 4,59 mg/dl 3,91 5,27 1,46 mmol/l 1,24 1,68 Dry chemistry 4,53 mg/dl 3,84 5,21 Kolorymetryczna z kalmagitem 0,92 mmol/l 0,81 1,03 Calmagite 2,24 mg/dl 1,97 2,50 Kolorymetryczna z bmnkitem ksylidylowym 0,88 mmol/l 0,77 0,99 Xylidyl blue 2,14 mg/dl 1,87 2,41 0,89 mmol/l 0,78 1,00 Dry chemistry 2,16 mg/dl 1,90 2,43 14,8 µmol/l 12,6 17,1 Atomic absorption 94,2 µg/dl 80,1-108

3 CORMAY SERUM HN Nr kat./cat. No Seria / Lot: E Data wa6n. / Exp.: WARTO78 7RODKOWA ASSIGNED VALUE POTAS POTASSIUM SÓD SODIUM WAP@ CALCIUM CA:KOWITA ZDOLNO78 WIAZANIA BELAZA TOTAL IRON BINDING CAPACITY (TIBC) BELAZO IRON Fotometria pmomieniowa / Flame photometry 4,00 mmol/l 3,68 4,32 ISE (metoda bezpojrednia) / ISE (direct method) 4,01 mmol/l 3,69 4,33 ISE (metoda pojrednia) / ISE (indirect method) 4,00 mmol/l 3,68 4,32 / Dry chemistry 3,99 mmol/l 3,67 4,31 Fotometria pmomieniowa / Flame photometry 142 mmol/l ISE (metoda bezpojrednia) / ISE (direct method) 141 mmol/l ISE (metoda pojrednia) / ISE (indirect method) 142 mmol/l / Dry chemistry 142 mmol/l Kolorymetryczna z o-krezoloftaleinl 2,21 mmol/l 1,99 2,43 o-cresolphthalein Complexone 8,86 mg/dl 7,98 9,74 Kolorymetryczna z Arsenazo III 2,22 mmol/l 2,00 2,44 Arsenazo III 8,90 mg/dl 8,02 9,78 2,18 mmol/l 1,96 2,40 Dry chemistry 8,74 mg/dl 7,86 9,62 Wysycanie Pelazem wytrlcanie wnglanem magnezu 47,7 µmol/l 37,7 57,7 Saturation with iron precipitation with magnesium carbonate 267 µg/dl ,9 µmol/l 41,0 62,8 Dry chemistry 290 µg/dl Kolorymetryczna, ferrozyna, feren 19,0 µmol/l 15,0 23,0 Ferrozine/Ferene 106 µg/dl 84, ,7 µmol/l 14,8 22,7 Dry chemistry 105 µg/dl 82, AMYLAZA CNP-G3 95 U/l (37 C) AMYLASE / Dry chemistry 68 U/l U/l (37 C) U/l (25 C) ALANINOWA 36 U/l (37 C) ALANINE AMINOTRANSFERASE IFCC with pyridoxal phosphate 20 U/l (25 C) (ALT, ALAT, GPT) 32 U/l (37 C) IFCC without pyridoxal phosphate 18 U/l (25 C) / Dry chemistry 44 U/l U/l (37 C) U/l (25 C) U/l (37 C) ASPARAGINIANOWA IFCC with pyridoxal phosphate 26 U/l (25 C) ASPARTATE AMINOTRANSFERASE (AST, ASAT, GOT) 37 U/l (37 C) IFCC without pyridoxal phosphate 18 U/l (25 C) / Dry chemistry 49 U/l DEHYDROGENAZA -HYDROKSYMA7LANOWA, kinetyczna, oksomajlan < 10 mmol/l 202 U/l (37 C) HYDROXYBUTYRATE DEHYDROGENASE, oxybutyrate < 10 mmol/l 134 U/l (25 C) DEHYDROGENAZA MLECZANOWA LACTATE DEHYDROGENASE, Pirogronian Mleczan 400 U/l (37 C) , Pyruvate Lactate 203 U/l (25 C) / Dry chemistry 612 U/l Kinetyczna z fosforanem 1-Naftylu 1-Naphthyl phosphate, kinetic 14,8 U/l (37 C) 9,92 19,7 FOSFATAZA KWA7NA (caekowita) ACID PHOSPHATASE (total) FOSFATAZA KWA7NA (prostatyczna) ACID PHOSPHATASE (prostatic) Kinetyczna z fosforanem 1-Naftylu, aktywacja pentanodiolem 1-Naphthyl phosphate, kinetic with pentane diol activation 20,5 U/l (37 C) 13,7 27,3 Kinetyczna z fosforanem 1-Naftylu 1-Naphthyl phosphate, kinetic 8,70 U/l (37 C) 5,83 11,6 Kinetyczna z fosforanem 1-Naftylu, aktywacja pentanodiolem 1-Naphthyl phosphate, kinetic with pentane diol activation 15,3 U/l (37 C) 10,3 20,3 IFCC, bufor AMP z p-nitrofenylofosforanem 197 U/l (37 C) FOSFATAZA ZASADOWA p-nitrophenylphosphate, AMP buffer (IFCC) 126 U/l (25 C) ALKALINE PHOSPHATASE, bufor DEA z p-nitrofenylofosforanem 278 U/l (37 C) (ALP) p-nitrophenylphosphate, DEA buffer () 178 U/l (25 C) / Dry chemistry 187 U/l Glutamylo-3-karboksy-4-nitroanilid 58 U/l (37 C) Glutamyl-3-carboxy-4-nitroanilide 36 U/l (25 C) GLUTAMYLOTRANSFERAZA -Glutamylo-4-nitroanilid 51 U/l (37 C) GLUTAMYLTRANSFERASE -Glutamyl-4-nitroanilide 31 U/l (25 C) / Dry chemistry 79 U/l KINAZA KREATYNOWA 206 U/l (37 C) CREATINE KINASE 88 U/l (25 C) (CK, CPK) / Dry chemistry 186 U/l Turbidymetryczna z kolipazl / Turbidimetric with Colipase 171 U/l (37 C) LIPAZA / LIPASE Kolorymetryczna / Colorimetric 36 U/l (37 C) / Dry chemistry 281 U/l

4 CORMAY SERUM HP Nr kat. / Cat. No Seria / Lot: D Data wa"n. / Exp.: CORMAY SERUM HP Nr kat. / Cat. No Seria / Lot: D Data wa"n. / Exp.: PARAMETR / COMPONENT 20,6 mmol/l 15,7 Kinetyczna z ureaz (UV) 124 mg/dl 94 - Kinetic with urease (UV) MOCZNIK 58 mg UREA 19,3 mmol/l 14,6 116 mg/dl 88 - Dry chemistry 54,2 mg 41,1 Lipaza - kinaza glicerolowa (GPO- 2,76 mmol/l 2,18 TRIGLICERYDY PAP), bez korekcji glicerolu 244 mg/dl TRIGLYCERIDES i i 3,19 mmol/l 2,52 Dry chemistry 282 mg/dl ISE (metoda bezporednia) / ISE 116 mmol/l CHLORKI ISE (metoda porednia) / ISE 116 mmol/l CHLORIDE / Dry chemistry 118 mmol/l CYNK 20,6 6mol/l 16,5 ZINC Atomic absorption 135 6g/dl LIT 1,80 ISE / ISE 1,99 mmol/l LITHIUM 2,20 FOSFOR Kolorymetryczna z molibdenianem 2,21 mmol/l 1,88 (nieorganiczny) amonowym 6,85 mg/dl 5,83 PHOSPHORUS h h l bd 2,12 mmol/l 1,80- (inorganic) Dry chemistry 6,57 mg/dl 5,58 Kolorymetryczna z kalmagitem 1,74 mmol/l 1,53 Calmagite 4,23 mg/dl 3,72 MAGNEZ Kolorymetryczna z b8kitem 1,71 mmol/l 1,50 MAGNESIUM ksylidylowym 4,16 mg/dl 3,65 lid l bl 1,70 mmol/l 1,50 Dry chemistry 4,13 mg/dl 3,65 MIED) 25,5 6mol/l 21,7 COPPER Atomic absorption 162 6g/dl POTAS POTASSIUM Fotometria p8omieniowa / Flame 6,18 mmol/l 5,68 ISE h t(metodat bezporednia) / ISE 6,06 mmol/l 5,57 (direct ISE (metoda method) porednia) / ISE 6,09 mmol/l 5,60 (indirect method) / Dry chemistry 5,86 mmol/l 5,39 SÓD SODIUM Fotometria p8omieniowa / Flame 157 mmol/l ISE h t(metodat bezporednia) / ISE 156 mmol/l (direct ISE (metoda method) porednia) / ISE 156 mmol/l (indirect method) / Dry chemistry 154 mmol/l Kolorymetryczna z o- 3,09 mmol/l 2,78 - krezoloftalein o-cresolphthalein Complexone 12,4 mg/dl 11,1 2,73 3,03 mmol/l WAP* Kolorymetryczna z Arsenazo III 3,33 CALCIUM Arsenazo III 10,9 12,1 mg/dl 13,3 3,02 mmol/l 2,72 Dry chemistry 12,1 mg/dl 10,9 CA&KOWITA ZDOLNO Wysycanie elazem wytrcanie 46 6mol/l 36,3 WIZANIA ELAZA wglanem magnezu 257 6g/dl TOTAL IRON BINDING i i h i 51,2 6mol/l 40,4 CAPACITY (TIBC) Dry chemistry 286 6g/dl Kolorymetryczna, ferrozyna, 35,4 6mol/l 28- +ELAZO feren 198 6g/dl IRON F i /F 33,2 6mol/l 26,2 Dry chemistry 185 6g/dl AMYLAZA ALANINOWA ALANINE AMINOTRANSFERASE (ALT, ALAT, GPT) ASPARAGINIANOWA ASPARTATE AMINOTRANSFERASE (AST, ASAT, GOT) DEHYDROGENAZA - HYDROKSYMA'LANOWA -HYDROXYBUTYRATE DEHYDROGENASE YDROGENAZA MLECZANOWA LACTATE DEHYDROGENASE CNP-G3 / Dry chemistry IFCC with pyridoxal phosphate IFCC without pyridoxal phosphate / Dry chemistry IFCC with pyridoxal phosphate IFCC without pyridoxal phosphate / Dry chemistry, kinetyczna, oksomalan < 10 mmol/l, oxybutyrate < 10 mmol/l, Pirogronian Mleczan, Pyruvate Lactate / Dry chemistry 315 U/l( ,25 µkat/l 4, U/l 156-3,07 µkat/l 2, U/l 112-2,37 µkat/l 1,87-80 U/l ,33 µkat/l 1, U/l 115-2,43 µkat/l 1,92-82 U/l ,37 µkat/l 1, U/l 107-2,25 µkat/l 1,78 76 U/l ,27 µkat/l 1, U/l 112-2,35 µkat/l 1, U/l 121-2,55 µkat/l 2,02 73 U/l ,22 µkat/l 0, U/l 156-3,30 µkat/l 2,60 94 U/l 74-1,57 µkat/l 1, U/l 124-2,62 µkat/l 2,07 75 U/l ,25 µkat/l 0, U/l 147-3,10 µkat/l 2, U/l 300-6,33 µkat/l 5, U/l 207-4,37 µkat/l 3, U/l ,33 µkat/l 9, U/l 296-6,25 µkat/l 4, U/l ,23 µkat/l 15,98

5 CORMAY SERUM HP Nr kat. / Cat. No Seria / Lot: D Data wa"n. / Exp.: CORMAY SERUM HP Nr kat. / Cat. No Seria / Lot: D Data wa"n. / Exp.: PARAMETR / COMPONENT FOSFATAZA KWA'NA (cakowita) ACID PHOSPHATASE (total) FOSFATAZA KWA'NA (prostatyczna) ACID PHOSPHATASE (prostatic) FOSFATAZA ZASADOWA ALKALINE PHOSPHATASE (ALP) -GLUTAMYLOTRANSFERAZA -GLUTAMYLTRANSFERASE KINAZA KREATYNOWA CREATINE KINASE (CK, CPK) LIPAZA / LIPASE Kinetyczna z fosforanem 1-39,5 U/l 26,5 Naftylu 0,66 µkat/l 0,44 Kinetyczna z fosforanem 1-Naftylu, 54,7 U/l 36,6 aktywacja pentanodiolem 0,91 µkat/l 0,61 1 Naphthyl phosphate kinetic with Kinetyczna z fosforanem 1-23,6 U/l 15,8 Naftylu 0,39 µkat/l 0,26 Kinetyczna z fosforanem 1-Naftylu, 40,9 U/l 27,4 aktywacja pentanodiolem 1 Naphthyl phosphate kinetic with 0,68 µkat/l 0, U/l 301-6,37 µkat/l 5, U/l IFCC, bufor AMP z p- nitrofenylofosforanem p-nitrophenylphosphate, AMP buffer (IFCC) 4,07 µkat/l 3,22, bufor DEA z p- 490 U/l nitrofenylofosforanem 8,17 µkat/l 6,45 p-nitrophenylphosphate, DEA 313 U/l buffer () 5,22 µkat/l 4,12 / Dry chemistry 340 U/l 269-5,67 µkat/l 4,48 -Glutamylo-3-karboksy U/l nitroanilid 3,23 µkat/l 2,55 -Glutamyl-3-carboxy U/l 94 - nitroanilide 2,00 µkat/l 1,57 -Glutamylo-4-nitroanilid -Glutamyl-4-nitroanilide / Dry chemistry 173 U/l 137-2,88 µkat/l 2, U/l 84-1,78 µkat/l 1, U/l 205-4,33 µkat/l 3, U/l 364-7,97 µkat/l 6, U/l 155-3,38 µkat/l 2,58 / Dry chemistry 415 U/l 316-6,92 µkat/l 5,27 Turbidymetryczna z kolipaz 473 U/l Turbidimetric with Colipase 7,90 µkat/l 6,36 Kolorymetryczna / Colorimetric 79 U/l ,32 µkat/l 1,05 / Dry chemistry 890 U/l ,86 µkat/l 11,91 Ziele bromokrezolowa 32 g/l 26,3 Bromocresol green (BCG) 3,20 g/dl 2,63 ALBUMINA Purpura bromokrezolowa 31,5 g/l 25,8 ALBUMIN Bromocresol purple (BCP) 3,15 g/dl 2,58 30,9 g/l 25,4 Dry chemistry 3,09 g/dl 2,54 71,4 ;mol/l 56,4 4,18 mg/dl 3,30 BILIRUBINA Malloy-Evelyn (Liquick Cor-BIL 71,4 ;mol/l 56,4 CA,KOWITA TOTAL) BILIRUBIN TOTAL 4,18 mg/dl 3,30 60,7 ;mol/l 48,0 Dry chemistry 3,55 mg/dl 2,81 22,3 ;mol/l 17,6 1,30 mg/dl 1,03 BILIRUBINA BEZPO'REDNIA Malloy-Evelyn (Liquick Cor-BIL 22,3 ;mol/l 17,6 BILIRUBIN DIRECT DIRECT) 1,30 mg/dl 1,03 18,3 ;mol/l 14,4 Dry chemistry 1,07 mg/dl 0,84 Kolorymetryczna z odczynnikiem 51,1 g/l 46,5 biuretowym, punktu kocowego BIA,KO CA,KOWITE Biuret reaction (end-point) 5,11 g/dl 4,65 TOTAL PROTEIN 50,8 g/l 46,3 Dry chemistry 5,08 g/dl 4,63 Enzymatyczna esteraza/oksydaza 7,40 mmol/l 6,07 CHOLESTEROL cholesterolu (CHOD/PAP) Cholesterol esterase/oxidase 286 mg/dl CA,KOWITY CHOLESTEROL TOTAL 7,20 mmol/l 5,90 Dry chemistry 279 mg/dl Metoda bezporednia oparta na 2,18 mmol/l 1,87 CHOLESTEROL HDL selektywnej inhibicji Direct method (selective 84,1 mg/dl 72,2 Enzymatyczna z oksydaz glukozy 15,2 mmol/l 12,9 (GOD/PAP) Glucose oxidase (GOD/PAP) 273 mg/dl GLUKOZA Enzymatyczna z heksokinaz 15,0 mmol/l 12,8 GLUCOSE Hexokinase 270 mg/dl ,6 mmol/l 12,4 Dry chemistry 263 mg/dl Kinetyczna Jaffe, bez odbiacczania 334 ;mol/l Kinetic Jaffe without deproteinization (CORMAY 3,78 mg/dl 3,10 KREATYNINA Kinetyczna Jaffe, bez odbiacczania 352 ;mol/l CREATININE Kinetic Jaffe without deproteinization (Liquick Cor- 3,98 mg/dl 3, ;mol/l Dry chemistry 3,90 mg/dl 3,20 Enzymatyczna, kolorymetryczna z 539 ;mol/l KWAS MOCZOWY urikaz 9,07 mg/dl 7,39 URIC ACID 550 ;mol/l Dry chemistry 9,24 mg/dl 7,56