BIOCHEMISTRY CONTROL SERUM

LEVEL: I LOT: 106

ENGLISH

COMPONENT METHOD VALUE RANGE 1S RANGE TRACEABILITY

* * - * * U/L
ACE FAPGG BMC
* * - * * μkat/L
7,76 3,88 - 11,64 1,29 U/L
ACID PHOSPHATASE Naphtyl phosphate/pentanediol BMC
0,129 0,065 - 0,194 0,022 μkat/L
ALBUMIN Bromocresol green 29,7 24,4 - 35,0 1,8 g/L ERM-DA470/IFCC (IRMM)
106 87 - 125 6 U/L C-RSE/IFCC
2-Amino-2-methyl-1-propanol buffer
1,76 1,44 - 2,08 0,11 μkat/L BMC
ALKALINE PHOSPHATASE
137 112 - 162 8 U/L
Diethanolamine buffer BMC
2,27 1,86 - 2,68 0,14 μkat/L
39,5 31,6 - 47,4 2,6 U/L
IFCC without pyridoxal phosphate BMC
0,656 0,525 - 0,787 0,044 μkat/L
ALT/GPT
44,0 35,2 - 52,8 2,9 U/L C-RSE/IFCC
IFCC with pyridoxal phosphate
0,730 0,584 - 0,876 0,049 μkat/L ERM-AD454/IFCC (IRMM)
96,0 78,7 - 113,3 5,8 U/L C-RSE/IFCC
IFCC
1,59 1,30 - 1,88 0,10 μkat/L IRMM/IFCC-456 (IRMM)
α-AMYLASE
138 113 - 163 8 U/L
Direct substrate BMC
2,30 1,89 - 2,71 0,14 μkat/L
* * - * * U/L C-RSE/IFCC
α-AMYLASE PANCREATIC Immunoinhibition
* * - * * μkat/L BMC
45,7 34,3 - 57,1 3,8 U/L
IFCC without pyridoxal phosphate BMC
0,759 0,569 - 0,949 0,063 μkat/L
AST/GOT
56,7 42,5 - 70,9 4,7 U/L C-RSE/IFCC
IFCC with pyridoxal phosphate
0,940 0,705 - 1,175 0,078 μkat/L ERM-AD457/IFCC (IRMM)
0,714 0,500 - 0,928 0,071 mg/dL
Diazotized sulfanilic BMC
12,2 8,5 - 15,9 1,2 μmol/L
0,907 0,635 - 1,179 0,091 mg/dL
BILIRUBIN (DIRECT) Dichlorophenyl diazonium A25/A15 BMC
15,5 10,9 - 20,2 1,6 μmol/L
0,714 0,500 - 0,928 0,071 mg/dL
Dichlorophenyl diazonium BA400/BA200 BMC
12,2 8,5 - 15,9 1,2 μmol/L
2,02 1,41 - 2,63 0,20 mg/dL
BILIRUBIN (TOTAL) Diazotized sulfanilic / Dichlorophenyl diazonium SRM 916 (NIST)
34,5 24,2 - 44,9 3,5 μmol/L
8,10 7,13 - 9,07 0,32 mg/dL
Arsenazo III SRM 956 (NIST)
2,03 1,79 - 2,27 0,08 mmol/L
8,18 7,20 - 9,16 0,33 mg/dL
CALCIUM o-Cresolphthalein SRM 956 (NIST)
2,05 1,80 - 2,30 0,08 mmol/L
9,09 8,00 - 10,18 0,36 mg/dL
Methylthymol blue SRM 956 (NIST)
2,27 2,00 - 2,54 0,09 mmol/L
CHLORIDE Selective electrode 81,2 73,1 - 89,3 2,7 mmol/L SRM 956 (NIST)
164 139 - 189 8 mg/dL
CHOLESTEROL Cholesterol oxidase/peroxidase SRM 909 (NIST)
4,24 3,60 - 4,88 0,21 mmol/L
* * - * * mg/dL CDC Reference Method
Direct detergent
* * - * * mmol/L BMC
* * - * * mg/dL CDC Reference Method
CHOLESTEROL HDL Direct TOOS
* * - * * mmol/L BMC

Phosphotungstate/Mg - Cholesterol 77,6 58,2 - 97,0 6,5 mg/dL

SRM 909 (NIST)
oxidase/peroxidase 2,01 1,51 - 2,51 0,17 mmol/L
* * - * * mg/dL CDC Reference Method
Direct detergent
* * - * * mmol/L BMC
CHOLESTEROL LDL
* * - * * mg/dL CDC Reference Method
Direct TOOS
* * - * * mmol/L BMC
* * - * * U/L
CHOLINESTERASE Butyrylthiocholine BMC
* * - * * μkat/L
195 156 - 234 13 U/L C-RSE/IFCC
CK IFCC
3,24 2,59 - 3,89 0,22 μkat/L ERM-AD455/IFCC (IRMM)
BIOCHEMISTRY CONTROL SERUM

LEVEL: I LOT: 106

ENGLISH

COMPONENT METHOD VALUE RANGE 1S RANGE TRACEABILITY

113 85 - 141 9 μg/dL
COPPER-PAESA 3,5-DiBr-PAESA BMC
17,8 13,4 - 22,3 1,5 μmol/L
1,69 1,39 - 1,99 0,10 mg/dL
Enzymatic SRM 967 (NIST)
149 122 - 176 9 μmol/L
1,63 1,34 - 1,92 0,10 mg/dL
CREATININE Jaffé compensated SRM 967 (NIST)
145 119 - 171 9 μmol/L
1,69 1,39 - 1,99 0,10 mg/dL
Jaffé non compensated SRM 909 (NIST)
149 122 - 176 9 μmol/L
Glucose oxidase/peroxidase 82,8 70,4 - 95,2 4,1 mg/dL
GLUCOSE SRM 965 (NIST)
Hexokinase 4,60 3,91 - 5,29 0,23 mmol/L
39,3 32,2 - 46,4 2,4 U/L C-RSE/IFCC
γ-GT IFCC
0,652 0,535 - 0,769 0,039 μkat/L ERM-AD452/IFCC (IRMM)
3,08 2,53 - 3,63 0,18 mg/dL
β-HYDROXYBUTYRATE Hydroxybutyrate dehydrogenase/diaphorase BMC
0,299 0,245 - 0,353 0,018 mmol/L
106 87 - 125 6 μg/dL
Ferrozine BMC
19,0 15,7 - 22,3 1,1 μmol/L
IRON
40,4 33,3 - 47,5 2,4 μg/dL
Chromazurol B BMC
7,22 5,96 - 8,48 0,42 μmol/L
105 86 - 124 6 mg/dL
LACTATE LOD/POD BMC
11,7 9,6 - 13,8 0,7 mmol/L
65,2 48,9 - 81,5 5,4 U/L
Color BMC
1,08 0,81 - 1,35 0,09 μkat/L
LIPASE
66,3 49,7 - 82,9 5,5 U/L
DGGR BMC
1,10 0,83 - 1,38 0,09 μkat/L
464 380 - 548 28 U/L
Pyruvate BMC
7,71 6,32 - 9,10 0,46 μkat/L
LDH
204 167 - 241 12 U/L C-RSE/IFCC
IFCC
3,39 2,78 - 4,00 0,20 μkat/L ERM-AD453/IFCC (IRMM)
1,49 1,19 - 1,79 0,10 mg/dL
MAGNESIUM Xylidyl Blue SRM 956 (NIST)
0,613 0,490 - 0,736 0,041 mmol/L
10,2 8,2 - 12,2 0,7 mg/dL
NEFA Acyl-CoA Oxidase/Peroxidase BMC
0,361 0,289 - 0,433 0,024 mmol/L
3,37 2,76 - 3,98 0,20 mg/dL
PHOSPHORUS Phosphomolybdate/UV BMC
1,09 0,89 - 1,29 0,07 mmol/L
POTASSIUM Selective electrode 3,89 3,50 - 4,28 0,13 mmol/L SRM 956 (NIST)
PROTEIN (TOTAL) Biuret 51,8 45,6 - 58,0 2,1 g/L SRM 927 (NIST)
SODIUM Selective electrode 113 102 - 124 4 mmol/L SRM 956 (NIST)
Cyclic enzymatic. Kit lot number higher than
16,1 13,2 - 19,0 1,0 μmol/L
51200 (1)
TOTAL BILE ACIDS BMC
Cyclic enzymatic. Kit lot number lower than
12,8 10,5 - 15,1 0,8 μmol/L
51200 (2)
39,3 33,4 - 45,2 2,0 mg/dL
TRIGLYCERIDES Glycerol phosphate oxydase/peroxydase SRM 909 (NIST)
0,445 0,378 - 0,512 0,022 mmol/L
171 137 - 205 11 μg/dL
UIBC Ferrozine BMC
30,6 24,5 - 36,7 2,0 μmol/L
55,5 44,4 - 66,6 3,7 mg/dL
UREA Urease (Color / UV) SRM 909 (NIST)
9,21 7,37 - 11,05 0,61 mmol/L
5,74 4,88 - 6,60 0,29 mg/dL
URIC ACID Uricase/peroxidase SRM 909 (NIST)
341 290 - 392 17 μmol/L
97,3 77,8 - 116,8 6,5 μg/dL
ZINC Br-PAPS ERM DA-120 (LGC8211)
14,9 11,9 - 17,9 1,0 μmol/L
NOTES:
The enzymes values (U/L and µkat/L) are for a incubation temperature of 37 ºC.
BMC: BioSystems master calibrator.
C-RSE/IFCC: Traceable to the reference system as described by the IFCC Committee on Reference Systems for Enzymes.
(1) Corresponding to bottle lot equal or higher than 030X for commercial code 12551, or bottle lot equal or higher than 51000 for commercial code 23551.
(2) Corresponding to bottle lot lower than 030X for commercial code 12551, or bottle lot lower than 51000 for commercial code 23551.
E.U.: Expanded uncertainty of the assigned value (95% confidence interval).
(*) Use the BIOCHEMISTRY CALIBRATOR (Human) and BIOCHEMISTRY CONTROL SERUM (Human) I, II
(**) Use the BIOCHEMISTRY CONTROL SERUM I