ELITROL I

: CONT-0060/1060

: 01-1090 : 2021-09 (OLWURO,

& )9&217


 

FOR SELECTRA / FLEXOR ANALYSERS

CODE REAGENT NAME METHOD TRACEABILITY UNITS TARGET RANGE
ALBU-0XXX ALBUMIN Bromocresol green ERM-DA 470k / IFCC g/dL 3.27 2.68 3.86
g/L 32.7 26.8 38.6
) ALBU-0XXX ALBUMIN Bromocresol green ERM-DA 470k / IFCC g/dL 3.07 2.52 3.62
IMPROVED APPLICATION Assay Code 101 g/L 30.7 25.2 36.2

PASL-0XXX ALP (DEA) SL DGKC Manual measurement IU/L 37°C 136 111 161

IFCC formulation (Schumann,2011),

ALPI-0XXX ALP IFCC IFCC IU/L 37°C 95 78 112
manual measurement
ALSL-0XXX ALT / GPT 4+1 SL IFCC without pyridoxal-phosphate IFCC formulation (Schumann, 2002),
IU/L 37°C 45.5 37.3 53.7
manual measurement
CNP-G3 substrate IFCC formulation (Schumann, 2006),
AMSL-0XXX AMYLASE SL IU/L 37°C 81 66 96
manual measurement
ASSL-0XXX AST / GOT 4+1 SL IFCC without pyridoxal-phosphate IFCC formulation (Schumann, 2002),
IU/L 37°C 37.1 30.4 43.8
manual measurement
BITO-0XXX TOTAL BILIRUBIN 4+1 Malloy-Evelyn modified NIST SRM 916a mg/dL 1.93 1.58 2.28
BITD-0XXX IMPROVED PRODUCT Assay Code 225 μmoL/L 33.1 27.1 39.1
BIDI-0XXX DIRECT BILIRUBIN 4+1 Malloy-Evelyn modified NIST SRM 916a mg/dL 1.62 1.23 2.01
BITD-0XXX IMPROVED PRODUCT Assay Code 205 μmoL/L 27.7 21.0 34.4
CALA-0XXX CALCIUM ARSENAZO Arsenazo )NIST SRM 956d mg/dL 8.69 7.65 9.73
mmoL/L 2.17 1.91 2.43
CHLO-0XXX CHLORIDE Colorimetric, end point NIST SRM 909c mEq/L 104.3 93.9 114.7
mmoL/L 104.3 93.9 114.7
3918-006 CHLORIDE I.S.E Indirect Potentiometry NIST SRM 918b / NIST SRM 919b mEq/L 92.1 82.9 101.3
mmol/L 92.1 82.9 101.3
CHSL-0XXX CHOLESTEROL SL mg/dL 111 94 128
Enzymatic colorimetric (CHOD-PAP) ID-GC-MS
mmol/L 2.86 2.43 3.29
HDLL-0XXX CHOLESTEROL HDL SL 2G mg/dL 31 26 36
Colorimetric, end point CDC method
mmol/L 0.81 0.69 0.93
LDLL-0XXX CHOLESTEROL LDL SL 2G mg/dL 53 45 61
Colorimetric, end point CDC method
mmol/L 1.37 1.16 1.58

CHES-0XXX CHOLINESTERASE Butyrylthiocholine substrate Manual measurement IU/L 37°C 5206 4269 6143

CKSL-0XXX CK NAC SL IFCC formulation (Schumann, 2002),

IFCC IU/L 37°C 124 102 146
manual measurement
CRSL-0XXX CREATININE PAP SL mg/dL 0.94 0.77 1.11
Enzymatic colorimetric (PAP) ID-MS
μmol/L 83 68 98
CRCO-0XXX CREATININE JAFFE mg/dL 0.78 0.64 0.92
Jaffe without deproteinization ID-MS
μmol/L 69 57 81
IFCC formulation (Schumann, 2002),
GISL-0XXX GAMMA GT PLUS SL IFCC IU/L 37°C 48.1 39.4 56.8
manual measurement
GPSL-0XXX GLUCOSE PAP SL Enzymatic colorimetric (GOD-PAP) mg/dL 91.1 77.4 104.8
ID-MS
mmol/L 5.06 4.30 5.82
GHSL-0XXX GLUCOSE HK SL Hexokinase mg/dL 90.9 77.3 104.5
ID-MS
mmol/L 5.05 4.29 5.81

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 ELITROL I ELITROL I
: CONT-0060/1060 : CONT-0060/1060

: 01-1090 : 2021-09 : 01-1090 : 2021-09

FOR SELECTRA / FLEXOR ANALYSERS FOR ENVOY ANALYSERS

CODE REAGENT NAME METHOD TRACEABILITY UNITS TARGET RANGE
CODE REAGENT NAME METHOD TRACEABILITY UNITS TARGET RANGE
ALBU-0850 ALBUMIN ENVOY Bromocresol green ERM-DA 470k / IFCC g/dL 3.07 2.52 3.62
FEFR-0XXX IRON FERROZINE NIST SRM 937 μg/dL 113 93 133
Ferrozine without deproteinization g/L 30.7 25.2 36.2
μmol/L 20.2 16.6 23.8
IFCC formulation (Schumann,2011),
FEFE-0XXX IRON FERENE NIST SRM 937 μg/dL 103 85 121 PIVD-0850 ALP ENVOY IFCC (AMP Buffer) IU/L 37°C 107 88 126
manual measurement
Ferene
μmol/L 18.4 15.1 21.7 IFCC formulation (Schumann,2002),
ALSL-0850 ALT ENVOY IFCC without pyridoxal-phosphate IU/L 37°C 45.5 37.3 53.7
LACT-0XXX LACTATE Enzymatic colorimetric Primary reference material mg/dL 17.8 14.6 21.0 manual measurement
(Lactate oxidase PAP) (weighed in purified material) mmol/L 1.98 1.62 2.34 IFCC formulation (Schumann,2006),
AMSL-0850 AMYLASE ENVOY CNP-G3 Substrate IU/L 37°C 81 66 96
IFCC formulation (Schumann, 2002), manual measurement
LLSL-0XXX LDH-L SL IFCC (LĺP) IU/L 37°C 174 143 205
manual measurement ASVD-0850 AST ENVOY IFCC without pyridoxal-phosphate
IFCC formulation (Schumann,2002),
IU/L 37°C 37.5 30.7 44.3
manual measurement
LPSL-0XXX LIPASE Enzymatic colorimetric Manual measurement IU/L 37°C 43 35 51 BITV-0850 TOTAL BILIRUBIN ENVOY Diazo (blanked) NIST SRM 916a mg/dL 2.72 2.23 3.21
MAGN-0XXX MAGNESIUM CALMAGITE Calmagite Atomic absorption mg/dL 2.25 1.98 2.52 μmol/L 46.6 38.2 55.0
mmol/L 0.93 0.82 1.04 BIDV-0850 DIRECT BILIRUBIN ENVOY Diazo (blanked) Jendrassik-Grof Manual method mg/dL 2.57 1.95 3.19
μmol/L 43.9 33.4 54.4
MAGX-0XXX MAGNESIUM XYLIDYL Xylidyl Blue Atomic absorption mg/dL 2.14 1.88 2.40
CALA-0850 CALCIUM ENVOY Arsenazo NIST SRM 956c mg/dL 8.86 7.80 9.92
mmol/L 0.88 0.77 0.99
mmol/L 2.21 1.94 2.48
PHOS-0XXX PHOSPHORUS Phosphomolybdate UV Primary reference material mg/dL 3.75 3.19 4.31
3918-006 CHLORIDE ENVOY I.S.E Indirect Potentiometry NIST SRM 956d mEq/L 97.8 88.0 107.6
(NERL/weighed in purified material) mmol/L 1.21 1.03 1.39 mmol/L 97.8 88.0 107.6
3918-005 POTASSIUM I.S.E Indirect Potentiometry NIST SRM 918b mEq/L 3.68 3.31 4.05 CHSL-0850 CHOLESTEROL ENVOY Enzymatic colorimetric (CHOD-PAP) ) ID-GC-MS mg/dL 111 94 128
mmol/L 3.68 3.31 4.05 mmol/L 2.87 2.44 3.30
3918-004 SODIUM I.S.E Indirect Potentiometry NIST SRM 919b mEq/L 126.3 113.7 138.9 HDLL-0850 HDL CHOLESTEROL ENVOY CDC mg/dL 31 26 36
Colorimetric, end point
mmol/L 126.3 113.7 138.9 mmol/L 0.80 0.68 0.92
PROB-0XXX TOTAL PROTEIN PLUS Biuret NIST SRM 909c g/dL 4.55 4.00 5.10 LDLL-0850 LDL CHOLESTEROL ENVOY CDC mg/dL 52 44 60
Colorimetric, end point
g/L 45.5 40.0 51.0 mmol/L 1.35 1.15 1.55
TGML-0XXX TRIGLYCERIDES SL mg/dL 96 81 111 IFCC formulation (Schumann,2002),
CKSL-0850 CK ENVOY IFCC IU/L 37°C 124 102 146
Enzymatic colorimetric (GPO-PAP) ID-GC-MS manual measurement
TRIGLYCERIDES MONO SL NEW mmol/L 1.09 0.92 1.26
CRSL-0850 CREATININE ENVOY Enzymatic colorimetric (PAP) ID-MS mg/dL 0.92 0.75 1.09
URSL-0XXX UREA UV SL Enzymatic UV ID-MS mg/dL 41.4 35.2 47.6
μmol/L 81 66 96
Urease / GLDH mmoL/L 6.89 5.86 7.92
IFCC formulation (Schumann,2002),
AUML-0XXX URIC ACID MONO SL Enzymatic colorimetric ID-MS mg/dL 5.29 4.50 6.08 GISL-0850 GGT ENVOY IFCC IU/L 37°C 48.1 39.4 56.8
manual measurement
(uricase-POD) μmol/L 314 267 361 GPSL-0850 GLUCOSE ENVOY Enzymatic colorimetric (GOD-PAP) ID-MS mg/dL 91.1 77.4 104.8
AUSL-0XXX URIC ACID SL Enzymatic colorimetric ID-MS mg/dL 4.81 4.09 5.53 mmol/L 5.06 4.30 5.82
(uricase-POD) μmol/L 286 243 329 FEFE-0850 IRON ENVOY Ferene NIST SRM 937 μg/dL 103 84 122
SPECIFIC PROTEINS / PROTEINES SPECIFIQUES μmol/L 18.4 15.1 21.7
IFRT-0230 FERRITIN Latex-enhanced immuno-turbidimetry International Standard of Recombinant Human ng/mL 57.4 40.2 74.6 LPSL-0850 LIPASE ENVOY Enzymatic Colorimetric manual measurement IU/L 37°C 47 39 55
Ferritin (94/572) from WHO-NIBSC μg/L 57.4 40.2 74.6
IFCC formulation (Schumann,2002),
IHAP-0400 HAPTOGLOBIN Immuno-turbidimetry ERM-DA470k / IFCC mg/dL 77 63 91 LLSL-0850 LDH ENVOY IFCC (L ĺ P) IU/L 37°C 168 138 198
manual measurement
g/L 0.77 0.63 0.91
MAGX-0850 MAGNESIUM ENVOY Xylidyl Blue Atomic absorption mg/dL 2.18 1.92 2.44
IIGA-0400 IgA Immuno-turbidimetry ERM-DA470k / IFCC mg/dL 154 126 182 mmol/L 0.90 0.79 1.01
g/L 1.54 1.26 1.82 PHOS-0850 PHOSPHORUS ENVOY Phosphomolybdate UV Primary reference material mg/dL 3.75 3.19 4.31
IIGG-0400 IgG Immuno-turbidimetry ERM-DA470k / IFCC mg/dL 610 500 720 (NERL/weighed in purified material) mmol/L 1.21 1.03 1.39
g/L 6.10 5.00 7.20 3918-005 POTASSIUM ENVOY I.S.E Indirect Potentiometry NIST SRM 956d mEq/L 3.81 3.43 4.19
IIGM-0400 IgM Immuno-turbidimetry ERM-DA470k / IFCC mg/dL 68 56 80 mmol/L 3.81 3.43 4.19
g/L 0.68 0.56 0.80 3918-004 SODIUM ENVOY I.S.E Indirect Potentiometry NIST SRM 956d mEq/L 128.3 115.5 141.1
IORO-0400 OROSOMUCOID Immuno-turbidimetry ERM-DA470k / IFCC mg/dL 49 40 58 mmol/L 128.3 115.5 141.1
PROB-0850 TOTAL PROTEIN ENVOY Biuret NIST SRM 909c g/dL 4.55 4.00 5.10
g/L 0.49 0.40 0.58
g/L 45.5 40.0 51.0
IPAL-0400 PREALBUMIN Immuno-turbidimetry ERM-DA470k / IFCC mg/dL 18 15 21
TGML-0850 TRIGLYCERIDES ENVOY Enzymatic colorimetric (GOD-PAP) ) ID-GC-MS mg/dL 97 82 112
g/L 0.18 0.15 0.21
mmol/L 1.09 0.91 1.27
ITRF-0400 TRANSFERRIN Immuno-turbidimetry ERM-DA470k / IFCC mg/dL 151 124 178 URSL-0850 UREA ENVOY Enzymatic UV Urease/GLDH ID-MS mg/dL 41.4 35.2 47.6
g/L 1.51 1.24 1.78 mmol/L 6.89 5.86 7.92
AUVD-0850 URIC ACID ENVOY Uricase NIST SRM 913a mg/dL 5.18 4.40 5.96
The values are defined with ELITech reagents ) : Modification from previous version μmol/L 308 262 354

The values are defined with ELITech reagents ) : Modification from previous version
SRM: Standard Reference Material DGKC: Deutsche Gesellschaft für Klinische Chemie
ERM: European Reference Material SFBC: Société Française Biologie Clinique SRM: Standard Reference Material )ID-GC-MS: Isotope Dilution – Gas Chromatography –Mass Spectrometry
ID-MS: Isotope Dilution – Mass Spectrometry WHO: World Health Organization ERM: European Reference Material IFCC: International Federation of Clinical Chemistry and Laboratory Medicine
ID-MS: Isotope Dilution – Mass Spectrometry CDC: Centers for Disease Control and Prevention
ID-GC-MS: Isotope Dilution – Gas Chromatography –Mass Spectrometry NIBSC: National Institute for Biological Standards and Control
IFCC: International Federation of Clinical Chemistry and Laboratory Medicine CDC: Centers for Disease Control and Prevention

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