Lyphochek Assayed Chemistry Control Leve

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Lyphochek® Assayed Chemistry Control

Levels 1 and 2
C-310-5 Level 1 12 x 5 mL Level 1 26431
C-315-5 Level 2 12 x 5 mL 0459 2020-02-29 26430 Level 2 26432
313X MiniPak 2 x 5 mL

http://www.myeinserts.com/26430

Revision Date 2018-04-04 Indicates Revised Information

METHOD (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
ACETAMINOPHEN
Emit 2000 (3) µg/mL 12.3 10.7 – 14.0 81.3 71.1 – 91.6
ALBUMIN
Bromcresol green (3) g/dL 3.95 3.50 – 4.40 2.82 2.46 – 3.17
Teco Diagnostics TC-Matrix (Bromcresol green) (4) g/dL 4.20 3.80 – 4.60 3.10 2.80 – 3.40
ALKALINE PHOSPHATASE (2)
PNPP, AMP Buffer (3) U/L 103 75.7 – 131 419 346 – 492
Teco Diagnostics TC-Matrix (Modified Bowers-McComb Liquid) (4) U/L 112 89.7 – 135 461 369 – 554
ALT/SGPT (2)
IFCC 2002 (UV with P5P) (3) U/L 32.1 25.5 – 38.7 99.2 84.7 – 114
IFCC 2002 (UV without P5P) (3) U/L 30.7 23.8 – 37.7 96.7 83.2 – 110
Teco Diagnostics TC-Matrix (Optimized Tris Liquid) (4) U/L 29.2 23.4 – 35.0 87.2 69.8 – 105
AMYLASE (2)
EPS-G7 (3) U/L 81.7 71.1 – 92.4 393 358 – 428
Teco Diagnostics TC-Matrix (4) U/L 79.5 63.6 – 95.4 441 353 – 529
Teco Diagnostics TC-Matrix (Kinetic) (4) U/L 86.0 68.8 – 103 328 – >400
AMYLASE (PANCREATIC) (2)
EPS-G7 Liquid (3) U/L 48.2 37.3 – 59.1 344 302 – 386
AST/SGOT (2)
IFCC 2002 (UV with P5P) (3) U/L 40.9 33.3 – 48.4 208 181 – 234
IFCC 2002 (UV without P5P) (3) U/L 37.6 30.0 – 45.2 196 171 – 222
Teco Diagnostics TC-Matrix (Optimized Tris Liquid) (4) U/L 38.3 30.6 – 46.0 191 153 – 229
BILIRUBIN (DIRECT)
Advanced Instruments BR2 Bilirubin Stat-Analyzer (Photometric) (4) mg/dL 0.120 0.000 – 0.200 0.950 0.500 – 1.40
Diazotization / DPD / Jendrassik Grof (3) mg/dL 0.281 0.124 – 0.438 1.28 0.939 – 1.61
Teco Diagnostics TC-Matrix (Diazotization) (4) mg/dL 0.400 0.300 – 0.500 1.40 1.10 – 1.70
Vanadate Oxidation (3) mg/dL 0.296 0.216 – 0.376 1.30 0.975 – 1.62
Wako L-Type (AU480) (4) mg/dL 0.303 0.279 – 0.327 1.30 1.14 – 1.46
BILIRUBIN (TOTAL)
Advanced Instruments BR2 Bilirubin Stat-Analyzer (Photometric) (4) mg/dL 1.67 1.30 – 2.00 4.76 3.80 – 5.70
DPD (3) mg/dL 0.827 0.550 – 1.10 4.57 3.82 – 5.31
Jendrassik Grof (3) mg/dL 0.859 0.555 – 1.16 4.71 4.10 – 5.32
Teco Diagnostics TC-Matrix (Sulphanilic acid, DMSO) (4) mg/dL 1.00 0.600 – 1.40 5.60 4.50 – 6.70
Vanadate Oxidation (3) mg/dL 0.879 0.726 – 1.03 4.84 4.29 – 5.38
Wako L-Type (AU480) (4) mg/dL 0.813 0.788 – 0.838 4.42 4.22 – 4.62

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Lyphochek® Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
CALCIUM
Arsenazo III (3) mg/dL 9.08 8.06 – 10.1 12.2 11.0 – 13.3
o-cresolphthalein complexone (3) mg/dL 8.77 7.91 – 9.63 12.3 11.2 – 13.3
Teco Diagnostics TC-Matrix (Arsenazo III) (4) mg/dL 9.50 7.60 – 11.4 12.2 9.80 – 14.6
Teco Diagnostics TC-Matrix (o-cresolphthalein complexone) (4) mg/dL 9.10 7.30 – 10.9 12.8 10.2 – 15.4
CALCIUM (IONIZED)
ISE Direct mg/dL 3.30 2.90 – 3.71 4.69 3.78 – 5.59
CARBAMAZEPINE
Emit 2000 (3) µg/mL 3.24 2.57 – 3.92 17.4 14.6 – >20.0
CARBON DIOXIDE (CO2)
Teco Diagnostics TC-Matrix (Enzymatic) (4) mEq/L 30.9 24.7 – 37.1 20.3 16.2 – 24.4
CHLORIDE
ISE Indirect (3) mEq/L 102 95.1 – 110 84.7 79.4 – 90.0
Teco Diagnostics TC-Matrix (Mercuric Thiocyanate) (4) mEq/L 97.6 87.8 – 107 84.5 76.0 – 93.0
CHOLESTEROL (HDL) (7)
Direct measure (3) mg/dL 61.2 47.5 – 74.8 28.0 20.1 – 36.0
Wako L-Type (AU480) (4) mg/dL 60.2 56.4 – 64.0 25.4 24.1 – 26.7
CHOLESTEROL (LDL)
Direct measure (3) mg/dL 145 119 – 172 57.5 45.1 – 69.9
Wako L-Type (AU480) (4) mg/dL 147 143 – 151 64.2 62.5 – 67.9
CHOLESTEROL (TOTAL)
CHOD-PAP (3) mg/dL 245 221 – 270 95.0 82.5 – 107
Teco Diagnostics TC-Matrix (Enzymatic Liquid) (4) mg/dL 243 219 – 268 96.8 87.2 – 107
CHOLINESTERASE (2)
Butyrylthiocholine (3) U/L 6757 5537 – 7978 4967 3904 – 6029
COPPER
Atomic Absorption µg/dL 99.8 76.6 – 123 66.0 47.2 – 84.9
CREATINE KINASE (CK) (2)
IFCC 2002 (3) U/L 141 118 – 164 440 388 – 491
Teco Diagnostics TC-Matrix (UV Kinetic) (4) U/L 158 127 – 190 485 388 – 582
CREATININE
Alkaline picrate-kinetic (3) mg/dL 2.31 1.78 – 2.85 5.78 4.95 – 6.62
Enzymatic (3) mg/dL 1.80 1.32 – 2.27 5.35 4.73 – 5.97
Teco Diagnostics TC-Matrix (Jaffe Kinetic) (4) mg/dL 2.10 1.70 – 2.50 5.20 4.20 – 6.20
DIGOXIN
Emit 2000 (3) ng/mL 1.53 1.18 – 1.88 3.55 2.94 – 4.16
GAMMA GLUTAMYLTRANSFERASE (GGT) (2)
IFCC 2002 (3) U/L 59.5 46.1 – 72.9 159 128 – 189
Teco Diagnostics TC-Matrix (Kinetic Liquid) (4) U/L 43.2 34.6 – 51.8 111 88.8 – 133
GENTAMICIN
Emit 2000 (3) µg/mL 1.65 1.16 – 2.14 8.13 6.82 – 9.44
GLUCOSE
GOD-POD (3) mg/dL 82.0 68.5 – 95.5 265 233 – 297
Hexokinase (3) mg/dL 80.1 70.7 – 89.4 271 249 – 294
Teco Diagnostics TC-Matrix (Glucose Oxidase Liquid) (4) mg/dL 85.1 76.6 – 93.6 276 248 – 304
Teco Diagnostics TC-Matrix (Hexokinase Liquid) (4) mg/dL 79.3 71.4 – 87.2 276 248 – 303
GLUTAMATE DEHYDROGENASE (GLDH) (2)
Standard Method without Correction for the Non-Specific Creep Reaction (3) U/L 12.1 10.4 – 13.7 30.8 27.7 – 33.9

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Lyphochek® Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
HAPTOGLOBIN
Immunoturbidimetric (3) mg/dL 119 104 – 135 90.4 78.7 – 102
IMMUNOGLOBULIN A (IGA)
Immunoturbidimetric (3) mg/dL 175 148 – 202 126 103 – 150
IMMUNOGLOBULIN G (IGG)
Immunoturbidimetric (3) mg/dL 848 733 – 962 571 485 – 656
IMMUNOGLOBULIN M (IGM)
Immunoturbidimetric (3) mg/dL 73.2 55.9 – 90.6 46.8 31.8 – 61.8
IRON
Ferrozine (3) µg/dL 238 218 – 258 71.4 61.1 – 81.7
Teco Diagnostics TC-Matrix (Ferrozine) (4) µg/dL 237 190 – 285 68.1 54.5 – 81.7
LACTATE (LACTIC ACID)
Enzymatic (3) mg/dL 41.6 37.0 – 46.3 10.0 7.91 – 12.2
LACTATE DEHYDROGENASE (LDH) (2)
IFCC 2002 (3) U/L 170 142 – 198 369 328 – 410
Teco Diagnostics TC-Matrix (Modified Wacker Tris, Kinetic) (Liquid) (4) U/L 151 121 – 181 341 273 – 409
LIPASE (2)
Colorimetric (3) U/L 190 157 – 223 289 231 – 347
Enzymatic, colorimetric (3) U/L 42.1 33.7 – 50.5 67.3 53.6 – 81.0
LITHIUM
Atomic Absorption mEq/L 0.640 0.537 – 0.744 1.88 1.60 – 2.16
Flame Photometry mEq/L
MAGNESIUM
Atomic Absorption mg/dL 1.91 1.56 – 2.26 4.25 3.38 – 5.13
Teco Diagnostics TC-Matrix (Calmagite) (4) mg/dL 2.00 1.60 – 2.40 4.30 3.40 – 5.20
Teco Diagnostics TC-Matrix (Xylidyl blue) mg/dL
Xylidyl blue (3) mg/dL 2.00 1.61 – 2.39 4.40 3.79 – 5.01
OSMOLALITY
Freezing Point Depression mOSM/kg 569 532 – 606 496 466 – 526
PHENOBARBITAL
Emit 2000 (3) µg/mL 13.5 9.36 – 17.7 45.3 36.3 – 54.4
PHENYTOIN
Emit 2000 (3) µg/mL 10.7 8.17 – 13.3 30.3 23.9 – 36.6
PHOSPHORUS
Phosphomolybdate-UV (3) mg/dL 3.62 3.18 – 4.07 7.52 6.85 – 8.18
Teco Diagnostics TC-Matrix (Molybdenum UV) (4) mg/dL 3.60 3.20 – 4.00 6.70 6.00 – 7.40
POTASSIUM
Flame Photometry mEq/L 3.91 3.49 – 4.32 6.12 5.05 – 7.19
ISE Indirect (3) mEq/L 3.97 3.72 – 4.21 6.19 5.85 – 6.53
Teco Diagnostics TC-Matrix (Turbidimetric) (4) mEq/L 4.20 3.80 – 4.60 6.40 5.80 – 7.00
PROTEIN SERUM (TOTAL)
Biuret, no serum blank, end point (3) g/dL 6.25 5.57 – 6.93 4.36 3.81 – 4.92
Biuret, serum blank, end point (3) g/dL 6.29 5.75 – 6.83 4.38 3.95 – 4.80
Teco Diagnostics TC-Matrix (Biuret) (4) g/dL 6.30 5.70 – 6.90 4.30 3.90 – 4.70
SALICYLATE
Emit (3) mg/dL 6.70 5.01 – 8.39 15.0 12.2 – 17.7
SODIUM
ISE Indirect (3) mEq/L 144 137 – 150 128 122 – 134

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Lyphochek® Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
THEOPHYLLINE
Emit 2000 (3) µg/mL 9.01 7.37 – 10.7 25.6 22.2 – 29.1
TOBRAMYCIN
Emit 2000 (3) µg/mL 7.31 5.80 – 8.82 1.80 1.24 – 2.36
TRANSFERRIN
Immunoturbidimetric (3) mg/dL 251 221 – 282 182 160 – 203
TRIGLYCERIDES
Enzymatic / GPO (3) mg/dL 201 177 – 225 91.8 75.8 – 108
Teco Diagnostics TC-Matrix (Enzymatic GPO Liquid) (4) mg/dL 188 150 – 226 70.2 56.2 – 84.2
UREA (5)
Urease (3) mg/dL 33.0 28.2 – 37.7 100 90.7 – 111
UREA NITROGEN (BUN) (5)
Teco Diagnostics TC-Matrix (Urease, GLDH Liquid) (4) mg/dL 16.4 14.9 – 17.9 49.7 45.2 – 54.2
Urease (3) mg/dL 15.4 13.2 – 17.6 46.9 42.2 – 51.6
URIC ACID
Teco Diagnostics TC-Matrix (Uricase Liquid) (4) mg/dL 5.90 4.90 – 6.90 10.4 8.60 – 12.2
Uricase, colorimetric (3) mg/dL 4.77 4.10 – 5.43 9.69 8.69 – 10.7
Uricase, UV (3) mg/dL 4.51 3.91 – 5.11 9.23 8.26 – 10.2
VALPROIC ACID
Emit 2000 (3) µg/mL 38.9 27.3 – 50.4 119 98.0 – 141
VANCOMYCIN
Emit 2000 (3) µg/mL 7.67 5.70 – 9.63 29.6 22.4 – 36.8

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Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
ABAXIS-PICCOLO (4)
Albumin g/dL 4.20 3.70 – 4.70 2.90 2.40 – 3.40
Alkaline Phosphatase (2) U/L 114 85.0 – 143 517 437 – 597
ALT/SGPT (2) U/L 34.0 20.0 – 48.0 92.0 76.0 – 108
Amylase (2) U/L 67.0 56.0 – 78.0 354 315 – 393
AST/SGOT (2) U/L 46.0 37.0 – 55.0 205 180 – 230
Bilirubin (Direct) mg/dL 0.300 0.100 – 0.500 1.30 1.00 – 1.60
Bilirubin (Total) mg/dL 1.00 0.600 – 1.40 4.50 3.80 – 5.20
Calcium mg/dL 8.90 8.10 – 9.70 11.9 10.7 – 13.1
Carbon Dioxide (CO2) mEq/L 33.0 26.0 – 40.0 20.0 16.0 – 24.0
Chloride mEq/L 98.0 90.0 – 106 84.0 <80.0 – 90.0
Cholesterol (HDL) (7) mg/dL 52.0 44.0 – 60.0 18.0 <15.0 – 23.0
Cholesterol (Total) mg/dL 237 202 – 272 99.0 86.0 – 112
Creatine Kinase (CK) (2) U/L 166 137 – 195 466 422 – 510
Creatinine mg/dL 1.80 1.30 – 2.30 5.30 4.50 – 6.10
Gamma Glutamyltransferase (GGT) (2) U/L 57.0 51.0 – 63.0 150 136 – 164
Glucose mg/dL 79.0 68.0 – 90.0 261 239 – 283
Lactate Dehydrogenase (LDH) (2) U/L 149 125 – 173 270 212 – 328
Magnesium mg/dL 1.90 1.60 – 2.20 4.50 4.00 – 5.00
Phosphorus mg/dL 4.10 3.50 – 4.70 8.10 7.20 – 9.00
Potassium mEq/L 3.80 3.30 – 4.30 5.90 5.30 – 6.50
Protein Serum (Total) g/dL 6.50 6.00 – 7.00 4.50 4.10 – 4.90
Sodium mEq/L 145 138 – 152 133 126 – 140
Triglycerides mg/dL 214 186 – 242 95.0 87.0 – 103
Urea Nitrogen (BUN) (5) mg/dL 16.0 13.0 – 19.0 46.0 41.0 – 51.0
Uric Acid mg/dL 3.90 3.10 – 4.70 9.70 8.10 – 11.3
ABBOTT ARCHITECT cSYSTEMS
Acetaminophen µg/mL 10.8 8.90 – 12.7 82.3 77.7 – 86.9
Albumin (Bromcresol Green (BCG)) g/dL 3.86 3.43 – 4.28 2.72 2.26 – 3.17
Albumin (Bromcresol Purple (BCP)) g/dL 3.69 3.37 – 4.01 2.67 2.42 – 2.91
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 105 85.5 – 125 442 382 – 502
ALT/SGPT (UV with P5P) (2) U/L 28.8 21.8 – 35.9 101 87.1 – 116
ALT/SGPT (UV without P5P) (2) U/L 31.0 25.5 – 36.5 100 86.0 – 114
Amylase (CNP-triose/CNPG3) (2) U/L 80.7 72.0 – 89.4 440 401 – 480
AST/SGOT (UV with P5P) (2) U/L 42.2 34.7 – 49.7 208 180 – 236
AST/SGOT (UV without P5P) (2) U/L 38.3 33.0 – 43.7 198 175 – 220
Bilirubin (Direct) (Diazotization) mg/dL 0.400 0.318 – 0.482 1.20 1.02 – 1.38
Bilirubin (Total) (Diazonium Ion) mg/dL 0.866 0.616 – 1.12 4.60 3.84 – 5.37
Calcium (Arsenazo III) mg/dL 9.13 8.42 – 9.85 12.2 11.2 – 13.1
Carbamazepine (Immunoturbidimetric) (5P05-21) µg/mL 3.40 2.68 – 4.12 15.1 12.5 – 17.6
Carbon Dioxide (CO2) (Enzymatic) mEq/L 33.6 25.5 – 41.6 18.6 12.9 – 24.2
Chloride (ISE indirect) mEq/L 102 95.1 – 108 84.6 79.4 – 89.7
Cholesterol (HDL) (Ultra HDL) mg/dL 63.0 52.5 – 73.6 30.0 24.2 – 35.8
Cholesterol (LDL) (Direct measure) mg/dL 137 124 – 150 52.9 46.6 – 59.1
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 251 236 – 265 94.6 87.5 – 102
Complement C3 (Immunoturbidimetric) mg/dL 135 120 – 149 97.7 86.1 – 109
Creatine Kinase (CK) (NAC activated) (IFCC) (2) U/L 141 124 – 158 448 388 – 507
Creatinine (Alkaline picrate-kinetic rate blanked,IFCC-IDMS Standardized) mg/dL 2.59 2.00 – 3.17 6.26 5.63 – 6.90
Digoxin (Immunoturbidimetric) ng/mL 1.15 0.860 – 1.44 2.87 2.35 – 3.39

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Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
ABBOTT ARCHITECT cSYSTEMS (continued)
Gamma Glutamyltransferase (GGT) (IFCC) (2) U/L 60.4 50.1 – 70.8 161 135 – 186
Gentamicin (Immunoturbidimetric) µg/mL 1.55 1.11 – 1.99 8.30 7.08 – 9.53
Glucose (Hexokinase) mg/dL 81.0 71.7 – 90.4 274 250 – 297
Haptoglobin (Immunoturbidimetric) mg/dL 122 106 – 138 91.7 79.9 – 103
Immunoglobulin A (IgA) (Immunoturbidimetric) mg/dL 169 138 – 200 128 104 – 152
Immunoglobulin G (IgG) (Immunoturbidimetric) mg/dL 872 781 – 962 579 516 – 641
Immunoglobulin M (IgM) (Immunoturbidimetric) mg/dL 74.9 57.7 – 92.1 47.0 30.8 – 63.2
Iron (Ferene) µg/dL 244 220 – 267 72.6 63.5 – 81.6
Iron (Sentinel) µg/dL 241 217 – 264 71.6 61.8 – 81.4
Iron (UIBC) µg/dL 99.5 73.8 – 125 184 156 – 213
Lactate (Lactic Acid) (Lactate to pyruvate) (9D89-21) mg/dL 41.9 35.3 – 48.5 9.68 7.86 – 11.5
Lactate (Lactic Acid) (Lactate to pyruvate) (9P18-21) mg/dL 41.8 35.2 – 48.3 9.45 7.80 – 11.1
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (IFCC) (2) U/L 166 138 – 194 379 339 – 419
Lipase (Enzymatic with colipase) (2) U/L 43.8 32.1 – 55.4 78.0 58.2 – 97.8
Magnesium (Arsenazo I) (7D70) mg/dL 2.04 1.71 – 2.36 4.33 3.72 – 4.94
Phenobarbital (Immunoturbidimetric) (5P07-21) µg/mL 14.0 9.88 – 18.1 44.0 34.5 – 53.4
Phenytoin (EIA) (5P08-21) µg/mL 10.7 7.53 – 13.8 29.7 21.6 – 37.8
Phosphorus (Phosphomolybdate method) mg/dL 3.66 3.35 – 3.98 7.56 7.09 – 8.03
Potassium (ISE indirect) mEq/L 4.02 3.77 – 4.27 6.19 5.84 – 6.54
Protein Serum (Total) (Biuret, no serum blank, end point) g/dL 6.08 5.55 – 6.60 4.11 3.68 – 4.54
Salicylate (Enzymatic) mg/dL <5.00 – 6.97 12.5 10.6 – 14.4
Sodium (ISE indirect) mEq/L 145 138 – 152 128 122 – 134
Theophylline (EIA) (5P06-21) µg/mL 10.2 8.25 – 12.1 28.1 23.7 – 32.5
Tobramycin (Immunoturbidimetric) µg/mL 9.29 7.52 – >10.0 3.14 2.34 – 3.95
Transferrin (Immunoturbidimetric) mg/dL 242 215 – 269 177 157 – 198
Triglycerides (Enzymatic, end point) mg/dL 199 185 – 214 94.9 86.1 – 104
Urea Nitrogen (BUN) (Urease, UV) (5) mg/dL 16.0 14.3 – 17.7 47.4 42.8 – 52.1
Uric Acid (Uricase, colorimetric) mg/dL 4.80 4.30 – 5.30 9.83 8.90 – 10.8
Valproic Acid (Immunoturbidimetric) µg/mL 35.0 30.3 – 39.7 117 106 – 127
Vancomycin (Immunoturbidimetric) µg/mL 7.23 5.71 – 8.76 32.8 27.9 – 37.6
ALFA WASSERMANN ACE
Albumin (Bromcresol Green (BCG)) g/dL 3.72 3.40 – 4.04 2.75 2.46 – 3.04
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 111 88.4 – 134 465 384 – 547
ALT/SGPT (UV without P5P) (2) U/L 18.2 10.9 – 25.6 79.1 67.6 – 90.6
AST/SGOT (UV without P5P) (2) U/L 31.1 20.9 – 41.3 188 168 – 209
Bilirubin (Direct) (Diazotization) mg/dL 0.700 0.539 – 0.861 1.92 1.61 – 2.22
Bilirubin (Total) (Sulphanilic acid, DMSO) mg/dL 1.20 1.00 – 1.40 5.35 4.72 – 5.98
Calcium (Arsenazo III) mg/dL 9.08 8.24 – 9.93 12.3 11.3 – 13.3
Chloride (ISE direct) mEq/L 105 93.9 – 115 85.8 77.5 – 94.2
Cholesterol (HDL) (Direct measure, polymer-polyanion) (7) mg/dL § §
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 239 217 – 261 97.0 88.3 – 106
Creatinine (Alkaline picrate-kinetic) mg/dL 2.12 1.69 – 2.54 5.16 4.33 – 6.00
Glucose (Hexokinase) mg/dL 87.1 78.4 – 95.8 286 263 – 309
Potassium (ISE direct) mEq/L 4.20 3.90 – 4.49 6.45 5.94 – 6.96
Protein Serum (Total) (Biuret, no serum blank, end point) g/dL 6.00 4.83 – 7.17 4.47 4.03 – 4.90
Sodium (ISE direct) mEq/L 151 140 – 161 129 123 – 136
Triglycerides (Enzymatic, end point) mg/dL 205 187 – 222 92.5 82.7 – 102
Urea Nitrogen (BUN) (Urease, UV) (5) mg/dL 14.3 11.5 – 17.2 45.5 39.4 – 51.6

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8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
BECKMAN COULTER ACCESS / 2 / 2i
Cortisol (Chemiluminescence) µg/dL § §
hCG (Total BhCG) (5th IS) mIU/mL § §
BECKMAN COULTER AU SYSTEMS
Acetaminophen (Emit 2000) µg/mL 12.3 10.7 – 14.0 81.3 71.1 – 91.6
Albumin (Bromcresol Green (BCG)) g/dL 3.90 3.50 – 4.31 2.77 2.48 – 3.06
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 108 75.5 – 141 454 326 – 583
Alkaline Phosphatase (PNPP, AMP Buffer) (IFCC 2002) (Europe/Asia) (2) U/L 136 93.4 – 178 565 400 – 730
ALT/SGPT (UV with P5P) (Europe/Asia) (2) U/L 32.3 25.4 – 39.3 101 85.1 – 117
ALT/SGPT (UV without P5P) (2) U/L 28.6 20.9 – 36.2 90.3 69.6 – 111
Amylase (CNP-triose/CNPG3) (2) U/L 58.0 35.9 – 80.1 351 278 – 425
Amylase (G7 PNP, Blocked) (Europe/Asia) (2) U/L 83.1 63.8 – 102 400 335 – 466
AST/SGOT (UV with P5P) (IFCC 2002)(Europe/Asia) (2) U/L 42.3 33.6 – 51.0 217 189 – 244
AST/SGOT (UV without P5P) (2) U/L 36.4 26.4 – 46.5 184 133 – 234
Bilirubin (Direct) (Diazotization) mg/dL 0.300 0.209 – 0.391 1.66 1.36 – 1.95
Bilirubin (Direct) (Diazotization) (Europe/Asia) mg/dL 0.278 0.181 – 0.376 1.57 1.26 – 1.88
Bilirubin (Total) (DPD) mg/dL 0.889 0.716 – 1.06 4.66 4.02 – 5.29
Bilirubin (Total) (DPD) (Europe/Asia) mg/dL 0.968 0.795 – 1.14 4.76 4.12 – 5.39
Calcium (Arsenazo III) mg/dL 9.01 8.32 – 9.70 12.1 11.2 – 12.9
Calcium (o-cresolphthalein complexone) mg/dL § §
Carbamazepine (EIA) (Emit 2000) µg/mL 3.24 2.57 – 3.92 17.4 14.6 – >20.0
Carbon Dioxide (CO2) (Enzymatic) mEq/L 35.0 26.4 – 43.6 18.8 13.3 – 24.2
Chloride (ISE indirect) mEq/L 99.9 95.0 – 105 84.0 79.4 – 88.6
Cholesterol (HDL) (Direct measure, immunoinhibition) (Europe/Asia) (7) mg/dL 63.2 51.3 – 75.1 25.3 19.4 – 31.3
Cholesterol (HDL) (Direct measure, polymer-polyanion) (7) mg/dL 66.0 48.6 – 83.4 29.8 21.6 – 37.9
Cholesterol (LDL) (OSR6X83) (Europe/Asia) mg/dL 160 111 – 210 68.2 45.5 – 91.0
Cholesterol (LDL) (OSR6X96) mg/dL 124 81.6 – 166 49.3 33.4 – 65.2
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 242 217 – 267 89.7 78.0 – 101
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) (Europe/Asia) mg/dL 260 232 – 288 96.9 85.3 – 109
Cholinesterase (Butyrylthiocholine (Trinder)) (Europe/Asia) (2) U/L 6235 5166 – 7305 4519 3769 – 5269
Creatine Kinase (CK) (NAC activated) (2) U/L 124 93.0 – 156 398 306 – 489
Creatine Kinase (CK) (NAC activated) (Europe/Asia) (2) U/L 149 115 – 182 474 374 – 573
Creatinine (Alkaline picrate-kinetic) (Europe/Asia) mg/dL 2.04 1.73 – 2.34 5.31 4.80 – 5.81
Creatinine (Alkaline picrate-kinetic, IFCC-IDMS Standardized) mg/dL 2.02 1.68 – 2.36 5.29 4.69 – 5.89
Digoxin (EIA) (Emit 2000) ng/mL 1.53 0.997 – 2.07 3.55 2.63 – 4.48
Gamma Glutamyltransferase (GGT) (2) U/L 48.6 34.0 – 63.3 128 94.5 – 162
Gamma Glutamyltransferase (GGT) (IFCC 2002)(Europe/Asia) (2) U/L 61.0 45.2 – 76.8 160 118 – 203
Gentamicin (EIA) (Emit 2000) µg/mL 1.65 1.45 – 1.85 8.13 6.35 – 9.92
Glucose (Hexokinase) mg/dL 77.5 69.6 – 85.3 270 246 – 293
Immunoglobulin A (IgA) (Immunoturbidimetric) mg/dL § §
Immunoglobulin G (IgG) (Immunoturbidimetric) mg/dL § §
Immunoglobulin M (IgM) (Immunoturbidimetric) mg/dL § §
Iron (TPTZ-no deproteinization) µg/dL 258 229 – 287 76.6 66.1 – 87.0
Iron (TPTZ-no deproteinization) (Europe/Asia) µg/dL 245 218 – 273 71.4 61.1 – 81.7
Iron (UIBC) (Nitroso-PSAP) µg/dL 83.8 58.6 – 109 157 131 – 182
Lactate (Lactic Acid) (Lactate to pyruvate) (OSR6193) (Europe/Asia) mg/dL 42.8 35.5 – 50.2 9.84 8.20 – 11.5
Lactate Dehydrogenase (LDH) (IFCC 2002)(Europe/Asia) (2) U/L 166 129 – 203 369 289 – 449
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (2) U/L 142 111 – 174 318 249 – 387
Lipase (Enzymatic, colorimetric) (2) U/L 38.8 25.0 – 52.5 71.2 41.7 – 101

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8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
BECKMAN COULTER AU SYSTEMS (continued)
Lithium (Colorimetric) mEq/L 0.603 0.536 – 0.671 1.81 1.62 – 2.00
Magnesium (Xylidyl blue) mg/dL 2.03 1.75 – 2.32 4.54 3.93 – 5.15
Phenobarbital (EIA) (Emit 2000) µg/mL 13.5 9.36 – 17.7 45.3 36.3 – 54.4
Phenytoin (EIA) (Emit 2000) µg/mL 10.7 9.31 – 12.1 30.3 24.6 – 36.0
Phosphorus (Phosphomolybdate method) mg/dL 3.47 2.99 – 3.95 7.18 6.44 – 7.93
Potassium (ISE indirect) mEq/L 3.89 3.69 – 4.08 6.04 5.72 – 6.37
Protein Serum (Total) (Biuret, reagent blank, end point) g/dL 6.28 5.66 – 6.90 4.33 3.85 – 4.81
Salicylate (EIA) mg/dL 6.70 5.16 – 8.24 15.0 11.6 – 18.3
Sodium (ISE indirect) mEq/L 141 135 – 147 126 121 – 131
Theophylline (EIA) (Emit 2000) µg/mL 9.01 7.37 – 10.7 25.6 22.2 – 29.1
Tobramycin (EIA) (Emit 2000) µg/mL 7.31 5.99 – 8.63 1.80 1.42 – 2.18
Transferrin (Immunoturbidimetric) mg/dL 246 223 – 269 180 160 – 201
Triglycerides (Enzymatic, end point) mg/dL 198 172 – 224 89.6 76.2 – 103
Triglycerides (Enzymatic, end point) (Europe/Asia) mg/dL 205 174 – 236 91.9 76.2 – 108
Urea Nitrogen (BUN) (Urease, UV) (5) mg/dL 15.4 11.9 – 19.0 46.7 29.8 – 63.5
Uric Acid (Uricase, colorimetric) mg/dL 4.66 4.20 – 5.11 9.72 8.63 – 10.8
Uric Acid (Uricase, colorimetric) (Europe/Asia) mg/dL 4.92 4.43 – 5.41 10.2 8.97 – 11.4
Valproic Acid (EIA) (Emit 2000) µg/mL 38.9 27.3 – 50.4 119 98.0 – 141
Vancomycin (EIA) (Emit 2000) µg/mL 7.67 5.70 – 9.63 29.6 22.4 – 36.8
BECKMAN COULTER SYNCRON/UniCel DxC SERIES
Acetaminophen (Immunoturbidimetric) µg/mL
Albumin (Bromcresol Purple (BCP)) g/dL 4.01 3.67 – 4.36 2.83 2.56 – 3.10
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 115 88.5 – 142 496 420 – 571
ALT/SGPT (UV with P5P) (IFCC 2002) (2) U/L 32.5 25.4 – 39.5 101 81.7 – 121
ALT/SGPT (UV without P5P) (2) U/L 33.5 27.0 – 39.9 97.8 84.4 – 111
Amylase (G7 PNP, Blocked) (2) U/L 83.6 73.6 – 93.5 419 381 – 457
Amylase (Pancreatic) (G7 PNP immunoinhibition) (2) U/L 44.1 34.0 – 54.3 308 284 – 332
AST/SGOT (UV with P5P) (IFCC 2002) (2) U/L 41.9 31.5 – 52.3 218 168 – 269
AST/SGOT (UV without P5P) (2) U/L 40.0 34.7 – 45.3 196 175 – 217
Bilirubin (Direct) (Diazotization) mg/dL 0.203 <0.100 – 0.325 0.970 0.807 – 1.13
Bilirubin (Total) (Jendrassik Grof) mg/dL 0.952 0.529 – 1.38 4.79 4.00 – 5.59
Calcium (ISE indirect) mg/dL 8.98 8.33 – 9.63 12.1 11.4 – 12.8
Carbamazepine (Immunoturbidimetric) µg/mL 2.18 <2.00 – 2.91 15.8 13.5 – 18.0
Carbon Dioxide (CO2) (ISE indirect) mEq/L 34.7 28.7 – 40.8 19.6 15.6 – 23.6
Chloride (ISE indirect) mEq/L 99.2 92.1 – 106 82.9 76.8 – 88.9
Cholesterol (HDL) (Direct measure, polymer-polyanion) (HDL)(REF A15625) (7) mg/dL 65.6 52.4 – 78.8 28.6 21.6 – 35.6
Cholesterol (LDL) (Direct measure) mg/dL 133 112 – 155 50.2 38.8 – 61.5
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 251 229 – 273 103 92.9 – 112
Cholinesterase (Butyrylthiocholine (Trinder)) (CHEX) (2) kU/L 6.37 5.73 – 7.01 4.66 4.15 – 5.17
Creatine Kinase (CK) (NAC activated) (2) U/L 146 120 – 171 469 400 – 537
Creatine Kinase (CK) (Rosalki, Other Modified) (2) U/L 143 123 – 163 449 389 – 510
Creatinine (Alkaline picrate-kinetic, IFCC-IDMS Standardized) mg/dL 2.31 1.63 – 2.99 5.84 4.86 – 6.83
Digoxin (Immunoturbidimetric) ng/mL 1.01 0.562 – 1.46 2.83 2.39 – 3.28
Gamma Glutamyltransferase (GGT) (2) U/L 60.4 47.7 – 73.2 168 142 – 195
Gentamicin (Immunoturbidimetric) µg/mL
Glucose (Glucose oxidase, oxygen consumption) (GLUCm) mg/dL 73.8 63.8 – 83.9 263 240 – 286
Glucose (Hexokinase) (GLU) mg/dL § §
Glucose (Hexokinase) (GLUH) mg/dL 78.8 67.5 – 90.1 273 247 – 299

Page 8 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
BECKMAN COULTER SYNCRON/UniCel DxC SERIES (continued)
Immunoglobulin A (IgA) (Immunoturbidimetric) mg/dL 177 152 – 202 127 105 – 149
Immunoglobulin G (IgG) (Immunoturbidimetric) mg/dL 870 795 – 944 593 500 – 686
Immunoglobulin M (IgM) (Immunoturbidimetric) mg/dL 78.1 68.2 – 88.1 49.8 37.5 – 62.0
Iron (Ferrozine-no deproteinization) µg/dL 239 217 – 262 71.8 62.9 – 80.8
Iron (TIBC) (Ion exchange resin, ferrozine) µg/dL 355 311 – 400 253 225 – 281
Lactate (Lactic Acid) (Enzymatic) mg/dL 38.8 34.3 – 43.3 9.95 7.92 – 12.0
Lactate Dehydrogenase (LDH) (IFCC) (2) U/L 170 157 – 182 369 337 – 401
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (2) U/L 143 112 – 173 320 257 – 383
Lipase (Colorimetric) (2) U/L 35.9 23.2 – 48.5 66.0 49.4 – 82.6
Magnesium (Calmagite) mg/dL 1.98 1.70 – 2.26 4.34 3.84 – 4.85
Phenobarbital (Immunoturbidimetric) µg/mL 14.8 10.5 – 19.0 43.9 34.8 – 53.0
Phenytoin (Immunoturbidimetric) µg/mL 10.0 8.68 – 11.4 24.3 20.2 – 28.4
Phosphorus (Phosphomolybdate method) (PHOSm) mg/dL 3.81 3.24 – 4.38 8.01 7.06 – 8.95
Phosphorus (Phosphomolybdate method) (PHS) mg/dL 3.66 3.08 – 4.23 7.72 6.77 – 8.67
Potassium (ISE indirect) mEq/L 3.95 3.65 – 4.26 6.19 5.81 – 6.57
Protein Serum (Total) (Biuret, kinetic) (TPm) g/dL 6.00 5.50 – 6.50 4.25 3.87 – 4.64
Protein Serum (Total) (Biuret, no serum blank, end point) (TP) g/dL 6.27 5.59 – 6.95 4.46 3.94 – 4.97
Salicylate (Enzymatic) mg/dL 6.12 4.13 – 8.11 15.0 13.0 – 17.0
Sodium (ISE indirect) mEq/L 143 135 – 151 128 121 – 135
Theophylline (Immunoturbidimetric) µg/mL 8.22 6.48 – 9.96 24.0 20.3 – 27.6
Tobramycin (Immunoturbidimetric) µg/mL 9.45 7.90 – 11.0 2.64 1.92 – 3.35
Transferrin (Immunoturbidimetric) mg/dL 251 219 – 282 180 158 – 202
Triglycerides (Enzymatic with glycerol blank) mg/dL 223 197 – 249 94.7 79.6 – 110
Urea Nitrogen (BUN) (Conductometry) (BUNm) (5) mg/dL 14.6 11.4 – 17.9 45.3 40.1 – 50.6
Urea Nitrogen (BUN) (Urease, UV) (BUN) (5) mg/dL 16.7 14.3 – 19.1 49.6 44.5 – 54.6
Uric Acid (Uricase, colorimetric) mg/dL 4.72 4.38 – 5.07 9.12 8.48 – 9.76
Valproic Acid (Immunoturbidimetric) µg/mL 35.0 23.3 – 46.7 106 86.3 – 125
Vancomycin (Immunoturbidimetric) µg/mL 7.60 6.08 – 9.12 36.8 30.9 – >40.0
ORTHO VITROS MICROSLIDE SERIES
Acetaminophen (Enzymatic, colorimetric) µg/mL <10.0 86.4 79.2 – 93.7
Albumin (Bromcresol green) g/dL 4.47 3.76 – 5.18 3.09 2.62 – 3.56
Alkaline Phosphatase (PNPP, AMP Buffer-VITROS) (2) U/L 67.9 52.5 – 83.4 279 228 – 329
ALT/SGPT (UV with P5P-VITROS) (2) U/L 35.8 19.5 – 52.0 100 79.8 – 120
Amylase (Amylopectin, colorimetric-VITROS) (2) U/L 65.0 47.8 – 82.2 213 168 – 257
AST/SGOT (Enzymatic, colorimetric-VITROS) (2) U/L 48.6 40.4 – 56.9 214 186 – 242
Bilirubin (Direct) (Spectrophotometric) mg/dL § §
Bilirubin (Indirect) (Direct measure) mg/dL 0.480 0.087 – 0.873 3.86 3.08 – 4.64
Bilirubin (Total) (Diphylline, Diazonium Salt-VITROS) (TBIL) mg/dL 0.856 0.449 – 1.26 4.48 3.48 – 5.49
Calcium (Arsenazo III) mg/dL 8.31 7.55 – 9.08 12.0 11.0 – 13.0
Carbamazepine (EIA) µg/mL <3.00 – 3.88 15.6 11.3 – 19.9
Carbon Dioxide (CO2) (Enzymatic) mEq/L 31.3 24.1 – 38.4 18.8 13.4 – 24.2
Chloride (ISE direct) mEq/L 100 92.5 – 108 84.4 77.8 – 91.0
Cholesterol (HDL) (Direct measure, PTA/MgCl2-VITROS) (7) mg/dL 56.4 44.6 – 68.3 24.6 19.8 – 29.4
Cholesterol (LDL) (Calculated) mg/dL 136 89.2 – 183 49.6 28.3 – 70.9
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 233 208 – 258 92.1 76.9 – 107
Creatine Kinase (CK) (Rosalki, Other Modified-VITROS) (2) U/L 79.6 60.1 – 99.1 314 245 – 384
Creatinine (Enzymatic-VITROS, IFCC-IDMS Standardized) mg/dL 1.81 1.53 – 2.10 5.37 4.64 – 6.09
Digoxin (EIA) ng/mL 1.29 0.707 – 1.88 3.22 2.44 – 3.99

Page 9 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
ORTHO VITROS MICROSLIDE SERIES (continued)
Gamma Glutamyltransferase (GGT) (2) U/L 59.5 49.7 – 69.2 204 179 – 229
Glucose (Glucose oxidase, hydrogen peroxide (Trinder)) mg/dL 83.2 73.5 – 93.0 258 235 – 281
Iron (Pyridyl azo dye) µg/dL 269 217 – 321 77.1 55.3 – 98.9
Lactate (Lactic Acid) (Lactate to pyruvate) mg/dL 40.5 37.1 – 43.9 8.52 6.58 – 10.5
Lactate Dehydrogenase (LDH) (Pyruvate to lactate-VITROS) (2) U/L 436 347 – 526 1086 962 – 1211
Lipase (Enzymatic with colipase-VITROS) (2) U/L 305 255 – 354 862 723 – 1001
Lithium (Colorimetric) mEq/L <0.200 – 0.330 1.35 1.10 – 1.59
Magnesium (Formazan dye) mg/dL 1.70 1.36 – 2.04 4.50 3.92 – 5.08
Phenytoin (EIA) µg/mL 9.40 6.50 – 12.3 26.7 18.3 – 35.1
Phosphorus (Phosphomolybdate reduction-VITROS) mg/dL 3.39 2.92 – 3.85 6.67 5.82 – 7.52
Potassium (ISE direct) mEq/L 4.11 3.79 – 4.43 6.31 5.83 – 6.78
Protein Serum (Total) (Biuret, no serum blank, end point-VITROS) g/dL 5.12 4.48 – 5.76 3.85 3.35 – 4.36
Salicylate (Colorimetric-VITROS) mg/dL 6.05 4.52 – 7.58 15.1 12.6 – 17.6
Sodium (ISE direct) mEq/L 145 135 – 155 129 120 – 139
Theophylline (Enzymetric) µg/mL 28.4 18.6 – 38.2 34.3 24.6 – >40.0
Triglycerides (Enzymatic, end point) mg/dL 205 181 – 229 89.7 75.6 – 104
Urea Nitrogen (BUN) (Urease, colorimetric) (2) mg/dL 15.2 13.1 – 17.3 41.2 36.7 – 45.7
Uric Acid (Uricase, colorimetric) mg/dL 4.51 4.10 – 4.92 8.80 7.97 – 9.62
ORTHO VITROS MICROTIP SERIES
Cholesterol (LDL) (Direct measure) mg/dL 131 106 – 157 51.3 34.1 – 68.4
Iron (TIBC) (Chromazurol B-VITROS) µg/dL 317 301 – 333 259 241 – 277
Tobramycin (EIA) µg/mL § §
Valproic Acid (EIA) µg/mL 33.3 18.1 – 48.6 111 78.7 – 143
Vancomycin (EIA) µg/mL 7.50 5.88 – 9.12 29.1 24.2 – 34.0
ROCHE / HITACHI COBAS C SYSTEMS
Acetaminophen (EIA) (ACET2) (REF 06769942190) µg/mL 13.1 9.81 – 16.5 80.8 72.7 – 88.9
Acetaminophen (Enzymatic, colorimetric) (REF 20767174160) µg/mL
Albumin (Bromcresol Green (BCG)) g/dL 4.09 3.66 – 4.53 2.89 2.41 – 3.37
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 92.3 77.1 – 108 357 307 – 406
ALT/SGPT (UV with P5P) (IFCC 2002) (2) U/L 30.6 26.2 – 34.9 96.6 84.4 – 109
ALT/SGPT (UV without P5P) (2) U/L 28.8 22.4 – 35.2 95.3 83.6 – 107
Amylase (G7 PNP, Blocked) (2) U/L 81.1 74.2 – 87.9 378 351 – 406
Amylase (Pancreatic) (G7 PNP immunoinhibition) (2) U/L 48.5 42.6 – 54.4 357 330 – 384
AST/SGOT (UV with P5P) (IFCC 2002) (2) U/L 39.1 31.4 – 46.8 206 173 – 240
AST/SGOT (UV without P5P) (2) U/L 39.2 33.1 – 45.4 205 180 – 230
Bilirubin (Direct) (Diazotization) (DBILI) mg/dL 0.212 <0.200 – 0.267 1.06 0.890 – 1.23
Bilirubin (Total) (Diazonium Ion, Blanked (Roche)) (BILT3) mg/dL 0.739 0.585 – 0.893 4.24 3.71 – 4.77
Bilirubin (Total) (Diazonium Ion, Blanked (Roche)) (BILTS) mg/dL 0.753 0.633 – 0.874 4.38 3.97 – 4.79
Calcium (BAPTA) (CA2) mg/dL 9.20 8.59 – 9.81 12.5 11.8 – 13.3
Carbamazepine (EIA) µg/mL 2.56 2.04 – 3.08 15.9 13.4 – 18.4
Carbon Dioxide (CO2) (Enzymatic) mEq/L 35.8 26.0 – 45.7 19.0 14.0 – 23.9
Chloride (ISE indirect) mEq/L 104 96.9 – 112 83.7 77.5 – 90.0
Cholesterol (HDL) (Direct measure-PEG) (7) mg/dL 49.0 42.2 – 55.8 21.1 18.3 – 24.0
Cholesterol (LDL) (Direct measure) mg/dL 144 129 – 159 57.5 50.8 – 64.3
Cholesterol (LDL) (Direct measure) (LDLC3) mg/dL 146 116 – 176 57.5 47.3 – 67.7
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 244 226 – 263 96.9 84.9 – 109
Cortisol (Electrochemiluminescence (ECL)) µg/dL 11.3 10.1 – 12.5 46.1 41.1 – 51.1
Creatine Kinase (CK) (NAC activated) (IFCC 2002) (2) U/L 137 123 – 151 437 374 – 501

Page 10 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
ROCHE / HITACHI COBAS C SYSTEMS (continued)
Creatine Kinase (CK) (NAC activated) (IFCC 2002) (Cobas 8000) (2) U/L 138 123 – 152 422 383 – 461
Creatinine (Alkaline picrate-kinetic rate blanked,IFCC-IDMS Standardized) mg/dL 1.93 1.58 – 2.29 5.48 4.76 – 6.20
Creatinine (Enzymatic IFCC-IDMS Standardized) mg/dL 1.83 1.67 – 1.99 5.44 5.05 – 5.83
Digoxin (KIMS (Roche)) ng/mL 1.19 0.796 – 1.58 3.02 2.54 – 3.50
Gamma Glutamyltransferase (GGT) (IFCC 2002) (2) U/L 61.8 50.3 – 73.3 165 136 – 194
Glucose (Hexokinase) mg/dL 78.0 69.1 – 86.9 270 245 – 294
Haptoglobin (Immunoturbidimetric) mg/dL 119 105 – 134 90.3 78.8 – 102
Immunoglobulin A (IgA) (Immunoturbidimetric) mg/dL 173 157 – 189 127 108 – 147
Immunoglobulin G (IgG) (Immunoturbidimetric) mg/dL 803 726 – 881 550 490 – 610
Immunoglobulin M (IgM) (Immunoturbidimetric) mg/dL 72.8 60.5 – 85.2 47.1 34.9 – 59.3
Iron (Ferrozine-no deproteinization) µg/dL 236 219 – 254 71.3 62.3 – 80.4
Iron (TIBC) (Calculated) µg/dL 320 296 – 344 224 208 – 241
Iron (UIBC) (Ferrozine) µg/dL 59.6 35.9 – 83.2 138 112 – 164
Lactate (Lactic Acid) (Enzymatic) mg/dL 41.4 38.6 – 44.2 10.0 8.81 – 11.3
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (2) U/L 170 156 – 185 381 349 – 412
Lipase (Enzymatic, colorimetric) (2) U/L 39.8 34.3 – 45.3 55.7 46.9 – 64.6
Lithium (Colorimetric) mEq/L 0.633 0.400 – 0.867 1.85 1.65 – 2.05
Magnesium (Chlorophosphonazo III) mg/dL 1.98 1.73 – 2.23 4.42 4.03 – 4.80
Magnesium (Xylidyl blue) (MG2) mg/dL 1.98 1.78 – 2.19 4.37 4.04 – 4.69
Phenobarbital (KIMS (Roche)) µg/mL 13.5 10.9 – 16.1 44.5 37.5 – 51.5
Phenytoin (KIMS (Roche)) µg/mL 9.77 6.76 – 12.8 25.4 17.5 – 33.2
Phosphorus (Phosphomolybdate method) mg/dL 3.44 3.06 – 3.81 7.21 6.36 – 8.06
Potassium (ISE indirect) mEq/L 4.05 3.81 – 4.28 6.28 5.94 – 6.62
Protein Serum (Total) (Biuret, serum blank, end point) g/dL 6.13 5.67 – 6.59 4.20 3.89 – 4.51
Salicylate (Enzymatic) mg/dL 5.31 3.52 – 7.09 13.0 11.4 – 14.6
Sodium (ISE indirect) mEq/L 144 137 – 151 127 121 – 133
Theophylline (KIMS (Roche)) µg/mL 8.43 7.48 – 9.39 23.6 20.5 – 26.7
Transferrin (Immunoturbidimetric) mg/dL 262 238 – 286 184 168 – 200
Triglycerides (Enzymatic, end point) mg/dL 201 185 – 218 92.9 83.7 – 102
Urea Nitrogen (BUN) (Urease, UV) (5) mg/dL 14.9 13.4 – 16.5 45.8 41.5 – 50.1
Uric Acid (Uricase, colorimetric) mg/dL 4.81 4.37 – 5.25 9.65 8.85 – 10.4
Valproic Acid (EIA) µg/mL 36.1 27.0 – 45.2 110 84.5 – 135
Vancomycin (EIA) µg/mL 7.49 5.97 – 9.01 30.9 26.3 – 35.5
ROCHE COBAS INTEGRA
Acetaminophen (EIA) (ACET2) µg/mL 11.0 8.95 – 13.0 74.7 64.1 – 85.3
Acetaminophen (Enzymatic, colorimetric) µg/mL § §
Albumin (Bromcresol Green (BCG)) g/dL 4.00 3.55 – 4.44 2.86 2.51 – 3.21
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 90.9 70.4 – 111 357 310 – 404
ALT/SGPT (UV with P5P) (IFCC 2002) (2) U/L 29.0 23.0 – 35.1 93.7 78.6 – 109
ALT/SGPT (UV without P5P) (2) U/L 29.4 23.9 – 35.0 95.3 83.3 – 107
Amylase (G7 PNP, Blocked) (2) U/L 79.2 70.2 – 88.2 379 335 – 422
AST/SGOT (UV with P5P) (2) U/L 38.9 32.6 – 45.3 203 179 – 228
AST/SGOT (UV without P5P) (2) U/L 36.1 29.8 – 42.4 192 166 – 219
Bilirubin (Direct) (Diazotization) (BIL-D) mg/dL 0.198 0.146 – 0.249 1.16 0.960 – 1.35
Bilirubin (Total) (Diazonium Ion, Blanked (Roche)) (BILT3) mg/dL 0.747 0.575 – 0.919 4.35 3.72 – 4.99
Bilirubin (Total) (Diazonium Ion, Blanked (Roche)) (BILTS) mg/dL 0.719 0.546 – 0.892 4.14 3.54 – 4.74
Calcium (BAPTA) (CA2) mg/dL 8.79 8.20 – 9.38 12.2 11.3 – 13.2
Carbamazepine (Fluorescence Polarization-Roche) µg/mL 2.85 2.47 – 3.23 17.6 14.5 – >20.0

Page 11 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
ROCHE COBAS INTEGRA (continued)
Carbon Dioxide (CO2) (Enzymatic) mEq/L 32.3 25.0 – 39.7 18.2 12.9 – 23.6
Chloride (ISE indirect) mEq/L 104 96.0 – 112 87.0 80.6 – 93.4
Cholesterol (HDL) (Direct measure-PEG) (7) mg/dL 50.3 40.9 – 59.7 22.0 17.9 – 26.2
Cholesterol (LDL) (Direct measure) mg/dL § §
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 245 223 – 268 94.3 85.1 – 103
Complement C3 (Immunoturbidimetric) mg/dL 140 125 – 154 102 89.2 – 114
Creatine Kinase (CK) (NAC activated) (2) U/L 140 119 – 161 442 375 – 509
Creatinine (Alkaline picrate-kinetic, IFCC-IDMS Standardized) (CREJ2) mg/dL 1.96 1.65 – 2.26 4.96 4.35 – 5.58
Creatinine (Enzymatic IFCC-IDMS Standardized) (CREP2) mg/dL 1.73 1.09 – 2.37 5.21 4.49 – 5.92
Digoxin (KIMS (Roche)) ng/mL 1.34 1.01 – 1.67 3.13 2.68 – 3.58
Gamma Glutamyltransferase (GGT) (2) U/L 57.5 43.2 – 71.9 156 117 – 194
Gentamicin (Fluorescence Polarization-Roche) µg/mL 1.67 1.46 – 1.88 7.02 – >10.0
Glucose (Hexokinase) mg/dL 77.9 69.3 – 86.5 268 242 – 293
Haptoglobin (Immunoturbidimetric) mg/dL 114 100 – 129 88.0 76.6 – 99.3
Immunoglobulin A (IgA) (Immunoturbidimetric) mg/dL 179 160 – 198 123 107 – 139
Immunoglobulin G (IgG) (Immunoturbidimetric) mg/dL 850 756 – 944 567 501 – 632
Immunoglobulin M (IgM) (Immunoturbidimetric) mg/dL 75.5 64.4 – 86.7 48.9 35.3 – 62.4
Iron (Ferrozine-no deproteinization) µg/dL 235 210 – 260 70.4 57.1 – 83.6
Lactate (Lactic Acid) (Enzymatic) mg/dL 43.8 37.1 – 50.5 10.4 9.06 – 11.7
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (2) U/L 164 146 – 183 373 330 – 417
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (IFCC 2002) (2) U/L 170 153 – 188 379 342 – 417
Lipase (Enzymatic, colorimetric) (2) U/L 41.5 34.2 – 48.7 61.9 50.7 – 73.1
Lithium (ISE direct) mEq/L 0.622 0.490 – 0.754 1.85 1.60 – 2.10
Magnesium (Chlorophosphonazo III) mg/dL 1.95 1.56 – 2.33 4.27 3.65 – 4.89
Phenobarbital (Fluorescence Polarization-Roche) µg/mL 13.9 11.4 – 16.3 43.4 36.5 – 50.2
Phenytoin (Fluorescence Polarization-Roche) µg/mL 10.5 8.54 – 12.5 25.4 19.8 – 31.1
Phosphorus (Phosphomolybdate method) mg/dL 3.57 3.21 – 3.92 7.43 6.82 – 8.04
Potassium (ISE indirect) mEq/L 3.87 3.62 – 4.12 6.16 5.81 – 6.51
Protein Serum (Total) (Biuret, serum blank, end point) g/dL 6.05 5.49 – 6.61 4.22 3.79 – 4.65
Salicylate (Enzymatic) mg/dL 5.36 3.45 – 7.26 12.8 11.2 – 14.5
Sodium (ISE indirect) mEq/L 140 131 – 148 125 118 – 132
Theophylline (Fluorescence Polarization-Roche) µg/mL 8.69 8.19 – 9.19 24.3 22.5 – 26.2
Tobramycin (Fluorescence Polarization-Roche) µg/mL § §
Transferrin (Immunoturbidimetric) mg/dL 260 236 – 285 182 166 – 199
Triglycerides (Enzymatic, end point) mg/dL 198 179 – 216 88.4 78.4 – 98.4
Urea Nitrogen (BUN) (Urease, UV) (5) mg/dL 14.4 12.5 – 16.2 46.0 41.4 – 50.5
Uric Acid (Uricase, colorimetric) mg/dL 4.73 4.22 – 5.24 9.70 8.77 – 10.6
Valproic Acid (Fluorescence Polarization-Roche) µg/mL 34.8 28.3 – 41.3 112 95.2 – 129
Vancomycin (Fluorescence Polarization-Roche) µg/mL 8.93 7.14 – 10.7 38.7 33.5 – 43.8
ROCHE HITACHI / MODULAR
Albumin (Bromcresol Green (BCG)) g/dL 4.13 3.73 – 4.53 2.93 2.57 – 3.30
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 90.0 66.1 – 114 351 253 – 448
ALT/SGPT (UV with P5P) (2) U/L 30.5 23.8 – 37.2 94.3 81.4 – 107
ALT/SGPT (UV without P5P) (2) U/L 32.8 26.7 – 38.8 99.6 84.6 – 115
Amylase (G7 PNP, Blocked) (2) U/L 80.4 72.5 – 88.3 381 344 – 418
AST/SGOT (UV with P5P) (2) U/L 39.5 33.0 – 46.0 194 167 – 221
AST/SGOT (UV without P5P) (2) U/L 39.2 32.9 – 45.6 200 177 – 223
Bilirubin (Direct) (Diazotization) (D-BILI) mg/dL <0.200 – 0.259 0.997 0.834 – 1.16

Page 12 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
ROCHE HITACHI / MODULAR (continued)
Bilirubin (Direct) (Diazotization) (DBILI)(Europe/Asia) mg/dL 0.363 0.278 – 0.448 1.63 1.32 – 1.95
Bilirubin (Total) (BILT3) mg/dL 0.765 0.580 – 0.950 4.48 3.78 – 5.18
Bilirubin (Total) (Diazonium Ion, Blanked (Roche)) (TBILI) mg/dL 0.729 0.516 – 0.942 4.48 3.86 – 5.11
Calcium (BAPTA) mg/dL 8.92 8.31 – 9.53 12.1 11.3 – 12.8
Calcium (o-cresolphthalein complexone) mg/dL 8.86 7.90 – 9.81 12.4 11.3 – 13.6
Carbon Dioxide (CO2) (Enzymatic) mEq/L 33.0 25.5 – 40.6 18.6 13.6 – 23.6
Chloride (ISE indirect) mEq/L 104 96.8 – 111 84.0 77.6 – 90.3
Cholesterol (HDL) (Direct measure-PEG) (7) mg/dL 50.9 41.9 – 60.0 21.4 17.4 – 25.4
Cholesterol (LDL) (Direct measure) mg/dL 157 133 – 181 61.6 50.1 – 73.1
Cholesterol (Total) (CHOD/PAP) mg/dL 246 224 – 267 95.3 85.3 – 105
Creatine Kinase (CK) (NAC activated) (2) U/L 141 126 – 156 424 386 – 463
Creatinine (Alkaline picrate-kinetic rate blanked,IFCC-IDMS Standardized) mg/dL 2.19 1.75 – 2.63 5.51 4.85 – 6.18
Digoxin (Immunoturbidimetric) ng/mL § §
Gamma Glutamyltransferase (GGT) (2) U/L 57.2 43.8 – 70.6 153 118 – 187
Glucose (Hexokinase) mg/dL 75.9 67.1 – 84.8 266 245 – 288
Haptoglobin (Immunoturbidimetric) mg/dL § §
Immunoglobulin A (IgA) (Immunoturbidimetric) mg/dL 176 136 – 217 126 90.9 – 161
Immunoglobulin G (IgG) (Immunoturbidimetric) mg/dL 823 673 – 974 556 426 – 687
Immunoglobulin M (IgM) (Immunoturbidimetric) mg/dL 70.2 55.5 – 84.8 44.8 32.2 – 57.4
Iron (Ferrozine-no deproteinization) µg/dL 235 217 – 253 70.3 61.4 – 79.1
Iron (TIBC) (Calculated) µg/dL 308 261 – 356 219 185 – 254
Iron (UIBC) (Ferrozine) µg/dL 73.3 43.9 – 103 149 124 – 175
Lactate (Lactic Acid) (Enzymatic) mg/dL § §
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (2) U/L 162 149 – 175 367 337 – 397
Lipase (Enzymatic, colorimetric) (2) U/L 41.2 32.3 – 50.1 57.6 44.8 – 70.4
Magnesium (Xylidyl blue) mg/dL 1.97 1.57 – 2.38 4.37 3.69 – >4.86
Phenobarbital (KIMS (Roche)) µg/mL 13.5 10.4 – 16.7 44.5 35.5 – 53.5
Phenytoin (KIMS (Roche)) µg/mL 9.77 6.76 – 12.8 25.4 17.5 – 33.2
Phosphorus (Phosphomolybdate method) mg/dL 3.47 3.08 – 3.85 7.37 6.69 – 8.06
Potassium (ISE indirect) mEq/L 4.06 3.82 – 4.29 6.32 5.98 – 6.66
Protein Serum (Total) (Biuret, serum blank, end point) g/dL 6.14 5.60 – 6.68 4.27 3.86 – 4.69
Sodium (ISE indirect) mEq/L 145 139 – 152 129 123 – 135
Transferrin (Immunoturbidimetric) mg/dL 258 219 – 297 184 158 – 209
Triglycerides (GPO/PAP) mg/dL 200 172 – 228 93.5 79.4 – 108
Urea Nitrogen (BUN) (Urease, UV) (5) mg/dL 15.3 13.2 – 17.3 46.8 42.6 – 51.1
Uric Acid (Uricase, colorimetric) mg/dL 4.63 4.19 – 5.06 9.53 8.71 – 10.3
Valproic Acid (EIA) µg/mL 36.1 26.4 – 45.9 110 83.7 – 136
SIEMENS ADVIA CENTAUR CP
Carbamazepine (CARB) µg/mL 2.71 2.09 – 3.34 16.4 14.4 – >18.0
Cortisol (COR) µg/dL 10.7 9.37 – 12.1 53.7 49.0 – 58.5
Digoxin (DIG) ng/mL 1.30 1.18 – 1.41 3.26 2.96 – 3.57
Gentamicin (GENT) µg/mL 1.25 1.11 – 1.39 7.83 6.60 – 9.06
Phenobarbital (PHNB) µg/mL 14.0 11.6 – 16.3 44.1 36.7 – 51.6
Phenytoin (PHTN) µg/mL 10.9 10.0 – 11.7 29.1 26.5 – 31.6
T3 (Total) (T3) ng/mL 0.793 0.684 – 0.902 4.65 4.34 – 4.95
T3 Uptake/T Uptake (TUp) T Uptake Unit 1.12 0.986 – 1.26 1.99 1.71 – 2.28
T4 (Free) (FT4) ng/dL 1.24 1.11 – 1.37 6.45 5.85 – 7.04
T4 (Total) (T4) µg/dL 6.72 6.42 – 7.02 22.1 20.8 – 23.3

Page 13 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
SIEMENS ADVIA CENTAUR CP (continued)
Theophylline (THEO2) µg/mL 8.95 7.87 – 10.0 22.4 20.7 – 24.1
Thyroid Stimulating Hormone (TSH) (TSH) µIU/mL 1.99 1.81 – 2.17 21.0 17.1 – 24.9
Thyroid Stimulating Hormone (TSH) (TSH3UL) µIU/mL 1.43 1.15 – 1.70 14.0 11.9 – 16.1
Valproic Acid (VALP) µg/mL 37.3 32.2 – 42.4 116 103 – 128
Vancomycin (VANC) µg/mL 5.49 4.51 – 6.46 23.6 21.9 – 25.4
Vitamin B12 (VB12) pg/mL 122 99.0 – 146 157 133 – 181
SIEMENS ADVIA CENTAUR SYSTEMS
Carbamazepine (CARB) µg/mL 2.63 1.98 – 3.29 16.6 15.4 – 17.7
Cortisol (COR) µg/dL 10.6 9.05 – 12.1 51.2 44.5 – 58.0
Digoxin (DIG) ng/mL 1.39 1.08 – 1.69 3.31 3.05 – 3.56
Gentamicin (GENT) µg/mL 1.38 0.962 – 1.81 8.94 6.67 – 11.2
Phenobarbital (PHNB) µg/mL 16.3 13.5 – 19.1 49.8 46.7 – 52.9
Phenytoin (PHTN) µg/mL 10.7 9.11 – 12.3 30.6 26.1 – 35.2
T3 (Total) (T3) ng/mL 0.779 0.643 – 0.915 4.37 4.08 – 4.67
T3 Uptake/T Uptake (TUp) T Uptake Unit 1.02 0.877 – 1.16 1.76 1.52 – 1.99
T4 (Free) (FT4) ng/dL 1.12 0.997 – 1.24 5.68 4.34 – 7.02
T4 (Total) (T4) µg/dL 6.37 5.85 – 6.89 21.2 19.7 – 22.6
Theophylline (THEO2) µg/mL 8.82 7.32 – 10.3 23.8 20.5 – 27.2
Thyroid Stimulating Hormone (TSH) µIU/mL 1.94 1.44 – 2.45 21.5 19.9 – 23.1
Thyroid Stimulating Hormone (TSH) (TSH3UL) µIU/mL 1.39 1.23 – 1.55 14.0 12.4 – 15.5
Valproic Acid (VALP) µg/mL 34.7 33.1 – 36.4 105 97.8 – 113
Vancomycin (VANC) µg/mL 5.34 4.71 – 5.98 24.0 21.9 – 26.2
Vitamin B12 (VB12) pg/mL 104 84.9 – 123 139 107 – 170
SIEMENS ADVIA CHEMISTRY SYSTEMS
Acetaminophen (Enzymatic) (ACET) µg/mL 12.4 10.0 – 14.8 79.5 65.7 – 93.2
Albumin (Bromcresol Green (BCG)) (ALB, ALB_c) g/dL 3.88 3.64 – 4.12 2.79 2.60 – 2.97
Albumin (Bromcresol Purple (BCP)) (ALBP) g/dL 3.72 3.42 – 4.02 2.62 2.38 – 2.86
Alkaline Phosphatase (PNPP, AMP Buffer) (ALPAMP, ALPA_c) (2) U/L § §
Alkaline Phosphatase (PNPP, AMP Buffer) (IFCC) (ALP_2c) (2) U/L 105 96.7 – 113 407 351 – 462
Alkaline Phosphatase (PNPP, DEA Buffer) (ALPDEA) (2) (4) U/L 160 136 – 184 531 451 – 610
ALT/SGPT (UV with P5P) (ALTP5P, ALTP_c) (2) U/L 33.8 26.9 – 40.7 102 88.2 – 116
ALT/SGPT (UV without P5P) (ALT, ALT_c) (2) U/L 31.9 25.4 – 38.4 101 88.7 – 113
Amylase (Ethylidene blocked-pNPG7) (AMYLAS) (2) U/L 82.6 72.8 – 92.4 398 346 – 450
Amylase (Pancreatic) (Antibody-blocked colorimetric analysis) (2) U/L 52.0 41.7 – 62.3 372 344 – 401
AST/SGOT (UV with P5P) (ASTP5P, ASTP_c) (2) U/L 40.4 29.8 – 51.0 208 184 – 231
AST/SGOT (UV without P5P) (AST, AST_c) (2) U/L 40.8 33.1 – 48.6 213 194 – 232
Bilirubin (Direct) (Vanadate Oxidation) (DBIL_2) mg/dL 0.296 0.211 – 0.381 1.30 0.978 – 1.61
Bilirubin (Total) (Vanadate Oxidation) (TBIL_2) mg/dL 0.879 0.754 – 1.00 4.84 4.31 – 5.36
Calcium (Arsenazo III) (CA_2, CA_2c) mg/dL 9.47 8.74 – 10.2 12.4 11.5 – 13.2
Calcium (o-cresolphthalein complexone) (CA, CA_c) mg/dL 8.91 8.12 – 9.70 12.4 11.5 – 13.3
Carbamazepine (EIA) (CARB_2) µg/mL 3.26 2.61 – 3.91 15.4 13.1 – 17.8
Carbon Dioxide (CO2) (Enzymatic) (CO2_L, CO2_c) mEq/L 35.6 27.5 – >40.0 19.4 14.0 – 24.9
Chloride (ISE indirect) (CL) mEq/L 103 97.4 – 108 85.1 80.5 – 89.7
Cholesterol (HDL) (Direct measure) (DHDL) (7) mg/dL 53.0 44.5 – 61.5 24.5 20.5 – 28.5
Cholesterol (LDL) (Direct measure) (DLDL) mg/dL 145 122 – 169 56.9 46.4 – 67.4
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) (CHOL_2, CHOL_c) mg/dL 249 232 – 267 107 98.0 – 116
Cholinesterase (Butyrylthiocholine (Trinder)) (CHE) (2) U/L 7430 6665 – 8194 5540 4944 – 6137
Creatine Kinase (CK) (CK_L) (2) (4) U/L 131 112 – 151 419 356 – 482

Page 14 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
SIEMENS ADVIA CHEMISTRY SYSTEMS (continued)
Creatine Kinase (CK) (NAC activated) (CKNAC) (2) U/L 128 113 – 143 414 369 – 458
Creatine Kinase (CK) (NAC activated) (IFCC) (CKNAC) (2) U/L 139 124 – 155 433 390 – 477
Creatinine (Enzymatic) (ECRE_2) mg/dL 1.80 1.61 – 1.99 5.44 5.02 – 5.86
Creatinine (Jaffe) (CREA, CREA_2, CRE_2c) mg/dL 2.22 1.90 – 2.54 5.43 4.99 – 5.87
Digoxin (Immunoturbidimetric) (DIG) ng/mL 1.14 0.752 – 1.53 3.08 2.75 – 3.41
Gamma Glutamyltransferase (GGT) (IFCC) (2) U/L 61.1 44.8 – 77.5 165 130 – 199
Gentamicin (EIA) (GENT_2) µg/mL 1.53 1.34 – 1.73 7.02 6.48 – 7.56
Glucose (GLUO, GLUO_2) mg/dL 80.8 70.9 – 90.7 272 248 – 296
Glucose (Hexokinase) (GLUH, GLUH_3, GLUH_c) mg/dL 76.9 68.2 – 85.6 266 243 – 290
Immunoglobulin A (IgA) (Immunoturbidimetric) (IGA_2) mg/dL 223 157 – 290 149 110 – 188
Immunoglobulin G (IgG) (Immunoturbidimetric) (IGG_2) mg/dL 870 717 – 1022 585 327 – 842
Immunoglobulin M (IgM) (Immunoturbidimetric) (IGM_2) mg/dL 76.9 64.8 – 89.1 47.6 36.3 – 58.8
Iron (Ferrozine-no deproteinization) (IRON_2) µg/dL 245 231 – 259 73.2 65.8 – 80.5
Iron (TIBC) (Ferric chloride, alumina) (TIBC) µg/dL 349 313 – 385 265 233 – 296
Lactate (Lactic Acid) (Lactate to pyruvate) (LAC) mg/dL 41.4 37.4 – 45.4 8.43 7.43 – 9.43
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (LDLP) (IFCC) (2) U/L 173 150 – 196 386 339 – 433
Lactate Dehydrogenase (LDH) (Pyruvate to lactate) (LDPL) (2) U/L 312 243 – 380 787 663 – 911
Lipase (Enzymatic, colorimetric) (LIP) (2) U/L 46.7 37.5 – 55.9 79.3 66.4 – 92.3
Lithium (Colorimetric) (LITH) mEq/L 0.570 0.435 – 0.705 1.80 1.56 – 2.04
Magnesium (Xylidyl blue) (MG, MG_c) mg/dL 2.02 1.73 – 2.31 4.33 3.80 – 4.87
Phenobarbital (EIA) (PHNB_2) µg/mL 14.2 8.51 – 19.8 43.5 32.5 – 54.6
Phenytoin (EIA) (PHYN_2) µg/mL 10.0 6.40 – 13.7 24.7 15.7 – 33.7
Phosphorus (Phosphomolybdate method) (IP, IP_c) mg/dL 3.71 3.37 – 4.06 7.70 7.16 – 8.23
Potassium (ISE indirect) (K) mEq/L 4.05 3.78 – 4.31 6.22 5.90 – 6.55
Protein Serum (Total) (Biuret, no serum blank, end point) (TP, TP_c) g/dL 6.48 5.85 – 7.11 4.60 4.14 – 5.06
Salicylate (Enzymatic) (SAL) mg/dL 5.52 3.73 – 7.32 14.0 12.4 – 15.5
Sodium (ISE indirect) (NA) mEq/L 146 141 – 152 130 125 – 135
Theophylline (EIA) (THEO_2) µg/mL 8.60 6.85 – 10.4 23.8 18.7 – 28.8
Tobramycin (EIA) (TOB_2) µg/mL 6.56 5.73 – 7.39 1.85 1.19 – 2.51
Transferrin (Immunoturbidimetric) (TRF) mg/dL 260 222 – 298 187 162 – 212
Triglycerides (Enzymatic, end point) (TRIG) mg/dL 213 197 – 229 99.6 89.1 – 110
Urea Nitrogen (BUN) (Urease, UV) (UN, UN_c) (5) mg/dL 15.7 14.0 – 17.3 45.8 42.1 – 49.5
Uric Acid (Uricase, colorimetric) (UA, UA_c) mg/dL 4.88 4.53 – 5.23 9.77 9.19 – 10.4
Valproic Acid (EIA) (VPA_2) µg/mL 41.5 25.1 – 57.8 125 91.0 – 159
Vancomycin (EIA) (VANC_2) µg/mL
SIEMENS BN SERIES NEPHELOMETERS
Alpha 1-Antitrypsin (Immunonephelometric, fixed time, kinetic) mg/dL 132 107 – 157 97.2 77.6 – 117
Apolipoprotein A-I (Immunonephelometric, fixed time, kinetic) mg/dL 139 122 – 155 91.0 82.4 – 99.5
Apolipoprotein B (Immunonephelometric, fixed time, kinetic) mg/dL 77.3 65.2 – 89.5 46.6 35.2 – 58.1
Ceruloplasmin (Immunonephelometric, fixed time, kinetic) mg/dL 25.3 20.9 – 29.7 16.4 14.6 – 18.2
Complement C3 (Immunonephelometric, fixed time, kinetic) mg/dL 152 144 – 161 105 101 – 109
Haptoglobin (Immunonephelometric, fixed time, kinetic) mg/dL 129 124 – 134 94.1 88.7 – 99.5
Immunoglobulin A (IgA) (Immunonephelometric, fixed time, kinetic) mg/dL 207 185 – 228 140 130 – 150
Immunoglobulin G (IgG) (Immunonephelometric, fixed time, kinetic) mg/dL 880 812 – 949 593 568 – 618
Immunoglobulin M (IgM) (Immunonephelometric, fixed time, kinetic) mg/dL 92.8 84.7 – 101 50.8 43.3 – 58.3
SIEMENS DIMENSION SERIES
Acetaminophen (Enzymatic, colorimetric) µg/mL 16.8 12.2 – 21.4 88.6 80.5 – 96.6
Albumin (Bromcresol Purple (BCP)) g/dL 3.66 3.36 – 3.96 2.59 2.37 – 2.81

Page 15 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
SIEMENS DIMENSION SERIES (continued)
Alkaline Phosphatase (PNPP, AMP Buffer) (IFCC ALPI) (2) U/L 107 69.1 – 145 427 279 – 575
ALT/SGPT (UV with P5P) (IFCC ALTI) (2) U/L 38.2 30.3 – 46.0 108 88.1 – 128
Amylase (CNP-triose/CNPG3) (2) U/L 80.4 72.5 – 88.4 501 461 – 541
AST/SGOT (UV with P5P) (2) U/L 42.6 34.4 – 50.8 204 180 – 227
AST/SGOT (UV with P5P) (IFCC 2002 Correlated) (2) U/L 42.7 34.5 – 50.8 204 181 – 228
Bilirubin (Direct) (Diazotization) (DBI) mg/dL 0.206 0.154 – 0.258 0.959 0.805 – 1.11
Bilirubin (Total) (Jendrassik Grof) (TBI) mg/dL 0.811 0.620 – 1.00 4.73 4.26 – 5.19
Calcium (o-cresolphthalein complexone) mg/dL 8.65 7.76 – 9.54 12.2 11.1 – 13.3
Carbamazepine (Immunoturbidimetric) µg/mL 2.73 2.05 – 3.42 16.0 13.4 – 18.6
Carbon Dioxide (CO2) (Enzymatic) mEq/L 36.8 30.4 – 43.2 20.2 15.4 – 25.0
Chloride (ISE indirect) (EXL/Xpand) mEq/L 118 106 – 130 97.5 87.2 – 108
Chloride (ISE indirect) (RxL) mEq/L 117 105 – 130 95.0 84.5 – 106
Cholesterol (HDL) (Direct measure-PEG) (DF48B) (7) mg/dL 54.2 39.6 – 68.8 26.0 19.7 – 32.3
Cholesterol (LDL) (Direct measure) (ALDL) mg/dL 141 122 – 161 55.7 46.7 – 64.7
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 239 214 – 263 85.2 73.2 – 97.3
Cholinesterase (Butyrylthiocholine (Trinder)) (2) U/L 10838 9938 – 11738 8572 7907 – 9237
Creatine Kinase (CK) (NAC activated) (IFCC CKI) (2) U/L 139 119 – 158 420 375 – 465
Creatinine (Alkaline picrate-kinetic) (CREA) mg/dL § §
Creatinine (Alkaline picrate-kinetic, IFCC-IDMS Standardized) (CRE2) mg/dL 2.62 2.24 – 2.99 6.21 5.52 – 6.90
Creatinine (Enzymatic IFCC-IDMS Standardized) (EZCR) mg/dL 1.77 1.55 – 1.98 5.27 4.89 – 5.65
Digoxin (EIA) ng/mL 0.789 0.545 – 1.03 2.35 1.96 – 2.74
Gamma Glutamyltransferase (GGT) (2) U/L 76.5 64.5 – 88.5 191 166 – 216
Gamma Glutamyltransferase (GGT) (IFCC 2002 Correlated) (2) U/L 65.5 53.5 – 77.5 164 139 – 189
Gentamicin (Immunoturbidimetric) µg/mL 1.47 0.957 – 1.98 7.43 6.41 – 8.45
Glucose (Hexokinase) mg/dL 85.1 76.2 – 94.0 272 248 – 297
Immunoglobulin A (IgA) (Immunoturbidimetric) mg/dL 168 141 – 195 119 90.1 – 147
Immunoglobulin G (IgG) (Immunoturbidimetric) mg/dL 851 592 – 1111 567 364 – 770
Immunoglobulin M (IgM) (Immunoturbidimetric) mg/dL 61.7 46.9 – 76.5 41.5 26.9 – 56.1
Iron (Ferene) µg/dL 239 220 – 258 71.0 61.4 – 80.7
Iron (TIBC) (Ferene) (IBCT) µg/dL 333 284 – 383 225 185 – 264
Lactate (Lactic Acid) (Enzymatic) mg/dL 41.5 35.0 – 48.1 9.81 5.96 – 13.7
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (IFCC LDI) (2) U/L 159 125 – 192 359 295 – 422
Lipase (Colorimetric) (2) U/L 182 151 – 213 260 221 – 299
Lithium (Colorimetric) mEq/L 0.605 0.462 – 0.748 1.89 1.54 – 2.24
Magnesium (Methylthymol blue) mg/dL 2.06 1.75 – 2.37 4.59 4.13 – 5.05
Phenobarbital (Immunoturbidimetric) µg/mL § §
Phenytoin (Immunoturbidimetric) µg/mL 11.0 8.46 – 13.6 28.1 23.1 – 33.1
Phosphorus (DF61) mg/dL § §
Phosphorus (DF61A) mg/dL 3.77 3.39 – 4.15 7.53 6.96 – 8.09
Potassium (ISE indirect) (EXL/Xpand) mEq/L 3.89 3.62 – 4.16 6.21 5.78 – 6.65
Potassium (ISE indirect) (RxL) mEq/L 3.87 3.59 – 4.15 6.08 5.67 – 6.50
Protein Serum (Total) (Biuret, serum blank, end point) g/dL 6.60 6.06 – 7.15 4.62 4.20 – 5.04
Salicylate (Trinder) mg/dL 7.39 6.11 – 8.67 9.21 7.66 – 10.8
Sodium (ISE indirect) (EXL/Xpand) mEq/L 144 136 – 152 129 122 – 136
Sodium (ISE indirect) (RxL) mEq/L 142 134 – 150 126 119 – 133
T3 Uptake/T Uptake (EIA) % Uptake 39.0 22.0 – 55.9 54.4 43.2 – 65.6
T4 (Free) ng/dL § §
T4 (Free) (Chemiluminescence) ng/dL 0.986 0.905 – 1.07 7.22 6.22 – >8.00

Page 16 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
SIEMENS DIMENSION SERIES (continued)
T4 (Total) (EIA) µg/dL 7.68 5.82 – 9.55 20.0 15.6 – >24.0
Theophylline (Immunoturbidimetric) µg/mL 8.62 6.89 – 10.3 23.0 17.7 – 28.2
Thyroid Stimulating Hormone (TSH) (Chemiluminescence) µIU/mL 1.58 1.37 – 1.78 16.9 15.4 – 18.4
Thyroid Stimulating Hormone (TSH) (EIA) µIU/mL 1.20 0.786 – 1.61 13.6 10.4 – 16.9
Tobramycin (Immunoturbidimetric) µg/mL 7.23 5.73 – 8.72 1.86 1.29 – 2.43
Transferrin (Immunoturbidimetric) mg/dL 224 195 – 253 175 153 – 198
Triglycerides (Enzymatic, end point) mg/dL 191 172 – 211 85.6 73.7 – 97.4
Urea Nitrogen (BUN) (Urease, UV) (5) mg/dL 14.7 11.5 – 17.8 47.2 40.9 – 53.5
Uric Acid (Uricase, UV) mg/dL 4.60 4.08 – 5.13 9.45 8.63 – 10.3
Valproic Acid (Immunoturbidimetric) µg/mL § §
Vancomycin (Immunoturbidimetric) µg/mL § §
SIEMENS DIMENSION VISTA SYSTEMS
Acetaminophen (Enzymatic, colorimetric) µg/mL 18.7 17.6 – 19.9 91.0 86.7 – 95.2
AFP (Chemiluminescence) ng/mL 2.71 2.50 – 2.91 1.88 1.67 – 2.09
Albumin (Bromcresol Purple (BCP)) g/dL 3.65 3.22 – 4.07 2.60 2.22 – 2.98
Alkaline Phosphatase (PNPP, AMP Buffer) (IFCC ALPI) (2) U/L 109 84.1 – 135 426 378 – 474
Alpha 1-Antitrypsin (Immunonephelometric, fixed time, kinetic) mg/dL 136 121 – 151 101 91.2 – 110
ALT/SGPT (UV with P5P) (IFCC ALTI) (2) U/L 33.6 28.4 – 38.7 94.2 83.7 – 105
Amylase (CNP-triose/CNPG3) (2) U/L 77.8 72.8 – 82.7 495 472 – 517
Apolipoprotein A-I (Immunonephelometric, fixed time, kinetic) mg/dL 136 122 – 150 89.9 79.3 – 100
Apolipoprotein B (Immunonephelometric, fixed time, kinetic) mg/dL 80.3 68.6 – 92.1 47.2 40.8 – 53.6
AST/SGOT (UV with P5P) (2) U/L 40.7 32.1 – 49.3 205 187 – 224
Bilirubin (Direct) (Diazotization) mg/dL 0.200 0.149 – 0.251 0.960 0.767 – 1.15
Bilirubin (Total) (Jendrassik Grof) mg/dL 0.817 0.701 – 0.933 4.54 4.14 – 4.95
Calcium (o-cresolphthalein complexone) mg/dL 8.68 7.98 – 9.38 12.0 11.2 – 12.9
Carbamazepine (Immunoturbidimetric) µg/mL 2.82 2.18 – 3.45 15.8 13.3 – 18.4
Carbon Dioxide (CO2) (Enzymatic) mEq/L 36.9 30.4 – 43.3 20.1 16.5 – 23.7
CEA (Chemiluminescence) ng/mL 0.922 0.716 – 1.13 0.702 0.532 – 0.872
Ceruloplasmin (Immunonephelometric, fixed time, kinetic) mg/dL 25.0 23.7 – 26.4 16.8 14.1 – 19.6
Chloride (ISE indirect) mEq/L 104 98.4 – 109 87.4 82.6 – 92.2
Cholesterol (HDL) (Direct measure-PEG) (HDLC) (7) mg/dL 54.9 45.1 – 64.8 26.1 19.9 – 32.4
Cholesterol (LDL) (Direct measure) (ALDL) mg/dL 148 121 – 175 58.0 45.6 – 70.5
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 239 219 – 259 85.1 74.4 – 95.8
Cholinesterase (Butyrylthiocholine (Trinder)) (2) U/L 10642 9230 – 12054 8236 6985 – 9488
Complement C3 (Immunonephelometric, fixed time, kinetic) mg/dL 146 121 – 171 102 89.6 – 115
Creatine Kinase (CK) (NAC activated) (IFCC CKI) (2) U/L 139 114 – 163 416 363 – 470
Creatinine (Alkaline picrate-kinetic rate blanked,IFCC-IDMS Standardized) (CRE2) mg/dL 2.67 2.29 – 3.05 6.32 5.68 – 6.96
Creatinine (Enzymatic IFCC-IDMS Standardized) (ECREA) mg/dL 1.84 1.35 – 2.33 5.41 4.80 – 6.03
Digoxin (Chemiluminescence) ng/mL 1.36 1.27 – 1.45 3.32 3.16 – 3.48
Gamma Glutamyltransferase (GGT) (2) U/L 72.2 58.3 – 86.0 193 161 – 224
Gentamicin (Immunoturbidimetric) µg/mL 1.41 0.948 – 1.87 7.85 6.71 – 8.98
Glucose (Hexokinase) mg/dL 82.8 75.9 – 89.7 267 248 – 287
Haptoglobin (Immunonephelometric, fixed time, kinetic) mg/dL 125 110 – 140 93.5 85.5 – 102
hCG (Chemiluminescence) mIU/mL 73.0 68.2 – 77.9 118 112 – 124
Immunoglobulin A (IgA) (Immunonephelometric, fixed time, kinetic) mg/dL 198 174 – 221 139 122 – 157
Immunoglobulin G (IgG) (Immunonephelometric, fixed time, kinetic) mg/dL 880 798 – 961 598 559 – 637
Immunoglobulin M (IgM) (Immunonephelometric, fixed time, kinetic) mg/dL 93.4 75.0 – 112 50.4 43.4 – 57.3
Iron (Ferene) µg/dL 240 222 – 258 71.8 60.0 – 83.7

Page 17 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26431 Level 2 - 26432
Units Mean Range Mean Range
SIEMENS DIMENSION VISTA SYSTEMS (continued)
Iron (TIBC) (Ferene) µg/dL 342 292 – 392 236 196 – 275
Lactate (Lactic Acid) (Lactate to pyruvate) mg/dL 41.5 36.2 – 46.8 10.3 8.54 – 12.1
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (IFCC LDI) (2) U/L 167 131 – 203 366 313 – 419
Lipase (Colorimetric) (2) U/L 198 166 – 231 317 273 – 362
Lithium (Colorimetric) mEq/L 0.638 0.467 – 0.809 1.93 1.70 – 2.16
Magnesium (Methylthymol blue) mg/dL 2.23 1.93 – 2.53 4.92 4.48 – 5.36
Phenobarbital (Immunoturbidimetric) µg/mL 15.3 10.4 – 20.2 45.5 35.4 – 55.7
Phenytoin (Immunoturbidimetric) µg/mL 11.2 9.22 – 13.1 27.3 22.5 – 32.2
Phosphorus (Phosphomolybdate method) mg/dL 3.37 3.04 – 3.70 7.13 6.50 – 7.76
Potassium (ISE indirect) mEq/L 3.95 3.76 – 4.14 6.08 5.76 – 6.41
Protein Serum (Total) (Biuret, serum blank, end point) g/dL 6.55 6.16 – 6.94 4.57 4.28 – 4.86
Salicylate (Trinder) mg/dL 7.49 6.70 – 8.28 12.7 11.2 – 14.1
Sodium (ISE indirect) mEq/L 146 139 – 154 131 125 – 137
T3 (Free) (Chemiluminescence) pg/mL 2.68 2.27 – 3.10 14.0 9.27 – 18.8
T3 Uptake/T Uptake (EIA) % Uptake 39.8 22.9 – 56.7 55.6 46.5 – >58.0
T4 (Free) (Chemiluminescence) ng/dL 1.00 0.903 – 1.11 7.24 6.24 – >8.00
T4 (Total) (EIA) µg/dL 9.01 6.90 – 11.1 23.2 18.0 – >24.0
Theophylline (Immunoturbidimetric) µg/mL 8.54 6.77 – 10.3 23.3 18.3 – 28.4
Thyroid Stimulating Hormone (TSH) µIU/mL 1.52 1.39 – 1.64 16.4 15.6 – 17.2
Tobramycin (Immunoturbidimetric) µg/mL 7.15 5.65 – 8.64 1.62 1.07 – 2.16
Transferrin (Immunonephelometric, fixed time, kinetic) mg/dL 253 221 – 285 181 166 – 196
Triglycerides (Enzymatic, end point) mg/dL 217 196 – 238 101 89.0 – 114
Urea Nitrogen (BUN) (Urease, UV) (5) mg/dL 15.4 13.0 – 17.7 46.4 41.2 – 51.7
Uric Acid (Uricase, UV) mg/dL 4.42 4.14 – 4.70 9.01 8.61 – 9.42
Valproic Acid (Immunoturbidimetric) µg/mL 37.9 30.8 – 44.9 114 94.5 – 134
Vancomycin (Immunoturbidimetric) µg/mL 7.46 5.92 – 9.00 31.5 26.8 – 36.2
Vitamin B12 (Chemiluminescence) pg/mL 296 257 – 336 255 226 – 283
SIEMENS IMMULITE / IMMULITE 1000
T4 (Total) µg/dL 7.10 5.67 – 8.53 19.3 16.3 – 22.3
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 1.65 1.39 – 1.91 17.1 14.3 – 19.9
SIEMENS IMMULITE 2000 / 2000 XPi
Cortisol µg/dL 9.23 7.09 – 11.4 43.0 35.2 – >50.0
T3 (Total) ng/dL 77.5 62.5 – 92.4 365 311 – 418
T4 (Total) µg/dL 6.94 5.79 – 8.10 19.5 16.8 – 22.2
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 1.75 1.50 – 2.00 16.0 12.9 – 19.1
Thyroid Stimulating Hormone (TSH) (Rapid TSH) µIU/mL 1.79 1.38 – 2.20 16.3 12.6 – 19.9

Page 18 English • 2017-03 • 4030-00

8
Lyphochek® Assayed Chemistry Control, Levels 1 and 2

FOOTNOTES
(1) All footnotes may not apply to your custom selected data chart.
(2) Values were obtained at 37°C.
(3) The mean value is calculated from data generated by instruments using this method.
(4) The assigned values were determined using the reagent and/or instrument manufacturer’s protocol and may not represent ±3SD ranges.
(5) mg/dL Urea Nitrogen x 2.14 = mg/dL Urea. S.I. Units value range is expressed as Urea.
(6) This product has been tested using the methodologies listed in the package insert. The performance of this product has not been evaluated for use with
capillary electrophoresis methods.
(7) Direct methods only.
(8) % Total Protein
Data is not available at this time. Please inquire.
§ The data required to establish the means and acceptable ranges for this assay were not obtained due to limited assignment participation. If your facility is
interested in participating in the Value Assignment Program for this assay, please contact your local Bio-Rad office.

Page 19 English • 2017-03 • 4030-00

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