Lyphochek® Assayed Chemistry Control

Levels 1 and 2
C-310-5 Level 1 12 x 5 mL Level 1 26481
C-315-5 Level 2 12 x 5 mL 0459 2023-07-31 26480 Level 2 26482
313X MiniPak 2 x 5 mL

http://www.myeinserts.com/26480

Revision Date 2020-10-26 Indicates Revised Information

METHOD (1)
Level 1 - 26481 Level 2 - 26482
Units Mean Range Mean Range
ACID PHOSPHATASE (TOTAL) (2)
Colorimetric Test Substrate Naphytl. Pentandiol (3) U/L 18.8 10.4 – 27.2 42.0 34.4 – 49.7
ALBUMIN
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) g/dL 4.38 3.89 – 4.86 3.40 2.83 – 3.95
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) g/dL 4.40 3.70 – 5.10 3.40 2.90 – 3.90
Agappe Diagnostics Ltd. (MISPA CCXL) (5) g/dL 4.39 3.80 – 5.03 3.21 2.61 – 3.81
Agappe Diagnostics Ltd. (MISPA NANO) (5) g/dL 4.30 3.50 – 5.00 3.49 2.75 – 4.23
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) g/dL 4.40 3.70 – 5.10 3.30 2.60 – 4.00
Catechem ChemWell-T (Bromcresol green) (5) g/dL § §
Fortress Diagnostics (Bromcresol green) (BXC0222) (5) g/dL 4.20 3.57 – 4.83 2.77 2.35 – 3.18
Sekisui Medical Clinimate, Autosera (Dye Binding-BCG) (5) g/dL 4.17 3.87 – 4.47 2.81 2.51 – 3.11
ALKALINE PHOSPHATASE (2)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) U/L 150 108 – 193 463 371 – 555
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia - IFCC) (5) U/L 110 82.7 – 137 445 374 – 516
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) U/L 146 108 – 183 460 366 – 555
Agappe Diagnostics Ltd. (MISPA CCXL - IFCC) (5) U/L 120 95.1 – 144 470 394 – 546
Agappe Diagnostics Ltd. (MISPA CCXL) (5) U/L 134 95.0 – 172 480 381 – 579
Agappe Diagnostics Ltd. (MISPA NANO) (5) U/L 145 103 – 187 485 395 – 575
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) U/L 160 129 – 191 480 385 – 576
Catachem ChemWell-T (5) U/L 102 73.0 – 131 433 358 – 508
Fortress Diagnostics (AMP) (BXC0184) (5) U/L 127 108 – 146 491 417 – 564
Fortress Diagnostics (DEA) (BXC0185) (5) U/L 182 155 – 209 609 518 – 700
Sekisui Medical Pureauto S, Autosera S, Qualigent ALP (5) U/L 289 264 – 314 932 862 – 1002
ALT/SGPT (2)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) U/L 26.0 18.9 – 33.2 104 81.2 – 127
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) U/L 29.7 22.1 – 37.4 107 84.0 – 129
Agappe Diagnostics Ltd. (MISPA CCXL) (5) U/L 25.3 18.6 – 32.1 99.2 77.4 – 121
Agappe Diagnostics Ltd. (MISPA NANO) (5) U/L 29.7 21.5 – 37.8 105 82.8 – 126
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) U/L 27.4 19.7 – 35.2 106 82.6 – 129
Catachem ChemWell-T (5) U/L 30.0 21.0 – 39.0 107 84.0 – 130
Fortress Diagnostics (IFCC UV Liquid) (BXCO213) (5) U/L 27.9 23.7 – 32.1 102 86.9 – 118
Sekisui Medical Pureauto S, Qualigent (ALT-L) (UV without P5P) (5) U/L 25.1 20.1 – 30.1 93.0 81.0 – 105
AMYLASE (2)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) U/L 60.7 50.2 – 71.2 420 350 – 489
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia - Jaffe) (5) U/L 57.3 48.2 – 66.4 427 353 – 501
Agappe Diagnostics Ltd. (MISPA CCXL) (3) U/L 58.0 48.5 – 67.5 413 328 – 498

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 Lyphochek® Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 26481 Level 2 - 26482
Units Mean Range Mean Range
AMYLASE (2) (continued)
Agappe Diagnostics Ltd. (MISPA NANO) (5) U/L 59.5 51.4 – 67.6 424 349 – 498
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) U/L 61.4 51.3 – 71.5 423 351 – 496
Catachem ChemWell-T (5) U/L 72.0 48.0 – 96.0 480 367 – 593
Fortress Diagnostics (CNPG3) (BXC0562) (5) U/L 69.6 59.1 – 80.0 366 311 – 421
Fortress Diagnostics (EPS) (BXC0563) (5) U/L 60.5 51.4 – 69.6 378 321 – 434
Sekisui Medical Pureauto S, Qualigent AMY-G2 (5) U/L 86.7 81.7 – 91.7 563 543 – 583
AMYLASE (PANCREATIC) (2)
Sekisui Medical Pureauto S, Qualigent P-AMY-G2 (5) U/L 58.1 53.1 – 63.1 530 505 – 555
AST/SGOT (2)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) U/L 37.5 29.0 – 46.0 200 144 – 256
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) U/L 37.5 29.1 – 46.0 193 147 – 239
Agappe Diagnostics Ltd. (MISPA CCXL) (5) U/L 36.5 29.6 – 43.4 192 148 – 237
Agappe Diagnostics Ltd. (MISPA NANO) (5) U/L 37.6 30.3 – 45.0 195 157 – 233
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) U/L 37.3 28.6 – 46.0 195 146 – 244
Catachem ChemWell-T (5) U/L 32.0 21.0 – 43.0 157 107 – 207
Fortress Diagnostics (IFCC UV Liquid) (BXCO203) (5) U/L 40.0 34.0 – 46.0 194 165 – 223
Sekisui Medical Pureauto S, Qualigent AST-L (UV without P5P) (5) U/L 40.9 35.9 – 45.9 202 190 – 214
BILIRUBIN (DIRECT)
Advanced Instruments BR2 Bilirubin Stat-Analyzer (Photometric) (5) mg/dL 0.100 0.000 – 0.200 0.800 0.400 – 1.20
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 0.240 0.171 – 0.309 0.738 0.579 – 0.896
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 0.250 0.200 – 0.300 0.700 0.600 – 0.800
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 0.171 0.123 – 0.219 0.749 0.532 – 0.965
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 0.300 0.200 – 0.400 0.880 0.710 – 1.05
Catachem ChemWell-T (5) mg/dL 0.350 0.220 – 0.480 0.930 0.670 – 1.19
Fortress Diagnostics (Jendrassik Grof) (BXC0191) (5) mg/dL 0.643 0.547 – 0.740 1.34 1.14 – 1.54
Wako L-Type (AU480) (5) mg/dL 0.350 0.325 – 0.375 1.20 1.04 – 1.36
BILIRUBIN (TOTAL)
Advanced Instruments BR2 Bilirubin Stat-Analyzer (Photometric) (5) mg/dL 1.80 1.40 – 2.20 4.40 3.50 – 5.30
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 1.18 0.830 – 1.53 4.30 3.25 – 5.35
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 1.20 0.900 – 1.40 4.50 3.60 – 5.40
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 1.06 0.800 – 1.31 4.38 3.57 – 5.19
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 1.20 0.900 – 1.50 4.42 3.60 – 5.24
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 1.12 0.852 – 1.39 4.35 3.49 – 5.21
Catachem ChemWell-T (5) mg/dL § §
Fortress Diagnostics (Jendrassik Grof) (BXC0192) (5) mg/dL 1.52 1.29 – 1.75 4.97 4.22 – 5.71
Wako L-Type (AU480) (5) mg/dL 1.08 1.05 – 1.11 4.27 4.13 – 4.41
CALCIUM
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 8.74 7.82 – 9.67 11.6 10.2 – 13.1
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 8.90 7.80 – 10.0 12.0 10.9 – 13.2
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 8.49 7.40 – 9.54 11.4 10.1 – 12.6
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 9.10 8.20 – 10.1 11.8 10.5 – 13.0
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 9.00 8.00 – 10.0 12.0 10.7 – 13.4
Catachem ChemWell-T (5) mg/dL 9.70 7.90 – 11.5 11.8 10.6 – 13.0
Fortress Diagnostics (Arsenazo III) (BXC0292) (5) mg/dL 8.80 7.48 – 10.1 11.4 9.72 – 13.2
Fortress Diagnostics (OCPC) (BXC0291) (5) mg/dL 8.48 7.20 – 9.72 11.8 10.0 – 13.6
Sekisui Medical Clinimate, Qualigent CA (5) mg/dL 7.96 7.06 – 8.86 11.4 10.2 – 12.6
CALCIUM (IONIZED)
ISE Direct (3) mg/dL § §

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 Lyphochek® Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 26481 Level 2 - 26482
Units Mean Range Mean Range
CHLORIDE
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mEq/L 95.7 87.3 – 104 93.4 84.9 – 102
Agappe Diagnostics Ltd. (MISPA NANO) (5) mEq/L 97.8 80.1 – 116 93.0 88.5 – 97.4
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mEq/L 99.3 89.2 – 109 92.8 84.7 – 101
Fortress Diagnostics (Thiocyanate) (BXC0281) (5) mEq/L 101 85.4 – 116 89.3 75.9 – 103
Sekisui Medical Internal Standard Solution -K/-B, Dilutent -K/-B (5) mEq/L 100 93.0 – 107 85.9 80.9 – 90.9
CHOLESTEROL (HDL) (7)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 55.8 46.7 – 64.9 24.9 20.1 – 29.7
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 55.0 45.0 – 65.0 25.8 20.3 – 31.3
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 55.4 45.7 – 65.2 25.3 19.6 – 31.1
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 61.0 50.5 – 71.5 27.6 21.7 – 33.6
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 61.5 52.5 – 70.5 30.4 23.7 – 37.0
Fortress Diagnostics (Direct) (BXC0421) (5) mg/dL 98.8 84.2 – 114 34.4 29.3 – 39.4
Sekisui Medical Cholestest N, Qualigent N HDL (5) mg/dL 82.4 73.4 – 91.4 30.5 26.5 – 34.5
Wako L-Type (AU480) (5) mg/dL 71.1 66.4 – 75.8 26.6 24.8 – 28.4
CHOLESTEROL (LDL)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 145 130 – 160 57.9 44.8 – 71.1
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 142 121 – 163 56.6 42.7 – 70.5
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 152 135 – 169 61.2 47.1 – 75.4
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 151 126 – 176 60.4 42.8 – 78.0
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 166 150 – 183 66.8 52.2 – 81.3
Fortress Diagnostics (Direct) (BXC0431) (5) mg/dL 133 113 – 153 56.4 47.9 – 64.9
Sekisui Medical Cholestest, Qualigent LDL (5) mg/dL 135 126 – 144 59.1 54.1 – 64.1
Wako L-Type (AU480) (5) mg/dL 156 149 – 163 70.4 67.0 – 73.8
CHOLESTEROL (TOTAL)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 278 253 – 303 103 87.8 – 117
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 285 236 – 334 107 93.2 – 121
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 277 224 – 331 105 92.4 – 118
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 280 236 – 325 104 90.2 – 118
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 280 228 – 332 106 91.7 – 120
Catachem ChemWell-T (5) mg/dL 282 230 – 334 106 125 – 87.0
Fortress Diagnostics (CHOD-PAP Liquid) (BXC0261) (5) mg/dL 268 228 – 308 105 88.8 – 120
Sekisui Medical Cholestest, Qualigent CHO (5) mg/dL 273 261 – 285 109 99.0 – 119
Sekisui Medical Pureauto S CHO-N (5) mg/dL 272 260 – 284 108 98.0 – 118
CHOLINESTERASE (2)
Fortress Diagnostics (Butyrylthiocholine DGKC) (BXC0801) (5) U/L 7464 6344 – 8583 4734 4024 – 5444
COMPLEMENT C3
Sekisui Medical (Immunotesta C3) (5) mg/dL § §
COPPER
Atomic Absorption µg/dL § §
Fortress Diagnostics (Colorimetric, End Point) (BXC0341) (5) µg/dL 114 97.1 – 131 66.9 56.9 – 76.9
CREATINE KINASE (CK) (2)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) U/L 125 99.8 – 151 482 419 – 545
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) U/L 120 98.9 – 140 458 389 – 526
Agappe Diagnostics Ltd. (MISPA CCXL) (5) U/L 131 105 – 158 513 445 – 582
Agappe Diagnostics Ltd. (MISPA NANO) (5) U/L 125 99.3 – 150 459 372 – 545
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) U/L 133 112 – 153 496 422 – 570
Catachem ChemWell-T (5) U/L 134 100 – 168 481 381 – 581
Fortress Diagnostics (NAC Activated Liquid) (BXCO252) (5) U/L 130 110 – 149 460 391 – 529

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 Lyphochek® Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 26481 Level 2 - 26482
Units Mean Range Mean Range
CREATINE KINASE (CK) (2) (continued)
Sekisui Medical Pureauto S CK (5) U/L 132 112 – 152 467 437 – 497
Sekisui Medical Pureauto S, Qualigent CK-L (5) U/L 129 109 – 149 460 430 – 490
CREATININE
Agappe Diagnostics Ltd. (Biolis/TMS Series - Enzymatic) (5) mg/dL 1.56 1.20 – 1.92 5.10 4.22 – 5.91
Agappe Diagnostics Ltd. (Biolis/TMS Series - Jaffe) (5) mg/dL 2.01 1.43 – 2.60 5.10 4.46 – 5.71
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia - Enzymatic) (5) mg/dL 1.50 0.800 – 2.20 4.90 4.00 – 5.70
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 2.20 1.90 – 2.50 5.20 4.50 – 5.80
Agappe Diagnostics Ltd. (MISPA CCXL - Enzymatic) (5) mg/dL 1.73 1.30 – 2.20 5.23 4.68 – 5.77
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 2.08 1.50 – 2.67 4.60 3.94 – 5.26
Agappe Diagnostics Ltd. (MISPA NANO - Enzymatic) (5) mg/dL 1.62 0.975 – 2.26 5.10 4.23 – 5.97
Agappe Diagnostics Ltd. (MISPA NANO - Jaffe) (5) mg/dL 1.90 1.30 – 2.40 4.82 4.12 – 5.52
Agappe Diagnostics Ltd. (Toshiba TBA Series - Enzymatic) (5) mg/dL 1.62 1.08 – 2.16 5.35 4.55 – 6.14
Agappe Diagnostics Ltd. (Toshiba TBA Series - Jaffe) (5) mg/dL 2.20 2.00 – 2.40 5.10 4.50 – 5.60
Catachem ChemWell-T (5) mg/dL 2.13 1.73 – 2.53 5.35 3.85 – 6.85
Fortress Diagnostics (Enzymatic) (BXC0113) (5) mg/dL 1.78 1.51 – 2.05 5.30 4.50 – 6.09
Fortress Diagnostics (Jaffe) (BXC0111) (5) mg/dL 2.53 2.15 – 2.90 5.91 5.03 – 6.80
Sekisui Medical Clinimate CRE (5) mg/dL 2.50 2.20 – 2.80 6.17 5.57 – 6.77
Sekisui Medical Pureauto S CRE-L (5) mg/dL 1.70 1.50 – 1.90 5.41 5.16 – 5.66
Sekisui Medical Pureauto S, Qualigent CRE-N (5) mg/dL 1.83 1.63 – 2.03 5.66 5.41 – 5.91
GAMMA GLUTAMYLTRANSFERASE (GGT) (2)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) U/L 62.9 53.0 – 72.8 166 126 – 206
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) U/L 61.3 50.6 – 72.0 167 131 – 203
Agappe Diagnostics Ltd. (MISPA CCXL) (5) U/L 61.9 52.3 – 71.6 163 128 – 199
Agappe Diagnostics Ltd. (MISPA NANO) (5) U/L 62.2 51.5 – 73.0 167 128 – 206
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) U/L 61.5 50.8 – 72.2 166 131 – 201
Catachem ChemWell-T (5) U/L 59.0 46.0 – 72.0 158 118 – 198
Fortress Diagnostics (Glycylglycine Liquid) (BXC0362) (5) U/L 64.1 54.5 – 73.7 166 141 – 191
Sekisui Medical Pureauto S GGT (5) U/L 64.2 59.2 – 69.2 172 157 – 187
Sekisui Medical Pureauto S, Qualigent y-GT (5) U/L 64.4 59.4 – 69.4 177 162 – 192
GLUCOSE
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 79.9 69.1 – 90.8 278 207 – 348
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 81.3 73.4 – 89.1 276 238 – 314
Agappe Diagnostics Ltd. (MISPA CCXL - Hexokinase) (5) mg/dL 79.5 71.5 – 87.4 272 235 – 310
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 78.6 70.1 – 87.2 270 230 – 310
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 79.4 70.9 – 87.8 275 239 – 310
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 83.0 74.9 – 91.1 276 236 – 316
Catachem ChemWell-T (5) mg/dL 94.0 74.0 – 114 301 267 – 335
EKF und Eppendorf (BIOSEN-, EBIO basic -und EBIO compact -Analysatoren)
GOD (5) mg/dL 84.7 75.3 – 94.1 278 248 – 309
Fortress Diagnostics (GOD-PAP) (BXC0101) (5) mg/dL 88.8 75.5 – 102 281 238 – 323
Fortress Diagnostics (Hexokinase) (BXC0103) (5) mg/dL 111 94.4 – 128 303 257 – 348
Kabe Labortechnik GmbH (GA 2/3 mit Dickschichtelectrode-DSE) (5) mg/dL 84.6 75.5 – 93.4 280 250 – 310
Sekisui Medical Pureauto S GLU (5) mg/dL 85.8 79.8 – 91.8 287 272 – 302
Sekisui Medical Pureauto S, Qualigent GLU-R (5) mg/dL 84.7 78.7 – 90.7 284 269 – 299
GLUTAMATE DEHYDROGENASE (GLDH) (2)
Catachem ChemWell-T U/L 6.60 5.60 – 7.60 11.0 7.60 – 14.4
Standard Method without Correction for the Non-Specific Creep Reaction (3) U/L

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 Lyphochek® Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 26481 Level 2 - 26482
Units Mean Range Mean Range
IMMUNOGLOBULIN A (IGA)
Sekisui Medical Pureauto S IgA (5) mg/dL § §
IMMUNOGLOBULIN G (IGG)
Sekisui Medical Pureauto S IgG (5) mg/dL § §
IMMUNOGLOBULIN M (IGM)
Sekisui Medical Pureauto S IgM (5) mg/dL § §
IRON
Fortress Diagnostics (Ferene) (BXC0232) (5) µg/dL 270 230 – 311 42.1 35.8 – 48.4
Fortress Diagnostics (Ferrozine) (BXC0235) (5) µg/dL 236 201 – 272 67.7 57.5 – 77.9
IRON (TIBC)
Fortress Diagnostics (BXC0237) (5) µg/dL 334 284 – 384 231 197 – 266
IRON (UIBC)
Sekisui Medical Pureauto S UIBC (5) µg/dL 73.5 58.5 – 88.5 151 136 – 166
LACTATE (LACTIC ACID)
Dr. Mueller Geraetebau GmbH, SUPER G1, SUPER G2, SUPER GL Serie (5) mg/dL § §
EKF und Eppendorf (BIOSENS-, EBIObasic-und EBIOcompact-Analysatoren) LOD
(5) mg/dL 40.5 35.9 – 44.9 12.6 11.3 – 14.1
Fortress Diagnostics (Enzymatic, colorimetric) (BXC0622) (5) mg/dL 43.3 36.8 – 49.8 11.3 9.55 – 13.0
LACTATE DEHYDROGENASE (LDH) (2)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) U/L 382 300 – 464 928 847 – 1008
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) U/L 380 290 – 470 910 832 – 989
Agappe Diagnostics Ltd. (MISPA CCXL) (5) U/L 369 291 – 448 869 791 – 947
Agappe Diagnostics Ltd. (MISPA NANO) (5) U/L 379 296 – 463 895 810 – 980
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) U/L 383 299 – 467 914 831 – 998
Fortress Diagnostics (L-P) (BXC0243) (5) U/L 154 131 – 177 346 294 – 398
Fortress Diagnostics (P-L) (BXC0242) (5) U/L 337 286 – 387 854 720 – 982
Sekisui Medical Pureauto S LD, Qualigent LD (5) U/L 176 166 – 186 389 369 – 409
Sekisui Medical Pureauto S LD-P (5) U/L 410 390 – 430 972 922 – 1022
LAP ARYLAMIDASE (2)
Sekisui Medical Pureauto LAP (5) U/L 46.9 40.9 – 52.9 31.0 28.0 – 34.0
LIPASE (2)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) U/L 39.9 31.0 – 48.7 58.3 53.5 – 63.2
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) U/L 40.7 35.1 – 46.2 59.9 48.9 – 70.8
ANALYTICON/Biocon: Fluitest Lipase (Colorimetric) (5) U/L § §
Fortress Diagnostics (BXC0511) (5) U/L 53.1 45.1 – 61.0 110 93.1 – 126
LITHIUM
Atomic Absorption mEq/L § §
MAGNESIUM
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 2.16 1.84 – 2.48 4.10 3.77 – 4.50
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 2.10 1.70 – 2.60 4.20 3.30 – 5.00
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 2.01 1.60 – 2.44 4.16 3.52 – 4.79
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 2.70 1.90 – 3.40 5.36 4.61 – 6.10
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 2.80 2.30 – 3.30 4.70 4.20 – 5.30
Atomic Absorption mg/dL § §
Catachem ChemWell-T (5) mg/dL 1.70 1.10 – 2.30 4.40 5.30 – 3.50
Fortress Diagnostics (Xylidyl blue) (BXC0352) (5) mg/dL 1.99 1.70 – 2.28 4.23 3.60 – 4.86
Sekisui Medical Clinimate MG (5) mg/dL 2.01 1.71 – 2.31 4.57 4.17 – 4.97
OSMOLALITY
Freezing Point Depression mOsm/kg 578 545 – 611 490 463 – 517

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 Lyphochek® Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 26481 Level 2 - 26482
Units Mean Range Mean Range
PHOSPHORUS
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 3.50 2.81 – 4.20 7.10 6.23 – 7.90
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 3.80 3.10 – 4.50 7.00 6.61 – 7.34
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 3.64 3.00 – 4.27 7.11 6.04 – 8.18
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 3.80 3.20 – 4.50 7.32 6.44 – 8.19
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 3.80 3.20 – 4.50 7.30 6.40 – 8.20
Catachem ChemWell-T (5) mg/dL 4.00 3.20 – 4.80 7.00 5.90 – 8.10
Fortress Diagnostics (UV Molybdate) (BXC0301) (5) mg/dL 3.75 3.19 – 4.30 7.49 6.38 – 8.61
Sekisui Medical Clinimate IP-2 (5) mg/dL 3.51 3.21 – 3.81 7.55 6.55 – 8.55
POTASSIUM
Flame Photometry mEq/L 3.83 3.42 – 4.25 5.90 4.70 – 7.09
Fortress Diagnostics (Colorimetric) (BXC0138) (5) mEq/L 3.95 3.36 – 4.54 6.35 5.40 – 7.30
Sekisui Medical Internal Standard Solution -K/-B, Dilutent -K/-B (5) mEq/L 3.89 3.69 – 4.09 6.09 5.59 – 6.59
PROTEIN SERUM (TOTAL)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) g/dL 6.78 5.74 – 7.82 4.60 4.06 – 5.20
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) g/dL 6.90 6.00 – 7.70 4.60 3.80 – 5.40
Agappe Diagnostics Ltd. (MISPA CCXL) (5) g/dL 6.83 6.20 – 7.47 4.63 3.40 – 5.85
Agappe Diagnostics Ltd. (MISPA NANO) (5) g/dL 6.70 5.50 – 7.90 4.55 4.13 – 4.97
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) g/dL 6.80 6.10 – 7.60 4.50 3.90 – 5.00
Catachem ChemWell-T (5) g/dL 6.80 5.30 – 8.30 4.50 3.60 – 5.40
Fortress Diagnostics (Biuret) (BXC0173) (5) g/dL 6.47 5.50 – 7.44 4.22 3.59 – 4.85
Sekisui Medical Clinimate, Autosera, Qualigent TP (5) g/dL 6.51 6.11 – 6.91 4.31 3.91 – 4.71
SODIUM
Fortress Diagnostics (BXC0142) (5) mEq/L 149 127 – 171 142 121 – 164
Sekisui Medical Internal Standard Solution -K/-B, Dilutent -K/-B (5) mEq/L 145 135 – 155 130 120 – 140
TRIGLYCERIDES
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 186 170 – 202 85.1 75.5 – 94.7
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 187 170 – 203 82.4 72.3 – 92.5
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 188 173 – 204 84.8 73.9 – 95.6
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 184 165 – 204 82.0 71.6 – 92.4
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 195 180 – 211 86.0 76.1 – 95.8
Fortress Diagnostics (GPO-PAP) (BXC0271) (5) mg/dL 187 158 – 214 97.3 83.2 – 112
Sekisui Medical Cholestest, Qualigent TG (5) mg/dL 186 166 – 206 92.8 83.8 – 102
Sekisui Medical Pureauto S, Autosera S TG-N (5) mg/dL 179 164 – 194 89.5 80.5 – 99.0
UREA NITROGEN (BUN) (4)
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 31.6 23.0 – 40.3 97.6 83.5 – 112
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia) (5) mg/dL 33.1 24.3 – 41.8 97.3 85.1 – 110
Agappe Diagnostics Ltd. (MISPA CCXL) (5) mg/dL 28.1 20.0 – 36.1 92.7 79.4 – 106
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 32.2 24.0 – 40.4 97.5 85.5 – 109
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 31.7 23.7 – 39.7 97.0 84.3 – 110
Catachem ChemWell-T (5) mg/dL 14.0 9.50 – 18.5 46.9 32.9 – 60.9
Fortress Diagnostics (BXC0123) (5) mg/dL 15.2 12.9 – 17.4 48.4 41.1 – 55.6
Sekisui Medical Pureauto S UN (5) mg/dL 15.6 13.1 – 18.1 48.5 43.5 – 53.5
Sekisui Medical Pureauto S, Qualigent UN-L (5) mg/dL 14.3 11.3 – 17.3 45.4 40.4 – 50.4
URIC ACID
Agappe Diagnostics Ltd. (Biolis/TMS Series) (5) mg/dL 4.71 4.22 – 5.20 9.80 8.25 – 11.3
Agappe Diagnostics Ltd. (MISPA BS 390/Clinia - PAP) (5) mg/dL 4.10 3.20 – 4.90 9.20 8.00 – 10.5
Agappe Diagnostics Ltd. (MISPA CCXL - PAP) (5) mg/dL 4.12 3.60 – 4.61 9.20 8.18 – 10.2
Agappe Diagnostics Ltd. (MISPA NANO) (5) mg/dL 4.40 3.70 – 5.10 9.52 8.15 – 10.9

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8
 Lyphochek® Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 26481 Level 2 - 26482
Units Mean Range Mean Range
URIC ACID (continued)
Agappe Diagnostics Ltd. (Toshiba TBA Series) (5) mg/dL 4.50 3.90 – 5.10 9.90 8.70 – 11.1
Catachem ChemWell-T (5) mg/dL 6.40 5.20 – 7.60 10.3 8.80 – 11.8
Fortress Diagnostics (Uricase PAP Monoliquid) (BXC0603) (5) mg/dL 5.25 4.46 – 6.04 9.97 8.47 – 11.5
Sekisui Medical Pureauto S, Autosera S, Qualigent UA (5) mg/dL 4.75 4.45 – 5.05 9.80 9.10 – 10.5
ZINC
Fortress Diagnostics (BXC0462) (5) µg/dL 63.7 54.1 – 73.3 42.3 35.9 – 48.6

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8
 Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26481 Level 2 - 26482
Units Mean Range Mean Range
SIEMENS DIMENSION SERIES
Acetaminophen (Enzymatic, colorimetric) µg/mL 21.3 16.1 – 26.6 95.3 86.4 – 104
Albumin (Bromcresol Purple (BCP)) g/dL 3.94 3.61 – 4.27 2.57 2.34 – 2.80
Alkaline Phosphatase (IFCC ALPI) (2) U/L 111 67.7 – 154 415 256 – 574
ALT/SGPT (IFCC ALTI) (2) U/L 29.4 21.4 – 37.4 93.5 76.9 – 110
Amylase (CNP-triose/CNPG3) (2) U/L 71.9 64.6 – 79.3 469 430 – 508
AST/SGOT (2) U/L 44.3 36.1 – 52.6 200 175 – 224
AST/SGOT (IFCC 2002 Correlated) (2) U/L 44.4 36.0 – 52.8 200 176 – 224
Bilirubin (Direct) (Diazotization) (DBI) mg/dL 0.205 0.092 – 0.317 0.837 0.647 – 1.03
Bilirubin (Total) (Jendrassik Grof) (TBI) mg/dL 0.987 0.776 – 1.20 4.27 3.81 – 4.73
Calcium mg/dL 8.45 7.63 – 9.27 12.0 10.9 – 13.0
Carbamazepine µg/mL 2.87 2.15 – 3.59 15.0 12.3 – 17.6
Carbon Dioxide (CO2) (Enzymatic) mEq/L 37.9 31.1 – 44.7 19.8 14.8 – 24.9
Chloride (EXL/Xpand) mEq/L 119 106 – 132 99.5 88.0 – 111
Cholesterol (HDL) (DF48B) (7) mg/dL 56.8 44.6 – 69.1 22.1 16.6 – 27.6
Cholesterol (LDL) (ALDL) mg/dL 139 118 – 161 59.7 49.3 – 70.1
Cholesterol (Total) mg/dL 273 246 – 299 94.6 80.8 – 108
Cholinesterase (Butyrylthiocholine (Trinder)) (2) U/L 9617 9012 – 10221 6575 6047 – 7103
Creatine Kinase (CK) (IFCC CKI) (2) U/L 127 106 – 148 445 397 – 493
Creatinine (CRE2) mg/dL 2.55 2.13 – 2.96 6.15 5.39 – 6.90
Creatinine (EZCR) mg/dL 2.71 2.07 – 3.36 6.42 5.41 – 7.43
Digoxin (EIA) ng/mL 0.748 0.490 – 1.01 2.39 1.98 – 2.80
Gamma Glutamyltransferase (GGT) (2) U/L 75.0 62.0 – 87.9 190 163 – 217
Gamma Glutamyltransferase (GGT) (IFCC 2002 Correlated) (2) U/L 64.2 52.3 – 76.2 163 139 – 188
Gentamicin (Immunoturbidimetric) µg/mL 1.49 0.976 – 2.00 6.93 5.90 – 7.96
Glucose (Hexokinase) mg/dL 89.3 80.2 – 98.4 280 254 – 305
Immunoglobulin A (IgA) mg/dL 193 164 – 222 136 111 – 161
Immunoglobulin G (IgG) mg/dL 980 814 – 1146 626 481 – 772
Immunoglobulin M (IgM) mg/dL 72.0 55.1 – 88.9 44.7 29.2 – 60.2
Iron (Ferene) µg/dL 242 222 – 263 65.7 55.5 – 75.9
Iron (TIBC) (IBCT) µg/dL 329 276 – 381 209 168 – 249
Lactate (Lactic Acid) (Enzymatic) mg/dL 39.5 33.2 – 45.9 11.3 7.30 – 15.3
Lactate Dehydrogenase (LDH) (IFCC LDI) (2) U/L 172 133 – 212 381 308 – 455
Lipase (Colorimetric) (2) U/L 162 131 – 193 240 200 – 280
Lithium (Colorimetric) mEq/L 0.744 0.604 – 0.883 2.02 1.65 – 2.39
Magnesium mg/dL 2.02 1.68 – 2.36 4.54 4.03 – 5.04
Phenobarbital µg/mL 13.7 9.27 – 18.2 48.5 38.1 – 58.9
Phenytoin µg/mL 11.3 8.54 – 14.0 27.9 22.7 – 33.1
Phosphorus (DF61A) mg/dL 3.69 3.29 – 4.08 7.64 7.04 – 8.24
Potassium (EXL/Xpand) mEq/L 3.77 3.48 – 4.06 5.99 5.54 – 6.44
Protein Serum (Total) g/dL 7.08 6.50 – 7.66 4.66 4.24 – 5.08
Salicylate (Trinder) mg/dL 7.78 6.45 – 9.12 10.8 9.14 – 12.5
Sodium (EXL/Xpand) mEq/L 142 134 – 150 128 120 – 136
T3 Uptake/T Uptake (EIA) % Uptake § §
T4 (Free) (Chemiluminescence) ng/dL 1.00 0.914 – 1.09 >8.00
T4 (Total) (EIA) µg/dL § §
Theophylline µg/mL 9.16 7.23 – 11.1 23.8 18.5 – 29.0
Thyroid Stimulating Hormone (TSH) (Chemiluminescence) µIU/mL 1.38 1.25 – 1.51 14.8 13.0 – 16.5
Thyroid Stimulating Hormone (TSH) (EIA) µIU/mL § §

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 Lyphochek® Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 26481 Level 2 - 26482
Units Mean Range Mean Range
SIEMENS DIMENSION SERIES (continued)
Tobramycin µg/mL § §
Transferrin mg/dL 230 202 – 259 168 146 – 190
Triglycerides (Enzymatic, end point) mg/dL 181 161 – 201 94.1 80.6 – 108
Urea Nitrogen (BUN) (Urease, UV) (4) mg/dL 14.8 12.1 – 17.5 47.6 41.8 – 53.4
Uric Acid (Uricase, UV) mg/dL 4.67 4.19 – 5.14 9.44 8.65 – 10.2
Valproic Acid µg/mL 34.0 28.0 – 40.0 112 91.9 – 132
Vancomycin µg/mL 7.23 5.63 – 8.84 31.0 26.3 – 35.7

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) mg/dL Urea Nitrogen x 2.14 = mg/dL Urea. S.I. Units value range is expressed as Urea.
(5) The assigned values were determined using the reagent and/or instrument manufacturer’s protocol and may not represent ±3SD ranges.
(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.

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