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Lyphochek Assayed Chemistry Control

Levels 1 and 2
C-310-5 Level 1 12 x 5 mL Level 1 89721
C-315-5 Level 2 12 x 5 mL 0459 2025-07-31 89720 Level 2 89722
313X MiniPak 2 x 5 mL

https://www.myeinserts.com/89720

INTENDED USE LIMITATIONS


Lyphochek Assayed Chemistry Control is intended for use as an assayed quality 1. This product should not be used past the expiration date.
control serum to monitor the precision of laboratory testing procedures for the 2. If there is evidence of microbial contamination or excessive turbidity in the
analytes listed in this package insert. reconstituted product, discard the vial.
SUMMARY AND PRINCIPLE 3. This product is not intended for use as a standard.
The use of quality control materials is indicated as an objective assessment of WARNING
the precision of methods and techniques in use and is an integral part of good
laboratory practices. Multiple levels of control are available to allow monitoring Biological source material. Treat as potentially infectious.
of the test system’s reliability. Each human donor unit used to manufacture this product was tested as required
For customers in Germany: Quality control materials are required for assessment by FDA accepted methods. Tests results were non-reactive or negative for
of laboratory performance as described in the “Guideline for Quality Assurance evidence of infection due to Human Immunodeficiency Virus (HIV), Hepatitis B
of Medical Laboratory Examinations following the German Medical Association” Virus (HBV) and Hepatitis C Virus (HCV). This product may also contain other
(Rili-BÄK regulation). human source materials for which there are no approved tests. In accordance
REAGENT with good laboratory practice, all human source material should be considered
This product is prepared from human serum with added chemicals, purified potentially infectious and handled with the same precautions used with
biochemical material (tissue extracts of human and animal origin), therapeutic patient specimens.
drugs, stabilizers and preservatives. This product is provided in lyophilized form Hazard (H) and Precautionary (P) Statements
for increased stability. EUH208 Contains Gentamicin, sulfate (salt) May produce an
STORAGE AND STABILITY allergic reaction.
Safety Data Sheet (SDS) available for professional users on www.bio-rad.com.
SPECIFIC PERFORMANCE CHARACTERISTICS
This product will be stable until the expiration date when stored This product is a freeze-dried product manufactured under rigid quality control
unopened at 2 to 8°C. standards. To obtain consistent assay values, the control requires proper storage
Reconstituted and Refrigerated: After reconstituting and storing tightly capped and handling as described.
at 2 to 8°C, this product will be stable as follows: ASSIGNMENT OF VALUES
- All analytes: 7 days The mean values and corresponding ±3SD ranges in the Assignment of Values
Except: Data Charts (available separately) were derived from replicate analyses and are
- T3 (Free), Acid Phosphatase (Total) and Prostatic Acid Phosphatase specific for this lot of product. Data from Unity™ Interlaboratory Program are
(PAP): 3 days included in the determination of some ranges. The tests listed were performed
Reconstituted and Frozen: When reconstituted and stored tightly capped by the manufacturer and/or independent laboratories using manufacturer
at -10 to -20°C, this product will be stable as follows: supported reagents and a representative sampling of this lot of product. It is
- All analytes: 30 days recommended that each laboratory establish its own acceptable ranges and use
Except: those provided only as guides. Laboratory established ranges may vary from
- Tobramycin: 20 days those listed during the life of this control. [Customers in Germany have to follow
- T3 (Free): 10 days the requirements as described in the Rili-BÄK regulation.] Variations over time
Once thawed, do not refreeze this product. Discard the remaining material. and between laboratories may be caused by differences in laboratory technique,
This product is shipped under refrigerated conditions. instrumentation and reagents, or by manufacturer test method modifications.
PROCEDURE
This product should be treated the same as patient specimens and run in Unity™ Interlaboratory Program is a proprietary Bio-Rad software program
accordance with the instructions accompanying the instrument, kit, or reagent holding more than 2 billion QC data points from thousands of laboratories.
being used. INSTRUCTIONS FOR OBTAINING THE DATA CHARTS
Using a volumetric pipet or equivalent, reconstitute each vial with 5.0 mL of The Data Charts are available through the Internet, at
distilled or deionized water. Replace the stopper and allow this product to stand www.myeinserts.com/89720. Follow the directions at the website to receive
for approximately 20 minutes swirling occasionally. email notifications of insert updates. Alternate methods for receiving data charts
Before sampling, gently swirl the vial several times to ensure homogeneity. If are available by contacting your local Bio-Rad Laboratories Office.
performing trace metal analysis, do not mix by inversion. After each use, IMPORTANT PRODUCT INFORMATION
promptly replace the stopper and return to the appropriate storage condition.
Dispose of any discarded materials in accordance with the requirements of your Significant changes are highlighted!
local waste management authorities. In the event of damage to packaging,
contact the local Bio-Rad Laboratories Sales Office or Bio-Rad Laboratories
Technical Services.

Page 1 English • 2023-02 • 4030-00S


Lyphochek Assayed Chemistry Control, Levels 1 and 2
ANALYTES
Acetaminophen CEA ◆ Immunoglobulin A (IgA) ◆ Sodium
Acid Phosphatase (Total) Ceruloplasmin ◆ Immunoglobulin G (IgG) ◆ T3 (Free) ◆
AFP ◆ Chloride Immunoglobulin M (IgM) ◆ T3 (Total)
Albumin Cholesterol (HDL) Iron T3 Uptake/T Uptake
Alkaline Phosphatase Cholesterol (LDL) Iron (TIBC) ◆ T4 (Free) ◆
Alpha 1-Antitrypsin ◆ Cholesterol (Total) Iron (UIBC) ◆ T4 (Total)
Alpha-HBDH ◆ ❑ Cholinesterase ◆ Lactate (Lactic Acid) Theophylline
ALT/SGPT Complement C3 ◆ Lactate Dehydrogenase (LDH) Thyroid Stimulating Hormone (TSH)
Amylase Complement C4 ◆ ❑ LAP Arylamidase ◆ Thyroxine Binding Globulin (TBG) ◆ ❍
Amylase (Alpha) ❍ Copper ◆ Lipase Tobramycin
Amylase (Pancreatic) Cortisol Lithium Transferrin ◆
Apolipoprotein A-I ◆ Creatine Kinase (CK) Magnesium Triglycerides
Apolipoprotein B ◆ Creatinine Osmolality ◆ Urea
AST/SGOT Digoxin Phenobarbital Urea Nitrogen (BUN)
Bilirubin (Direct) Gamma Glutamyltransferase (GGT) Phenytoin Uric Acid
Bilirubin (Indirect) Gentamicin Phosphorus Valproic Acid
Bilirubin (Total) Globulin ◆ Potassium Vancomycin
Calcium Glucose Prostatic Acid Phosphatase (PAP) ❍ Vitamin B12 ◆
Calcium (Ionized) ◆ Glutamate Dehydrogenase (GLDH) ◆ Protein Serum (Total) Zinc ◆
Carbamazepine Haptoglobin ◆ PSA (Total) ◆ ❍
Carbon Dioxide (CO2) hCG-Beta Subunit ◆ Salicylate

NOTES
◆ Endogenous levels only.
❑ No claim is made for expected value or stability of this analyte.
❍ Values are not provided.

LEXICON

Reconstitute with

Page 2 English • 2023-02 • 4030-00S


Lyphochek Assayed Chemistry Control, Levels 1 and 2

UNITED STATES, Bio-Rad Laboratories


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© 2023 Bio-Rad Laboratories Inc. Printed in the USA


Lyphochek is a trademark of Bio-Rad Laboratories in certain jurisdictions. Page 3 English • 2023-02 • 4030-00S
Lyphochek Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
ACID PHOSPHATASE (TOTAL) (2)
Colorimetric Test Substrate Naphytl. Pentandiol (3) U/L 21.7 7.65 – 35.7 55.4 29.5 – 81.4
ALBUMIN
Catechem ChemWell-T (Bromcresol green) (5) g/dL 4.50 3.00 – 6.00 2.70 1.80 – 3.60
ALKALINE PHOSPHATASE (2)
Catachem ChemWell-T (5) U/L 102 73.0 – 131 435 360 – 510
ALT/SGPT (2)
Catachem ChemWell-T (5) U/L 32.0 23.0 – 41.0 121 98.0 – 144
AMYLASE (2)
Catachem ChemWell-T (5) U/L 71.0 47.0 – 95.0 452 339 – 565
AST/SGOT (2)
Catachem ChemWell-T (5) U/L 43.0 32.0 – 54.0 194 144 – 244
BILIRUBIN (DIRECT)
Advanced Instruments BR2 Bilirubin Stat-Analyzer (Photometric) (5) mg/dL 0.100 0.000 – 0.200 0.800 0.400 – 1.20
Catachem ChemWell-T (5) mg/dL 0.370 0.240 – 0.500 0.960 0.690 – 1.23
Wako L-Type (AU480) (5) mg/dL § §
BILIRUBIN (TOTAL)
Advanced Instruments BR2 Bilirubin Stat-Analyzer (Photometric) (5) mg/dL 1.80 1.40 – 2.20 3.90 3.10 – 4.70
Catachem ChemWell-T (5) mg/dL 0.920 0.570 – 1.27 4.53 3.73 – 5.33
Wako L-Type (AU480) (5) mg/dL § §
CALCIUM
Catachem ChemWell-T (5) mg/dL 11.9 10.1 – 13.7 13.3 12.1 – 14.5
CALCIUM (IONIZED)
ISE Direct (3) mg/dL § §
CARBON DIOXIDE (CO2)
Catachem ChemWell-T (5) mEq/L 41.0 32.0 – 50.0 20.8 13.9 – 27.7
CHOLESTEROL (HDL) (7)
Wako L-Type (AU480) (5) mg/dL § §
CHOLESTEROL (LDL)
Wako L-Type (AU480) (5) mg/dL § §
CHOLESTEROL (TOTAL)
Catachem ChemWell-T (5) mg/dL 266 214 – 318 110 91.0 – 129
COPPER
Atomic Absorption µg/dL 101 77.4 – 125 62.3 42.4 – 82.2
CREATINE KINASE (CK) (2)
Catachem ChemWell-T (5) U/L 132 98.0 – 166 445 345 – 545
CREATININE
Catachem ChemWell-T (5) mg/dL 2.59 2.19 – 2.99 6.52 5.02 – 8.02
GAMMA GLUTAMYLTRANSFERASE (GGT) (2)
Catachem ChemWell-T (5) U/L 53.6 40.6 – 66.6 168 128 – 208
GLUCOSE
Catachem ChemWell-T (5) mg/dL 92.0 58.0 – 126 305 271 – 339
GLUTAMATE DEHYDROGENASE (GLDH) (2)
Standard Method without Correction for the Non-Specific Creep Reaction (3) U/L 6.93 4.53 – 9.32 14.3 12.0 – 16.7
IRON
Catachem ChemWell-T (5) µg/dL 270 220 – 320 63.0 51.0 – 75.0
LACTATE DEHYDROGENASE (LDH) (2)
Catachem ChemWell-T (5) U/L 184 149 – 219 441 371 – 511

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8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

METHOD (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
LIPASE (2)
Catachem ChemWell-T (5) U/L 62.0 47.0 – 77.0 93.0 71.0 – 115
LITHIUM
Atomic Absorption mEq/L § §
OSMOLALITY
Freezing Point Depression (3) mOsm/kg § §
PHOSPHORUS
Catachem ChemWell-T (5) mg/dL 4.40 3.60 – 5.20 7.80 6.60 – 9.00
POTASSIUM
Flame Photometry mEq/L § §
PROTEIN SERUM (TOTAL)
Catachem ChemWell-T (5) g/dL 7.70 6.20 – 9.20 4.90 4.00 – 5.80
TRIGLYCERIDES
Catachem ChemWell-T (5) mg/dL 197 157 – 237 100 85.0 – 115
UREA NITROGEN (BUN) (4)
Catachem ChemWell-T (5) mg/dL 17.8 13.3 – 22.3 55.8 41.8 – 69.8
URIC ACID
Catachem ChemWell-T (5) mg/dL 5.90 4.70 – 7.10 10.7 9.15 – 12.2

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Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
ABAXIS-PICCOLO (5)
Albumin g/dL 4.60 4.10 – 5.10 3.10 2.60 – 3.60
Alkaline Phosphatase (2) U/L 126 95.0 – 157 537 455 – 619
ALT/SGPT (2) U/L 28.0 15.0 – 41.0 94.0 78.0 – 110
Amylase (2) U/L 64.0 54.0 – 74.0 384 342 – 426
AST/SGOT (2) U/L 49.0 37.0 – 61.0 197 168 – 226
Bilirubin (Direct) mg/dL 0.400 0.100 – 0.700 1.50 1.10 – 1.90
Bilirubin (Total) mg/dL 1.20 0.700 – 1.70 4.20 3.60 – 4.80
Calcium mg/dL 10.8 9.70 – 11.9 12.9 11.5 – 14.3
Carbon Dioxide (CO2) mEq/L 35.0 25.0 – >40.0 23.0 17.0 – 29.0
Chloride mEq/L 98.0 90.0 – 106 87.0 <80.0 – 94.0
Cholesterol (HDL) (7) mg/dL 82.0 72.0 – 92.0 20.0 <15.0 – 25.0
Cholesterol (Total) mg/dL 247 213 – 281 113 98.0 – 128
Creatine Kinase (CK) (2) U/L 144 107 – 181 451 396 – 506
Creatinine mg/dL 1.80 1.30 – 2.30 5.50 4.70 – 6.30
Gamma Glutamyltransferase (GGT) (2) U/L 58.0 52.0 – 64.0 166 151 – 181
Glucose mg/dL 90.0 78.0 – 102 284 260 – 308
Lactate Dehydrogenase (LDH) (2) U/L 157 133 – 181 324 262 – 386
Magnesium mg/dL 2.10 1.80 – 2.40 5.30 4.70 – 5.90
Phosphorus mg/dL 4.80 4.10 – 5.50 8.80 7.90 – 9.70
Potassium mEq/L 4.00 3.50 – 4.50 6.30 5.70 – 6.90
Protein Serum (Total) g/dL 7.10 6.60 – 7.60 4.60 4.20 – 5.00
Sodium mEq/L 150 143 – 157 137 130 – 144
Triglycerides mg/dL 228 193 – 263 109 100 – 118
Urea Nitrogen (BUN) (4) mg/dL 16.0 13.0 – 19.0 48.0 43.0 – 53.0
Uric Acid mg/dL 3.90 3.10 – 4.70 9.40 7.90 – 10.9
Abbott Alinity c Analyzer
Albumin (Bromcresol Green (BCG)) g/dL 3.98 3.50 – 4.45 2.41 2.04 – 2.78
Albumin (Bromcresol Purple (BCP)) g/dL 3.96 3.67 – 4.25 2.38 2.17 – 2.59
Alkaline Phosphatase (2) U/L 114 93.5 – 135 470 409 – 532
ALT/SGPT (IFCC) (2) U/L 25.6 18.4 – 32.8 99.8 86.5 – 113
Amylase (CNP-triose/CNPG3) (2) U/L 73.5 65.2 – 81.8 450 404 – 496
Amylase (CNP-triose/CNPG3) (IFCC) (2) U/L 72.3 64.2 – 80.5 433 390 – 477
AST/SGOT (2) U/L 47.8 38.2 – 57.5 212 174 – 250
Bilirubin (Direct) mg/dL 0.483 0.393 – 0.574 1.77 1.50 – 2.04
Bilirubin (Total) mg/dL 1.18 0.895 – 1.47 4.57 3.78 – 5.36
Calcium mg/dL 10.7 9.81 – 11.6 12.2 11.2 – 13.2
Carbamazepine µg/mL 3.19 1.97 – 4.41 10.8 8.81 – 12.8
Chloride mEq/L 98.9 90.6 – 107 84.4 78.0 – 90.8
Cholesterol (HDL) (7) mg/dL 81.3 70.9 – 91.8 29.2 24.0 – 34.4
Cholesterol (LDL) mg/dL 107 94.4 – 120 52.5 46.2 – 58.8
Cholesterol (Total) mg/dL 258 227 – 290 109 94.8 – 123
Cholinesterase (2) U/L 7793 6883 – 8702 1389 934 – 1843
Creatine Kinase (CK) (2) U/L 141 121 – 160 484 420 – 549
Creatinine (Alkaline picrate-kinetic rate blanked,IFCC-IDMS Standardized) mg/dL 2.63 2.04 – 3.22 6.48 5.95 – 7.02
Creatinine (Enzymatic IFCC-IDMS Standardized) mg/dL § §
Digoxin ng/mL 1.05 0.609 – 1.49 2.91 2.45 – 3.37
Gamma Glutamyltransferase (GGT) (2) U/L 53.3 43.5 – 63.0 156 131 – 180
Gentamicin (8P55) µg/mL 1.35 0.877 – 1.82 6.73 5.80 – 7.65

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8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
Abbott Alinity c Analyzer (continued)
Glucose mg/dL 80.9 71.4 – 90.5 281 256 – 305
Haptoglobin mg/dL 129 113 – 144 74.8 65.3 – 84.3
Immunoglobulin A (IgA) mg/dL 185 159 – 212 128 107 – 148
Immunoglobulin G (IgG) mg/dL 965 871 – 1058 634 571 – 696
Immunoglobulin M (IgM) mg/dL 80.5 63.7 – 97.3 51.0 37.5 – 64.5
Iron µg/dL 242 220 – 264 71.7 63.0 – 80.3
Lactate (Lactic Acid) mg/dL 37.2 32.7 – 41.8 10.5 9.06 – 12.0
Lactate Dehydrogenase (LDH) (2) U/L 180 154 – 207 424 377 – 470
Lithium mEq/L 0.638 0.499 – 0.778 1.90 1.67 – 2.12
Magnesium mg/dL 1.98 1.70 – 2.25 5.17 4.61 – 5.72
Phenobarbital µg/mL 12.0 7.77 – 16.2 46.8 37.2 – 56.4
Phenytoin µg/mL 10.0 8.04 – 12.0 25.5 20.8 – 30.2
Phosphorus mg/dL 3.73 3.29 – 4.16 7.15 6.45 – 7.85
Potassium mEq/L 3.91 3.67 – 4.15 6.41 6.06 – 6.75
Protein Serum (Total) g/dL 6.77 6.37 – 7.17 4.19 3.86 – 4.51
Sodium mEq/L 148 141 – 155 131 125 – 138
Theophylline (09P89) µg/mL 8.95 7.16 – 10.7 24.5 19.7 – 29.2
Transferrin (08P38) mg/dL 284 255 – 312 174 155 – 193
Triglycerides mg/dL 201 177 – 225 94.0 79.5 – 108
Urea Nitrogen (BUN) (4) mg/dL 14.3 12.5 – 16.2 44.8 40.6 – 49.0
Uric Acid mg/dL 4.83 4.24 – 5.42 10.2 9.21 – 11.2
Valproic Acid (09P92) µg/mL 33.6 28.4 – 38.7 101 90.4 – 112
Vancomycin µg/mL 7.17 4.79 – 9.54 32.3 27.3 – 37.4
ABBOTT ARCHITECT cSYSTEMS
Acetaminophen µg/mL 18.3 12.8 – 23.7 83.1 69.1 – 97.2
Albumin (Bromcresol Green (BCG)) g/dL 4.08 3.62 – 4.55 2.50 2.21 – 2.79
Albumin (Bromcresol Purple (BCP)) g/dL 4.05 3.67 – 4.43 2.53 2.26 – 2.81
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 115 90.2 – 140 469 389 – 549
ALT/SGPT (UV with P5P) (2) U/L 25.0 17.2 – 32.9 105 88.7 – 121
ALT/SGPT (UV without P5P) (2) U/L 26.7 21.4 – 32.0 104 91.1 – 116
Amylase (CNP-triose/CNPG3) (2) U/L 77.8 68.8 – 86.9 470 426 – 515
AST/SGOT (UV with P5P) (2) U/L 43.6 35.5 – 51.6 198 174 – 221
AST/SGOT (UV without P5P) (2) U/L 43.2 36.9 – 49.5 191 166 – 215
Bilirubin (Direct) (Diazotization) mg/dL 0.467 0.383 – 0.551 1.61 1.38 – 1.83
Bilirubin (Total) (Diazonium Ion) mg/dL 1.23 0.963 – 1.50 4.52 3.80 – 5.24
Calcium (Arsenazo III) mg/dL 10.6 9.67 – 11.5 12.3 11.3 – 13.2
Carbamazepine (5P05-21) µg/mL 3.88 3.07 – 4.70 11.0 9.11 – 12.8
Carbon Dioxide (CO2) (Enzymatic) mEq/L 32.6 25.0 – 40.2 17.7 12.5 – 22.9
Chloride (ISE indirect) mEq/L 96.8 90.1 – 104 82.8 76.9 – 88.7
Cholesterol (HDL) (Ultra HDL) (7) mg/dL 83.6 73.9 – 93.2 28.8 24.2 – 33.4
Cholesterol (LDL) (Direct measure) mg/dL 115 102 – 128 56.0 49.5 – 62.5
Cholesterol (Total) mg/dL 257 241 – 272 109 101 – 116
Complement C3 mg/dL 146 130 – 162 91.4 79.4 – 103
Creatine Kinase (CK) (NAC activated) (IFCC) (2) U/L 147 127 – 167 502 439 – 566
Creatinine (Alkaline picrate-kinetic rate blanked,IFCC-IDMS Standardized) mg/dL 2.74 2.16 – 3.32 6.66 5.63 – 7.69
Digoxin (Immunoturbidimetric) ng/mL 1.14 0.671 – 1.60 2.94 2.48 – 3.40
Gamma Glutamyltransferase (GGT) (2) U/L 62.5 49.3 – 75.7 184 151 – 218
Gentamicin µg/mL 1.50 1.04 – 1.95 6.84 5.97 – 7.71

Page 6 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
ABBOTT ARCHITECT cSYSTEMS (continued)
Glucose (Hexokinase) mg/dL 82.7 72.6 – 92.8 286 260 – 311
Haptoglobin mg/dL 127 112 – 143 73.5 64.2 – 82.8
Immunoglobulin A (IgA) mg/dL § §
Immunoglobulin G (IgG) mg/dL 975 873 – 1076 634 560 – 709
Immunoglobulin M (IgM) mg/dL 82.6 67.0 – 98.3 55.1 42.1 – 68.1
Iron (Ferene) µg/dL 251 231 – 270 76.2 67.2 – 85.2
Iron (UIBC) µg/dL 112 81.1 – 142 133 97.9 – 168
Lactate (Lactic Acid) (Lactate to pyruvate) (9P18-21) mg/dL 40.2 33.0 – 47.4 10.8 8.79 – 12.9
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (IFCC) (2) U/L 175 134 – 216 413 368 – 458
Lipase (Enzymatic with colipase) (2) U/L 64.4 47.3 – 81.5 96.4 76.8 – 116
Magnesium (Arsenazo I) (7D70) mg/dL § §
Magnesium (Enzymatic) (3P68) mg/dL 1.85 1.64 – 2.07 4.73 4.23 – 5.22
Phenobarbital (5P07-21) µg/mL § §
Phenytoin (EIA) (5P08-21) µg/mL 9.76 7.17 – 12.4 24.0 19.1 – 28.9
Phosphorus (Phosphomolybdate method) mg/dL 3.77 3.46 – 4.08 7.23 6.72 – 7.74
Potassium (ISE indirect) mEq/L 3.90 3.62 – 4.18 6.36 5.92 – 6.80
Protein Serum (Total) (Biuret method) g/dL 6.73 6.10 – 7.35 4.22 3.78 – 4.65
Salicylate (Enzymatic) mg/dL <5.00 – 7.86 13.4 11.5 – 15.3
Sodium (ISE indirect) mEq/L 148 139 – 157 130 122 – 138
Theophylline (EIA) (5P06-21) µg/mL 9.94 8.00 – 11.9 26.9 19.5 – 34.4
Tobramycin µg/mL 9.61 7.96 – >10.0 2.47 1.75 – 3.19
Transferrin mg/dL 268 234 – 302 165 146 – 185
Triglycerides (Enzymatic, end point) mg/dL 203 187 – 218 93.6 84.0 – 103
Urea Nitrogen (BUN) (Urease, UV) (4) mg/dL 15.2 13.5 – 17.0 47.3 43.4 – 51.3
Uric Acid (Uricase, colorimetric) mg/dL § §
Valproic Acid µg/mL 34.0 29.2 – 38.8 104 93.6 – 114
Vancomycin µg/mL 7.30 5.83 – 8.77 31.8 27.2 – 36.5
BECKMAN COULTER ACCESS / 2 / 2i
Cortisol µg/dL 10.8 8.88 – 12.7 48.6 39.1 – 58.2
hCG (Total BhCG) (5th IS) mIU/mL § §
BECKMAN COULTER AU SYSTEMS
Acetaminophen (Emit 2000) µg/mL 20.5 17.2 – 23.8 83.5 75.7 – 91.3
Albumin (Bromcresol Green (BCG)) g/dL 4.16 3.77 – 4.54 2.62 2.33 – 2.91
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 124 86.7 – 162 509 354 – 664
Alkaline Phosphatase (PNPP, AMP Buffer) (IFCC 2002) (Europe/Asia) (2) U/L 138 96.3 – 179 570 397 – 742
ALT/SGPT (UV with P5P) (Europe/Asia) (2) U/L 27.9 21.0 – 34.7 105 82.7 – 127
ALT/SGPT (UV without P5P) (2) U/L 23.5 16.5 – 30.5 88.9 68.2 – 110
Amylase (CNP-triose/CNPG3) (2) U/L 57.8 34.7 – 80.9 356 272 – 440
Amylase (G7 PNP, Blocked) (Europe/Asia) (2) U/L 77.8 59.2 – 96.4 398 347 – 449
AST/SGOT (UV with P5P) (IFCC 2002)(Europe/Asia) (2) U/L 48.3 37.3 – 59.2 223 183 – 262
AST/SGOT (UV without P5P) (2) U/L 38.9 27.2 – 50.5 170 118 – 221
Bilirubin (Direct) (Diazotization) mg/dL 0.299 0.226 – 0.372 1.31 1.08 – 1.54
Bilirubin (Direct) (Diazotization) (Europe/Asia) mg/dL 0.335 0.257 – 0.413 1.47 1.22 – 1.73
Bilirubin (Total) (DPD) mg/dL 1.15 0.972 – 1.33 4.11 3.59 – 4.63
Bilirubin (Total) (DPD) (Europe/Asia) mg/dL 1.20 0.914 – 1.48 4.30 3.57 – 5.04
Calcium (Arsenazo III) mg/dL 10.5 9.76 – 11.3 12.1 11.3 – 13.0
Carbamazepine (EIA) (Emit 2000) µg/mL 3.05 <2.00 – 4.12 15.8 12.1 – 19.5
Carbon Dioxide (CO2) (Enzymatic) mEq/L 36.0 26.7 – >45.0 22.9 16.3 – 29.4

Page 7 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
BECKMAN COULTER AU SYSTEMS (continued)
Chloride (ISE indirect) mEq/L 96.8 91.0 – 103 83.6 78.5 – 88.6
Cholesterol (HDL) (Direct measure, immunoinhibition) (Europe/Asia) (7) mg/dL 81.2 68.1 – 94.4 28.6 23.0 – 34.3
Cholesterol (HDL) (Direct measure, polymer-polyanion) (7) mg/dL § §
Cholesterol (LDL) (OSR6X83) (Europe/Asia) mg/dL 137 86.3 – 187 60.4 38.0 – 82.9
Cholesterol (LDL) (OSR6X96) mg/dL 102 59.6 – 144 46.0 26.8 – 65.2
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 251 218 – 283 103 89.1 – 118
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) (Europe/Asia) mg/dL 266 233 – 298 110 95.2 – 124
Cholinesterase (Butyrylthiocholine (Trinder)) (Europe/Asia) (2) U/L 6345 5503 – 7187 1220 <1000 – 1663
Creatine Kinase (CK) (NAC activated) (2) U/L 125 93.9 – 155 423 330 – 517
Creatine Kinase (CK) (NAC activated) (Europe/Asia) (2) U/L 147 113 – 182 501 394 – 609
Creatinine (Alkaline picrate method) (Europe/Asia) mg/dL 2.12 1.78 – 2.45 5.62 5.02 – 6.21
Creatinine (Alkaline picrate method, IFCC-IDMS Standardized) mg/dL 2.09 1.79 – 2.39 5.61 5.04 – 6.19
Digoxin (EIA) (Emit 2000) ng/mL 1.36 0.759 – 1.95 3.22 2.45 – 3.98
Gamma Glutamyltransferase (GGT) (2) U/L 46.3 31.4 – 61.3 137 100 – 175
Gamma Glutamyltransferase (GGT) (IFCC 2002)(Europe/Asia) (2) U/L 59.6 43.9 – 75.4 175 132 – 217
Gentamicin (EIA) (Emit 2000) µg/mL 1.73 1.24 – 2.22 6.90 5.98 – 7.82
Glucose (Hexokinase) mg/dL 83.2 74.9 – 91.5 283 257 – 308
Immunoglobulin A (IgA) (Immunoturbidimetric) mg/dL 186 158 – 215 134 110 – 158
Immunoglobulin G (IgG) (Immunoturbidimetric) mg/dL 889 745 – 1033 606 503 – 708
Immunoglobulin M (IgM) (Immunoturbidimetric) mg/dL 84.1 67.2 – 101 57.5 44.6 – 70.4
Iron (TPTZ-no deproteinization) µg/dL 270 235 – 306 74.6 62.1 – 87.1
Iron (TPTZ-no deproteinization) (Europe/Asia) µg/dL 250 218 – 282 69.4 58.0 – 80.8
Iron (UIBC) (Nitroso-PSAP) µg/dL § §
Lactate (Lactic Acid) (Lactate to pyruvate) (OSR6193) (Europe/Asia) mg/dL 39.3 28.6 – 50.1 10.1 8.29 – 11.9
Lactate Dehydrogenase (LDH) (IFCC 2002)(Europe/Asia) (2) U/L 178 133 – 222 411 316 – 505
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (2) U/L 148 111 – 184 340 260 – 419
Lipase (Enzymatic, colorimetric) (2) U/L 62.1 46.4 – 77.7 99.5 79.5 – 119
Lithium (Colorimetric) mEq/L 0.633 0.555 – 0.711 1.90 1.70 – 2.10
Magnesium (Xylidyl blue) mg/dL 1.97 1.73 – 2.20 4.72 4.19 – 5.25
Phenobarbital (EIA) (Emit 2000) µg/mL 13.3 9.11 – 17.5 51.7 42.8 – 60.6
Phenytoin (EIA) (Emit 2000) µg/mL 10.3 6.19 – 14.4 25.2 18.9 – 31.5
Phosphorus (Phosphomolybdate method) mg/dL 4.07 3.56 – 4.57 7.45 6.63 – 8.28
Potassium (ISE indirect) mEq/L 3.80 3.59 – 4.01 6.15 5.81 – 6.50
Protein Serum (Total) (Biuret method) g/dL 6.66 6.06 – 7.26 4.17 3.76 – 4.59
Salicylate (EIA) mg/dL 6.98 5.34 – 8.62 14.9 13.1 – 16.6
Sodium (ISE indirect) mEq/L 146 140 – 153 128 122 – 134
Theophylline (EIA) (Emit 2000) µg/mL 9.66 7.77 – 11.5 28.2 20.2 – 36.1
Tobramycin (EIA) (Emit 2000) µg/mL 6.78 5.26 – 8.31 1.74 1.13 – 2.34
Transferrin (Immunoturbidimetric) mg/dL 254 230 – 278 161 142 – 181
Triglycerides (Enzymatic, end point) mg/dL § §
Triglycerides (Enzymatic, end point) (Europe/Asia) mg/dL 202 179 – 226 90.9 79.0 – 103
Urea Nitrogen (BUN) (Urease, UV) (4) mg/dL 15.6 11.3 – 19.8 46.8 29.5 – 64.2
Uric Acid (Uricase, colorimetric) mg/dL 4.54 3.93 – 5.16 9.91 8.73 – 11.1
Uric Acid (Uricase, colorimetric) (Europe/Asia) mg/dL 4.76 4.18 – 5.34 10.3 9.19 – 11.5
Valproic Acid (EIA) (Emit 2000) µg/mL 40.7 25.6 – 55.7 115 88.3 – 142
Vancomycin (EIA) (Emit 2000) µg/mL 7.01 4.32 – 9.70 26.8 17.6 – 36.0
BECKMAN COULTER SYNCRON/UniCel DxC SERIES
Acetaminophen (Immunoturbidimetric) µg/mL 26.1 20.0 – 32.2 102 87.9 – 116

Page 8 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
BECKMAN COULTER SYNCRON/UniCel DxC SERIES (continued)
Albumin (Bromcresol Purple (BCP)) g/dL 4.33 3.94 – 4.72 2.68 2.42 – 2.94
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 119 94.1 – 145 512 429 – 596
ALT/SGPT (UV with P5P) (IFCC 2002) U/L 26.9 19.7 – 34.1 93.4 73.7 – 113
ALT/SGPT (UV without P5P) (2) U/L 29.5 23.8 – 35.2 102 87.9 – 115
Amylase (G7 PNP, Blocked) (2) U/L 80.7 70.1 – 91.3 430 391 – 470
AST/SGOT (UV without P5P) (2) U/L 44.4 37.9 – 51.0 189 165 – 214
Bilirubin (Direct) (Diazotization) mg/dL 0.201 <0.100 – 0.313 0.966 0.799 – 1.13
Bilirubin (Total) (Jendrassik Grof) mg/dL 1.18 0.771 – 1.59 4.38 3.79 – 4.98
Calcium (ISE indirect) mg/dL 10.5 9.85 – 11.2 12.2 11.5 – 12.9
Carbamazepine (Immunoturbidimetric) µg/mL 2.58 2.07 – 3.10 16.4 14.0 – 18.8
Carbon Dioxide (CO2) (ISE indirect) mEq/L 34.9 28.3 – 41.4 19.6 15.3 – 24.0
Chloride (ISE indirect) mEq/L 97.3 91.2 – 103 84.5 79.0 – 89.9
Cholesterol (HDL) (Direct measure, polymer-polyanion) (HDL)(REF A15625) (7) mg/dL 90.0 73.7 – 106 27.8 21.7 – 34.0
Cholesterol (LDL) (Direct measure) mg/dL 107 87.9 – 126 50.2 40.6 – 59.8
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 265 238 – 292 112 99.2 – 124
Cholinesterase (Butyrylthiocholine (Trinder)) (CHEX) (2) kU/L 6.78 5.78 – 7.78 1.36 1.08 – 1.63
Creatine Kinase (CK) (NAC activated) (2) U/L 143 109 – 176 485 381 – 588
Creatine Kinase (CK) (Rosalki, Other Modified) (2) U/L 141 122 – 160 482 418 – 546
Creatinine (Alkaline picrate method, IFCC-IDMS Standardized) mg/dL 2.03 1.43 – 2.63 5.60 4.78 – 6.42
Digoxin (Immunoturbidimetric) ng/mL 1.29 0.910 – 1.67 2.88 2.42 – 3.35
Gamma Glutamyltransferase (GGT) (Szasz) (2) U/L 54.0 42.6 – 65.5 177 144 – 210
Gentamicin (Immunoturbidimetric) µg/mL 1.63 1.29 – 1.97 8.52 8.09 – 8.95
Glucose (Glucose oxidase, oxygen consumption) (GLUCm) mg/dL 80.5 71.0 – 90.0 276 250 – 301
Glucose (Hexokinase) (GLUH) mg/dL 83.3 71.1 – 95.5 283 253 – 314
Immunoglobulin A (IgA) (Immunoturbidimetric) mg/dL § §
Immunoglobulin G (IgG) (Immunoturbidimetric) mg/dL § §
Immunoglobulin M (IgM) (Immunoturbidimetric) mg/dL § §
Iron (Ferrozine-no deproteinization) µg/dL 247 211 – 283 71.4 58.7 – 84.1
Iron (TIBC) (Ion exchange resin, ferrozine) µg/dL 374 319 – 428 228 191 – 264
Lactate (Lactic Acid) (Enzymatic) mg/dL 40.1 35.6 – 44.5 11.2 9.10 – 13.3
Lactate Dehydrogenase (LDH) (IFCC) U/L § §
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (2) U/L 144 113 – 175 335 264 – 406
Lipase (Colorimetric) (2) U/L 54.5 41.7 – 67.3 94.8 79.9 – 110
Magnesium (Calmagite) mg/dL 1.98 1.69 – 2.26 4.67 4.11 – 5.22
Phenobarbital (Immunoturbidimetric) µg/mL 14.6 10.2 – 18.9 53.0 42.6 – 63.3
Phenytoin (Immunoturbidimetric) µg/mL 10.3 9.11 – 11.4 23.0 19.5 – 26.5
Phosphorus (Phosphomolybdate method) (PHOSm) mg/dL § §
Phosphorus (Phosphomolybdate method) (PHS) mg/dL 4.01 3.46 – 4.55 7.77 6.82 – 8.72
Potassium (ISE indirect) mEq/L 3.89 3.57 – 4.22 6.38 5.99 – 6.76
Protein Serum (Total) (Biuret, kinetic) (TPm) g/dL § §
Protein Serum (Total) (Biuret, no serum blank, end point) (TP) g/dL 6.98 6.15 – 7.81 4.56 3.81 – 5.31
Salicylate (Enzymatic) mg/dL 5.59 <4.00 – 7.90 14.1 11.7 – 16.6
Sodium (ISE indirect) mEq/L 149 141 – 156 132 125 – 138
Theophylline (Immunoturbidimetric) µg/mL 9.08 7.33 – 10.8 24.4 21.3 – 27.6
Tobramycin (Immunoturbidimetric) µg/mL 9.41 7.68 – 11.1 2.69 1.90 – 3.49
Transferrin (Immunoturbidimetric) mg/dL 273 234 – 311 164 141 – 188
Triglycerides (Enzymatic with glycerol blank) mg/dL 216 192 – 241 99.5 84.9 – 114
Urea Nitrogen (BUN) (Conductivity (Conductometry)) (BUNm) (4) mg/dL § §

Page 9 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
BECKMAN COULTER SYNCRON/UniCel DxC SERIES (continued)
Urea Nitrogen (BUN) (Urease, UV) (BUN) (4) mg/dL 15.3 12.8 – 17.9 47.3 41.2 – 53.4
Uric Acid (Uricase, colorimetric) mg/dL 4.67 4.32 – 5.01 9.15 8.47 – 9.83
Valproic Acid (Immunoturbidimetric) µg/mL 39.3 26.6 – 51.9 98.1 77.9 – 118
Vancomycin (Immunoturbidimetric) µg/mL 7.80 6.28 – 9.32 34.8 29.8 – 39.8
ORTHO VITROS MICROSLIDE SERIES
Acetaminophen (Enzymatic, colorimetric) µg/mL 14.8 12.7 – 16.8 86.2 80.0 – 92.3
Albumin (Bromcresol green) g/dL 4.74 3.97 – 5.51 2.72 2.36 – 3.07
Alkaline Phosphatase (PNPP, AMP Buffer-VITROS) (2) U/L 68.3 52.2 – 84.3 307 248 – 366
ALT/SGPT (2) U/L § §
ALT/SGPT (ALTv) (2) U/L 21.6 15.3 – 28.0 75.1 63.0 – 87.2
Amylase (Amylopectin, colorimetric-VITROS) (2) U/L 67.5 42.5 – 92.5 204 151 – 256
AST/SGOT (2) U/L 54.2 46.5 – 62.0 216 189 – 244
Bilirubin (Direct) (Spectrophotometric) mg/dL <0.001 0.565 0.346 – 0.784
Bilirubin (Indirect) (Direct measure) mg/dL 0.797 0.403 – 1.19 3.91 3.18 – 4.64
Bilirubin (Total) (Diphylline, Diazonium Salt-VITROS) (TBIL) mg/dL 0.978 0.534 – 1.42 4.41 3.44 – 5.39
Calcium (Arsenazo III) mg/dL 9.63 8.72 – 10.5 11.6 10.5 – 12.6
Carbamazepine (EIA) µg/mL <3.00 – 3.47 14.6 11.5 – 17.7
Carbon Dioxide (CO2) (Enzymatic) mEq/L 30.3 23.2 – 37.5 16.9 11.3 – 22.5
Chloride (ISE direct) mEq/L 96.4 84.5 – 108 82.4 71.1 – 93.7
Cholesterol (HDL) (Direct measure, PTA/MgCl2-VITROS) (7) mg/dL 81.6 64.6 – 98.7 29.9 24.7 – 35.1
Cholesterol (LDL) (Calculated) mg/dL 120 77.8 – 162 57.3 34.3 – 80.3
Cholesterol (Total) (Cholesterol oxidase, esterase, peroxidase) mg/dL 249 218 – 280 108 93.6 – 122
Creatine Kinase (CK) (Rosalki, Other Modified-VITROS) (2) U/L 77.9 59.5 – 96.3 325 254 – 396
Creatinine (Enzymatic-VITROS, IFCC-IDMS Standardized) mg/dL 1.75 1.48 – 2.02 5.62 4.95 – 6.29
Digoxin (EIA) ng/mL 1.14 0.517 – 1.76 2.68 1.88 – 3.47
Gamma Glutamyltransferase (GGT) (2) U/L 60.5 50.1 – 70.8 229 202 – 257
Glucose mg/dL 92.0 81.6 – 102 268 244 – 292
Iron (Pyridyl azo dye) µg/dL 258 209 – 307 60.0 39.6 – 80.4
Lactate (Lactic Acid) (Lactate to pyruvate) mg/dL 38.9 34.8 – 43.0 9.38 7.40 – 11.4
Lactate Dehydrogenase (LDH) (2) U/L § §
Lipase (Enzymatic with colipase-VITROS) (2) U/L 518 447 – 589 1262 1100 – 1424
Lithium (Colorimetric) mEq/L <0.200 1.14 0.865 – 1.42
Magnesium (Formazan dye) mg/dL 1.69 1.42 – 1.96 4.84 4.30 – 5.39
Phenytoin (EIA) µg/mL 9.02 6.11 – 11.9 23.2 16.0 – 30.4
Phosphorus mg/dL 3.66 3.14 – 4.18 6.78 5.91 – 7.65
Potassium (ISE direct) mEq/L 3.86 3.58 – 4.14 6.13 5.71 – 6.54
Protein Serum (Total) g/dL 5.51 4.89 – 6.13 3.70 3.17 – 4.23
Salicylate (Colorimetric-VITROS) mg/dL 6.60 4.94 – 8.26 15.5 12.6 – 18.3
Sodium (ISE direct) mEq/L 144 135 – 153 127 120 – 135
Theophylline (Enzymetric) µg/mL 32.4 27.8 – 37.0 36.9 – >40.0
Triglycerides (Enzymatic, end point) mg/dL 221 196 – 246 98.6 83.7 – 114
Urea Nitrogen (BUN) (Urease, colorimetric) (4) mg/dL 17.1 14.7 – 19.4 42.2 37.7 – 46.6
Uric Acid (Uricase, colorimetric) mg/dL 4.47 4.05 – 4.88 9.13 8.23 – 10.0
ORTHO VITROS MICROTIP SERIES
Cholesterol (LDL) (Direct measure) mg/dL 108 87.9 – 127 48.7 37.9 – 59.5
Iron (TIBC) (Chromazurol B-VITROS) µg/dL 337 291 – 382 219 180 – 258
Valproic Acid (EIA) µg/mL 37.1 27.9 – 46.3 113 91.8 – 133
Vancomycin (EIA) µg/mL 6.81 5.22 – 8.39 28.7 24.5 – 33.0

Page 10 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
ROCHE / HITACHI COBAS C SYSTEMS
Acetaminophen (EIA) (ACET2) (REF 06769942190) µg/mL 18.5 15.6 – 21.4 79.2 72.3 – 86.2
Albumin (Bromcresol Green (BCG)) g/dL 4.31 3.94 – 4.68 2.63 2.34 – 2.91
Alkaline Phosphatase (ALP2 (IFCC Schumann calibration)) (2) U/L 113 97.0 – 129 440 391 – 490
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L § §
ALT/SGPT (UV with P5P) (IFCC 2002) (2) U/L 28.0 22.2 – 33.8 101 87.2 – 114
ALT/SGPT (UV without P5P) (2) U/L 24.9 19.7 – 30.1 97.2 84.8 – 110
Amylase (G7 PNP, Blocked) (2) U/L 77.7 71.2 – 84.3 380 354 – 406
Amylase (Pancreatic) (G7 PNP immunoinhibition) (2) U/L § §
AST/SGOT (UV with P5P) (IFCC 2002) (2) U/L 45.8 32.5 – 59.2 215 154 – 276
AST/SGOT (UV without P5P) (2) U/L 42.3 35.7 – 48.9 196 169 – 222
Bilirubin (Direct) (DBILI) mg/dL 0.239 <0.200 – 0.317 0.979 0.774 – 1.18
Bilirubin (Total) (BILT3) mg/dL 0.958 0.796 – 1.12 3.91 3.42 – 4.39
Bilirubin (Total) (BILTS) mg/dL § §
Calcium (BAPTA) (CA2) mg/dL 10.5 9.83 – 11.1 12.3 11.5 – 13.0
Carbamazepine (EIA) µg/mL 3.00 1.90 – 4.10 16.0 13.2 – 18.7
Carbon Dioxide (CO2) (Enzymatic) mEq/L 32.9 25.4 – 40.4 18.1 13.1 – 23.0
Chloride (ISE indirect) mEq/L 101 93.0 – 109 84.7 78.5 – 90.9
Cholesterol (HDL) (HDLC4) (7) mg/dL 77.8 63.5 – 92.1 19.7 15.5 – 23.9
Cholesterol (LDL) (LDLC3) mg/dL 126 101 – 151 52.2 42.0 – 62.4
Cholesterol (Total) mg/dL 251 231 – 271 105 94.6 – 116
Cortisol (Electrochemiluminescence (ECL)) µg/dL 12.1 9.95 – 14.3 45.0 39.9 – 50.2
Creatine Kinase (CK) (NAC activated) (IFCC 2002) (2) U/L 139 121 – 157 453 402 – 505
Creatine Kinase (CK) (NAC activated) (IFCC 2002) (Cobas 8000) (2) U/L 141 127 – 154 456 415 – 497
Creatinine (Alkaline picrate-kinetic rate blanked,IFCC-IDMS Standardized) mg/dL 1.82 1.52 – 2.12 5.57 4.93 – 6.22
Creatinine (Enzymatic IFCC-IDMS Standardized) mg/dL 1.81 1.62 – 1.99 5.53 5.12 – 5.94
Digoxin (KIMS (Roche)) ng/mL 1.26 0.913 – 1.61 2.96 2.49 – 3.43
Gamma Glutamyltransferase (GGT) (IFCC 2002) (2) U/L 57.1 45.2 – 69.0 168 135 – 201
Glucose (Hexokinase) mg/dL 83.0 70.8 – 95.2 265 236 – 294
Haptoglobin mg/dL 124 111 – 136 72.4 64.6 – 80.2
Immunoglobulin A (IgA) mg/dL 186 141 – 231 123 97.8 – 147
Immunoglobulin G (IgG) mg/dL 943 847 – 1038 628 557 – 699
Immunoglobulin M (IgM) mg/dL 75.8 64.4 – 87.2 50.2 39.7 – 60.7
Iron (Ferrozine-no deproteinization) µg/dL 249 229 – 268 72.0 61.4 – 82.6
Iron (TIBC) (Calculated) µg/dL 337 286 – 389 199 160 – 237
Iron (UIBC) (Ferrozine) µg/dL 106 72.1 – 139 131 94.4 – 167
Lactate (Lactic Acid) (Enzymatic) mg/dL 41.0 37.2 – 44.9 10.8 9.15 – 12.5
Lactate Dehydrogenase (LDH) (Lactate to pyruvate) (2) U/L 176 161 – 192 409 376 – 441
Lipase (Enzymatic, colorimetric) (2) U/L 63.8 53.6 – 73.9 97.4 84.1 – 111
Lithium (Colorimetric) mEq/L 0.617 0.465 – 0.769 1.88 1.68 – 2.09
Magnesium (Xylidyl blue) (MG2) mg/dL 1.98 1.70 – 2.26 4.43 – >4.86
Phenobarbital (KIMS (Roche)) µg/mL 12.9 8.81 – 16.9 49.9 39.3 – >60.0
Phenytoin (KIMS (Roche)) µg/mL 9.10 6.23 – 12.0 22.8 17.1 – 28.5
Phosphorus mg/dL 3.88 3.55 – 4.22 7.37 6.82 – 7.93
Potassium (ISE indirect) mEq/L 3.88 3.64 – 4.12 6.35 6.00 – 6.69
Protein Serum (Total) g/dL 6.80 6.33 – 7.27 4.29 3.97 – 4.61
Salicylate (Enzymatic) mg/dL 6.00 3.84 – 8.16 12.9 10.8 – 15.0
Sodium (ISE indirect) mEq/L 148 141 – 155 129 123 – 136
Theophylline (KIMS (Roche)) µg/mL 9.07 7.37 – 10.8 24.0 17.9 – 30.1

Page 11 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
ROCHE / HITACHI COBAS C SYSTEMS (continued)
Transferrin mg/dL 280 253 – 307 168 152 – 183
Triglycerides (Enzymatic, end point) mg/dL 213 198 – 228 98.9 90.4 – 107
Urea Nitrogen (BUN) (Urease, UV) (4) mg/dL 14.9 13.3 – 16.5 47.0 42.4 – 51.6
Uric Acid (Uricase, colorimetric) mg/dL 4.58 4.16 – 5.00 9.64 8.83 – 10.4
Valproic Acid (EIA) µg/mL 38.2 28.0 – 48.4 108 82.9 – 132
Vancomycin (KIMS (Roche)) (VANC3) µg/mL 6.75 5.18 – 8.32 29.8 25.4 – 34.1
ROCHE COBAS INTEGRA
Albumin (Bromcresol Green (BCG)) g/dL 4.52 4.05 – 4.99 2.75 2.44 – 3.07
Alkaline Phosphatase (PNPP, AMP Buffer) (2) U/L 117 95.8 – 139 458 392 – 525
ALT/SGPT (UV with P5P) (IFCC 2002) (2) U/L 24.3 17.8 – 30.8 95.5 80.6 – 110
Amylase (G7 PNP, Blocked) U/L § §
AST/SGOT (UV with P5P) (2) U/L 44.5 37.4 – 51.5 216 191 – 242
Bilirubin (Total) (BILT3) mg/dL 0.975 0.745 – 1.20 3.99 3.34 – 4.64
Calcium (BAPTA) (CA2) mg/dL 10.7 9.92 – 11.5 12.8 11.9 – 13.7
Carbamazepine µg/mL § §
Creatine Kinase (CK) (NAC activated) (2) U/L 137 117 – 157 450 392 – 508
Creatinine (Alkaline picrate method, IFCC-IDMS Standardized) (CREJ2) mg/dL 2.00 1.70 – 2.30 5.21 4.57 – 5.86
Gamma Glutamyltransferase (GGT) (2) U/L 56.2 44.7 – 67.6 167 131 – 203
Gentamicin µg/mL 1.65 1.16 – 2.13 7.00 6.07 – 7.92
Glucose (Hexokinase) mg/dL 86.2 77.5 – 94.9 291 267 – 316
Iron (Ferrozine-no deproteinization) µg/dL 244 221 – 267 68.0 55.4 – 80.7
Lactate Dehydrogenase (LDH) (IFCC 2002) (2) U/L 178 159 – 197 415 375 – 456
Lipase (Enzymatic, colorimetric) (2) U/L 60.7 48.9 – 72.5 89.9 72.8 – 107
Lithium (ISE direct) mEq/L § §
Phenobarbital µg/mL § §
Phenytoin µg/mL § §
Phosphorus (Phosphomolybdate method) mg/dL 3.91 3.54 – 4.28 7.52 6.89 – 8.14
Protein Serum (Total) g/dL 6.52 5.84 – 7.19 4.07 3.57 – 4.57
Sodium (ISE indirect) mEq/L 145 136 – 153 128 121 – 136
Theophylline µg/mL 9.69 7.83 – 11.6 24.9 18.2 – 31.6
Uric Acid (Uricase, colorimetric) mg/dL 4.72 4.12 – 5.32 9.94 8.95 – 10.9
Valproic Acid µg/mL 33.6 27.3 – 39.9 103 82.7 – 123
Vancomycin µg/mL 6.98 4.39 – 9.57 31.2 21.0 – 41.4
SIEMENS ADVIA CENTAUR CP
Carbamazepine (CARB) µg/mL 2.85 2.25 – 3.45 16.8 14.0 – >18.0
Cortisol (COR) µg/dL 11.9 9.41 – 14.3 47.9 40.1 – 55.7
Digoxin (DIG) ng/mL 1.28 0.905 – 1.66 3.28 2.77 – 3.79
Gentamicin (GENT) µg/mL 1.37 0.906 – 1.83 7.55 6.57 – 8.52
Phenobarbital (PHNB) µg/mL 16.3 11.8 – 20.8 73.5 62.7 – >80.0
Phenytoin (PHTN) µg/mL 11.1 8.80 – 13.5 28.3 22.7 – 33.9
T3 (Total) (T3) ng/mL 0.680 0.538 – 0.822 4.17 3.31 – 5.03
T3 Uptake/T Uptake (TUp) T Uptake Unit 0.933 0.768 – 1.10 2.20 1.88 – 2.51
T4 (Free) (FT4) ng/dL 1.26 0.986 – 1.53 10.3 9.01 – 11.6
T4 (Total) (T4) µg/dL 6.96 5.25 – 8.68 23.8 18.2 – 29.4
Theophylline (THEO2) µg/mL 9.13 7.39 – 10.9 21.9 16.3 – 27.5
Thyroid Stimulating Hormone (TSH) (TSH) µIU/mL 1.74 1.11 – 2.36 21.4 17.7 – 25.1
Thyroid Stimulating Hormone (TSH) (TSH3UL) µIU/mL 1.52 1.01 – 2.03 16.9 13.2 – 20.5
Valproic Acid (VALP) µg/mL 36.9 29.3 – 44.6 112 93.8 – 130

Page 12 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
SIEMENS ADVIA CENTAUR CP (continued)
Vancomycin (VANC) µg/mL 5.22 3.75 – 6.68 20.8 17.5 – 24.0
Vitamin B12 (VB12) pg/mL 120 85.9 – 153 153 119 – 186
SIEMENS ADVIA CENTAUR SYSTEMS
Carbamazepine (CARB) µg/mL 2.66 2.08 – 3.23 16.3 13.6 – >18.0
Cortisol (COR) µg/dL 11.4 8.06 – 14.8 45.7 36.6 – 54.9
Digoxin (DIG) ng/mL 1.35 0.965 – 1.73 3.24 2.74 – 3.75
Gentamicin (GENT) µg/mL 1.55 1.08 – 2.03 7.63 6.65 – 8.61
Phenobarbital (PHNB) µg/mL 18.2 13.4 – 23.1 69.9 59.1 – >80.0
Phenytoin (PHTN) µg/mL 10.5 8.27 – 12.7 28.5 22.9 – 34.1
T3 (Total) (T3) ng/mL 0.824 0.614 – 1.03 4.26 3.56 – 4.96
T3 Uptake/T Uptake (TUp) T Uptake Unit 0.920 0.743 – 1.10 1.95 1.66 – 2.24
T4 (Free) (FT4) ng/dL 1.23 0.962 – 1.50 9.66 8.37 – 10.9
T4 (Total) (T4) µg/dL 6.52 4.91 – 8.13 22.7 17.1 – 28.2
Theophylline (THEO2) µg/mL 9.83 7.94 – 11.7 23.1 17.1 – 29.0
Thyroid Stimulating Hormone (TSH) µIU/mL 1.93 1.26 – 2.59 22.7 19.0 – 26.4
Thyroid Stimulating Hormone (TSH) (TSH3UL) µIU/mL 1.65 1.04 – 2.25 17.6 13.9 – 21.3
Valproic Acid (VALP) µg/mL 36.7 29.0 – 44.3 112 93.5 – 130
Vancomycin (VANC) µg/mL 5.86 4.40 – 7.32 23.5 19.9 – 27.1
Vitamin B12 (VB12) pg/mL 136 85.3 – 187 158 100 – 216
SIEMENS ADVIA CHEMISTRY SYSTEMS
Acetaminophen (Enzymatic) (ACET) µg/mL 18.0 14.3 – 21.6 78.4 65.2 – 91.7
Albumin (Bromcresol Green (BCG)) (ALB, ALB_c) g/dL 4.24 3.95 – 4.52 2.66 2.45 – 2.86
Albumin (Bromcresol Purple (BCP)) (ALBP) g/dL 3.96 3.49 – 4.43 2.47 2.10 – 2.84
Alkaline Phosphatase (IFCC) (ALP_2c) (2) U/L 114 80.3 – 147 435 351 – 519
ALT/SGPT (ALT, ALT_c) (2) U/L
ALT/SGPT (ALTP5P, ALTP_c) (2) U/L 28.7 22.8 – 34.7 105 93.4 – 116
Amylase (Ethylidene blocked-pNPG7) (AMYLAS) (2) U/L 76.8 67.6 – 86.1 388 345 – 432
Amylase (Pancreatic) (PAMY) (2) U/L 45.4 36.3 – 54.4 376 339 – 414
AST/SGOT (AST, AST_c) (2) U/L
AST/SGOT (ASTP5P, ASTP_c) (2) U/L 42.9 30.4 – 55.4 220 159 – 281
Bilirubin (Direct) (Vanadate Oxidation) (DBIL_2) mg/dL 0.359 0.269 – 0.449 1.69 1.33 – 2.04
Bilirubin (Total) (Vanadate Oxidation) (TBIL_2) mg/dL 1.16 1.01 – 1.30 4.55 4.05 – 5.04
Calcium (Arsenazo III) (CA_2, CA_2c) mg/dL 10.6 9.61 – 11.6 12.1 11.0 – 13.2
Calcium (CA, CA_c) mg/dL 10.5 9.67 – 11.3 12.7 11.7 – 13.7
Carbamazepine (EIA) (CARB_2) µg/mL 2.75 2.16 – 3.34 14.6 11.9 – 17.3
Carbon Dioxide (CO2) (Enzymatic) (CO2_L, CO2_c) mEq/L
Chloride (ISE indirect) (CL) mEq/L 98.7 93.4 – 104 83.1 78.4 – 87.8
Cholesterol (HDL) (Direct measure) (DHDL) (7) mg/dL 68.5 56.2 – 80.9 17.6 12.3 – 22.9
Cholesterol (LDL) (Direct measure) (DLDL) mg/dL 129 104 – 153 54.8 44.5 – 65.0
Cholesterol (Total) (CHOL_2, CHOL_c) mg/dL
Cholinesterase (Butyrylthiocholine (Trinder)) (CHE) (2) U/L 8152 5964 – 10340 <1500
Creatine Kinase (CK) (CK_L) (2) U/L 143 116 – 169 465 404 – 526
Creatine Kinase (CK) (IFCC) (CKNAC) (2) U/L 139 120 – 158 453 402 – 503
Creatinine (Enzymatic) (ECRE_2) mg/dL 1.78 1.60 – 1.97 5.58 5.14 – 6.02
Creatinine (Jaffe) (CREA, CREA_2, CRE_2c) mg/dL
Digoxin (Immunoturbidimetric) (DIG) ng/mL 1.15 0.817 – 1.47 3.04 2.66 – 3.42
Gamma Glutamyltransferase (GGT) (IFCC) (2) U/L 55.6 37.3 – 73.9 168 128 – 208
Gentamicin (EIA) (GENT_2) µg/mL 1.63 1.14 – 2.11 5.86 5.02 – 6.70

Page 13 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
SIEMENS ADVIA CHEMISTRY SYSTEMS (continued)
Glucose (GLUH, GLUH_3, GLUH_c) mg/dL 80.0 70.7 – 89.3 269 245 – 292
Glucose (GLUO, GLUO_2) mg/dL 86.6 76.5 – 96.6 276 251 – 300
Immunoglobulin A (IgA) (IGA_2) mg/dL 208 157 – 260 143 113 – 172
Immunoglobulin G (IgG) (IGG_2) mg/dL 937 781 – 1092 618 510 – 725
Immunoglobulin M (IgM) (IGM_2) mg/dL 83.8 66.9 – 101 54.8 40.1 – 69.5
Iron (Ferrozine-no deproteinization) (IRON_2) µg/dL 237 222 – 252 65.9 59.0 – 72.9
Iron (TIBC) (TIBC) µg/dL 353 312 – 394 221 190 – 253
Lactate (Lactic Acid) (Lactate to pyruvate) (LAC) mg/dL
Lactate Dehydrogenase (LDH) (LDLP) (IFCC) (2) U/L 186 164 – 207 437 390 – 484
Lactate Dehydrogenase (LDH) (LDPL) (2) U/L
Lipase (Enzymatic, colorimetric) (LIP) (2) U/L 64.8 52.2 – 77.4 107 89.3 – 125
Lithium (Colorimetric) (LITH) mEq/L
Magnesium (Xylidyl blue) (MG, MG_c) mg/dL 1.94 1.66 – 2.21 4.51 3.98 – 5.04
Phenobarbital (EIA) (PHNB_2) µg/mL 12.9 8.86 – 17.0 49.9 39.9 – 59.9
Phenytoin (EIA) (PHYN_2) µg/mL 8.85 6.40 – 11.3 20.7 16.4 – 25.1
Phosphorus (IP, IP_c) mg/dL 3.95 3.38 – 4.51 7.54 6.62 – 8.46
Potassium (ISE indirect) (K) mEq/L 3.89 3.63 – 4.15 6.36 6.02 – 6.70
Protein Serum (Total) (TP, TP_c) g/dL 6.74 6.23 – 7.24 4.30 3.94 – 4.67
Salicylate (Enzymatic) (SAL) mg/dL 6.84 4.70 – 8.98 14.7 12.7 – 16.8
Salicylate (SAL) (Cal. Lots 9520531 9520341 and above) mg/dL 5.61 3.47 – 7.75 12.1 10.0 – 14.1
Sodium (ISE indirect) (NA) mEq/L 149 143 – 155 130 125 – 136
Theophylline (EIA) (THEO_2) µg/mL 9.47 7.64 – 11.3 23.4 17.2 – 29.6
Tobramycin (EIA) (TOB_2) µg/mL 6.41 4.97 – 7.86 1.78 1.17 – 2.38
Transferrin (Immunoturbidimetric) (TRF) mg/dL 271 236 – 305 171 150 – 191
Triglycerides (Enzymatic, end point) (TRIG) mg/dL 211 195 – 227 100 88.6 – 111
Urea Nitrogen (BUN) (Urease, UV) (UN, UN_c) (4) mg/dL
Uric Acid (Uricase, colorimetric) (UA, UA_c) mg/dL 4.77 4.39 – 5.15 9.87 9.22 – 10.5
Valproic Acid (EIA) (VPA_2) µg/mL
Vancomycin (EIA) (VANC_2) µg/mL
SIEMENS BN SERIES NEPHELOMETERS
Alpha 1-Antitrypsin mg/dL 156 116 – 195 88.7 68.8 – 109
Apolipoprotein A-I mg/dL 154 128 – 180 71.3 56.1 – 86.5
Apolipoprotein B mg/dL 76.5 59.6 – 93.4 45.8 33.3 – 58.3
Ceruloplasmin mg/dL 32.3 22.9 – 41.7 22.8 15.0 – 30.5
Complement C3 mg/dL 160 144 – 175 98.2 87.2 – 109
Haptoglobin mg/dL 132 117 – 146 73.7 65.1 – 82.2
Immunoglobulin A (IgA) mg/dL 214 186 – 242 138 113 – 164
Immunoglobulin G (IgG) mg/dL 1006 887 – 1125 671 579 – 763
Immunoglobulin M (IgM) mg/dL 101 83.4 – 119 62.6 48.0 – 77.1
SIEMENS DIMENSION SERIES
Acetaminophen (Enzymatic, colorimetric) µg/mL 22.7 17.6 – 27.7 91.7 82.8 – 101
Albumin (Bromcresol Purple (BCP)) g/dL 4.00 3.67 – 4.33 2.53 2.30 – 2.76
Alkaline Phosphatase (IFCC ALPI) (2) U/L 111 76.0 – 145 435 342 – 529
ALT/SGPT (IFCC ALTI) (2) U/L 31.2 23.6 – 38.7 104 86.7 – 121
Amylase (CNP-triose/CNPG3) (2) U/L 71.0 64.4 – 77.5 494 455 – 533
AST/SGOT (2) U/L 44.3 36.1 – 52.5 206 181 – 230
Bilirubin (Direct) (Diazotization) (DBI) mg/dL 0.234 0.139 – 0.329 0.985 0.786 – 1.18
Bilirubin (Total) (Jendrassik Grof) (TBI) mg/dL 1.05 0.834 – 1.27 4.33 3.84 – 4.83

Page 14 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
SIEMENS DIMENSION SERIES (continued)
Calcium mg/dL 10.3 9.33 – 11.2 12.7 11.5 – 13.8
Carbamazepine µg/mL 2.95 2.25 – 3.65 15.2 12.5 – 18.0
Carbon Dioxide (CO2) (Enzymatic) mEq/L 33.9 27.0 – 40.8 19.0 13.9 – 24.1
Chloride mEq/L 113 99.8 – 127 92.5 81.4 – 104
Cholesterol (HDL) (DF48B) (7) mg/dL 79.2 64.8 – 93.6 38.2 30.8 – 45.6
Cholesterol (LDL) (ALDL) mg/dL 115 97.9 – 131 58.6 49.2 – 68.0
Cholesterol (Total) mg/dL 252 226 – 279 100 86.5 – 114
Cholinesterase (Butyrylthiocholine (Trinder)) (2) U/L 11798 10888 – 12707 2003 1503 – 2503
Creatine Kinase (CK) (IFCC CKI) (2) U/L 135 113 – 158 446 393 – 499
Creatinine (CRE2) mg/dL 2.61 2.25 – 2.96 6.38 5.74 – 7.01
Creatinine (EZCR) mg/dL § §
Digoxin (EIA) ng/mL § §
Gamma Glutamyltransferase (GGT) (2) U/L 76.1 63.4 – 88.7 203 176 – 229
Gentamicin (Immunoturbidimetric) µg/mL 1.67 1.15 – 2.18 6.95 6.00 – 7.90
Glucose (Hexokinase) mg/dL 91.8 82.0 – 102 287 261 – 313
Immunoglobulin A (IgA) mg/dL § §
Immunoglobulin G (IgG) mg/dL § §
Immunoglobulin M (IgM) mg/dL § §
Iron (Ferene) µg/dL 241 207 – 274 65.1 53.7 – 76.5
Iron (TIBC) (IBCT) µg/dL 345 291 – 399 187 148 – 226
Lactate (Lactic Acid) (Enzymatic) mg/dL 37.2 32.6 – 41.7 8.22 5.09 – 11.4
Lactate Dehydrogenase (LDH) (IFCC LDI) (2) U/L 174 134 – 213 406 345 – 467
Lipase (Colorimetric) (2) U/L 201 166 – 237 274 231 – 317
Lipase (Lip (DF56A) U/L 64.0 51.0 – 76.0 89.0 71.0 – 107
Lithium (Colorimetric) mEq/L 0.635 0.506 – 0.765 1.97 1.70 – 2.24
Magnesium mg/dL 2.13 1.77 – 2.49 4.98 4.43 – 5.53
Phenobarbital µg/mL 14.7 10.2 – 19.1 52.5 41.9 – 63.1
Phenytoin µg/mL 9.58 6.85 – 12.3 24.3 19.3 – 29.2
Phosphorus (DF61A) mg/dL 4.09 3.66 – 4.52 7.76 7.14 – 8.38
Potassium mEq/L 3.79 3.51 – 4.07 6.33 5.87 – 6.79
Protein Serum (Total) g/dL 6.89 6.36 – 7.43 4.44 4.04 – 4.84
Salicylate (Trinder) mg/dL 7.92 6.64 – 9.20 10.8 9.09 – 12.4
Sodium mEq/L 145 137 – 154 129 121 – 137
T3 Uptake/T Uptake (EIA) % Uptake § §
T4 (Free) ng/dL § §
T4 (Free) (Chemiluminescence) ng/dL 0.968 0.740 – 1.20 >8.00
T4 (Total) (EIA) µg/dL § §
Theophylline µg/mL 8.98 7.18 – 10.8 24.1 19.3 – 29.0
Thyroid Stimulating Hormone (TSH) (Chemiluminescence) µIU/mL 1.37 0.814 – 1.93 23.0 19.2 – 26.8
Thyroid Stimulating Hormone (TSH) (EIA) µIU/mL § §
Tobramycin µg/mL 7.14 5.56 – 8.73 1.73 1.13 – 2.33
Transferrin mg/dL 236 207 – 265 159 139 – 178
Triglycerides (Enzymatic, end point) mg/dL 206 181 – 230 94.0 81.3 – 107
Urea Nitrogen (BUN) (Urease, UV) (4) mg/dL 15.3 12.6 – 18.0 47.8 42.1 – 53.6
Uric Acid (Uricase, UV) mg/dL 4.66 4.19 – 5.13 9.85 9.08 – 10.6
Valproic Acid µg/mL 34.8 28.5 – 41.1 94.0 77.3 – 111
Vancomycin µg/mL 7.26 5.73 – 8.80 29.7 25.1 – 34.3

Page 15 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
SIEMENS DIMENSION VISTA SYSTEMS
Acetaminophen µg/mL 24.0 18.7 – 29.4 93.9 85.1 – 103
AFP ng/mL 2.85 2.58 – 3.13 1.91 1.64 – 2.18
Albumin (Bromcresol Purple (BCP)) g/dL 4.00 3.66 – 4.34 2.55 2.27 – 2.82
Alkaline Phosphatase (IFCC ALPI) (2) U/L 109 92.3 – 126 424 377 – 471
Alpha 1-Antitrypsin mg/dL 159 135 – 184 98.8 83.0 – 115
ALT/SGPT (IFCC ALTI) (2) U/L 31.6 26.5 – 36.6 100 92.2 – 109
Amylase (CNP-triose/CNPG3) (2) U/L 71.2 66.4 – 75.9 501 478 – 524
Apolipoprotein A-I mg/dL 154 123 – 184 72.1 61.9 – 82.2
Apolipoprotein B mg/dL 78.0 60.6 – 95.4 51.3 37.8 – 64.8
AST/SGOT (2) U/L 45.0 36.3 – 53.7 206 187 – 224
Bilirubin (Direct) (Diazotization) mg/dL 0.288 0.213 – 0.362 1.00 0.856 – 1.14
Bilirubin (Total) (Jendrassik Grof) mg/dL 1.06 0.925 – 1.20 4.14 3.76 – 4.52
Calcium mg/dL 9.90 8.99 – 10.8 12.2 11.2 – 13.2
Carbamazepine µg/mL 2.97 2.36 – 3.59 15.5 13.1 – 18.0
Carbon Dioxide (CO2) (Enzymatic) mEq/L 35.9 30.4 – 41.4 20.8 17.5 – 24.1
CEA ng/mL 0.975 0.845 – 1.11 0.837 0.703 – 0.971
Ceruloplasmin mg/dL 33.9 23.6 – 44.1 25.0 16.3 – 33.7
Chloride (ISE indirect) mEq/L 98.0 92.9 – 103 85.8 81.1 – 90.4
Cholesterol (HDL) (HDLC) (7) mg/dL 78.2 68.0 – 88.5 34.6 28.7 – 40.4
Cholesterol (LDL) (ALDL) mg/dL 128 110 – 147 66.8 56.3 – 77.2
Cholesterol (Total) mg/dL 251 229 – 273 101 90.0 – 112
Cholinesterase (Butyrylthiocholine (Trinder)) (2) U/L 9927 7790 – 12065 1165 897 – 1433
Complement C3 mg/dL 158 144 – 173 94.5 84.0 – 105
Creatine Kinase (CK) (IFCC CKI) (2) U/L 134 113 – 156 444 393 – 494
Creatinine (CRE2) mg/dL 2.68 2.28 – 3.09 6.54 5.83 – 7.25
Creatinine (ECREA) mg/dL 1.68 1.18 – 2.19 5.37 4.55 – 6.19
Digoxin (Chemiluminescence) ng/mL 1.39 1.00 – 1.77 2.78 2.31 – 3.26
Gamma Glutamyltransferase (GGT) (2) U/L 72.1 58.4 – 85.8 206 173 – 239
Gentamicin µg/mL 1.53 1.08 – 1.99 6.93 6.07 – 7.80
Glucose (Hexokinase) mg/dL 85.6 78.5 – 92.7 278 257 – 298
Haptoglobin mg/dL 127 113 – 141 73.6 65.3 – 81.8
hCG mIU/mL 11.0 9.86 – 12.1 6.60 5.46 – 7.74
Immunoglobulin A (IgA) mg/dL 216 187 – 244 144 118 – 169
Immunoglobulin G (IgG) mg/dL 970 855 – 1085 647 560 – 735
Immunoglobulin M (IgM) mg/dL 94.1 74.4 – 114 60.7 44.7 – 76.7
Iron (Ferene) µg/dL 237 214 – 260 61.2 49.1 – 73.4
Iron (TIBC) µg/dL 367 297 – 437 206 157 – 256
Lactate (Lactic Acid) mg/dL 40.4 34.7 – 46.1 10.7 8.95 – 12.5
Lactate Dehydrogenase (LDH) (IFCC LDI) (2) U/L 175 136 – 214 404 344 – 464
Lipase (Colorimetric) (2) U/L 269 227 – 311 393 348 – 437
Lithium (Colorimetric) mEq/L 0.661 0.524 – 0.798 1.86 1.63 – 2.08
Magnesium mg/dL 2.21 1.89 – 2.53 5.08 4.60 – 5.56
Phenobarbital µg/mL 14.8 10.3 – 19.3 49.7 39.6 – 59.8
Phenytoin µg/mL 10.3 8.29 – 12.4 24.3 19.9 – 28.8
Phosphorus mg/dL 3.74 3.42 – 4.05 7.51 6.83 – 8.18
Potassium (ISE indirect) mEq/L 3.80 3.53 – 4.07 6.26 5.84 – 6.68
Protein Serum (Total) g/dL 7.08 6.66 – 7.49 4.43 4.14 – 4.72
Salicylate (Trinder) mg/dL 7.62 6.81 – 8.43 11.4 10.2 – 12.5

Page 16 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 89721 Level 2 - 89722
Units Mean Range Mean Range
SIEMENS DIMENSION VISTA SYSTEMS (continued)
Sodium (ISE indirect) mEq/L 145 136 – 154 130 122 – 138
T3 (Free) (Chemiluminescence) pg/mL 3.07 2.38 – 3.76 23.5 20.2 – 26.9
T3 Uptake/T Uptake (EIA) % Uptake 35.2 29.0 – 41.3 54.0 45.5 – >58.0
T4 (Free) (Chemiluminescence) ng/dL 0.996 0.857 – 1.14 >8.00
T4 (Total) (EIA) µg/dL 8.97 6.73 – 11.2 23.5 17.9 – >24.0
Theophylline µg/mL 9.19 7.38 – 11.0 22.4 18.1 – 26.6
Thyroid Stimulating Hormone (TSH) µIU/mL 1.48 0.909 – 2.04 22.8 19.1 – 26.5
Tobramycin µg/mL 6.99 5.44 – 8.54 1.61 1.03 – 2.20
Transferrin mg/dL 274 243 – 305 162 142 – 182
Triglycerides (Enzymatic, end point) mg/dL 223 198 – 247 108 92.1 – 123
Urea Nitrogen (BUN) (Urease, UV) (4) mg/dL 15.7 13.5 – 17.9 50.2 44.9 – 55.5
Uric Acid (Uricase, UV) mg/dL 4.80 4.32 – 5.28 10.0 9.23 – 10.8
Valproic Acid µg/mL 38.4 31.5 – 45.3 109 91.8 – 126
Vancomycin µg/mL 7.31 5.81 – 8.81 29.9 25.4 – 34.4
Vitamin B12 pg/mL 285 228 – 342 198 141 – 255
SIEMENS IMMULITE / IMMULITE 1000
T4 (Total) µg/dL 6.95 5.31 – 8.58 20.0 – >24.0
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 1.90 1.25 – 2.55 19.8 16.2 – 23.5
SIEMENS IMMULITE 2000 / 2000 XPi
Cortisol µg/dL 8.87 7.24 – 10.5 37.2 33.0 – 41.5
T3 (Total) ng/dL 83.9 65.3 – 103 510 404 – >600
T4 (Total) µg/dL 6.91 5.28 – 8.54 20.9 16.1 – >24.0
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 1.82 1.19 – 2.45 17.3 13.7 – 20.9
Thyroid Stimulating Hormone (TSH) (Rapid TSH) µIU/mL 1.90 1.25 – 2.54 17.9 14.3 – 21.6

Page 17 English • 2023-02 • 4030-00S

8
Lyphochek Assayed Chemistry Control, Levels 1 and 2

PROTEIN ELECTROPHORESIS (1) (6) (8)


Lot 89721 Lot 89722
Units Mean Range Mean Range
AGAROSE GEL-ACID BLUE
Albumin % 54.4 49.7 – 59.1 58.1 53.5 – 62.7
Globulin % 45.6 37.8 – 53.5 41.9 34.5 – 49.3
Globulin (Alpha-1) % 4.30 2.97 – 5.63 3.22 2.07 – 4.38
Globulin (Alpha-2) % 12.1 10.6 – 13.6 11.4 10.0 – 12.7
Globulin (Beta) % 16.1 14.3 – 17.9 14.2 11.9 – 16.5
Globulin (Gamma) % 13.1 9.90 – 16.4 13.1 10.5 – 15.7

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.

Lyphochek is a trademark of Bio-Rad Laboratories in certain jurisdictions. Page 18 English • 2023-02 • 4030-00S

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