Lyphochek® Immunology Plus Control

Levels 1 and 2
Level 1 27551
430 Bilevel 12 x 1 mL 2020-04-30 27550 Level 2 27552
430X MiniPak 2 x 1 mL

http://www.myeinserts.com/27550

INTENDED USE WARNING

Lyphochek Immunology Plus Control is intended for use as an assayed quality
control serum to monitor the precision of laboratory testing procedures for the Biological source material. Treat as potentially infectious.
analytes listed in this package insert. Each human donor unit used to manufacture this product was tested by FDA
SUMMARY AND PRINCIPLE accepted methods and found non-reactive for Hepatitis B Surface Antigen
The use of quality control materials is indicated as an objective assessment of (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product
the precision of methods and techniques in use and is an integral part of good may also contain other human source materials for which there are no approved
laboratory practices. Multiple levels of control are available to allow monitoring tests. In accordance with good laboratory practice, all human source material
of the test system’s reliability. should be considered potentially infectious and handled with the same
For customers in Germany: Quality control materials are required for assessment precautions used with patient specimens.
of laboratory performance as described in the “Guideline for Quality Assurance Safety Data Sheet (SDS) available for professional users on www.bio-rad.com.
of Medical Laboratory Examinations following the German Medical Association” SPECIFIC PERFORMANCE CHARACTERISTICS
(Rili-BÄK regulation). This product is a freeze-dried product manufactured under rigid quality control
REAGENT standards. To obtain consistent assay values, the control requires proper storage
This product is prepared from defibrinated human plasma with added serum and handling as described.
proteins, stabilizers and preservatives. This product is provided in lyophilized OPTIONAL SUPPLIES
form for increased stability. Item No. 987000 Dispenser Tips for Screw Caps (100/package).
STORAGE AND STABILITY ASSIGNMENT OF VALUES
This product will be stable until the expiration date when stored The mean values and corresponding ±3SD ranges in the Assignment of Values
unopened at 2 to 8°C. Data Charts (available separately) were derived from replicate analyses and are
After reconstituting and storing tightly capped at 2 to 8°C, this product will be specific for this lot of product. Data from Unity™ Interlaboratory Program are
stable as follows: included in the determination of some ranges. The tests listed were performed
- All analytes: 15 days by the manufacturer and/or independent laboratories using manufacturer
This product is shipped under ambient conditions. supported reagents and a representative sampling of this lot of product. It is
PROCEDURE recommended that each laboratory establish its own acceptable ranges and use
This product should be treated the same as patient specimens and run in those provided only as guides. Laboratory established ranges may vary from
accordance with the instructions accompanying the instrument, kit, or reagent those listed during the life of this control. [Customers in Germany have to follow
being used. the requirements as described in the Rili-BÄK regulation.] Variations over time
Using a volumetric pipet or equivalent, reconstitute each vial with 1.0 mL of and between laboratories may be caused by differences in laboratory technique,
distilled or deionized water. Replace the stopper and allow this product to stand instrumentation and reagents, or by manufacturer test method modifications.
for approximately 10 minutes swirling occasionally.
Before sampling, allow this product to reach room temperature (18 to 25°C). Unity™ Interlaboratory Program is a proprietary Bio-Rad software program
Gently swirl the vial several times to ensure homogeneity. After each use, holding more than 2 billion QC data points from thousands of laboratories.
promptly replace the stopper and return to 2 to 8°C storage. INSTRUCTIONS FOR OBTAINING THE DATA CHARTS
Dispose of any discarded materials in accordance with the requirements of your The Data Charts are available through the Internet, at
local waste management authorities. In the event of damage to packaging, www.myeinserts.com/27550. Follow the directions at the website to receive
contact the local Bio-Rad Laboratories Sales Office or Bio-Rad Laboratories email notifications of insert updates. Alternate methods for receiving data charts
Technical Services. are available by contacting your local Bio-Rad Laboratories Office.
LIMITATIONS IMPORTANT PRODUCT INFORMATION
1. This product should not be used past the expiration date.
2. If there is evidence of microbial contamination or excessive turbidity in Significant changes are highlighted!
the reconstituted product, discard the vial.
3. This product is not intended for use as a standard.
4. Values may increase over the product shelf life for the following
analytes: Ceruloplasmin and Complement C4. Individual laboratory
means may fall outside of the corresponding acceptable range printed
in the data charts.

Page 1 English • 2017-05 • 5137-00

 Lyphochek® Immunology Plus Control, Levels 1 and 2
ANALYTES
Albumin Ceruloplasmin Haptoglobin Lambda Light Chain
Alpha 1-Antitrypsin Complement C1q ❑ Immunoglobulin A (IgA) Prealbumin
Alpha 2-Macroglobulin Complement C3 Immunoglobulin E (IgE) Retinol Binding Protein (RBP)
Alpha-1-Acid Glycoprotein Complement C4 Immunoglobulin G (IgG) Rheumatoid Factor
Antistreptolysin-O C-Reactive Protein (CRP) Immunoglobulin M (IgM) Transferrin
Beta-2-Microglobulin C-Reactive Protein (hsCRP) Kappa Light Chain

NOTES
❑ No claim is made for expected value or stability of this analyte.

LEXICON

Reconstitute with

UNITED STATES, Bio-Rad Laboratories

9500 Jeronimo Road, Irvine, CA 92618

Bio-Rad FRANCE, Bio-Rad

3 boulevard Raymond Poincare, 92430 Marnes-la-Coquette
Laboratories Phone:(33) 1-4795-6000 / Fax:(33) 1-4741-9133

Australia, Bio-Rad Laboratories Pty. Ltd., Level 5, 446 Victoria Road, Gladesville NSW 2111 • Phone 61-2-9914-2800 • Telefax 61-2-9914-2888
Clinical Austria, Bio-Rad Laboratories Ges.m.b.H., Hummelgasse 88/3-6, A-1130 Vienna • Phone 43-1-877-8901 • Telefax 43-1-876-5629
Belgium, Bio-Rad S.A.-N.V. Winninglaan 3, BE-9140 Temse • Phone +32 (3)710-53-00 • Telefax +32 (3)710-53-01
Diagnostics Group Brazil, Bio-Rad Laboratórios Brasil Ltda, Rua Alfredo Albano da Costa, 100, Lagoa Santa - MG, CEP: 33400-000 • Phone +55 (31)3689-6600 • Telefax +55 (31)3689-6611
Canada, Bio-Rad Laboratories, Ltd., 2403 Guénette Street, Montréal, Québec H4R 2E9 • Phone 1-514-334-4372 • Telefax 1-514-334-4415
China, Bio-Rad Laboratories Shanghai Ltd., 3rd Floor, #18 Dong Fang Road, Bldg E, Poly Plaza, Pudong, Shanghai, PRC 200120 • Phone 86-21-61698500 • Telefax 86-21-61698599
9500 Jeronimo Road Czech Republic, Bio-Rad spol. s r.o., Nad ostrovem 1119/7, 147 00 Prague 4 • Phone 420-241-430-532 • Telefax 420-241-431-642
Irvine, California 92618 Denmark, Bio-Rad Laboratories, Symbion Science Park, Fruebjergvej 3, DK-2100 Copenhagen East • Phone +45-4452-1000 • Telefax +45-4452-1001
(800) 854-6737 Finland, Bio-Rad Laboratories, Linnanherrankuja 16, FIN-00950 Helsinki • Phone 358-9-804-22-00 • Telefax 358-9-7597-5010
France, Bio-Rad, 3 boulevard Raymond Poincaré, 92430 Marnes-la-Coquette • Phone 33-1-47-95-60-00 • Telefax 33-1-47-41-91-33
FAX (949) 598-1550 Germany, Bio-Rad Laboratories GmbH, Heidemannstrasse 164, D-80939 Munich • Phone +49 (0)89-318-840 • Telefax +49 (0)89-318-84100
bio-rad.com/qualitycontrol Greece, Bio-Rad Laboratories M E.P.E, 2-4 Mesogeion Street, Fourth Floor 115 27 Athens • Phone 30-210-7774396 • Telefax 30-210-7774376
Hong Kong, Bio-Rad Pacific Ltd., Unit 1101, 11/F DCH Commercial Centre, 25 Westlands Road, Quarry Bay • Phone 852-2789-3300 • Telefax 852-2789-1290
Hungary, Bio-Rad Hungary Ltd., H-1082 Budapest, Futo street 47-53, Hungary • Phone +36-1-459-6100 • Telefax +36-1-459-6101
Technical Service: India, Bio-Rad Laboratories (India) Pvt. Ltd., Bio-Rad House, 86-87, Udyog Vihar Phase IV, Gurgaon, Haryana 122 015 • Phone 1800-180-1224 • Telefax 91-124-2398115
Israel, Bio-Rad Laboratories Ltd., 14 Homa Street, New Industrial Area, Rishon Le Zion 75655 • Phone 972-3-9636050 • Telefax 972-3-9514129
(800) 854-6737
Italy, Bio-Rad Laboratories S.r.l., Via Cellini 18/A, 20090 Segrate, Milan • Phone +39-02-216091 • Telefax +39-02-21609553
Japan, Bio-Rad Laboratories K.K., Tennoz Central Tower 20F, 2-2-24 Higashi-Shinagawa, Shinagawa-ku, Tokyo 140-0002 • Phone 81-3-6361-7070 • Telefax 81-3-5463-8481
Korea, Bio-Rad Korea Ltd., 10th Floor, Hyunjuk Building, 832-41, Gangnam-gu, Seoul 135-080 • Phone 82-2-3473-4460 • Telefax 82-2-3472-7003
Mexico, Bio-Rad, S.A., Avenida Eugenia 197, Piso 10-A, Col. Narvarte, C.P. 03020 Mexico, D.F. • Phone +52 (55)5488-7670 • Telefax +52 (55)1107-7246
The Netherlands, Bio-Rad Laboratories B.V., Fokkerstraat 2-8, 3905 KV Veenendaal • Phone +31-318-540666 • Telefax +31-318-542216
New Zealand, Bio-Rad New Zealand, 189 Bush Road Unit B, Albany, Auckland • Phone 64-9-415-2280 • Telefax 64-9-415-2284
Norway, Bio-Rad Laboratories, Nydalsveien 33, 0484 Oslo • Phone +47-23-38-41-30 • Telefax +46(0)8-5551-2780
Poland, Bio-Rad Polska Sp. z o.o., Nakielska Str. 3, 01-106 Warsaw • Phone 48-22-3319999 • Telefax 48-22-3319988
Portugal, Bio-Rad Laboratories, Lda., Edificio Prime, Ave. Quinta Grande, 53 – Fracção 3B Alfragide 26114-521 Amadora • Phone 351-21-472-7700 • Telefax 351-21-472-7777
Russia, Bio-Rad Laboratorii, 117105, Russian Federation, Moscow, Varshavskoe sh., 9, Bldg., 1B • Phone +7-495-721-1404 • Telefax +7-495-721-1412
Singapore, Bio-Rad Laboratories (Singapore) Pte. Ltd., 27 International Business Park, #01-02 iQuest @IBP, Singapore 609924 • Phone 65-6415-3170 • Telefax 65-6415-3189
South Africa, Bio-Rad Laboratories (Pty) Ltd., 34 Bolton Road, Parkwood, Johannesburg 2193 • Phone 27-11-442-85-08 • Telefax 27-11-442-85-25
Spain, Bio-Rad Laboratories, S.A., C/ Caléndula, 95, Edificio M. Miniparc II, El Soto de la Moraleja, 28109 Madrid • Phone 34-91-590-5200 • Telefax 34-91-590-5211
Sweden, Bio-Rad Laboratories A.B., Box 1097, Solna Strandväg 3, SE-171 54, Solna • Phone +46-8-555-127-00 • Telefax +46-8-555-127-80
Switzerland, Bio-Rad Laboratories AG, Pra Rond 23, CH-1785 Cressier • Phone +41 (0)26-674-55-05/06 • Telefax +41 (0)26-674-52-19
Taiwan, Bio-Rad Laboratories Taiwan Ltd., 14F-B, No. 126 Nan-King East Road, Sec. 4, Taipei, Taiwan 10546 R.O.C. • Phone 886-2-2578-7189 • Telefax 886-2-2578-6890
Thailand, Bio-Rad Laboratories Ltd., 1st & 2nd Floor, Lumpini I Bldg., 239/2 Rajdamri Rd., Lumpini, Pathumwan, Bangkok 10330 • Phone 662-651-8311 • Telefax 662-651-8312
United Kingdom, Bio-Rad Laboratories Ltd., Bio-Rad House, Maxted Road, Hemel Hempstead, Herts HP2 7DX • Phone +44 (0)20-8328-2000 • Telefax +44 (0)20-8328-2550 10/14

© 2017 Bio-Rad Laboratories Inc. Printed in the USA Page 2 English • 2017-05 • 5137-00
 Lyphochek® Immunology Plus Control, Levels 1 and 2

METHOD (1)
Level 1 - 27551 Level 2 - 27552 (2)
Units Mean Range Mean Range
ALBUMIN
Abbott ARCHITECT cSystems (Bromcresol green) mg/dL 3156 2808 – 3504 6344 5818 – 6870
Abbott ARCHITECT cSystems (Bromcresol purple) mg/dL § §
Beckman Coulter IMMAGE mg/dL 3082 2483 – 3681 >6000
Roche cobas INTEGRA (Bromcresol green) mg/dL 3172 2823 – 3521 6363 5110 – 7617
Roche Hitachi/Modular mg/dL 3179 2380 – 3978 6256 4917 – 7594
Siemens ADVIA Chemistry Systems (ALB, ALB_c) mg/dL 3164 2836 – 3493 6523 5804 – 7241
Siemens ADVIA Chemistry Systems (ALBP) mg/dL 3164 2791 – 3537 6432 6077 – 6787
Siemens BN Series Nephelometers mg/dL 3260 2453 – 4067 6778 5340 – 8217
Siemens Dimension Series mg/dL 3090 2973 – 3208 6471 6092 – 6850
ALPHA 1-ANTITRYPSIN
Beckman Coulter IMMAGE mg/dL 85.0 66.0 – 104 218 159 – 277
Roche cobas INTEGRA mg/dL 93.9 79.8 – 108 219 183 – 256
Siemens ADVIA Chemistry Systems (AAT) mg/dL 81.9 60.7 – 103 223 181 – 266
Siemens BN Series Nephelometers mg/dL 94.1 73.9 – 114 249 191 – 308
ALPHA 2-MACROGLOBULIN
Siemens BN Series Nephelometers mg/dL 140 63.1 – 217 343 217 – 469
ALPHA-1-ACID GLYCOPROTEIN
Siemens ADVIA Chemistry Systems (AAG) mg/dL 46.2 30.6 – 61.7 136 103 – 169
Siemens BN Series Nephelometers mg/dL 50.3 32.4 – 68.1 134 88.6 – 179
ANTISTREPTOLYSIN-O
Abbott ARCHITECT cSystems (Biokit) U/mL § §
Beckman Coulter AU 400/480/600/640/680/2700/5400/5800 U/mL <100 153 113 – 194
Beckman Coulter IMMAGE U/mL 56.8 34.3 – 79.3 117 81.3 – 153
Roche cobas INTEGRA U/mL 67.0 46.4 – 87.6 168 132 – 203
Siemens ADVIA Chemistry Systems (ASO_2) U/mL 71.5 53.3 – 89.8 188 149 – 228
Siemens BN Series Nephelometers U/mL 73.0 <50.0 – 98.5 172 122 – 222
BETA-2-MICROGLOBULIN
Siemens ADVIA Chemistry Systems (B2M) mg/dL 0.138 0.104 – 0.172 0.543 0.468 – 0.617
Siemens BN Series Nephelometers mg/dL 0.157 0.108 – 0.206 0.541 0.407 – 0.675
CERULOPLASMIN
Beckman Coulter IMMAGE mg/dL 18.6 <12.0 – 28.5 53.6 34.8 – 72.4
Siemens BN Series Nephelometers mg/dL 17.2 10.9 – 23.5 46.1 30.4 – 61.8
COMPLEMENT C3
Abbott ARCHITECT cSystems mg/dL 89.9 74.9 – 105 234 201 – 266
Beckman Coulter AU Systems mg/dL 88.4 73.5 – 103 221 188 – 254
Beckman Coulter IMMAGE mg/dL 79.7 60.2 – 99.1 220 178 – 262
Ortho Vitros MicroTip Series mg/dL § §
Roche cobas INTEGRA mg/dL § §
Siemens ADVIA Chemistry Systems (C3) mg/dL 86.6 73.5 – 99.7 224 186 – 263
Siemens BN Series Nephelometers mg/dL 94.6 76.0 – 113 253 185 – 321
Siemens Dimension Series mg/dL 90.4 76.6 – 104 244 197 – 290
COMPLEMENT C4
Abbott ARCHITECT cSystems mg/dL 12.8 10.2 – 15.3 44.2 38.1 – 50.3
Beckman Coulter AU Systems mg/dL 12.7 9.96 – 15.4 47.4 40.3 – 54.5
Beckman Coulter IMMAGE mg/dL 14.5 11.8 – 17.2 53.2 40.7 – 65.6
Ortho Vitros MicroTip Series mg/dL § §
Roche cobas INTEGRA mg/dL 11.2 7.44 – 15.0 40.0 34.4 – 45.7
Siemens ADVIA Chemistry Systems (C4) mg/dL 11.8 9.09 – 14.5 40.2 34.6 – 45.7

Page 3 English • 2017-05 • 5137-00

8
 Lyphochek® Immunology Plus Control, Levels 1 and 2

METHOD (1)
Level 1 - 27551 Level 2 - 27552 (2)
Units Mean Range Mean Range
COMPLEMENT C4 (continued)
Siemens BN Series Nephelometers mg/dL 13.2 10.7 – 15.8 45.6 31.1 – 60.2
Siemens Dimension Series mg/dL § §
C-REACTIVE PROTEIN (CRP)
Abbott ARCHITECT cSystems mg/dL 1.05 0.772 – 1.33 4.18 3.53 – 4.83
Beckman Coulter AU Systems (OSR 6147) mg/dL 0.992 0.714 – 1.27 3.98 3.41 – 4.56
Beckman Coulter AU Systems (OSR 6199) mg/dL 1.06 0.860 – 1.26 4.06 3.40 – 4.73
Beckman Coulter IMMAGE mg/dL 1.02 0.787 – 1.26 4.04 3.08 – 5.00
Beckman Coulter Synchron/UniCel DxC Series (CRP) (REF
465131) mg/dL 0.911 0.550 – 1.27 4.04 3.32 – 4.76
EUROLyser Smart/Cube-S/Cube mg/dL 1.27 0.980 – 1.56 4.58 3.53 – 5.63
Ortho Vitros MicroSlide Series mg/dL 1.55 0.923 – 2.18 3.74 2.72 – 4.77
Roche cobas INTEGRA (CRPLX) mg/dL 0.990 0.803 – 1.18 4.02 3.46 – 4.58
Roche Hitachi/Modular (CRPL3) mg/dL 0.892 0.706 – 1.08 3.60 2.90 – 4.29
Roche/Hitachi cobas c Systems (CRPL3) mg/dL 0.978 0.679 – 1.28 3.88 3.14 – 4.62
Siemens ADVIA Chemistry Systems (CRP_2) mg/dL 1.19 0.956 – 1.42 4.07 3.45 – 4.69
Siemens ADVIA Chemistry Systems (wrCRP) mg/dL 1.17 0.938 – 1.40 4.02 3.42 – 4.62
Siemens BN Series Nephelometers mg/dL
Siemens Dimension Series (CRP) (DF37) mg/dL 1.09 0.552 – 1.62 4.75 3.71 – 5.78
Siemens Dimension Series (RCRP) (DF34) mg/dL 1.12 0.602 – 1.64 4.19 3.24 – 5.14
C-REACTIVE PROTEIN (HSCRP)
Beckman Coulter IMMAGE mg/dL § §
Beckman Coulter Synchron/UniCel DxC Series (hsCRP) mg/dL 0.975 0.787 – 1.16 3.72 3.10 – 4.35
Ortho Vitros MicroTip Series mg/dL § §
Roche cobas INTEGRA mg/dL 1.06 0.894 – 1.22 4.66 4.12 – 5.20
Roche Hitachi/Modular mg/dL 1.01 0.734 – 1.28 3.97 2.77 – 5.17
Roche/Hitachi cobas c Systems mg/dL 1.11 0.940 – 1.28 4.45 3.86 – 5.05
Siemens ADVIA Chemistry Systems (hsCRP) mg/dL 1.10 0.930 – 1.27 4.57 3.91 – 5.23
Siemens Dimension Series mg/dL § §
Siemens Dimension Vista Systems mg/dL 0.873 0.700 – 1.05 3.73 3.28 – 4.18
HAPTOGLOBIN
Abbott ARCHITECT cSystems mg/dL 88.8 61.8 – 116 205 146 – 265
Beckman Coulter IMMAGE mg/dL 80.4 66.3 – 94.6 184 154 – 214
Roche cobas INTEGRA mg/dL § §
Roche Hitachi/Modular mg/dL § §
Roche/Hitachi cobas c Systems mg/dL 82.5 74.2 – 90.7 195 178 – 211
Siemens ADVIA Chemistry Systems (HAPT) mg/dL 84.2 71.5 – 97.0 190 166 – 213
Siemens BN Series Nephelometers mg/dL 86.1 70.5 – 102 216 178 – 254
IMMUNOGLOBULIN A (IGA)
Abbott ARCHITECT cSystems mg/dL 135 98.8 – 171 309 231 – 387
Beckman Coulter AU Systems mg/dL 133 108 – 158 322 275 – 369
Beckman Coulter IMMAGE mg/dL 118 96.5 – 140 328 272 – 384
Ortho Vitros MicroTip Series mg/dL 125 103 – 146 347 298 – 395
Roche cobas INTEGRA mg/dL 126 94.0 – 159 327 281 – 373
Roche Hitachi/Modular mg/dL 128 98.9 – 157 316 237 – 395
Roche/Hitachi cobas c Systems mg/dL 126 106 – 146 293 259 – 327
Siemens ADVIA Chemistry Systems (IGA_2) mg/dL 139 114 – 163 360 304 – 416
Siemens BN Series Nephelometers mg/dL 140 113 – 166 352 267 – 437
Siemens Dimension Series mg/dL § §

Page 4 English • 2017-05 • 5137-00

8
 Lyphochek® Immunology Plus Control, Levels 1 and 2

METHOD (1)
Level 1 - 27551 Level 2 - 27552 (2)
Units Mean Range Mean Range
IMMUNOGLOBULIN E (IGE)
Siemens ADVIA Centaur Systems U/mL 64.6 54.1 – 75.1 249 201 – 296
Siemens BN Series Nephelometers U/mL § §
IMMUNOGLOBULIN G (IGG)
Abbott ARCHITECT cSystems mg/dL 650 524 – 777 1541 1256 – 1827
Beckman Coulter AU Systems (OSR 61172) mg/dL 647 523 – 771 1497 1239 – 1755
Beckman Coulter IMMAGE mg/dL 646 528 – 765 1527 1285 – 1768
Ortho Vitros MicroTip Series mg/dL 612 527 – 698 1560 1350 – 1769
Roche cobas INTEGRA mg/dL 639 534 – 743 1544 1279 – 1810
Roche Hitachi/Modular mg/dL 639 545 – 733 1344 1131 – 1557
Roche/Hitachi cobas c Systems mg/dL 611 526 – 696 1472 1269 – 1675
Siemens ADVIA Chemistry Systems (IGG_2) mg/dL 640 534 – 746 1495 1252 – 1739
Siemens BN Series Nephelometers mg/dL 675 554 – 795 1570 1212 – 1928
Siemens Dimension Series mg/dL § §
IMMUNOGLOBULIN M (IGM)
Abbott ARCHITECT cSystems mg/dL 57.1 37.6 – 76.5 237 182 – 292
Beckman Coulter AU Systems (OSR 61173) mg/dL 53.7 40.0 – 67.4 214 182 – 247
Beckman Coulter IMMAGE mg/dL 62.3 50.8 – 73.7 278 237 – 320
Ortho Vitros MicroTip Series mg/dL 61.5 48.9 – 74.1 262 230 – 294
Roche cobas INTEGRA mg/dL 58.8 44.2 – 73.4 263 230 – 296
Roche Hitachi/Modular mg/dL 56.7 34.3 – 79.2 245 164 – 326
Siemens ADVIA Chemistry Systems (IGM_2) mg/dL 56.7 43.0 – 70.3 235 194 – 277
Siemens BN Series Nephelometers mg/dL 64.5 51.0 – 78.0 277 204 – 351
Siemens Dimension Series mg/dL § §
KAPPA LIGHT CHAIN
Beckman Coulter IMMAGE mg/dL 572 415 – 728 1475 1140 – 1810
Siemens BN Series Nephelometers mg/dL 166 125 – 206 400 298 – 501
LAMBDA LIGHT CHAIN
Beckman Coulter IMMAGE mg/dL 299 238 – 360 723 605 – 841
Siemens BN Series Nephelometers mg/dL 88.5 63.6 – 113 213 154 – 273
PREALBUMIN
Abbott ARCHITECT cSystems mg/dL 15.7 13.0 – 18.3 40.3 37.6 – 43.0
Beckman Coulter IMMAGE mg/dL 17.1 14.6 – 19.5 47.4 40.4 – 54.4
Roche cobas INTEGRA mg/dL § §
Roche/Hitachi cobas c Systems mg/dL 15.3 12.1 – 18.5 42.6 35.6 – 49.7
Siemens ADVIA Chemistry Systems (PREALB) mg/dL 14.8 11.7 – 17.9 39.7 34.1 – 45.2
Siemens BN Series Nephelometers mg/dL 16.3 13.6 – 19.0 46.2 38.1 – 54.2
Siemens Dimension Series mg/dL 16.8 14.0 – 19.5 49.8 42.3 – 57.3
RETINOL BINDING PROTEIN (RBP)
Siemens BN Series Nephelometers mg/dL 2.25 2.04 – 2.46 7.19 5.95 – 8.44
RHEUMATOID FACTOR
Abbott ARCHITECT cSystems (REF 6K44) IU/mL <7.00 111 94.1 – 128
Abbott ARCHITECT cSystems (REF 8G66) IU/mL <15.0 133 115 – 151
Beckman Coulter AU Systems IU/mL <10.0 141 100 – 182
Beckman Coulter IMMAGE IU/mL <20.0 182 137 – 227
Ortho Vitros MicroTip Series IU/mL <8.60 110 96.9 – 123
Roche cobas INTEGRA IU/mL <10.0 116 92.7 – 139
Roche Hitachi/Modular (RFII) IU/mL § §
Siemens ADVIA Chemistry Systems (RF) IU/mL 6.10 <3.50 – 10.7 188 81.8 – 293

Page 5 English • 2017-05 • 5137-00

8
 Lyphochek® Immunology Plus Control, Levels 1 and 2

METHOD (1)
Level 1 - 27551 Level 2 - 27552 (2)
Units Mean Range Mean Range
RHEUMATOID FACTOR (continued)
Siemens BN Series Nephelometers IU/mL <10.0 102 57.5 – 146
TRANSFERRIN
Abbott ARCHITECT cSystems mg/dL 171 137 – 206 423 371 – 475
Beckman Coulter AU Systems mg/dL 172 150 – 194 420 389 – 451
Beckman Coulter IMMAGE mg/dL 155 124 – 186 439 343 – 535
Beckman Coulter Synchron/UniCel DxC Series mg/dL 170 151 – 189 400 346 – 453
Roche cobas INTEGRA mg/dL § §
Roche Hitachi/Modular mg/dL 174 131 – 218 429 328 – 529
Siemens ADVIA Chemistry Systems (TRF) mg/dL 179 147 – 212 439 372 – 506
Siemens BN Series Nephelometers mg/dL 167 129 – 205 440 332 – 548
Siemens Dimension Series mg/dL § §

FOOTNOTES
(1) All footnotes may not apply to your custom selected data chart.
(2) A dilution should be made prior to running those tests where the value listed exceeds the highest standard.
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 6 English • 2017-05 • 5137-00