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    Lyphochek ® Immunoassay Plus ControlLevels 1, 2 and 3

    370

    371

    372

    373

    370X

    Trilevel

    Level 1

    Level 2

    Level 3

    MiniPak 

    12 x 5 mL

    12 x 5 mL

    12 x 5 mL

    12 x 5 mL

    3 x 5 mL

    40310

    Level 1 40311

    Level 2 40312

    Level 3 403130459 2017-12-31

    http://www.myeinserts.com/40310

    Revision Date 2016-01-19 Indicates Revised Information

    Page 1 • 2015-01 • 1536English

    METHOD (1)

    Level 1 - 40311 Level 2 - 40312 Level 3 - 40313

    Units Mean Range Mean Range Mean Range

    HCG

    Beckman Coulter IRMA (IM2110) (2) mIU/mL 200

    Institute of Isotopes IRMA (ßhCG) (2) mIU/mL 7.31 5.85 – 8.77 22.3 17.8 – 26.7 237 189 – 284

    Monobind AccuBind ELISA mIU/mL

    Monobind AccuLite CLIA mIU/mL

    Wallac DELFIA TR-FIA (2) mIU/mL 11.0 7.40 – 14.0 23.0 17.0 – 29.0 288 230 – 346

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    Lyphochek ® Immunoassay Plus Control, Levels 1, 2 and 3

    Page 2 • 2015-01 • 1536English

    INSTRUMENT (1)

    Level 1 - 40311 Level 2 - 40312 Level 3 - 40313

    Units Mean Range Mean Range Mean Range

    SIEMENS IMMULITE / IMMULITE 1000

     AFP ng/mL 21.5 14.2 – 28.9 103 69.4 – 137 221 159 – 283

     Androstenedione ng/mL § § §

     Androstenedione (LKAO1, Lot 433+) (Revised) ng/mL 0.854

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    Lyphochek ® Immunoassay Plus Control, Levels 1, 2 and 3

    Page 3 • 2015-01 • 1536English

    INSTRUMENT (1)

    Level 1 - 40311 Level 2 - 40312 Level 3 - 40313

    Units Mean Range Mean Range Mean Range

    SIEMENS IMMULITE 2000 / 2000 XPi (continued)

    Human Growth Hormone (hGH) (L2KGRH/L5KGRH) ng/mL 3.40 1.90 – 4.90 8.50 4.91 – 12.1 15.1 8.80 – 21.4

    IGF-1/Somatomedin C ng/mL 112 53.5 – 171 138 67.0 – 209 130 61.3 – 198

    Immunoglobulin E (IgE) IU/mL 414 290 – 538 110 79.3 – 140 96.1 67.8 – 124

    Insulin µIU/mL 5.71 1000

    FOOTNOTES

    (1) All footnotes may not apply to your custom selected data chart.

    (2) The assigned values were determined using the reagent and/or instrument manufacturer’s protocol and may not represent ±3SD ranges.

    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 isinterested in participating in the Value Assignment Program for this assay, please contact your local Bio-Rad office.

    Not applicable