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8/18/2019 40310
1/3
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