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Lyphochek Immunoassay Plus Control Levels 1, 2 and 3: Revision Date 2020-06-29 Indicates Revised Information

This document provides reference ranges for levels 1, 2, and 3 of Lyphochek Immunoassay Plus Control across various assays and instruments. It includes the mean and reference range values for each level and assay. The document is a technical reference for quality control materials.

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MDD Engineering
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100% found this document useful (6 votes)
8K views2 pages

Lyphochek Immunoassay Plus Control Levels 1, 2 and 3: Revision Date 2020-06-29 Indicates Revised Information

This document provides reference ranges for levels 1, 2, and 3 of Lyphochek Immunoassay Plus Control across various assays and instruments. It includes the mean and reference range values for each level and assay. The document is a technical reference for quality control materials.

Uploaded by

MDD Engineering
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
  • Product Details: Provides detailed specifications for Lyphochek Immunoassay Plus Control Levels 1, 2, and 3, including test parameters, expiration and lot information.
  • Notes and Disclaimers: Contains important notes and disclaimers regarding the usage of the product, including methodological assumptions and limitations.

Lyphochek® Immunoassay Plus Control

Levels 1, 2 and 3
370 Trilevel 12 x 5 mL
Level 1 40371
371 Level 1 12 x 5 mL
0459 2021-10-31 40370 Level 2 40372
372 Level 2 12 x 5 mL
Level 3 40373
373 Level 3 12 x 5 mL
370X MiniPak 3 x 5 mL

http://www.myeinserts.com/40370

Revision Date 2020-06-29 Indicates Revised Information

INSTRUMENT (1)
Level 1 - 40371 Level 2 - 40372 Level 3 - 40373
Units Mean Range Mean Range Mean Range
SIEMENS IMMULITE / IMMULITE 1000
AFP ng/mL 15.6 9.79 – 21.3 90.8 58.4 – 123 205 135 – 274
Androstenedione ng/mL 0.818 0.338 – 1.30 2.45 1.44 – 3.46 4.84 1.11 – 8.56
CEA ng/mL 2.67 1.75 – 3.58 21.2 16.0 – 26.5 49.7 37.8 – 61.6
Cortisol µg/dL 2.80 1.78 – 3.82 18.0 13.0 – 23.0 27.4 19.9 – 34.9
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 66.4 44.7 – 88.1 151 107 – 196 497 358 – 636
Estradiol pg/mL 76.1 47.5 – 105 288 206 – 370 556 402 – 711
Estriol (Free) (UE3) ng/mL 1.17 0.335 – 2.01 5.15 2.89 – 7.40 7.31 – >11.2
Ferritin ng/mL 62.6 46.0 – 79.2 119 87.0 – 151 252 183 – 320
Follicle Stimulating Hormone (FSH) mIU/mL 5.51 4.16 – 6.86 24.5 19.1 – 30.0 48.7 37.7 – 59.7
hCG mIU/mL 6.00 2.18 – 9.83 33.3 20.7 – 45.8 151 101 – 202
hCG (Turbo) mIU/mL 6.60 <5.00 – 8.60 34.1 27.5 – 40.8 171 141 – 201
Human Growth Hormone (hGH) (LKGRH) ng/mL 2.81 2.31 – 3.30 7.57 6.43 – 8.72 13.3 11.5 – 15.1
Immunoglobulin E (IgE) (Rgt. Lots 401+) IU/mL 367 252 – 483 144 100 – 188 192 132 – 251
Insulin µIU/mL 5.41 <2.00 – 10.4 16.7 6.68 – 26.7 43.3 21.7 – 64.9
Luteinizing Hormone (LH) mIU/mL 1.48 1.14 – 1.82 19.1 13.9 – 24.3 70.7 51.7 – 89.7
Progesterone (LKPW1) ng/mL 0.750 0.459 – 1.04 9.36 6.32 – 12.4 23.0 15.6 – 30.4
Prolactin ng/mL 7.60 5.60 – 9.60 20.7 15.6 – 25.7 50.8 41.3 – 60.4
PSA (Free) ng/mL 0.212 0.108 – 0.316 1.46 1.08 – 1.84 7.53 5.69 – 9.38
PSA (Total) ng/mL 0.712 0.536 – 0.888 3.22 2.44 – 4.00 15.9 12.1 – 19.7
PSA (Total) (Gen. 3) ng/mL 0.620 0.559 – 0.681 2.50 2.14 – 2.85 14.7 12.3 – 17.2
T3 (Free) pg/mL 2.98 1.83 – 4.13 6.22 4.50 – 7.95 9.97 7.61 – 12.3
T3 (Total) ng/dL 69.4 45.9 – 92.9 199 149 – 248 357 275 – 438
T3 Uptake/T Uptake % Uptake 40.5 31.9 – 49.0 35.7 28.7 – 42.6 42.7 33.4 – 52.0
T4 (Free) ng/dL 0.985 0.740 – 1.23 2.60 2.05 – 3.16 5.14 4.08 – >6.00
T4 (Total) µg/dL 4.16 2.69 – 5.63 11.1 8.11 – 14.1 15.4 11.4 – 19.4
Testosterone ng/dL 122 66.0 – 178 463 270 – 656 813 – >1600
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 0.430 0.318 – 0.542 5.17 3.77 – 6.56 36.7 26.7 – 46.7
Thyroid Stimulating Hormone (TSH) (Rapid) µIU/mL 0.450 0.338 – 0.562 5.43 3.96 – 6.89 35.6 25.6 – 45.5
Vitamin B12 pg/mL 359 264 – 455 705 487 – 923 955 631 – >1200

Page 1 English • 2019-10 • 1536-00

7
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

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.
(3) For the conversion factor, refer to the manufacturer’s instruction for use.
(4) Values are not suitable for the following method/instrument: Mindray CL-900i)
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.
Not applicable

Page 2 English • 2019-10 • 1536-00

Lyphochek® Immunoassay Plus Control
Levels 1, 2 and 3
370
371
372
373
370X
Trilevel
Level 1
Level 2
Level 3
MiniPak
12 x 5 mL
Lyphochek
® Immunoassay Plus Control, Levels 1, 2 and 3
Page 2
 • 2019-10 • 1536-00
English
FOOTNOTES
(1) All footnotes may n

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