Lyphochek® Diabetes Control

Levels 1 and 2
Level 1 85841
740 Bilevel 6 x 0.5 mL 2024-05-31 85840 Level 2 85842
740X MiniPak 2 x 0.5 mL

http://www.myeinserts.com/85840

METHOD (1)
Level 1 - 85841 Level 2 - 85842
Units (2) Mean Range Mean Range
HEMOGLOBIN A1C
Bio-Rad D-10 Dual A2/F/A1c Program 220-0201 (4) % 5.00 4.34 – 5.66 10.3 9.15 – 11.4
Roche cobas INTEGRA (Tina-quant Hemoglobin A1c) % 4.93 <4.30 – 5.60 10.1 8.59 – 11.7

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 Lyphochek® Diabetes Control, Levels 1 and 2

INSTRUMENT (1)
Level 1 - 85841 Level 2 - 85842
Units (2) Mean Range Mean Range
Roche cobas INTEGRA
Hemoglobin A1C (Tina-quant Hemoglobin A1c) % 4.93 <4.30 – 5.60 10.1 8.59 – 11.7

FOOTNOTES
(1) All footnotes may not apply to your custom selected data chart.
(2) NGSP units = %; IFCC unit = mmol/mol
(3) The assigned values were determined using the reagent and/or instrument manufacturer’s protocol and may not represent ±3SD ranges.
(4) The assigned values were obtained by using 1:300 dilution (Pipet 1.5 mL of Wash/Diluent Solution into a labeled 1.5 mL vial, followed by 5 µL of the
reconstituted control. Cap each control vial and mix thoroughly).
(5) The assigned values were obtained by using 1:200 dilution (Pipet 1.0 mL of Wash/Diluent Solution into a labeled 1.5 mL vial, followed by 5 µL of the control.
Cap each control vial and mix thoroughly).
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.

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