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Next Generation Beta-hydroxybutyrate Assay for Reliable Ketosis Management β-Hydroxybutyrate 21FS vidandiagnostics.com Elevating the standard of care for people around the world BHB Liquid-Stable, Ready-To-Use Reagent

β-Hydroxybutyrate 21 FS - Vidan Diagnostics · 2019-12-06 · 137119943018 β-Hydroxybutyrate 21 FS Reagent Kit (Architect™) (R1: 2 x 18 mL; R2: 2 x 5 mL; Std. 1 x 3 mL) 137209943052

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Page 1: β-Hydroxybutyrate 21 FS - Vidan Diagnostics · 2019-12-06 · 137119943018 β-Hydroxybutyrate 21 FS Reagent Kit (Architect™) (R1: 2 x 18 mL; R2: 2 x 5 mL; Std. 1 x 3 mL) 137209943052

Next Generation Beta-hydroxybutyrate Assayfor Reliable Ketosis Management

β-Hydroxybutyrate21 FS

v i d a n d i a g n o s t i c s . c o m

Elevating the standard of carefor people around the world

BHB Liquid-Stable, Ready-To-Use Reagent

Page 2: β-Hydroxybutyrate 21 FS - Vidan Diagnostics · 2019-12-06 · 137119943018 β-Hydroxybutyrate 21 FS Reagent Kit (Architect™) (R1: 2 x 18 mL; R2: 2 x 5 mL; Std. 1 x 3 mL) 137209943052

Part # Description

137119943019 β-Hydroxybutyrate 21 FS Reagent Kit (AU®) (R1: 2 x 18 mL; R2: 2 x 5 mL; Std. 1 x 3 mL)

137119943018 β-Hydroxybutyrate 21 FS Reagent Kit (Architect™) (R1: 2 x 18 mL; R2: 2 x 5 mL; Std. 1 x 3 mL)

137209943052 β-Hydroxybutyrate 21 Linearity Standards (6 x 4 mL)43018-201 Architect™ 20mL Reagent Cartridge Adapters (2 units)

595409943084 β-Hydroxybutyrate 21 Bi-level Controls (6 x 4 mL)595709943085 β-Hydroxybutyrate 21 Tri-level Controls (6 x 4 mL)

Test Characteristics

Methodology Beta-hydroxybutyrate-dehydrogenase (UV Colorimetric/Kinetic)Sample Type Serum and PlasmaSample Volume 9 μL for Architect™ (Varies by analyzer)Method Comparison n = 171; y-intercept = +0.001 mmol/L; slope = 1.012; R = 0.9991

LOD, LOB, LOQ 0.05 mmol/L, 0.01 mmol/L, 0.05 mmol/LLinear Range 0.05 - 6.0 mmol/L

Calibration Single-point Calibration

CPT Code 82010

βHB Liquid-stable, Ready-to-use Reagentβ-Hydroxybutyrate21 FS

Vidan Diagnostics, LLC24123 Boerne Stage Rd, Ste 205San Antonio, TX [email protected] : +800-869-5992Fax : +210-802-4684

Product Features and Benefits

Β-H

ydro

xybu

tyra

te 2

1 FS

(m

mol

/L)

Prefilled Reagent KitsMakes it easy to load directly onto Architect™ and Beckman AU® clinical chemistry systems.Other instrument applications available uponrequest.

n = 171; y-intercept = +0.001 mmol/L; slope = 1.012; R = 0.9991

6.0

5.0

4.0

3.0

2.0

1.0

1.0 3.0 4.0 5.0 6.02.00

0

Manufactured by Diasys Diagnostics Systems GmbH and distributed exclusively in the U.S.A. by Vidan Diagnostics, LLC.

Less InterferenceLipid Clearing System (LCS) that overcomes the burden of lipemia by eliminating turbidity in the sample before measurement is performed.

Up to 12 Weeks StabilitySuperior stability reduces the frequency of calibration and allows reagent to stay onboardlonger.

The Best Indicator of DKAThe βHB/Acetoacetate ratio is typically between 3:1 and 7:1 in severe ketotic states.1

Method Comparison

1 Vassault A, Bonnefont JP, Specola N, et al: Lactate, pyruvate, and ketone bodies. InTechniques in Diagnostic Human Biochemical Genetics - A Laboratory Manual. Edited byF Hommes. New York, Wiley-Liss, 1991.

VID-BHB21FS-003-11.19

Competitor β-Hydroxybutyrate (mmol/L)