FERRITIN ASSAY

FERRITIN ASSAY

FERRITIN ASSAY

Product catalog summary
Introduction
Diazyme's Ferritin Assay is a cost-effective, latex-enhanced immunoturbidimetric reagent system designed for anemia diagnosis. It offers high sensitivity, precision, and stability, with reagents traceable to WHO standards. The assay is designed for efficient laboratory workflow with fast results and minimal sample handling.

Advantages
  • Improves laboratory efficiency and workflow.
  • Provides results in under 10 minutes.
  • Offers a wide range of instrument parameters for easy implementation.
  • Liquid stable format eliminates the need for reagent preparation.

Regulatory Status
The assay is 510(k) cleared and compliant with EU regulations (D069, valid until 04/2024).

Assay Specifications
  • Method: Latex Enhanced Immunoturbidimetric Assay
  • Sample Type: Serum, Plasma (K2 EDTA, Li-heparin)
  • Sample Volume: 10 μL
  • Linearity: 13 - 1000 ng/mL
  • Correlation: Deming Regression with R² = 0.9964
  • Precision: Intra-Assay CV: 1.2% - 4.1%, Inter-Assay CV: 0% - 4.9%, Total CV: 2.3% - 9.5%
  • Limits: LOB: 6.0 ng/mL, LOD: 9.2 ng/mL, LOQ: 13.0 ng/mL

Assay Precision
Precision was evaluated using CLSI EP5-A2 guidelines. Two levels of serum controls and four serum samples were tested over 20 days. Results showed consistent precision across different concentrations.

Contact Information
For sales inquiries, contact [email protected]. For technical support, call +1-858-455-4768 or email [email protected].

Global Offices
  • USA: Diazyme Laboratories, Inc., Poway, CA
  • Europe: Diazyme Europe GmbH, Dresden, Germany
  • China: Shanghai Diazyme Co., Ltd., Shanghai
See more

Catalog excerpts

FERRITIN ASSAY-1

Diazyme’s Ferritin Assay is a cost effective latex enhanced immunoturbidimetric reagent system that demonstrates outstanding sensitivity, precision and on-board stability. The test provides liquid stable reagent, calibrator and controls and is directly traceable to WHO international standards. For added convenience the Ferritin test offers a wide range of instrument parameters for facilitating and simplifying implementation in the laboratory. DIAZYME FERRITIN ASSAY ADVANTAGES • Improves laboratory efficiency and workflow • Fast test results (under 10 minutes) • Wide range of instrument parameters available for facilitating and simplifying implementation • Liquid stable format that requires no reagent preparatio, saving time and reducing sample handling REGULATORY STATUS Innovations in Clinical Diagnostics

 Open the catalog to page 1
FERRITIN ASSAY-2

Dual Vial Liquid Stable The precision of the Diazyme Ferritin Assay was evaluated according to CLSIEP5-A2 guideline. In the study, 2 levels of serum based controls containing 112.8 and 318.2 ng/mL of ferritin, and four serum sample containing approxi-mately 35.8, 247.7, 616.2 and 855.2 ng/mL of ferritin, respectively, were tested with 2 runs per day in duplicates over 20 working days. Results were calculated using the EP Evaluator software precision statistic template and summarized in the following table: Two very low serum samples containing ferritin concentrations of 15.7 ng/mL and 23.4 ng/mL...

 Open the catalog to page 2

All Diazyme Laboratories, Inc. catalogs and technical brochures

  1. DZ-LiteTM c270

    14  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.