(Assure)Ferritin Test Device(FRT Test Device)

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Product Overview

Description

FRT-W23Fq

FRT

INTENDED USE

    The FRT Quantitative Rapid Test Device (Whole Blood/Serum/Plasma) is used for quantitative determination of Ferritin concentrations in whole blood/serum/plasma specimens. This test is intended for professional use as an aid in the diagnosis of diseases like iron deficiency anaemia.

 

INTRODUCTION

    Ferritin is a ubiquitous intracellular protein that stores iron and releases it in a controlled fashion. The protein is produced by almost all living organisms, including bacteria, algae and higher plants, and animals. In humans, it acts as a buffer against iron deficiency and iron overload. Ferritin is a globular protein complex consisting of 24 protein subunits and is the primary intracellular iron-storage protein in both prokaryotes and eukaryotes, keeping iron in a soluble and non-toxic form.Ferritin that is not combined with iron is called apoferritin.Serum ferritin is a good measure of iron stores, especially for someone who is iron-deficient. 2 billion people in the world are iron- deficient. In America, 68% of the infants at 6 months to 2 year-old are iron-deficient.

 

Materials Provided

· Individually pouched test devices

· Package insert

· ID card

· Buffer

 

 

PROCEDURE

Bring tests, specimens,and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.

2. Check/insert ID card into the equipment.

3. Place the test device on a clean and level surface.

4. Take 10µL serum/plasma/whole blood, and add to the buffer, fully mixed .Then transfer 75µL mixture into the specimen well (S) of the device with the pipette, Start the timer.

5. Testing

FRT

5.1. Scheduled Test: Choose the “Scheduled test” and choose the sample type. Insert the Test Cartridge onto the Test Cartridge Holder and click “Standard Test”.15minutes later, the result will show in the display and print out when click the Print button.

 

5.2. Immediate Test: Choose the “Immediate Test” and choose the sample type. 15minutes later, insert the Test Cartridge Holder and click “Quick Test”, then the result will show in the display and print out when click the Print button.

 

Please refer to the Operation in user manual of AFI 6000 Fluorescence Immunoassay Analyzer for details.

 

 

PERFORMANCE CHARACTERISTICS

Analytical Sensitivity Linearity
no less than 10 ng/mL 10-1000 ng/mL

 

 

 

our company

 

Assure Tech.(Hangzhou) Co., LTD.  

 

    Assure Tech (Hangzhou) Co., Ltd was established by senior experts of in-vitro diagnostics industry in 2008. As a high-tech biotechnology company, Assure Tech is specialized in research & development, production, sell of diagnostic reagents, POCT and biological materials.

 

    At present, the company has 6,000 square meters of R&D and manufacture base which contains the advanced level of colloidal gold diagnostic reagents production lines with annual production capacity of hundred millions of devices.

 

    Currently, Assure R&D team has more than 100 staff who builds an extensive cooperation with the advanced domestic and foreign research institutions. And in domestic, Assure tech includes an advanced level in the rapid diagnostic reagents area, rapid molecular diagnostic area, the development and preparation of antibody, small molecular antigen synthesis and genetic engineering. What’s more, Assure Tech is committed to R&D in vitro diagnostic reagents area and related products: colloidal gold rapid detection reagents, Quantitative determination of chemilumineseent immunoassay reagent and bioactive materials. More than 100 products in 8 series are developed successfully which contain the following tests: pregnancy test, DOA test, infectious disease test, tumor markers test, cardiac markers test, food safety test, biochemical reagent series test, integration of instruments and reagents.

 

    The Assure Tech products are sold to more than 100 countries and regions, such as Europe, Asia, Africa, Oceania and so on. Especially the drug detection reagent which has won a wide praise and owned more than 60% market share in some European countries.

our company

 

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