DE Medical Technology Jiangsu Co.,Ltd

Fluoroimmunoassay (FIA) is a kind of trace analysis method developed

in recent years. It also is one of the most sensitive trace analysis

technologies for now. Certain substances molecules can absorb energy

and emit fluorescence, do qualitative or quantitative analysis on

substances depending on the fluorescence spectra and fluorescence

intensity, this method is called fluorescence analysis.

FIA has advantages of high sensitivity, strong selectivity, small sample

volume and simple methods, and usually its lower limit is 2-4

magnitude higher than spectrophotometry, it is widely used for

biochemical analysis.

Features:

1.Fast-under continuous mode,over 200 Tests/Hour,under step mode,only 3 mins/test

2.Intelligent -under intelligent mode,it can detect automatically without manual operation

3.Report- Built-in printer,it can print result of multi-parameters one time.

4.Storage- It can store over 10,000 kinds of test results

5.Accurate- Multi-times quality control to make sure test results much more accurate

6.Connection- Connecting to LIS by COM or USB etc.

Product Performance

a) Sensitivity

The minimum detectable amount for CRP is 0.5mg/L.

b) Linear range

For the range of CRP 0.5 mg/L～200mg/L, the correlation coefficient r ≥ 0.98.

c) Accuracy

In the range of CRP 0.5mg/L～5mg/L(include 5): Error does not exceed ±15％.

In the range of CRP 5mg/L～200mg/L: Error does not exceed ±10％.

1. Repeatability: CV≤5％

1. Stability: CV≤5％

 Structure and Principles

1 .Main Structure

The analyzer is composed of optical inspection (light source, filter,

sample room, photocell, signal amplification and conversion), SCM

analysis and control, display and print.

2 .Working Principle

When the test card that has been added sample is inserted in the

Fluorescence Immunoassay Quantitative Analyzer, LED light source

irradiate test area and control area of the test card, excite attached

fluorescent substance, emitted light is collected and converted into an

electrical signal, the strength of the electrical signal is strictly related

with the number of fluorescent molecules. Detector automatically scans

and calculates the content of the analyte in the test sample.

Scope of Application

     Fluorescence Immunoassay Quantitative Analyzer applies to test CRP  

     indicator with immunofluorescence method

The test system is only for in vitro diagnosis, is widely applicable for the

central laboratory of medical institutions, outpatient and emergency

laboratory, clinical departments and other medical services station(eg.

Community medical station), medical center etc, and also applies to

scientific research and laboratory testing.

 Ensure the Effectiveness of the Diagnosis

When using the analyzer, the user has to operate as per the reagent

instruction and analyzer instruction. Cannot simplify the process.

The test results need to combine with other clinical and laboratory data.

When the test results do not match with the clinical assessment,

further examination is needed. Please do not use expired reagents or

reagents those are about to expire.

Diagnosis results should be made combined with clinical symptoms.

For these results in the critical region should re-test or re-test the in

one day.

2 System Components

After opening the package, please configure every components as

below table, meanwhile, check if the analyzer components have any

deficiency or damage.

 Standard Configuration of the Analyzer