In Vitro Diagnostic Reagents Products
Interleukin-6 (IL-6) Test Kit CE Approved

Interleukin-6 (IL-6) Test Kit

(Fluorescence Immunochromatography)


[Product name]

Interleukin-6IL-6Test Kit (Fluorescence immunochromatography)

[Packaging specifications]

10 tests/box, 20 tests/box, 25 tests/box, 30 tests/box, 50 tests/box, 100 tests/box.

[Indicated use]

The kit is used for quantitative determination of interleukin-6 (IL-6) in human serum, plasma or whole blood samples in vitro.

Interleukin-6 is mainly produced by Th2 cells and secreted by T lymphocytes, B lymphocytes, fibroblasts, endothelial cells, keratinocytes, hepatocytes and bone marrow cells. Its relative molecular weight is 26kDa. It is a glycoprotein composed of 212 amino acid residues. Interleukin-6 is the first biomarker to appear after inflammatory reaction. In different inflammatory diseases, the content of interleukin-6 is significantly different. The increased level of interleukin-6 caused by bacterial infection is significantly higher than that caused by non-bacterial infection, and the level of interleukin-6 is directly proportional to the severity of inflammation and infection. Interleukin-6 is also a sensitive early warning index of sepsis, and has a good correlation with the severity and prognosis of sepsis. As an inflammatory factor, the level of interleukin-6 is also closely related to cardiovascular and cerebrovascular diseases such as atherosclerosis and acute myocardial infarction (AMI).

 

[Test principle]

This test kit uses fluorescence immunochromatography technology to quantitatively detrmine the content of interleukin-6 (IL-6) in serum, plasma or whole blood samples. After the sample is added to the test card, IL-6 in the sample reacts with fluorescent labeled IL-6 monoclonal antibody 1 to form a complex, which continues to chromatography forward along the nitrocellulose membrane to the test line, and forms a complex with coated IL-6 monoclonal antibody 2 to bind on the test line. Under the action of excitation light source, the content of interleukin-6 (IL-6) in the sample is positively correlated with the fluorescent antibody signal, and the content of interleukin-6 (IL-6) in the sample is calculated by fluorescence immunoanalyzer.

Principle of the supporting instrument: the measuring system of the instrument scans the binding area between the marker and the analyte on the test card after the reaction, and obtains the optical signal. Then the optical signal is measured and analyzed to quantitatively obtain the concentration of the analyte.

[Main components]

NO.

Name

Components

1

interleukin-6   (IL-6) Test Kit (fluorescence immunochromatography)

Each pouch contains a test card and a desiccant;   the test card is composed of a shell and a test strip, the test strip is   composed of sample pad, fluorescent pad (fixed with fluorescent labeled IL-6   monoclonal antibody 1), nitrocellulose membrane (coated with IL-6 monoclonal   antibody 2 and goat anti-mouse IgG), filter paper and PVC plastic plate

2

Whole blood diluent

1 bottle of diluent for 10 tests/box, 20tests/box, 25   tests/box, 30 tests/box; 2 bottles of diluent for 50 tests/box; 2 bottles of   diluent for 100 test/box; 3.0mL/bottle

3

ID card

1pc/box

[Applicable instrument]

Fluorescence immunoanalyzer

[Storage conditions and validity period]

The test kit should be stored in a sealed aluminum foil bag at 4℃30℃, and the validity period is 18 months. After the foil bag is opened, the validity period is 1 hour.

[Sample requirements]

1. Human serum, plasma or whole blood samples; other body fluids and samples may not give accurate results.

2. Venous blood or fingertip blood should be collected under sterile conditions. It is recommended to use human serum or plasma for testing.

3. Anticoagulation with EDTA, sodium citrate or heparin is recommended for plasma and whole blood samples.

4. After the clinical blood samples are collected, the test must be completed within 4 hours at room temperature; serum and plasma can be stored at 2~8°C for 3 days and stored below -20°C for 5 months. Whole blood samples should not be frozen and stored at 2~8°C for 3 days. Avoid heat inactivating samples, and hemolyzed samples should be discarded.

5. Samples must be returned to room temperature before testing. Cryopreserved samples need to be completely thawed, rewarmed, and evenly mixed before use. Do not freeze and thaw repeatedly.

 

[Test method]

Please read the instructions of the test kit and the manual of the fluorescence immunoanalyzer carefully before use.

a) Bring the test kit and sample to be tested to room temperature.

b) Make sure the ID card matches the batch number of the kit, and insert the ID card into the card reading area of the instrument to read the information.

c) Open the inner package of the test card, take out the test card; draw 75μL of serum plasma sample, drop vertically to the test card sampling place, and start timing; draw 75μL whole blood, vertically drop it to the test card sampling place, and immediately add 1 drop whole blood diluent at the sampling place and start timing.

d) After adding the sample, click "Start Test" on the screen of the fluorescence immunoanalyzer, and the test card will react at room temperature for 15 minutes; insert the test card into the test card slot of the fluorescence immunoanalyzer, and the instrument will automatically test the test card; The test results can be seen on the display screen of the immunoassay analyzer. Click "Print" on the screen to print the results.

[Positive judgment value or reference interval]

Normal reference value<7pg/mL

Due to differences in geography, race, gender and age, it is recommended that each laboratory establish its own positive judgment value or reference interval.

[Interpretation of test results] (For reference only, not used as clinical diagnostic criteria, test results need to be combined with other clinical and laboratory data for clinical diagnosis)

Content of IL-6(pg/mL)

Clinical application suggestions

<7

Normal value

7-150

Indicates mild inflammation or mild infection.

150-250

Suggests general bacterial infection   or systemic inflammatory reaction.

250

Suggests may be sepsis.

 

[Quality Control]

Quality control should be carried out on a regular basis to ensure the validity and accuracy of test results. The kit does not contain quality control product, it is recommended to select appropriate quality control product for quality management.

[Limitations of the test method]

a) This test kit is only for the test of human serum, plasma or whole blood samples. Abnormal hematocrit samples have an impact on the results of the whole blood test. The test results of serum, plasma and whole blood are not significant difference when the hematocrit is between 21% and 48%.

b) The test results need to be combined with other clinical and laboratory data, and if the IL-6 test results do not match the clinical assessment, further testing is required.

c) False positive results can be caused by: cross-reaction of antibody-like components in the blood; some non-specific components in blood have similar antigenic determinants to capture fluorescent-labeled antibodies, such as anisotropic antibodies and rheumatoid factors. In view of the above reasons, the test results should be combined with the patient's medical history and other laboratory results performed.

d) Hemoglobin, triglycerides and bilirubin in the blood sample can interfere with the test results, where the maximum allowable concentrations are 5g/L, 10g/L and 0.2g/L, respectively.

e) False positive results can be caused by: some unknown components shield the antigenic determinants from binding to the antibody; the unstable IL-6 antigen gradually degrades with time and temperature and cannot be recognized by the antibody. Valid test results depend on a good reagent and sample storage environment.

f) Other factors, including technical reasons, operational errors and other sample factors, may also cause errors in test results.

[Product performance index]

a) AccuracyWhen tested with standard IL-6, the relative deviation (B%) between the detection mean value and the target value shall be within ± 15%.

b) Linear range: The linear range is 7pg / ml ~ 5000pg / ml, and the linear correlation coefficient r≥0.9900.

c) Blank limit: not higher than 7ng/mL;

d) Precision:

In-batch precision: The coefficient of variation (CV) is not more than 15%;

Precision between batches: The relative range between batches is not more than 15%.

[Precautions]

1) This product is a single-use in vitro diagnostic reagent. Do not use expired products.

2) The ID card and the test card cannot be used together, if they are different batches.

3) Please read the instructions of the test kit and the manual of the fluorescence immunoanalyzer carefully before the test.

4) The temperature of the experimental environment should be avoided too high. The reaction temperature should be 15℃~30℃. The test card stored at low temperature needs to be returned to room temperature before opening to avoid moisture absorption.

5) The test card and fluorescence immunoanalyzer should avoid vibration and electromagnetic environment when using. It is normal for the instrument itself to vibrate during normal use.

6) There is a desiccant in the aluminum foil bag, do not take it orally.

7) Appropriate biosafety assurance procedures should be in place for those substances containing or suspected of containing infectious agents. The following are the relevant precautions: Handle the sample with gloves or disinfect this reagent; disinfect spilled samples or reagents with disinfectant; disinfect and handle all specimens, reagents and potential contaminants in accordance with local regulations.

8) This product is used for rapid clinical diagnosis and screening, and the final diagnosis should be made by a doctor after comprehensive examination indicators and clinical symptoms.

9)The used material must be discarded immediately after test. Disposal should be in accordance with accepted medical practice and applicable national, local or institutional guidelines.  

10) Do not use if package is open or damaged.  


Specifications
10 tests/box 20 tests/box 25 tests/box 30 tests/box 50 tests/box 100 tests/box
Applicable scope

The kit is used for quantitative determination of interleukin-6 (IL-6) in human serum, plasma or whole blood samples in vitro.


The kit is used for quantitative determination of interleukin-6 (IL-6) in human serum, plasma or whole blood samples in vitro.


The kit is used for quantitative determination of interleukin-6 (IL-6) in human serum, plasma or whole blood samples in vitro.


The kit is used for quantitative determination of interleukin-6 (IL-6) in human serum, plasma or whole blood samples in vitro.


The kit is used for quantitative determination of interleukin-6 (IL-6) in human serum, plasma or whole blood samples in vitro.


The kit is used for quantitative determination of interleukin-6 (IL-6) in human serum, plasma or whole blood samples in vitro.