The GO IL-6 Test Cassette (Whole Blood/Serum/Plasma) is based on
Fluorescence Immunoassay for the quantitative determination of Interleukin-6 (IL-6) in
serum, plasma or whole blood. It is mainly used to monitor the immune status and
inflammation of the body Response etc..
【SUMMARY】
Interleukin-6 (IL-6) is a pleiotropic cytokine with a wide range of biological roles in
inflammation, immunomodulatory, hematopoietic and tumor1 . IL-6 is involved in the
occurrence and development of many diseases. Its blood level is closely related to
inflammation, viral infection, and autoimmune diseases. It changes earlier than CRP
and PCT. Studies have shown that IL-6 increases rapidly after bacterial infection, PCT
increases after 2h, and CRP increases rapidly after 6h. Its mechanism is: when the
body infected or tissue damage and other white blood cells are activated macrophages,
produce interleukin 6 (IL-6), IL-6 induced liver cells after the creation of c-reactive
protein (CRP) and calcitonin original (PCT) and inducing mature B cells to produce
antibodies, therefore directly related to degree of inflammatory bowel disease and
infection2,3 .
【PRINCIPLE】
The IL-6 Test Cassette is detects interleukin 6 (IL-6) based on
Fluorescence Immunoassay. The sample moves through the strip from sample pad to
absorbent pad. If the specimen contains IL-6, it attaches to the fluorescent
microspheres-conjugated anti-IL-6 antibodies. Then the complex will be captured by the
capture antibodies coated on the nitrocellulose membrane (Test line). The
concentration of IL-6 in the sample correlates linearly with the fluorescence signal
intensity captured on the T line. According to the fluorescence intensity of the test and
standard curve, the concentration of IL-6 in the sample can be calculated by
Analyzer to
show IL-6 concentration in specimen.
【REAGENTS】
The test include anti-IL-6 antibody coated fluorophore and anti-IL-6 antibody coated on
the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if
the foil pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled.
Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout the procedure and follow
standard procedures for proper disposal of specimens. Wear protective clothing
such as laboratory coats, disposable gloves and eye protection when specimens
are assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The IL-6 Test Cassette should only be used with the Analyzer by
approved medical professionals.
【STORAGE AND STABILITY】
1. The test should be stored at 4-30°C until the expiry date printed on the sealed
pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the test from contamination.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false
results.
【SPECIMEN COLLECTION AND PREPARATION】
1. Collect the specimens according to standard procedures.
2. Do not leave specimens at room temperature for prolonged periods. Serum and
Plasma specimens may be stored at 2-8°C for up to 5 days, for long term storage,
specimens should be kept below -20 °C. Whole blood collected by venipuncture
should be stored at 2-8 °C if the test is to be used within 2 days of collection. Do not
freeze whole blood specimens. Whole blood collected by finger stick should be
tested immediately.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and
thawing of specimens. Only clear, non-hemolyzed specimens can be used.
4. EDTA, Sodium citrate, can be used as the anticoagulant tube for collecting the
blood specimen.
Sample Dilution/Sample Stability
1. The specimen (75 μl of serum/plasma/whole blood) can be added directly with the
micro pipette into the buffer.
2. Close the tube and shake the sample by hand vigorously for approximately 10
seconds to mix the sample and dilution buffer.
3. Let the diluted sample homegenize for approximately 1 minute.
4. The diluted sample can then be used immediately or stored for up to 8 hours.
【MATERIALS】
Materials Provided
• Test Cassettes
• Specimen Collection Tubes with buffer
• ID Card
• Package Insert
Materials Required But Not Provided
• Timer
• Centrifuge • Fluorescence Immunoassay Analyzer
• Pipette
• Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions on use of the Test. The test should be in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature
(15-30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “Standard test” or
“Quick test” mode and sample type to whole blood or serum/plasma(S/P).
2. Take out the ID card and insert it into the Analyzer port.
3. Pipette 75 μl serum/plasma/whole blood into the buffer tube, mix the specimen
and the buffer well.
4. Pipette 75 μl diluted specimen into the sample well of the cassette. Start the timer
at the same time.
5. There are two test modes for Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of
Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: Insert the test cassette into the Analyzer at 15 minutes after
sample application and click “QUICK TEST”, fill the test information and click "NEW
TEST" immediately. The Analyzer will automatically give the test result after a few
seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
sample application, click “STANDARD TEST”, fill the test information and click
"NEW TEST" at the same time, the Analyzer will automatically counting down 15
minutes. After the countdown, the Analyzer will give the result at once.
【INTERPRETATION OF RESULTS】
Results read by Fluorescence Immunoassay Analyzer.
The result of tests for IL-6 is calculated by Fluorescence Immunoassay
Analyzer and display the result on the screen. For additional information, please refer to
the user manual of Fluorescence Immunoassay Analyzer.
Assay range of IL-6 is 3.0-5000 pg/mL.
