【Product name】IL-6.pdf

Diagnostic Kit for Interleukin-6(Immunochromatographic assay)

【Intended use】

The kit is used for quantitative determination of Interleukin-6 (IL-6) in human whole blood, plasma and serum.

Interleukin 6 is a member of the family of interleukins. It plays an important role in the inflammatory response and is a sensitive indicator for the early diagnosis of acute infection.

【Test procedure】

1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.
2. Start NIR-1000 dry fluoroimmunoassay analyser according to the instruction manual of the instrument, and carry out quality control verification according to the instruction manual of the instrument(Note: the reagent has been calibrated in advance, and the calibration curve parameters of each batch of reagent have been stored in the ID card. The test can be carried out only after the quality control is passed. Otherwise, the cause should be found out before testing.)
3. Remove the test card from the aluminum foil bag and use it within 15 minutes.
4. Place the test card on a clean horizontal table and mark it horizontally.
5. Mix 100 µL of patient sample with 300µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, read and record the results at 10 minutes after addition of samples, then dispose of used test appropriately.

【Reference interval】

The normal reference value is less than 10pg/mL in this assay. It is strongly recommended that each laboratory should determine its own normal and abnormal values.

【Interpretation of test results】

1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
2. For samples with IL-6 concentration lower than 5.00pg/mL and higher than 4000.00pg/mL, the detection results are reported as "＜5.00pg/mL "and "＞4000.00pg/mL ", respectively.

【Limitation of rest method】

1. This kit is only used to detect human serum/plasma/whole blood samples
2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.
3. The content of triglyceride in the sample shall not exceed 30mg/mL, the content of hemoglobin shall not exceed 10mg/mL, and the content of bilirubin shall not exceed 0.25mg/mL, and the relative deviation of the test results shall not exceed ±15%.

4. When the concentration of IL-6 in the sample is less than 10000ng/mL, there is no hook effect.

5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
6. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±15.0%.

【Performance】

1. Limits of detection

No higher than 5.00 pg/mL.

2. Accuracy

The relative deviation from the target value is limited to ±15.0%.

3. Repeatability

The within and between assay coefficient of variations are within 15.0%.

4. Linearity range

Within the linear range (5.00~ 4000.00)ng/mL, the linear correlation coefficient R≥0.990.

About NIR-1000 Dry Fluoroimmunoassay Analyser

It is a fluorescence immunochromatographic analysing system with internal temperature control,

which can help diagnose conditions such as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc.

Immunofluorescence technology

Testing time less than 15 minutes

Easy-to-use touch-screen platform,multi-language system

Reagents stored at room temperature for 12 months