【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】
- 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.
- 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.)
- Remove the test card from the aluminum foil bag and use it within
15 minutes.
- Place the test card on a clean horizontal table and mark it
horizontally.
- Mix 100 µL of patient sample with 300µL of sample diluent. Apply
100 µL of diluted samples to the well of the test card.
- 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】
- 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.
- 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】
- This kit is only used to detect human serum/plasma/whole blood
samples
- 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.
- 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.
- HAMA effect was not produced when the concentration of human anti
rat in the sample was less than 50ng/ml.
- 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.
| WWHS Assay list | Inflammation | | | | |
| cat#. | Product Item | Specimen | Reaction Time | Measure Range | Clinical Range | Intended Use |
| 10 | CRP / hs-CRP | WB/Serum/Plasma | 3min. | 0.5-200mg/L | CRP<10mg/L,hs-CRP<1mg/L | nonspecficity inflammatory marker. |
| 11 | SAA | Serum | 5min. | 1-200mg/L | <10mg/L | inflammation&infection. |
| 12 | PCT | WB/Serum/Plasma | 10min. | 0.2-100ng/ml | <0.5ng/ml | Sepsis |
| 13 | CRP+SAA | WB/Serum/Plasma | 5min. | same with single item | same with single item | inflammation&infection. |
| 14 | IL-6 | WB/Serum/Plasma | 10min. | 5-4000pg/ml | 10pg/ml | diabetes,rheumatoid arthritis,etc |
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
