【Product name】
Diagnostic Kit for Interleukin-6(Immunochromatographic assay)
【Packing specification】
25 Tests/kit
【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 principle】
The kit is a one-step chromatographic sandwich immunoassay designed
for the quantitative measurement of IL-6. The IL-6 antigen in the
sample was first bound with the conjugated compound of fluorescent
labeled IL-6 monoclonal antibody, then moved and combined with
another IL-6 monoclonal antibody fixed on the nitrocellulose
membrane, and the double antibody sandwich complex was formed at
the detection line of the cellulose nitrate membrane. The
quantitative detection results were obtained by NIR-1000 dry
fluoroimmunoassay analyser.
【Components】
| Name | Quantity | Component |
| Test cards | 25 | It is composed of fluorescent pad (coated with
fluorescently-labeled IL-6 monoclonal antibody), nitrocellulose
membrane (coated with IL-6 monoclonal antibody and Goat anti mouse
IgG antibody), absorbent paper and backing. |
| Sample diluent | 25 (0.3mL/ tube) | Phosphate buffer |
| ID card | 1 | With specific stand curve file |
The components in different batches of kits cannot be used
interchangeably.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is
valid for 18 months. The test card should be used within 15 minutes
after unsealing under the environment of 15℃~30℃ and 20% ~ 90%
relative humidity.
The production date, batch number and expiration date are shown in
the outer package of the product.
【Applicable instrument】
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech.
Inc.
【Sample requirements】
- Plasma, serum and whole blood can be used as samples. The whole
blood should be collected in a tube containing heparin, citrate or
EDTA as the anticoagulant. If the serum procedure is used, collect
blood in a tube without anticoagulant and allow clotting. Hemolyzed
samples should not be used.
- Venous blood was collected according to routine laboratory methods
to avoid hemolysis.
- It is highly recommended to use fresh samples instead of keeping
the samples at room temperature for a long time. After samples were
collected, the detection should be completed within 4 hours at room
temperature (15℃~30℃). The whole blood sample can be stored at
2℃~8℃ for 24 hours. Plasma and serum samples can be stored at 2℃~
8℃ for 7 days, -20℃ for 30 days.
- Before testing, the sample should return to room temperature
(15℃~30℃). The frozen samples should be completely thawed,
rewarming and mixed evenly before use. Repeated freeze-thaw cycles
should be avoided.
【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.
【Note】
1. The kit can be used for in vitro diagnosis only.
2. Test card and buffer solution are single-use and they cannot be
reused.
3. Please check the integrity and validity of the kit package
before use, and then open the package. When it is stored at low
temperature, it should be restored to room temperature (15℃ ~ 30℃)
before opening the package for use. The reagents with damaged inner
package and beyond the validity period cannot be used.
4. Take the test card out of the aluminum foil bag and carry out
experiment in 15min. Do not place it in the air for a long time to
avoid dampness.
5. It is required to strictly comply with the requirements for
sample collection and storage. If the sample is turbid, please
centrifuge and precipitate it before use.
6. The kit used should be disposed of as latent infective material,
and all samples, reagents and latent contaminants should be
disinfected and disposed of according to relevant local
regulations.
| WWHS Assay List | | | | | |
| Inflammation | | | | | |
| cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended 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 |
Storage Conditions and Validity
The product should be stored at 4℃-30℃ in a dry and dark place,
sealed using aluminum foil bag and must not be frozen. The storage
life is 12 months. The test card should be unpacked at room
temprature (15℃-30℃) and should be used in 15min after unpacked at
a temperature of (15-30)℃ and relative humidity of 20%-90%.
See outer packing for production date, batch number and expiry
date.
Our Services
1. Provide LOGO, color, outlook and GUI customization
2. Provide technical support and training
3. Provide training video
Applicable Instrument
NIR-1000 dry fluoroimmunoassay analyser
About WWHS Biotech Inc
WWHS Biotech. Inc Is A High-Tech Enterprise Incubated By The
Research Institute Of Tsinghua University In Shenzhen In 2016. The
Company Is Located In The National Biomedical Industrial Base In
Pingshan District, Shenzhen, With About 32,000 Square Feet Space
For Workshop And Office.
As A Fast-Growing Biotechnology Company, We Dedicate To The
Development Of World-Class Bio-Detection Technologies That Meet The
Ever-Increasing Demands On Clinical Diagnostics. We Focus On
Developing Cost-Effective And Precise Rapid Diagnostic Products
Based On Our Unique Near Infrared (NIR) Fluorescence Platform
Technologies (PGOLD™ And IR-LF™) With Major Interests In
Cardiology, Infectious Diseases, Oncology, Metabolic Diseases And
Women And Children’s Health.
About Payment
1. We accept the T/T, 30% as deposit, and the rest should be payed
before shipment.
2. L/C is welcome when the account is too large.
3. Our price is often FOB shenzhen, or FOB shenzhen airport, and
EXW, CIF, and so on.
4. We normally ship by Shenzhen.All products shipped with careful
packaging to protect and ensure safety of contents during shipment.
5. We do not responsible for any custom taxation if applicable in
some country.
6. We do everything to provide you the most reliable way of
shipping service. Yet sometimes international delivery is highly
depended on the local customs and post service.
