Place of Origin:
CN
Brand Name:
WWHS
Certification:
CE, ISO 13485
Model Number:
Cys-C
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【Product name】
Diagnostic Kit for Cystain C(Immunochromatographic assay)
【Package specification】
25 Tests/kit
【Intended use】
It is used to quantitatively detect the content of cystatin C in human serum, plasma and whole blood samples. It is mainly used as one of the indicators reflecting glomerular filtration rate
【Test principle】
The Cys-C Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of Cys-C. The Cys-C antigen in the sample was first bound with the conjugated compound of fluorescent labeled Cys-C monoclonal antibody, then moved and combined with another Cys-C 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 fluorescent labeled Cys-C monoclonal antibody), nitrocellulose membrane (coated with Cys-C monoclonal antibody and Goat anti mouse IgG antibody), absorbent paper and backing |
Sample diluent | 25(1.50mL/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 instruments】
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc
【Sample requirements】
【Test procedure】
【Reference interval】
Healthy non-pregnant adults are expected to have serum Cys-C values 0.5mg/L~1.1mg/L. It is strongly recommended that each laboratory should determine its own normal and abnormal values based on population.
【Interpretation of results】
【Limitations of methods】
【Performance】
1. Limits of detection
No more than 0.40mg/L.
2. Accuracy
The relative deviation from the target value is within ±15%.
3. Precision
The within and between assay coefficient of variations are within 15%.
4. Linear range
Within the linear range (0.40 ~ 9mg/L), the linear correlation coefficient R≥0.990.
【Note】
1. This kit is only used for in vitro diagnosis.
2. The test card and sample diluent are disposable and 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. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.
5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.
Note:
1) Any variation in operator, pipetting and washing technique, incubation time or temperature, and kit age can cause variation in
result. Each user should obtain their own standard curve.
2) If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.
3) If specimens generate values higher than the highest standard, dilute the specimens and repeat the assay
Assay list | Renal Injury | |||||
cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended Use |
45 | CysC | WB/Serum/Plasma | 5min. | 0.4-9mg/L | 0.5-1.1mg/L | renal function |
46 | NGAL | Urine | 10min. | 10-1500ng/mL | <132ng/mL | acute kidney injury. |
Advantage:
1. Advanced Quality: We have strict quality control system and enjoy good reputation in the market.
2. Sincerly Service: We treat clients as friend and aims at building long term business relatiionship.
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FAQ:
1. What is the MOQ?
Generally if you choose the different products, our minimum order qty. also will be different. One sample available.
2. What about the delivery time?
The goods need 7-21 work days to be made upon deposit.
3. Does your product have any warranty?
Yes, we offer 6 months limited warranty for our products.
Damage due to misuse, ill treatment and unauthorized modifications and repairs are not covered by our warranty.
4. What's your payment method?
We usually accept the payment methods include PayPal, TT, and Western Union.
50% deposit in advance and balance before shipping. Buyer can choose which payment ways that you accept.
PayPal is most useful and safe, please don’t refuse PayPal fee when you choose PayPal.
5. What's your shipping method?
We provide comprehensive shipping methods.
For small quantity orders we ship by DHL Air-Express, or EMS/TNT/UPS/FEDEX Express service, it is safe and fast.
For large quantity orders we ship by Air transportation or sea transportation, we can also ship order to buyer’s cargo agent in China.
Disclaimer
While every efforts were made to ensure the accuracy of the information provided in this datasheet, FIA POCT will not be liable for any omissions or errors contained herein. FIA POCT reserves the right to make changes to this datasheet at any time without prior notice.
All of WWHS's Products are for scientific laboratory research purposes and diagnostic, therapeutics analysis, and are not for prophylactic or in vivo use. Through your purchase, you expressly represent and warrant to WWHS that you will properly test and use any Products purchased from WWHS in accordance with industry standards. WWHS and its authorized distributors reserve the right to refuse to process any order where we reasonably believe that the intended use will fall outside of our acceptable guidelines.
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