|Place of Origin:||CN|
|Minimum Order Quantity:||1000|
|Price:||US 1.50 - 2.50 Kit|
|Packaging Details:||Colorful Paper Box|
|Delivery Time:||7 Days|
|Supply Ability:||50000 Kits per Week|
|Product Name:||SAA Rapid Test Kit||Manufacturer:||WWHS Biotech INC|
|Application In:||WWHS NIR-1000||Package:||25 Tests|
|Storage:||At Room Temperature||Advantage:||High Sensitivity|
|Reactivity:||Human||Formal Name:||Serum Amyloid A Protein|
|Usage:||Inflammation||Production Capacity:||5 Million A Year|
SAA Rapid Test kit,
Rapid Diagnostics IVD Test Kit
Diagnostic Kit for C-reactive Protein and Serum Amyloid A protein(Immunochromatographic assay)
The kit is used for quantitative determination of C-reactive protein (CRP) and Serum Amyloid A protein (SAA) in human whole blood, plasma and serum. SAA and CRP are sensitive indicators reflecting infectious diseases.
The CRP/SAA Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of CRP and SAA. The CRP or SAA antigen in the sample was first bound with the conjugated compound of fluorescent labeled CRP or SAA monoclonal antibody, then moved and combined with another CRP or SAA 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.
|Test cards||25||It is composed of fluorescent pad (coated with fluorescently-labeled CRP/SAA monoclonal antibody), nitrocellulose membrane (coated with CRP/SAA monoclonal antibody and Goat anti mouse IgG antibody), absorbent paper and backing|
|Sample diluent||25 (1.0mL/ 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.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
CRP normal reference value is less than 10.0mg/L and SAA normal reference value is less than 10.0mg/L. It is strongly recommended that each laboratory should determine its own normal and abnormal values.
【Interpretation of test results】
【Limitation of rest method】
4. When the concentration of CRP in the sample is less than 400mg/L, the concentration of SAA in the sample is less than 400mg/L, there is no hook effect.
1. Limits of detection
CRP: No higher than 1.00mg/L; SAA: No higher than 1.00mg/L.
CRP: the relative deviation from the target value is limited to ±10.0%;
SAA: the relative deviation from the target value is limited to ±15.0%.
CRP: the within assay coefficient of variations are within 10.0%;
SAA: the within assay coefficient of variations are within 15.0%.
4. Batch-to-batch variation
CRP: the extreme difference are within 15.0%; SAA: the extreme difference are within 15.0%.
5. Linearity range
CRP: Within the linear range(1.00~200.00)mg/L, the linear correlation coefficient R≥0.990；Within the linear range(1.00~ 5.00)mg/L, the linear absolute deviation is limited to ±0.50 mg/L；Within the linear range(5.00~ 200.00)mg/L, the linear relative deviation is limited to ±10.0%.
SAA: Within the linear range (1.00~ 200.00)mg/L, the linear correlation coefficient R≥0.990.
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.
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.
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
|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.|
|13||CRP+SAA||WB/Serum/Plasma||5min.||same with single item||same with single item||inflammation&infection.|
Manual of WWHS POCT Test Kit 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 fluorescence immunoassay analyzer 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 information card. The information card is inserted before use, so it is not necessary to calibrate again, and 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 fluorescent immunoanalyzer, read and record the results at 15 minutes after addition of samples, then dispose of used test appropriately.
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.
Contact Person: sales
Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen
Factory Address:Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen