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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.
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.
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