Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO13485
Model Number:
SAA
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SAA Rapid Quantitative Test Kits Fluorescence Immunoassay Blood Diagnostic POCT Test Cassette
Intended use
It is used to quantitatively detect the content of amyloid A (SAA) in human serum, plasma and whole blood samples. It is mainly used as a non-specific inflammatory index.
Test principle
The kit is used the principle of fluorescence immunochromatography. The SAA antigen in the sample first combines with the fluorescent labeled SAA monoclonal antibody conjugate, and then continues to move and combine with another SAA monoclonal antibody fixed on the nitrocellulose membrane to form a double antibody sandwich immune complex at the detection line of nitrocellulose membrane. The quantitative detection results are obtained by NIR-1000 dry fluoroimmunoassay analyzer.
Sample requirements
1. 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.
2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.
3. 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.
4. 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.
| Item Name | Quantity | Component |
| Test Cards | 25 Strip | It is composed of fluorescent pad (coated with fluorescent labeled SAA monoclonal mouse antibody), nitrocellulose membrane (coated with SAA monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing |
| Sample Buffer | 25(300μL/tube) | Phosphate buffer |
| Information Card | 1 Individual | With AFP specific stand curve file |
Performance
1. Detection limit: No higer than 1mg/L.
2. Accuracy: the relative deviation from the target value is not more than±15%.
3. Repeatability: coefficient of variation (CV) should be no more than 15%.
4. Inter batch difference: the relative range (R) between batches should be no more than 15%.
5. Linear range: within the specified linear range of 1-200mg/L, the linear correlation coefficient R ≥ 0.990.
| 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 |
Interpretation of results
1. 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.
2. For samples with AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /ml", respectively.
Limitations of methods
1. This kit is only used to detect human plasma/whole blood samples
2. 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.
3. The content of triglyceride in the sample shall not exceed 15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the content of bilirubin shall not exceed 0.5mg/ml, and the relative deviation of the test results shall not exceed ±15%.
4. When the concentration of AFP in the sample is less than 20000ng/ml, there is no hook effect.
5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
6. When RF concentration in the sample is less than 2000IU/ml, the relative deviation of the test results is within ±15%.
Applicable Instrument
WWHS NIR-1000 dry fluoroimmunoassay analyser
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.
FAQ
Q1: Are you trading company or manufacturer?
A1: We are manufacturer.
Q2: Do you provide samples ?
A2: Yes,we do provide samples.If you need it, please contact us.
Q3: How about the quality?
A3: We have the best professional engineer and strict QA and QC system to ensure you get high quality products from us.
Q4: How’s the package?
A4: Normally are cartons, but also we can pack it according to your requirements.
Q5: How’s the delivery time?
A5: It depends on the quantity you need.
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