SAA Rapid Quantitative Test Kits Fluorescence Immunoassay Blood
Diagnostic POCT Test Cassette
CRP+SAA.pdf
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.
