POCT Analyser ST2 High Sensitivity FIA Rapid Quantitative Test Kit IVD Assay

CysC.pdf【Product name】

Diagnostic Kit for growth STimulation expressed gene 2(Immunochromatographic assay)

【Package specification】

25 Tests/kit

【Intended use】

This kit is used for quantitative determination of ST2 in human whole blood, plasma and serum.

It is used to evaluate the prognosis and clinical diagnosis of patients with chronic heart failure.

【Test principle】

The ST2 Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of ST2. The ST2 antigen in the sample was first bound with the conjugated compound of fluorescent labeled ST2 monoclonal antibody, then moved and combined with another ST2 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】

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】

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.

【Test 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 fluoroimmunoassay analyser and correctly select the corresponding sample type on the instrument.
3. Take out the ID card, make sure that the batch number of the ID card is consistent with that of the test card, and insert the ID card into the ID card port of the instrument.
4. Take out the test card from the aluminum foil bag and use it within 15 minutes.
5. Place the test card on a clean horizontal table and mark it horizontally.
6. Mix 100 µL of sample with 400µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
7. At 10 minutes after addition of samples, insert the test card into NIR-1000 dry fluoroimmunoassay analyser and click the “Instant test” button to read the results.

【Reference interval】

Healthy non-pregnant adults are expected to have serum ST2 values below 35.00ng/mL. It is strongly recommended that each laboratory should determine its own normal and abnormal values based on population.

【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 ST2 concentration lower than 10.00ng/mL and higher than 400.00ng/mL, the detection results are reported as "<10.00ng/mL" and "> 400.00ng/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 ST2 in the sample is less than 4000ng/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%.

【Performance】

1. Limits of detection

No more than 10.00ng/mL.

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 (10.00~ 400.00ng/mL), 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.

Interpretation of Test Results

1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose cTnI concentration is lower than 0.1ng/mL and higher than 40ng/mL, test result is “＜0.1ng/mL” and “＞40ng/mL” respectively.

Why Choose Us
1. Precision
Deviation is less than 3.0%
2. Upgraded data storage
10000 data storage
3. Long life
Support to use 3 years

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.