cTnI Cardiac Troponin I Kit Fluorescence Immunoassay 20 Test Pack For IVD Device

[Product Name]  cTnI.pdf

Cardiac Troponin I (cTnI) Rapid Quantitative Test(Fluorescence immunoassay)

[Test Principle]

The kit uses immunochromatographic assay. First, cTnI antigen in the sample combines with the fluorescently-labeled cTnI monoclonal antibody conjugate. Then, it continues to move and combines with another cTnI monoclonal antibody fixed on the nitrocellulose membrane to form double-antibody sandwich immune complex in the position of the nitrocellulose membrane test line and analyze and obtain quantitative test result using NIR-1000 dry fluoroimmunoassay analyser.

[Main Ingredients]

Ingredients of kits of different batch numbers cannot be exchanged.

[Storage Conditions and Validity]

The product should be stored at 4℃-30℃ in a dry and dark place, sealed using aluminum foil bag and must not be frozen. The storage life is 12 months. The test card should be unpacked at room temperature (15℃-30℃) and should be used in 15min after unpacked at a temperature of (15-30)℃ and relative humidity of 20%-90%.

See outer packing for production date, batch number and expiry date.

[Applicable Instrument]

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

[Test Method]

1. Please thoroughly read the specification before test. Frozen test card and sample should be placed at room temperature (15-30)℃ for at least 30min before use.
2. Start NIR-1000 dry fluoroimmunoassay analyser and verify quality control according to the specification. (Note: Reagent has been calibrated in advance and calibration curve parameters of each batch of reagents have been stored in the information card. Insert the information card before use and carry out test without re-calibration after passing quality inspection; otherwise, identify the cause before test.)
3. Take out the test card from the aluminum foil bag and use it within 15min
4. Place the test card on a clean horizontal table top and label it.
5. Serum, plasma or whole blood specimen: Take 100μL of sample and add it into 300μL of buffer solution (1:3). Then, mix the solution evenly, take 100μL of the solution and add it into the test card well.
6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser and press “Timing test” to keep time for 12min automatically. The analyser will judge and read the test result automatically and display it in the screen. Or insert the test card into the analyser after 12min and press “Instant test”, the instrument will judge and read the result automatically.

[Limitation of Test Method]

1. The kit can be used to test serum/plasma/whole blood specimens of human body only.

2. Due to limitations of serological methods for antigen and antibody response, the test result cannot be used as the only basis for clinical diagnosis and should be evaluated together with all existing clinical and experimental data.

3. The content of triglyceride contained in the sample is no more than 15mg/mL, that of hemoglobin is no more than 5mg/mL and that of hemoglobin is no more than 0.5mg/mL, and the relative deviation is limited to ±15%.

4. When cTnI concentration of samples is less than 250ng/mL, Hook effect is not observed.

5. When human anti mouse concentration of samples is less than 50ng/mL, HAMA effect will not be observed.
6. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±15%.

[Precautions]

1. Test card and buffer solution are single-use and they cannot be reused.
2. Please inspect packaging integrity and validity of kit before use and then unpack the product. If the product is stored at low temperature, restore to room temperature (15℃-30℃) before unpacking and use. Reagent cannot be used if packaging is damaged and the validity period expires.
3. 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.
4. 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.
5. The kit contains products from animals. Eligible information about animal source and sanitary condition cannot absolutely ensure inexistence of infectious pathogen. Therefore, these products 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.
6. Too high or too low hematocrit of red cells may affect whole blood test result, so verification should be conducted using other methods .