[Product Name]cTnI.pdf

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

This product is used to determine human whole blood, plasma and Serum Cardiac Troponin I (CTNI) content, mainly for the clinical diagnosis of myocardial infarction. The Kit is immunochromatographic. First, the CTNI Antigen in the sample binds to a fluorescent labeled monoclonal antibody conjugate. It then moves on and binds to another CTNI monoclonal antibody fixed to the nitrocellulose membrane, forming a double antibody sandwich Immune complex at the nitrocellulose membrane test line, the quantitative results were analyzed by NIR 1000 dry-type fluorescence immunoassay instrument.

[Main Ingredients]

Ingredients of kits of different batch numbers cannot be exchanged.

[Storage Conditions and Validity]

Products should be stored in a dry and dark place at 4 °C to 30 °C and sealed in foil bags. Do not refrigerate. The shelf life is 12 months. The Test Card shall be opened at room temperature (15 °C to 30 °C) and used at 15 °C to 30 °C and 20% to 90% relative humidity within 15 minutes of opening. Production date, lot number and expiry date are shown on the outer packing.

[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.

[Reference Interval]

Determine 252 healthy people aged 18-68 and carry out statistical analysis using 95^th percentile method. Result shows that cTnI reference interval＜0.3ng/mL.

The laboratory should establish a reference range according to characteristics of local people.

[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.

[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%.

As A Fast-Growing Biotechnology Company, WWHS Biotech.Inc(exclusive marketed by Dawin) Dedicate To The Development Of World-Class Bio-Detection Technologies That Meet The Ever-Increasing Demands On Clinical Diagnostics. We Focus On Developing Cost-Effective And Precise Rapid Diagnostic Products Based On Our Unique Near Infrared (NIR) Fluorescence Platform Technologies (PGOLD™ And IR-LF™) With Major Interests In Cardiology, Infectious Diseases, Oncology, Metabolic Diseases And Women And Children’s Health...