Place of Origin:
ISO 13485, CE
Diagnostic Kit for Cardiac troponin I(Immunochromatographic assay)
25 Tests/kit,40 Tests/kit
CTnI Cardiac Troponin I Test 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.
|Test card||25/40||The product consists of fluorescent mat (coated with fluorescently-labeled cTnI monoclonal murine antibody), nitrocellulose membrane (coated with cTnI monoclonal murine antibody and goat anti mouse IgG antibody), absorbent paper and bottom lining.|
|Sample diluent||25/40||Phosphate buffer|
|ID card||1||Record standard curve information of this batch of reagents|
Ingredients of CTnI Cardiac Troponin I Test Kits of different batch numbers cannot be exchanged.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
Determine 252 healthy people aged 18-68 and carry out statistical analysis using 95th 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. CTnI Cardiac Troponin I Test 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. CTnI Cardiac Troponin I Test 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 bilirubin 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%.
[Product Performance Indicators]
1. Limit of detection
No more than 0.1ng/mL.
The relative deviation to the target value is limited to ±15%.
Within-run precision CV≤15%; between-run relative limit R≤15%.
4. Linearity range
Within the specified linearity range cTnI (0.1-40) ng/mL, linearly dependent coefficient r≥0.990.
5. Analytical Specificity
Determine cardiac troponin T, cardiac troponin C and skeletal muscle troponin I samples whose concentration is 1000ng/mL and the result does not exceed 0.1ng/mL.
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. CTnI Cardiac Troponin I Test 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 .
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