Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO 13485, CE
Model Number:
cTnI
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[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]
Name | Loading capacity | Ingredient |
Test card | 25 | 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 | Phosphate buffer |
ID card | 1 | Record standard curve information of this batch of reagents |
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]
[Reference Interval]
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. 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.
WWHS Assay list | ||||||
Cardiac | ||||||
cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended Use |
1 | cTnI | WB/Serum/Plasma | 12min. | 0.1-40ng/ml | <0.3ng/ml | several heart diseases including myocardial infarction and heart failure. |
2 | Myo | WB/Serum/Plasma | 12min. | 5-400ng/ml | <58ng/ml | acute myocardial infarction (AMI) in early stage. |
3 | CK-MB | WB/Serum/Plasma | 12min. | 1-200ng/ml | <5ng/ml | acute myocardial infarction (AMI) in early stage. |
4 | NT-proBNP | WB/Serum/Plasma | 10min. | 20-35000pg/ml | Under 75:0~347pg/mL, Over 75:0~449pg/mL |
heart failure . |
5 | D-Dimer | WB/Plasma | 10min. | 40-10000ng/ml | <500ng/ml | disseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc. |
6 | cTnI+Myo+CKMB | WB/Serum/Plasma | 12min. | same with single item | same with single item | Triple marker of myocardial infarction. |
7 | ST2 | WB/Serum/Plasma | 10min. | 10-400ng/ml | <35ng/ml | heart failure . |
8 | Lp-PLA2 | WB/Serum/Plasma | 10min. | 10-900ng/ml | <175ng/ml | Risk evaluation of ACS and atherosclerotic ischemic stroke patients. |
9 | S100-β | WB/Serum/Plasma | 10min. | 0.05-10ng/ml | <0.2ng/ml | Cerebral infarction, cerebral injury. |
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