Place of Origin:
ISO 13485, CE
Cardiac Troponin I (cTnI) Rapid Quantitative Test(Fluorescence immunoassay)
The product is used to determine the content of cardiac troponin I (cTnI) in whole blood, plasma and serum of human body and is mainly used clinically for auxiliary diagnosis of myocardial infarction.
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.
|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]
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.
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. 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.
[Product Performance Indicators]
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%.
Within the specified linearity range cTnI (0.1-40) ng/mL, linearly dependent coefficient r≥0.990.
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.
|Cat#.||Product Item||Specimen||Reaction Time||Measure Range||Clinical Range||Intended 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.|
|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.|
WWHS NIR-1000 dry fluoroimmunoassay analyser
Deviation is less than 3.0%
2. Upgraded data storage
10000 data storage
3. Long life
Support to use 3 years
About NIR-1000 Dry Fluoroimmunoassay Analyser
It is a fluorescence immunochromatographic analysing system with internal temperature control,
which can help diagnose conditions such as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc.
Send your inquiry directly to us