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Cardiac Troponin I (cTnI) Rapid Quantitative Test(Fluorescence immunoassay)
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.
1) The test card can be used only once at room temperature, do not reuse or use test card out of expiry date.
2) Return all reagents and sample into room temperature before use.
3) Be careful when prepare sample, wear glove and mask.
4) The whole blood need add anticoagulants, not frozen; serum sample can store in frozen, avoid repeated freezing and thawing.
5) This product is only for in vitro rapid diagnostic human use, can be quantified, not only qualitative testing.
Q: What's the minimum order quantity (MOQ)?
A: For most of our medical products, even order for only one unit is warmly welcomed.
Q: Can you do OEM/ private label?
A: Of course we can do OEM/private label for you.
Q: How about your delivery time?
A: 2~10 day depends your order quantity.
Q: What is your terms of delivery?
A: DHL, UPS, FedEx, TNT, EMS, customer's freight forwarder is also available.
Q: What is your terms of payment?
A: Trade Assurance, T/T in advance, L/C, Western union, paypal
Please suggest your preferred payment method.
Q: Do you have certification?
A: ISO13485, CE
Q: Do you test all your goods before delivery?
A: Yes, we have 100% test before delivery
Q:How about after-sale serive?
A:We will send you any parts within 15 months warranty, and supply you technology support for long time, solve problem as soon as possible .
Send your inquiry directly to us