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Cardiac Troponin I Rapid Quantitative Test Kit Rapid Blood Diagnosis

Cardiac Troponin I Rapid Quantitative Test Kit Rapid Blood Diagnosis

Cardiac Troponin I Rapid Quantitative Test Kit Rapid Blood Diagnosis
Cardiac Troponin I Rapid Quantitative Test Kit Rapid Blood Diagnosis
Cardiac Troponin I Rapid Quantitative Test Kit Rapid Blood Diagnosis
Product Details:
Place of Origin: CN
Brand Name: WWHS
Certification: ISO 13485, CE
Model Number: cTnI
Payment & Shipping Terms:
Minimum Order Quantity: 1000
Price: US 1.50-2.99 Kit
Packaging Details: Colorful Paper Box
Delivery Time: 7 Days
Payment Terms: L/C, T/T
Supply Ability: 20000 Kits per Week
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Detailed Product Description
Product Name: Cardiac Troponin I Rapid Test Storage: Room Temperature
Sample Buffer: 25 Vials Manufacturer: WWHS BIOTECH INC
Type: One Step Assay Application: Human
Advantage: High Sensitivity Usage: Medical Hospital Clinical
Throughput: 5000 Tests/Day Production Capacity: 5 Million A Year
High Light:

Cardiac Troponin I Fast Test Kit

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Blood Cardiac Troponin I Fast Test Kit

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Quantitative Troponin I Rapid Test Kit

[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]

  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 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.

  1. When human anti mouse concentration of samples is less than 50ng/mL, HAMA effect will not be observed.
  2. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±15%.

 

 

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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Contact Details
WWHS Biotech.Inc(exclusive marketed by Dawin)

Contact Person: sales

Tel: +8613823276027

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Contact

Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen

Factory Address:Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen