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IgG IgM Dengue Rapid Test Kit

China Newscen Biopharm Co., Limited certification
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IgG IgM Dengue Rapid Test Kit

IgG IgM Dengue Rapid Test Kit
IgG IgM Dengue Rapid Test Kit IgG IgM Dengue Rapid Test Kit IgG IgM Dengue Rapid Test Kit IgG IgM Dengue Rapid Test Kit

Large Image :  IgG IgM Dengue Rapid Test Kit

Product Details:
Place of Origin: China
Brand Name: Newscen
Certification: ISO9001, CE, TUV, FDA
Model Number: Dengue IgG/IgM
Payment & Shipping Terms:
Minimum Order Quantity: 10 Boxes or 400 Kits (40 Kits/Box)
Price: Negotiable as per Order Quantity
Packaging Details: 40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm
Delivery Time: 8 days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 100,000 Kits Per Day
Detailed Product Description
Specimen: Serum, Plasma, Whole Blood Methodology: Colloidal Gold
OEM/ODM: Acceptable Box Color: Light Green
Temperature Request: 2-30°C Category: Infectious Disease Detection
High Light:

100% Dengue Rapid Test Kit

,

IgG IgM Dengue Rapid Test Kit

Dengue IgG/IgM Ab Rapid Test

 

For the qualitative detection of Dengue ( IgG & IgM ) in serum/plasma and whole blood

 

Main Features

 

☀ High Sensitivity: 100%

Specificity: 100%

☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

Reliable: Accuracy higher than 97.5%, early detection of the presence of Dengue Antibody

Simple: No Instrument Required

Convenient: Room Temperature Storage, Built-In Control

Certified by Authoritative Certification System and Standards

Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

 

Intended Use


The Dengue IgG and IgM Combo Rapid Test is a qualitative test for the detection of IgG and IgM Antibodies to dengue virus in human serum plasma ,or whole blood.

 

The test provides a differential detection of anti-dengue IgG and anti-dengue-IgM antibodies and can be used for the presumptive distinction between a primary and secondary dengue infection. This test is for In-Vitro Diagnostic use only.

 

Principle


Serum, plasma, or Whole blood samples may be used with this test. A sample is dispensed on to the membrane The sample then migrates by capillary action towards the test site where anti-Human IgG and anti-Human IgM are immobilized as two distinct lines. The IgG & IgM antibodies present in the sample will bind to the immobilized anti-Human IgG and Anti-Human IgM lines on the membrane.

 

Next the sample buffer is applied which in turn reconstitutes the dried Dengue gold conjugate. The Dengue conjugate then migrates towards the test zone and binds to Dengue Anti-Human IgG and Dengue Anti-Human IgM complex on the membrane as two separate purple/blue lines if Dengue antibodies are present in the sample.

 

The intensity of the test lines will vary depending upon the amount of antibody present in the sample. The appearance of purple/blue line in a specific test region (IgG or IgM) should be considered as positive for that particular Antibody type (IgG or IgM).

 

There will be a third control line on the membrane which will be invisible until the test is run. It will show up as a Red control line to indicate that the test is functioning properly.

 

Materials Required But Not Provided

 

☀ Stop watch.

☀ Adjustable 0.5 - 10μl pipette (adjustable)

 

Reagents and Materials Provided

 

☀ 40 pouched cassettes with desiccant.

☀ Dropper bottle of sample diluent buffer.

☀ One operating instruction.

 

Interpretation of Results

 

IgG IgM Dengue Rapid Test Kit 0

 

☀ Negative:

The control line is the only line visible in the test zone. No IgG or IgM antibodies were detected. The result does not exclude dengue infection. A new sample should be drawn from the patient in 3-5 days and then should be retested.


☀ IgG Positive:

The control line and G line are visible in the test zone. The test is positive for IgG antibodies. This is indicative of a past dengue infection.
 

☀ IgM Positive:

The control line and M line are visible in the test zone. The test is positive for IgM antibodies. This is indicative of a primary dengue infection.
 

☀ IgM and IgG Positive:

The control line, M and G lines are visible in the test zone. The test is positive for IgM and IgG antibodies. This is indicative of a secondary dengue infection (see limitation).


☀ Invalid:

The test results are INVALID, if no control line is visible, regardless of the presence or absence of lines in the IgG or IgM test zone of the strip. Repeat the test using a new cassette.

 

Storage

 

Store the kit between 4°C and 30°C. Do not store the kit in direct sunlight. Only remove and open the number of cassettes to be immediately used. The test kit should be used until the expiration date of the kit. Please refer to the package label for the expiration date.

 

Performance Characteristics

 

1.A panel of samples containing confirmed positive and negative samples were used. The reference test kit used was from Pan Bio (Australia). The results are tabulated below.

 

  Dengue Duo Cassette
Rapid Dengue Test   Positive Negative
IgM Positive 35 0
IgG Positive 12 0
IgM/IgG Pos. 13 0
Negative 0 40

 

2. CROSS REACTIVITY: No cross reactivity was observed with Hemoglobin (20 mg/100 ml) , and Triglycerides (500 mg/100 ml).

Contact Details
Newscen Biopharm Co., Limited

Contact Person: Mr. Randy.Zhang

Tel: 008618611273771

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