Payment Terms | T/T, Western Union, MoneyGram |
Supply Ability | 100,000 Kits Per Day |
Delivery Time | 8 days |
Packaging Details | 40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm |
Methodology | Colloidal Gold |
Shelf Life | 2 Years |
Format | Cassette |
OEM/ODM | Available |
Usage | For In Vitro Diagnostic Use Only |
Temperature Request | 2-30°C |
Brand Name | Newscen |
Model Number | Dengue IgG/IgM |
Certification | ISO9001, CE, TUV, FDA |
Place of Origin | China |
View Detail Information
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Product Specification
Payment Terms | T/T, Western Union, MoneyGram | Supply Ability | 100,000 Kits Per Day |
Delivery Time | 8 days | Packaging Details | 40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm |
Methodology | Colloidal Gold | Shelf Life | 2 Years |
Format | Cassette | OEM/ODM | Available |
Usage | For In Vitro Diagnostic Use Only | Temperature Request | 2-30°C |
Brand Name | Newscen | Model Number | Dengue IgG/IgM |
Certification | ISO9001, CE, TUV, FDA | Place of Origin | China |
High Light | 100% Dengue Rapid Test Kit ,IgG IgM Dengue Test Kit ,IgG IgM Combo Dengue Test Kit |
Dengue IgG/IgM Antibody Rapid Test
For the qualitative detection of Dengue ( IgG & IgM ) in serum/plasma and whole blood
Dengue IgG/IgM Combo Rapid Test Kit Home Use Dengue Fever In Vitro Test Cassette Mosquito-Borne Infectious Disease
Main Features
♦ High Sensitivity: 100%
♦ Specificity: 100%
♦ 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 line
♦ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes
♦ 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.
Storage
Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).
Assay Procedure
All test cassettes, buffers and specimens must be at room temperature (4- 300C) before running the assay procedure. Whole blood samples should be used immediately.
1. Pipette 5μl sample (serum/plasma/whole blood) into the sample well. Wipe the outside of the pipette tip carefully to remove excess of sample.
2. Next dispense 4 drops (120μl) of sample diluent buffer into the buffer well.
3. Record the results after 15-20 minutes. Discard the test cassette after 20 minutes.
Interpretation of Results
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.
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).
Company Details
Business Type:
Manufacturer,Seller
Year Established:
2003
Employee Number:
200~300
Ecer Certification:
Active Member
Newscen Biopharm Co., Limited is a professional manufacturer of in vitro diagnostic products and related supporting apparatuses, which is jointly founded by Tianjin Pharmaceutical Group, Tianjin Zhongxin Pharmaceuticals Co., Ltd and oversea Chinese entrepreneurs. Founded in 2003, the co... Newscen Biopharm Co., Limited is a professional manufacturer of in vitro diagnostic products and related supporting apparatuses, which is jointly founded by Tianjin Pharmaceutical Group, Tianjin Zhongxin Pharmaceuticals Co., Ltd and oversea Chinese entrepreneurs. Founded in 2003, the co...
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