ODM Dengue IGg IGm Rapid Test Sheet Antibody Uncut Sheet

Brand Name:Aichek
Certification:CE
Model Number:DEN-A01
Minimum Order Quantity:5000 Test
Payment Terms:T/T
Place of Origin:China
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Location: Hangzhou Zhejiang China
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
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Product Details

Infection Disease Dengue iggigm Antibody Rapid Test with CE certificate uncut sheet

Product Name

Dengue IggIgm Antibody Rapid Test uncut sheet

FormatsStrip(3mm)Device(4mm) uncut sheet
Place of OrigenChina
SpecimenBlood
Read Time15 minutes
Shelf life2 years
Packageuncut sheet
Storage2℃-30℃

For professional in vitro diagnostic use only.


INTENDED USE

The Dengue IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–dengue virus and IgM anti-dengue virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with dengue viruses. Any reactive specimen with the Dengue IgG/IgM Rapid Test must be confirmed with alternative testing method(s).


PRINCIPLE

The Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of Dengue antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in test line region 1 of the test. During testing, the specimen reacts with Dengue antigen-coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in test line region 1. If the specimen contains IgG antibodies to Dengue, a colored line will appear in test line region 1. In the IgM component, anti-ligand is coated in test line region 2 of the test. During testing, the specimen reacts with ligand anti-human IgM. Dengue IgM antibodies, if present in the specimen, reacts with the ligand anti-human IgM and the Dengue antigen-coated particles in the test strip, and this complex is captured by the anti-ligand, forming a colored line in test line region 2.

Therefore, if the specimen contains Dengue IgG antibodies, a colored line will appear in test line region 1. If the specimen contains Dengue IgM antibodies, a colored line will appear in test line region 2. If the specimen does not contain Dengue antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appeared in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.


PERFORMANCE CHARACTERISTICS

1. Clinical Performance For IgM Test

A total of 314 patient samples from susceptible subjects were tested by the Dengue IgG/IgM Rapid Test and by a reference EIA. Comparison for all subjects is showed in the following table:

Dengue IgG/IgM Rapid Test
IgM EIA TestPositiveNegativeTotal
Positive31132
Negative3279282
Total34280314

Relative Sensitivity: 96.9%, Relative Specificity: 98.9%, Overall Agreement: 98.7%

2. Clinical Performance For IgG Test

A total of 326 patient samples from susceptible subjects were tested by the Dengue IgG/IgM Rapid Test and by a reference EIA. Comparison for all subjects is showed in the following table:

Dengue IgG/IgM Rapid Test
IgG EIA TestPositiveNegativeTotal
Positive36137
Negative2287289
Total38288326

Relative Sensitivity: 97.3%, Relative Specificity: 99.3%, Overall Agreement: 99.1%


China ODM Dengue IGg IGm Rapid Test Sheet Antibody Uncut Sheet supplier

ODM Dengue IGg IGm Rapid Test Sheet Antibody Uncut Sheet

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