One Step Dengue IgG/IgM Whole Blood/Serum/Plasma Test cassette is an immunochromatographic assay designed for the qualitative detection and differentiation of specific IgM and IgG antibodies to dengue virus in human whole blood, serum or plasma. The test provides a differential detection of anti-dengue IgM and anti-dengue-IgG antibodies and can be used for the presumptive distinction between a primary and secondary dengue infection. The results obtained should not be the sole determinant for clinical decision.
Cat. No: DEN-A01
Benefits
Fast：Instant results within 15 minutesConvenient: Room temperature storage (2-30℃) , valid for 24 months
Easy to Use: No equipment is required to process the specimens or read the results
Non-Invasive Sampling: Whole Blood/Serum/Plasma
Blood Dengue Igg Igm Rapid Test 50 Strips Rapid Dengue Igg Igm Test Kit
Description| Storage: | 2℃-30℃ | Sample Type: | Blood |
|---|---|---|---|
| User: | Professional | Accuracy: | 99.6% (97.7%-99.9%) |
| Certificate: | CE ISO 13485 | OEM: | OEM Customized Packing Avaliable |
| Formats: | 25T/box 1T/box | After-sales Service: | Available |
| Key Words: | Dengue Iggigm Antibody Rapid Test | For The Crowd: | Preliminary Screening Of Infected People |
| High Light: | Blood Dengue Igg Igm Rapid Test50 Strips Rapid Dengue Igg Igm Test KitDengue Igg Igm Rapid Test 50 Strips | ||
Infection Disease Dengue IgG/IgM Antibody Rapid Test with CE certificate Test Device
| Product Name | Dengue IggIgm Antibody Rapid Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-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).
INTRODUCTION
Dengue viruses, a family of four distinct serotypes of viruses (Den 1,2,3,4), are single-strained, enveloped, positive-sense RNA viruses. The viruses are transmitted by mosquitoes of the daytime biting Stegeman family, principally Aedes aegypti, and Aedes albopictus. Today, more than 2.5 billion people living in the areas of tropical Asia, Africa, Australia, and the Americas are at risk for dengue infection. An estimated 100 million cases of dengue fever and 250,000 cases of life-threatening dengue hemorrhagic fever occur annually on a worldwide basis1-3.
Serological detection is a common method for the diagnosis of infection with dengue viruses. IgM anti-dengue virus starts to appear at 3 days after initial exposure and remain in the circulation for about 30-60 days. IgG anti-dengue virus raise at around 7 days, peak at 2-3 weeks, and persist for the life4-6.
The Dengue IgG/IgM Rapid Test detects IgG and IgM anti-dengue virus in one test within 25 minutes. The test is user friendly, without cumbersome laboratory equipment, and requires minimal staff trainings.
Performance
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 Test | Positive | Negative | Total |
| Positive | 31 | 1 | 32 |
| Negative | 3 | 279 | 282 |
| Total | 34 | 280 | 314 |
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 Test | Positive | Negative | Total |
| Positive | 36 | 1 | 37 |
| Negative | 2 | 287 | 289 |
| Total | 38 | 288 | 326 |
Relative Sensitivity: 97.3%, Relative Specificity: 99.3%, Overall Agreement: 99.1%
Storage
1.Store at 4~30℃ in the sealed pouch up to the expiration date printed on the package. Do not freeze.
2.The test cassette/strip should be used within 1 hour after taking out from the sealed pouch.
3.Keep away from sunlight, moisture and heat.
4.The manufacturing date is printed on the outer box.