One Step Dengue NS1 Antigen Whole Blood/Serum/Plasma Test is an immunochromatographic assay designed for the qualitative detection of dengue virus NS1 antigen in human whole blood, serum or plasma as an aid in the diagnosis of early Dengue infections.
Cat. No: DEN-A02
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
99.9% Dengue NS1 Rapid Test Infectious Disease Rapid Test Kits
| 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 NS1 Rapid Test | For The Crowd: | Preliminary Screening Of Infected People |
| High Light: | 99.9% Dengue NS1 Rapid Test99.9% Infectious Disease Rapid Test KitsDengue NS1 Infectious Disease Rapid Test Kits | ||
Infection Disease Dengue NS1 Rapid Test with CE certificate Test Device
| Product Name | Dengue NS1 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 NS1 Rapid Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of dengue virus antigen (Dengue Ag) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Dengue viruses. Any reactive specimen with the Dengue NS1 Rapid Test Device must be confirmed with alternative testing method(s) and clinical findings.
SUMMARY AND EXPLANATION OF THE TEST
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-bitting Stegemyia 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 of IgM antibody is the most common method for the diagnosis of dengue virus infection. Lately, detection of antigens released during virus replication in the infected patient showed very promising result. It enables diagnosis from the first day after the onset of fever up to day 9, once the clinical phase of the disease is over, thus allows early treatment in placed promptly4.
The Dengue NS1 Rapid Test is developed to detect circulating dengue antigen in human whole blood, serum or plasma. The test can be performed by untrained or minimally skilled personnel, without laboratory equipment.
Performance
Clinical Performance
A total of 114 patient samples from susceptible subjects were tested by the Dengue NS1 Rapid Test and by a commercial EIA. Comparison for all subjects is showed in the following table:
| Dengue NS1 Rapid Test | |||
| Dengue Ag EIA Test | Positive | Negative | Total |
| Positive | 66 | 3 | 69 |
| Negative | 2 | 43 | 45 |
| Total | 68 | 46 | 114 |
Relative Sensitivity: 95.6%, Relative Specificity: 95.5%, Overall Agreement: 95.6%
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.