CE Approved Dengue Ns1 Antigen Test Kit Antibody Rapid Test Cassette

Product Specification

CE Mark Dengue IgG / IgM Antibody Rapid Test Cassette, WB / S / P Avaliable

Introduction

Dengue virus is a mosquito-borne flavivirus, consisting of four serotypes, it is considered as a major public health problem in tropical / subtropical areas. 2.5-3.0 billion global population is estimated at risk in these regions. Annually about 50 million cases of dengue fever and more than 250,000 cases of dengue hemorrhagic fever occur based on WHO report.

Dengue virus infection includes 1. dengue fever or simple dengue fever usually seen with high fever, headache, myalgia, arthralgias, rashes and leucopenia; 2. dengue haemorrhagic fever is characterized with the acute onset, high fever, haemorrhagic diarrhea, thrombocytopenia, haemostasis and plasma leakage with a tendency to develop fatal shock (dengue shock syndrome).

Dengue infection can be also classified as primary and secondary infection. Due to four serotype dengue viruses, there is no cross-protection each other for each subtype, multiple infections are common in the infected patients. Infants or children dengue fever is usuauly present as primary infection;

Dengue IgM is usually detectable in primary infection between 5 to 7 days after fever, while dengue IgG appears after 7 days. Therefore, the appearance of dengue IgM or IgM/IgG is mostly found in the primary infection depending on the time window of test; while dengue IgG usually appears in the secondary infection in the early days of infection with or without dengue IgM. Based on the tests from different geographic regions, our dengue IgG/IgM test has the sensitivity with clear signal over 90% for all four dengue serotypes, and equal sensitivity tested in the different geographic region, the specifity is over 95%.

Dengue IgM/IgG rapid test cassette

 Early detection of Dengue IgM and Dengue IgG in serum or plasma for in vitro diagnostic use

 Each test kit contains:

 1. A sealed pouch

 2. Pouch contains one cassette test device

 3. One  plastic pipette

 4.  Each 25 tests with one 3 ml dropper bottle with  buffe

Stability and Storage Conditions

Dengue IgG/IgM test kit is stable at room temperature between 10-28°C for one and half year in the unopened pouches. DO NOT FREEZE the kit or expose to temperature extremes.

Limitation of the Test

This instruction should be followed carefully and performed properly. Dengue IgM/IgG test is designed to detect antibodies against Dengue virus in serum or plasma. Testing of any other body fluids has not been validated and may not yield appropriate results. For samples that test positive by Dengue IgM/IgG test, more specific confirmatory testing may be done. A clinical evaluation of the patient’s situation and history should also be made before a final diagnosis is  established.