Dengue NS1 Ag Rapid Test Uncut sheet(Strip/Cassette)

INTENDED USE

The One Step Dengue NS1 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of dengue virus NS1 antigen in serum or plasma and whole blood to aid in the diagnosis of Dengue viral infection.

SUMMARY

Dengue is transmitted by the bite of an Aedes mosquito infected with any one of the four dengue viruses. It occurs in tropical and sub-tropical areas of the world. Symptoms appear 3—14 days after the infective bite. Dengue fever is a febrile illness that affects infants, young children and adults. Dengue haemorrhagic fever (fever, abdominal pain, vomiting, bleeding) is a potentially lethal complication, affecting mainly children. Early clinical diagnosis and careful clinical management by experienced physicians and nurses increase survival of patients. One step Dengue NS1 Ag Test is a simple, visual qualitative test that detects dengue virus NS1 antigen in human serum or plasma. The test is based on immunochromatography and can give a result within 15 minutes.

PRINCIPLE OF THE PROCEDURE

The One Step Dengue NS1 Ag Test is a qualitative membrane strip based immunoassay for the detection of dengue virus NS1 antigen in serum or plasma and whole blood. In this test procedure, anti-Dengue NS1 antibody is immobilized in the test line region of the device. After a Serum or plasma or blood specimen is placed in the specimen well, it reacts with anti-Dengue NS1 antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-Dengue NS1 antibody. If the specimen contains dengue virus NS1 antigen, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain dengue virus NS1 antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred..

REAGENTS AND MATERIALS SUPPLIED

1.Test cards/ test strips individually foil pouched with a desiccant

2.Sample diluent

3.Package Insert

MATERIALS REQUIRED BUT NOT PROVIDED

1.Timer

2.Centrifuge

3.Specimen Collection Containers

RAGE AND STABILITY

1.Store unused kit at 2 - 30°C.

2.Store test cards/strips at 2 - 30°C and away from direct sunlight.

WARNINGS AND PRECAUTIONS

1.For professional in vitro diagnostic use only. Do not use after expiration date.

2.Do not eat, drink or smoke in the area where the specimens and kits are handled.

3.Handle all specimens as if they contain infectious agents.

4.Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

5.Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

6.Follow standard biosafety guidelines for handling and disposal of potential y infective material.

7.Humidity and temperature can adversely affect results