DENGUE NS1-IgM / IgG Rapid Test Whole Blood / Serum Lateral Flow Immunoassay

INTENDED USE

The Dengue Ag NS1-IgM/IgG rapid test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti– dengue virus, IgM anti-dengue virus and dengue antigen (Dengue Ag) in human serum, plasma or whole blood. It is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with dengue virus. Any reactive specimen with the Dengue Ag NS1-IgM/IgG rapid test must be confirmed with alternative testing method(s). Dengue virus is an enveloped, single-stranded, positive-sense RNA virus that comprises four related but distinct serotypes (Den 1, 2, 3, and 4). The virus is transmitted by mosquitoes of the daytime-biting Stegomyia 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 basis. Serological detection is a common method for the diagnosis of infection with dengue virus. IgM anti-dengue virus starts to appear at 3 days after initial exposure and remains in circulation for about 30-60 days. IgG anti-dengue virus is raised at around 7 days, peaks at 2-3 weeks and persists for the duration of life4-6. Detection of antigens released during virus replication in the infected patient show very promising results; 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, allowing early detection and prompt treatment. The Dengue Ag NS1-IgM/IgG rapid test detects IgG and IgM anti-dengue virus and circulating dengue antigen in one test within 20 minutes. The test is user friendly, does not require cumbersome laboratory equipment and requires minimal staff training.

 

Features:

• Product Name: DENGUE NS1-IgM/IgG Rapid test
• Shelf Life: 24 Months
• Manufacturer: Biovantion
• Format: Kit
• Sample Type: Serum, Plasma
• Specificity: High

 

 

STORAGE AND STABILITY

All reagents are ready to use as supplied. Store unused test device unopened, preferably at 2°C-30°C. Do not expose the kit over 40°C. Do not freeze the kit. The positive and negative controls should be kept at 2°C-8°C. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch if it is stored at 2°C-30°C.

TEST PROCEDURE

Step 1: Bring the specimen and test components to room temperature, if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: Be sure to label the device with specimen’s ID number. For detection of Dengue IgG/IgM or Dengue AgNS1 For serum or plasma specimen : Hold the dropper vertically and transfer 3 drops of serum or plasma (appoximately 100μl) to the specimen well(s) of the test device, then start the timer. For whole blood specimen : Hold the dropper vertically and transfer 1 drops of whole blood (appoximately 35μl) to the specimen well(s) of the test device, then add 2 drops of buffer (appoximately 70μl) and start the timer. For detection of Dengue AgNS1 For serum or plasma specimen : Hold the dropper vertically and transfer 3 drops of serum or plasma (appoximately 100μl) to the specimen well(s) of the test device, then start the timer. For whole blood specimen : Hold the dropper vertically and transfer 1 drops of whole blood (appoximately 35μl) to the specimen well(s) of the test device, then add 2 drops of buffer (appoximately 70μl) and start the timer.

Step4: Set up timer.

Step5: Results can be read after 20 minutes. Do not read result after 30 minutes. To avoid confusion, discard the test device after interpreting the result.

 

PRECAUTIONS

 

For in vitro diagnostic use and professional use only. Read the package insert instruction before use the kit. Do not use beyond the expiration date which appears on the package label. Do not open the sealed pouch, unless ready to conduct the assay. Bring all reagents to room temperature (15°C-30°C) before use. Do not use the components in any other type of test kit as a substitute for the components in this kit. Haemolized blood may be used for the testing, but do not take precipitants. Wear protective clothing and disposable gloves while assaying samples. Wash hands thoroughly after performing the test. Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving them for at least one hour. Alternatively, they can be treated with 0.5 to 1% solution of sodium hypochlorite for one hour before disposal. 10) Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled  

Support and Services:

The Assay Procedure and Interpretation of Assay Result sections must be followed closely when testing for the presence of antibodies to dengue virus and dengue Ag in serum, plasma or whole blood from individual subjects. Failure to follow the procedure may give inaccurate results. The Dengue Ag NS1-IgM/IgG rapid test is limited to the qualitative detection of antibodies to dengue virus and dengue Ag in human serum, plasma or whole blood. The intensity of the test line does not have a linear correlation with the antibody and Ag titers in the specimen. The Dengue Ag NS1-IgM/IgG rapid test can not be used to differentiate whether the infection is primary or secondary. No information about dengue serotypes can be provided with this test. Serological cross-reactivity with other flaviviruses is common (e.g., Japanese encephalitis, West Nile, yellow fever, etc.), therefore, it is possible that patients infected with these viruses may show some level of reactivity with this test.A negative or non-reactive result for an individual subject indicates absence of detectable dengue virus antibodies or antigen. However, a negative or non-reactive test result does not preclude the possibility of exposure to or infection with dengue virus.