Testsealabs Dengue IgG/IgM+NS1 Combo Rapid Test Kit

Short Description:

Specimen volume:
Serum or Plasma Specimens for lgG/1gM Test5pl,for NS1 Test:75μL,or Whole Blood (Venipuncture/Fingerstick)Specimens:for lgG/lgM Test: 10 ul; for NS1 Test: 75 uL
Reading time: 10 minutes
Relative Sensitivity: for lgG/lgM test 95.7%
for NS1 test:95.8%
Relative Specificity: for lgG/lgM test>99.9%
For NS1test:96.2%
Accuracy: for lgG/lgM test99.3%
for NS1 test:96.1%


Product Detail

Product Tags

Intended Use

DengueIgG/gM/NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of lgG and IgM antibodies and non-structural protein antigen to Dengue virus in human whole blood,serum,or plasma as an aid in the diagnosis of Dengue infections.

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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.

Test Procedure

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Allow the test cassette, specimen, buffer, and/or controls to reach room temperature (15-30°℃) prior to testing
1.Bring the pouch to room temperature before opening. Remove the test cassette from the sealed pouch and use it within one hour
2. Place the test cassette on a clean and level surface
For Serum or Plasma Specimens:
To use a 5μL dropper for Dengue Ab: Hold the dropper vertically draw the specimen up to the Fill Line (approximately 5μL),and transfer the specimen to the S area(Marked S) of the test cassette, then add 1 drop of buffer (approximately 40μL) to the B area (Marked B) and start the timer. Avoid trapping air bubbles in the specimen well.
To use a 25μL dropper for Dengue Ag: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75μL) to the specimen area and then start the timer. See illustration below.
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a 5μL dropper for Dengue Ab: Hold the dropper vertically, draw the specimen about 1cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10μL) to the S area (Marked S) of the test cassette, then add 1 drop of buffer (approximately 40μL) to the B area (Marked B) and start the timer.
To use a 25μL dropper for Dengue Ag: Hold the dropper vertically and transfer 3 drops whole blood (approximately 75μL) to the specimen area, then add 1 drops of buffer (approximately 40μL). and start the timer. See illustration below.
To use a micropipette for Dengue Ab: Pipette and dispense 10μL of whole blood to the S area (Marked S) of the test cassette. then add 1 drop of buffer (approximately 40μL) to the B area (Marked B) and start the timer.
3. Wait for the colored line(s) to appear the fest result should be read at 10 minutes. Do not interpret the result after 20 minutes

Limitations

1. Dengue IgG/IgM/NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of Dengue antibodies and NS1 antigen in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Dengue antibody and NS1 antigen concentration can be determined by this qualitative test.

2. In the early onset of fever, anti-Dengue IgM concentrations may be below detectable levels. For primary infection, an IgM antibody-capture enzyme linked immunosorbent assay(MAC-ELISA) showed that 80% of the Dengue patients tested exhibited detectable levels of IgM antibody by the fifth day after infection, and 99% of the patients tested IgM positive by day 10.lt is recommended that patients be tested within this time. For the secondary Infection, a low molar fraction of anti- Dengue IgM and a high molar fraction of IgG that is broadly reactive to flavivirus characterize the antibodies. 5 The IgM signal may be faint and the cross reaction in the region of IgG line may appear.

3.Serological cross-reactivity across the flavivirus group (Dengue 1,2,3 & 4, St. Louis encephalitis, West Nile virus, Japanese encephalitis and yellow fever viruses) is common.6,7,8 Positive results should be confirmed by other means.

4.The continued presence or absence of antibodies and NS1 antigen cannot be used to determine the success or failure of therapy.

5.As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

6.lf the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of Dengue infection

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