Dengue Virus Testing - Quest Diagnostics

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Dengue virus is a flavivirus transmitted to humans by Aedes mosquitoes. An estimated 50-100 million infections occur annually throughout the world. Dengue virus primarily affects persons living in or traveling to tropical areas. Nearly all dengue cases reported in the 48 continental states were acquired elsewhere by travelers or immigrants, with sporadic cases reported along the southern U.S. border (eg, in Arizona, Texas, Florida) and in Hawaii.

Symptoms of dengue infection can range from mild febrile illness to bleeding (dengue hemorrhagic fever) or hypotension (dengue shock syndrome) with potentially high mortality. It is important to diagnose dengue promptly, since other tropical infections can produce similar patterns of illness and may require different treatment.

Dengue nonstructural protein 1 (NS1) is an antigen produced in abundance by the replicating dengue virus as early as the first day of symptoms and as late as day 18 of symptoms.1 NS1 can be detected in the blood sooner than IgM, which cannot be reliably detected until days 6 to 10.1

Detection of NS1 antigen allows an accurate diagnosis of current infection within the first week of illness (ie, during the febrile phase). Detection of IgM antibody, on the other hand, indicates possible current infection or recent infection (within the past 2 to 3 months).1 An acute and convalescent specimen is thus required to diagnose current infection. Additionally, the NS1 antigen is specific to dengue, whereas the antibody may cross react with other flaviviruses such as West Nile virus, St. Louis and Japanese encephalitis viruses, and yellow fever virus.1

Specimen collection requirements are the same as for the antibody test (ie, 1 mL of room-temperature serum). However, only 1 specimen collection is needed; ie, acute and convalescent specimens are not needed to make the diagnosis.

The company is the world’s best dengue rapid test supplier. We are your one-stop shop for all needs. Our staff are highly-specialized and will help you find the product you need.

Yes. The Dengue Fever Antibodies (IgG, IgM) and NS1 Antigen Panel (test code ) includes NS1 antigen and IgM and IgG antibody tests. The panel may be helpful for diagnosing dengue in certain patients. Diagnostic sensitivity during early dengue infection is higher when NS1 is combined with IgM—a significant number of patients will have measurable NS1 but no measurable IgM or IgG during the first week of illness.2,3

NS1 antigen may be ordered separately (test code ). An additional test, Dengue Virus RNA PCR (test code ), may also be useful to detect acute infection in the first five days of illness

There is no specific antiviral therapy currently available to treat dengue infection. Treatment is supportive, based on observation of hemorrhagic and circulatory abnormalities and laboratory test results (eg, electrolytes, platelets and hemoglobin).

Intended Use

Dengue Day 1 Test is a rapid solid phase immuno-chromatographic test for the qualitative detection of Dengue NS1 Antigen and differential detection of IgM and IgG antibodies to Dengue virus in Human serum/plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of Dengue infection & presumptive diagnosis between primary and secondary Dengue infection.

Salient Features

• First line testing kit for detecting dengue infection from day 1 using NS1 Antigen & differential detection of IgM & IgG Antibodies.
• Diagnosis of both Primary & Secondary Infection.
• Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4).
• Highly Sensitive & Highly Specific
• Long shelf life: 30 months at 2-30°C.
• Convenient pack sizes: 10 Tests, 30 Tests & 50 Tests.

Principle

Dengue Day 1 test kit consists of two devices: one device for detection of Dengue NS1 antigen and second device for the differential detection of Dengue IgM/IgG antibodies in Human serum/plasma. Dengue NS1 Antigen device contains two lines; ‘C’ (Control line) & “T” (Dengue NS1 Antigen test line). Test line is coated with anti-dengue NS1 Ag. When a sample is added to the device, Dengue NS1 antigen if present in the sample will bind to the anti-dengue NS1 gold colloidal conjugate making antigen antibodies complex. This complex migrates along the membrane to the test region and forms the visible pink line at “T” as antibody-antigen-antibody gold colloid forms. Dengue IgM/IgG test device contains three lines; “C” (Control line), “M”(IgM test line) & “G”(IgG test line).IgM test line is coated with anti-human IgM and IgG test line is coated with anti-human IgG.When a sample is added to the device, IgG and IgM antibodies in the sample react with anti-human IgM or IgG antibodies coated on the membrane respectively. Colloidal gold complexes containing dengue 1-4 antigens is captured by the bound anti-dengue IgM or IgG on respective test bands located in the test window causing a pale to dark red band to form at the IgG or IgM region of the test device window.

The intensity of the test bands in the respective device will vary depending upon the amount of antigen /antibody present in the sample. The appearance of any pink/ red colour in a specific test region should be considered as positive for that particular antigen and/or antibody type (IgG or IgM). A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.

Ordering Information

Product Name Pack Size Catalog No. Dengue Day 1 Test 10 Tests IR Dengue Day 1 Test 30 Tests IR Dengue Day 1 Test 50 Tests IR

Performance Characteristics (Internal Evaluation) Of Dengue Day 1 Test

Sample Type No. Of Samples tested Result of Licenced test Dengue NS1 Ag Dengue IgM/IgG Negative for Ag & Ab Dengue Antigen Positive 175 175 168 – Dengue IgM Positive 120 120 – 114 Dengue IgG Positive 79 79 – 75

Dengue NS1 Ag :
Sensitivity–96% and Specificity– 98%.

Dengue IgM/IgG Antibody test :
Sensitivity–95% and Specificity– 97%.

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