Dengue Combo Rapid Test Cassette
(Whole Blood/Serum/Plasma)
Package Insert
English
For more information, please visit Accu-Tell.
A rapid test for a qualitative test
for the detection of NS1 antigen, IgG and IgM antibodies of dengue virus in human whole blood, serum
or plasma. For professional in vitro diagnostic use only.
INTENDED USE
The Dengue Combo Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of NS1
antigen and IgG and IgM antibodies of Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of Dengue infections.
SUMMARY
Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitoes. It is widely distributed throughout the tropical and
subtropical areas of the world,1 and causes up to 100 million infections annually.2 Classic Dengue infection is characterized by a sudden onset
of fever, intense headache, myalgia, arthralgia and rash.
Primary Dengue infection causes IgM antibodies to increase to a detectable level in 3 to 5 days after the onset of fever. IgM antibodies generally
persist for 30 to 90 days.3 Most Dengue patients in endemic regions have secondary infections,4 resulting in high levels of specific IgG
antibodies prior to or simultaneous with IgM response.5 Therefore, the detection of specific anti-Dengue IgM and IgG antibodies can also help
to distinguish between primary and secondary infections.
NS1 is one of 7 Dengue Virus non-structural proteins which are thought to be involved in viral replication. NS1 exists as a monomer in its
immature form but is rapidly processed in the endoplasmic reticulum to form a stable dimer. A small amount of NS1 remains associated with
intracellular organelles where it is thought to be involved in viral replication. The rest of NS1 is found either associated with the plasma
membrane or secreted as a soluble hexadimer. NS1 is essential for viral viability but its precise biological function is unknown. Antibodies
raised in response to NS1 in viral infection can cross react with cell surface antigens on epithelial cells and platelets and this has been
implicated in the development of Dengue Hemorrhagic fever.
The Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of Dengue antigen coated colored
particles for the detection of IgG and IgM Dengue antibodies in human whole blood, serum, or plasma.
The Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of Dengue antibodies coated colored
particles for the detection of Dengue NS1 antigen in human whole blood, serum, or plasma.
PRINCIPLE
The Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane- based immunoassay for the detection of
Dengue antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG
component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with Dengue antigen-coated particles in the
test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in
IgG test line region. If the specimen contains IgG antibodies to Dengue, a colored line will appear in IgG test line region. In the IgM
component, anti-human IgM is coated in IgM test line region. During testing, the specimen reacts with anti-human IgM. Dengue IgM antibodies,
if present in the specimen, reacts with the anti- human IgM and the Dengue antigen-coated particles in the test cassette, and this complex is
captured by the anti-human IgM, forming a colored line in IgM test line region.
Therefore, if the specimen contains Dengue IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains Dengue
IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain Dengue antibodies, no colored line will
appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear
in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane- based immunoassay for the detection of Dengue
NS1 antigen in whole blood, serum, or plasma. During testing, the specimen reacts with Dengue antibody-conjugate in the test cassette. The
Gold antibody conjugate will bind to Dengue antigen in the specimen sample which in turn will bind with Anti-Dengue NS1 coated on the membrane.
As the reagent moves across the membrane, the Dengue NS1 antibody on the membrane will bind the antibody-antigen complex causing pale or dark
pink line to form at the test line region of the test membrane. The intensity of the lines will vary depending upon the amount of antigen present
in the sample. The appearance of pink line in the test region should be considered as positive result.
REAGENTS
The Dengue IgG/IgM Rapid Test Cassette contains Dengue antigen conjugated gold colloid particles, anti-human IgM, anti-human IgG coated on
the membrane.
The Dengue NS1 Rapid Test Cassette contains anti-Dengue Ag conjugated colloid particles, anti- Dengue Ag coated on the membrane.
PRECAUTIONS
CATALOG
Product Name
Specimen
Catalog No.
Quantity per box
Certificate
Dengue IgG/IgM/NS1 Combo Cassette
Whole Blood/Serum/Plasma
ABT-IDT-B217
20T
CE
KEY POINTS
&#; Detection for: IgG and IgM antibodies and non-structural protein antigen to Dengue virus in human whole blood, serum, or plasma
&#; Specimen volume:
Serum or Plasma Specimens: for IgG/IgM Test: 5 μl, for NS1 Test: 75 μL
Whole Blood (Venipuncture/Fingerstick) Specimens: for IgG/IgM Test: 10 μl; for NS1 Test: 75 μL
&#; Reading time: 10 minutes
&#; Relative Sensitivity: for IgG/IgM test: 95.7%; for NS1 test: 95.8%
&#; Relative Specificity: for IgG/IgM test: >99.9%; for NS1 test: 96.2%
&#; Accuracy: for IgG/IgM test: 99.3%; for NS1 test: 96.1%
INTRODUCTION
Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitoes. It is widely distributed throughout the tropical and subtropical areas of the world, and causes up to 100 million infections annually. Classic Dengue infection is characterized by a sudden onset of fever, intense headache, myalgia, arthralgia and rash.
The Dengue Combo Rapid Test Cassette is a diagnostic tool designed to simultaneously detect multiple markers associated with dengue virus infection in a single test. It typically screens for both the dengue NS1 antigen and specific antibodies (IgM and IgG) against the dengue virus in human serum, plasma, or whole blood samples.
Here's how each component of the test works:
&#; NS1 Antigen Detection: The NS1 antigen is a non-structural protein that is present in the acute phase of dengue infection, usually during the first week. Its presence can indicate an early stage of dengue infection before antibodies have been produced.
&#; IgM Antibody Detection: IgM antibodies are typically the first type of antibody produced by the immune system in response to a new infection. The presence of dengue-specific IgM antibodies suggests a recent or current dengue infection.
&#; IgG Antibody Detection: IgG antibodies are produced later in the infection and remain in the body for longer periods. Their presence indicates a past exposure to the dengue virus, but it may also suggest a secondary dengue infection if detected alongside IgM antibodies.
The test cassette employs a lateral flow technology where the sample flows across a test strip coated with reagents. If the corresponding markers (NS1, IgM, and/or IgG) are present in the sample, they will bind to the specific reagents and produce colored lines at the designated test areas on the cassette. A control line should also appear to confirm that the test has functioned correctly.
The Dengue Combo Rapid Test Cassette offers the advantage of providing comprehensive information about the infection status in a short time, typically within 15 to 20 minutes. It is particularly useful in areas where dengue is prevalent and during outbreaks when quick diagnosis is critical for patient management and public health control measures. However, as with any rapid test, it should be used in conjunction with clinical symptoms and possibly confirmed with more definitive laboratory tests.
INTENDED USE
Accu-Tell® Dengue IgG/IgM/NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG 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.
TEST PROCEDURE
Allow the test cassette, specimen, buffer, and/or controls to reach room temperature (15-30°C) 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.
Contact us to discuss your requirements of dengue rapid test. Our experienced sales team can help you identify the options that best suit your needs.
To use a 25ul 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 test result should be read at 10 minutes. Do not interpret the result after 20 minutes.
PERFORMANCE CHARACTERISTICS
Sensitivity and Specificity
Accu-Tell® Dengue IgG/IgM/NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial Dengue ELISA test.The results show that the overall relative sensitivity for the primary and secondary infection of Accu-Tell® Rapid Dengue IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) is 95.7% , and the relative specificity is >99.9%,and the relative accuracy is 99.3%, and for the Accu-Tell® Rapid Dengue NS1 Test Cassette (Whole Blood/Serum/Plasma) is 95.8%,and the relative specificity is 96.2%, and the accuracy is 96.1%.
Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of five specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive, NS1 positive. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 15 independent assays on the same five specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive, NS1 positive. Three different lots of ACCU-TELL® Dengue IgG/IgM/NS1 Cassette (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.
Cross-reactivity
Accu-Tell® Dengue IgG/IgM/NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, HCV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.
Interfering Substances
The following potentially interfering substances were added to Dengue negative and positive specimens.
Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL
Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL
Ascorbic Acid: 2g/dL Albumin: 2 g/dL
Creatin: 200 mg/dL Hemoglobin mg/dL
Bilirubin: 1g/dL Oxalic Acid: 600mg/dL
None of the substances at the concentration tested interfered in the assay.
LIMITATIONS
1.Accu-Tell® Dengue IgG/IgM/NS1 Combo 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. It 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. If 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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