The Dengue IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) is based on
Fluorescence Immunoassay for in vitro detection of Dengue IgG and IgM antibodies in
human whole blood, serum, or plasma. It is intended to aid in the rapid 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.
The Dengue IgG/IgM 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.
【PRINCIPLE】
The Dengue IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) is a membrane
based fluorescence immunoassay for the detection of Dengue antibodies in whole
blood, serum, or plasma. The sample moves through the strip from sample pad to
absorbent pad. If the specimen contains Dengue IgG or/and IgM, it attaches to the
fluorescent microspheres-conjugated Dengue antigen. Then the complex will be
captured by the capture anti-human IgM or/and anti-human IgG coated on the
nitrocellulose membrane (Test line). The concentration of Dengue IgG or/and IgM in
the sample correlates with the fluorescence signal intensity captured on the T line,
testing result of Dengue IgG or/and IgM will display on the Novatrend Plus Fluorescence
Immunoassay Analyzer screen.
【REAGENTS】
The test cassette contains Dengue antigen conjugated fluorophores and anti-human
IgM, anti-human IgG coated on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if
the foil pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled.
Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout the procedure and follow
standard procedures for proper disposal of specimens. Wear protective clothing such
as laboratory coats, disposable gloves and eye protection when specimens are
assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The Novatrend Plus Dengue IgG/IgM Test Cassette should only be used with the
Novatrend Plus Analyzer by approved medical professionals.
【STORAGE AND STABILITY】
1. The kit should be stored at 4-30 °C until the expiry date printed on the sealed
pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination. Do
not use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false
results.
【SPECIMEN COLLECTION AND PREPARATION】
Preparation
Before performing the test, please make sure that all components are brought to room
temperature (15-30 °C). Cold buffer solution or moisture condensation on the
membrane can lead to invalid test results.
Sample Handling
1. Collect the specimen according to standard procedures.
2. Do not leave specimens at room temperature for prolonged periods. Serum/Plasma
specimens may be stored at 2-8 °C for up to 3 days, for long term storage,
specimens should be kept below -20 °C. Whole blood collected by venipuncture
should be stored at 2-8 °C if the test is to be run within 2 days of collection. Do not
freeze whole blood specimens. Whole blood collected by finger stick should be
tested immediately.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and
thawing of specimens.
4. EDTA K2, Heparin sodium, Citrate sodium and Potassium Oxalate can be used as
the anticoagulant for collecting the specimen.
【MATERIALS】
Materials Provided
• Test Cassettes
• ID Card
• Specimen Collection Tubes with dilution buffer
• Package Insert
Materials Required But Not Provided
• Timer
• Centrifuge • FIATESTTM Fluorescence Immunoassay Analyzer
• Pipette • Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to FIATESTTM Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions on use of the Test. The test should be conducted in room
temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-
30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “standard test” or
“Quick test” mode.
2. Take out the ID card and insert it into the Analyzer ID Card Slot.
3. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
Best results will be obtained if the assay is performed immediately after opening the
foil pouch.
4. Transfer 5μl specimen into the buffer tube with pipette; mix the specimen and the
buffer well.
5. Add 75μl diluted specimen into the sample well of the test cassette. Start the
timer at the same time.
6. There are two test modes for Novatrend Plus Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of
Novatrend Plus Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: After 15 minutes of adding sample, Insert the test cassette into
the Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST"
immediately. The Analyzer will automatically give the test result after a few
seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
adding specimen, click “STANDARD TEST”, fill the test information and click "NEW
TEST" at the same time, The Analyzer will automatically countdown 15 minutes.
After the countdown, the Analyzer will give the result at once.
