Appearance of three pinkish purple LIMITATIONS

one each at M, G and Control 1. The Dengue IgG/IgM Antibody Detection Test kit
reason (C)indicates that the sample (Seum/Plasma/Whole Blood) is for in vitro diagnostic use
M
G

is “POSITIVE”for Dengue IgG & only. The test should be used for the detection of Dengue
IgM Antibodies. antibodies in serum, plasma or whole blood specimens only.
INVALID
2. For more accuracy of immune status, additional follow-up
The presence of 1 pinkish purple testing using other laboratory method is recommended.
colored line at G “INVALID”. 3. The continued presence or absence of antibodies cannot
M
G

be used to determine the success or failure of therapy.

The presence of 1 pinkish purple
4. Results from immunosuppressed patients should be
colored line at M “INVALID”.
M
G

interpreted with caution.

The presence of 2 pinkish purple 5. As with all diagnostic tests, all results must be interpreted
colored line at G & M “INVALID”. together with other clinical information available to the
M
G

physician.
The presence of no pinkish purple 6. If the test result is negative and clinical symptoms persist,
colored line a “INVALID”. additional testing using other clinical methods is
M
G

recommended. A negative result does not at any time

*Above shown cassettes are diagrammatic illustration only , actual product may vary. preclude the possibility of Dengue infection.
7. Neither the quantitative value nor the rate of anti-Dengue
IgM/IgG concentration can be determined by this qualitative
PERFORMANCE CHARACTERISTICS test.

The Sensitivity and Specicity of Dengue IgG/IgM

Antibody Rapid test kit was observed with 200 BIBLIOGRAPHY Dengue IgG/IgM
tests. It was found 98% sensitivity and 97% 1. Price DD, Wilson SR, Dengue Fever, e-medicine,
specicity. The results are summarized below: http://www.emedicine.com/EMERG/topic124.htm, Antibody Detection Test
Jan,2002.
Total no. of
Samples
Dengue IgG/IgM
Antibody Rapid Test Kit Sensitivity Specicity
2. Innis BL, and Nisalak A, et al. An enzyme-linked Kit
Sample tested
Negative (%) (%) immunosorbent assay to characterize dengue infections
Positive
Dengue IgM
where denude and Japanese encephalitis co-circulate. Am. Instruction For Use
Positive Samples 60 58 2 98 ---- J. Trap. Med. Hygiene. 1989: 40: 418-427.
Dengue lgG
3. Anonymous. Dengue hemorrhagic fever:
40 37 3 97 ----
Positive Samples diagnosis,treatment, prevention and control. 2nd ed.
Dengue lgG
Negative Samples 100 0 100 ---- 100 Geneva: World Health Organization, 1997. Rapid test for Differential
Total 200 100 100 ---- ----
Detection of Dengue IgG/IgM
INDEX OF SYMBOLS
Antibody in Human Serum /
Single Use Only Manufacturer For In Vitro Diagnostic Use
Plasma / Whole Blood
Temperature Limitation LOT LOT / Batch Number Keep away from Sunlight

Do not use if package is Expiry

damaged

Read Instruction Manual Keep it dry

before performingg test
INTRODUCTION If the specimen does not contain Dengue antibodies, no 3. Serum: Collect the whole blood into a collection tube
Dengue IgG/IgM Antibody detection test kit is a solid phase colored line will appear in either of the test line regions, containing no anticoagulants. Allow the blood to clot.
immuno-chromatographic assay for the rapid, qualitative, indicating a negative result. The Pinkish purple line at the Separate the serum by centrifugation, 1500 rpm for 10 min.
and differential detection of IgG and IgM antibodies to control region should always appear if the buffer is performing Carefully withdraw the plasma into a new labeled tube.
dengue virus in human serum, plasma, or whole correctly. To serve as a procedural control, indicating that the 4. Test the specimens as soon as possible after collection.
blood.Dengue is an infectious disease caused by dengue proper volume of specimen has been added and membrane 5. Store whole blood specimen at 2-8°C upto 3 days, can be
virus which is a RNA virus belonging to the genus Flavivirus. wicking has occurred. used for testing. Serum/ plasma specimens should be
The major complications are high grade fever, frozen at -20°C for storage longer then 2 weeks.
haemorrhage and low platelets count. The virus is
MATERIALS SUPPLIED
transmitted by the Aedes asgypti mosquitoes which bite 1.Test Device with silica gel 2.Assay Buffer Bottle
3. Sample applicator 4.IFU TEST PROCEDURE
during the day and lay eggs in articial water containers.
The immune response includes IgM antibodies produced on 1: Bring the test device and sample at room temperature
the 3rd to 5th day of symptoms and persist for 30 to 60 days. MATERIALS REQUIRED NOT PROVIDED (20-30°C).
IgG appear on the 14th day and persist for life. Secondary 1. Timer 2. Disposable gloves 2: Open the pouch at the notch and remove the device.
infections often result in high fever and in many cases with
Place the test device on a clean, at surface.
hemorrhagic events and circulatory failure. Secondary STORAGE AND STABILITY:
infections show that IgG rise within 1 to 2 days after the 3. Add 1 Drop approx. (10μL) serum/plasma or whole
1. The kit should be store in sealed pouch in a dry place in
onset of symptoms and induce IgM response after 20 days blood sample, and 2 Drops of Assay buffer into the
between temperature 2° to 40°C. Do not freeze.
of infection. sample well.
2. It must be protected from exposure to humidity.
3. Materials are stable until the expiration date printed on 4. Set up the timer.
INTENDED USE the box. 5. Read the result in 15-20 minutes. Do not interpret the
Dengue IgG/IgM Antibody detection test (Serum/
Plasma or Whole Blood) is a rapid chromatographic result after 20 minutes.
immunoassay for the qualitative detection of IgG and PRECAUTIONS
IgM antibodies to in human whole blood, serum, or 1. For In Vitro use only. Do not reuse the test device.
plasma as an aid in the diagnosis of primary and 2. Please read all the information in this package insert be
secondary Dengue infections. This test is for in-vitro fore performing the test.

M
G
C

M
G
C

M
G
C
1Drop (10µL) serum/plasma 2 Drops of Assay buffer. 15-20 min
diagnostic use only 3. Do not use the kit after expiry. or whole blood sample.

4. Used disposable gloves while handling potentially

PRINCIPLE infectious samples and performing the assay. Wash hand
INTERPRETATION OF RESULT
Dengue IgG/IgM Antibody detection test has IgG, IgM and thoroughly afterwards.
control line are immobilised on the Nitrocellulose 5. Do not use if pouch is torn and damaged. NEGATIVE Appearance of only one pinkish
membrane. In the IgM component, anti-human IgM is 6. Decontaminate and dispose of all specimens, reaction purple coloured line at Control
coated in test line region (IgM) of the test. During testing, if waste in a biohazard chamber. reason ( C )indicates that the sample

C
the Dengue IgM antibodies present in the specimen, react 7. Do not mix reagents from different batches. Is “NEGATIVE” for Dengue IgG/IgM
with the Dengue antigen-coated particles in the test strip,
8. Do not open the foil pouch until it attains room
and this complex is captured by the anti-human IgM, POSITIVE Appearance of two pinkish purple
forming a colored line in test line region (IgM). In the IgG temperature. one each at M and Control reason (C)
component anti-human IgG is coated in test line region indicates that the sample is
SPECIMEN COLLECTION AND STORAGE

C
(IgG) of the test. During testing, the specimen reacts with “POSITIVE” for Dengue IgM
Dengue antigen-coated particles in the test strip. The 1. Whole Blood: Collect the whole blood into a collection Antibodies.
mixture then migrate upward on the membrane tube (containing EDTA, Citrate or Heparin) by venipuncture. Appearance of two pinkish purple
chromatographically by capillary action and reacts with the 2. Plasma: Collect the whole blood into a collection tube one each at G and Control reason( C )
anti-human IgG in test line region (IgG). If the specimen containing EDTA, Citrate or Heparin. Separate the plasma indicates that the sample Is
contains IgG antibodies to Dengue, a colored line will by centrifugation, 1500 rpm for 10 min. Carefully withdraw “POSITIVE” for Dengue IgG

C
appear in test line region (IgG) the plasma into a new labeled tube. Antibodies.