Dengue Duo Rapid Test

Rapid Dengue Duo Test

(IgG+IgM)A Rapid qualitative Immunochromatographic test

for the simultaneous detection of IgG and IgM Antibodies to Dengue Virus in Human Serum,

Whole Blood or Plasma

DENGUE VIRUSMost common arthropod-borne disease worldwide with an

increasing incidence in the tropical regions

Can be life-threatening

Caused by 4 closely related serotypes (serotypes 1-4)

Genus Flavivirus, Family Flaviviridae

Transmitted by Aedes aegypti and Aedes albopictus mosquitoes

“Breakbone" or “Dandy fever."

DENGUE VIRUS

Infection confers life long immunity

But cross protection between serotypes is of short duration.

Reinfection with different serotype after primary attack is more dangerous causes Dengue

Hemorrhagic Fever.

Aedes albopictusAedes aegypti

Urban dengue “Tiger mosquito” Breeds in clear water stored indoor and

outdoor containers such as old tires, vases, jars and bottles

Rural dengue Breeds in clear water stored indoor and

outdoor containers such as bamboo stumps, empty coconut shells, and tree holes.

SIGNS AND SYMPTOMS Malaise Severe headache High fever and chills Severe back ache, joint

pains, muscular pain

SIGNS AND SYMPTOMS

Temperature may persist for 3 -5 days.

On some occasions once again raises in about 5 – 8 days ( Saddle back fever )

Nausea, vomiting and diarrhea

Red eyes, pain in the eyes

SIGNS AND SYMPTOMS

Biphasic pattern- fever lasts about two to seven days, with a smaller peak of fever at the trailing end of the disease.

Clinically, the platelet count will drop until the patient's temperature is normal.

DENGUE HEMORRHAGIC FEVER

Severe, potentially

deadly infection spread by

certain species of mosquitoes

(Aedes aegypti).

Common in children.

In other ( Adults ) the presence of antibodies

due to previous infection with

different serotype

Initially presents like

classical Dengue infection

DENGUE HEMORRHAGIC FEVER

Symptoms

similar to those of dengue fever, but after several days the patient becomes irritable, restless, and sweaty. These

symptoms are followed by a shock -like state.

PATHOGENESIS

Presence of existing Dengue antibody, associated with fresh viral infection with new serotype complexes and forms within few days of the second dengue infection.

Non neutralizing enhancing antibodies promote infection of higher number of Mononuclear cells.

DIAGNOSISPrimary infection- patients diagnosed with dengue infection in non- endemic areas.

Secondary infection- patients diagnosed with dengue infection in endemic areas.

Hemorrhagic tendency

Thrombocytopenia

Evidence of plasma leakage

Encephalitic occurrences

TREATMENTNo Anti viral therapy available

No Vaccine available

Symptomatic management in majority of cases

Dengue Hemorrhagic fever to be treated with suitable fluid replacement

Increased oral fluid intake is recommended to prevent dehydration.

Supplementation with intravenous fluid may be necessary.

platelet transfusion

RAPID DENGUE DUO TEST

PRINCIPLESUBSTANC

E DETECTED

SAMPLE PORT TEST AREA CONTROL

AREA

Human IgG and IgM

antibodies against Dengue

Virus

Colored- Dengue specific

recombinant antigen-

colloidal gold

conjugate

Specific Human IgG

and IgM binding proteins

Anti-rabbit Ig

antiserum


Reagents and Materials Supplied

1. FirstSign™- Dengue Duo(WB) Test Card: 25 Individually pouched Card tests with a dessicant pouch and a Sample loop2. Running Reagent – 1 bottle3. Product Insert


Storage and Stability

The sealed pouches in the test kit and the kit

components

4-30˚C

Testing Procedure

Once the pouch is opened and the card is retrieved, it must be used immediately.

Kit Component

s

Room temperatur

e

Label the card with patient’s

identity



5µl of serum/plasma or

whole blood

micropipette

Sample port A

5µl sample loop

kit

Dip the loop into the sample

Blot into the sample

port “A”

Important!

loop does not retrieve

clots or debris from the sample


4 drops of the Running

Reagent

Reagent port “B”

Read the results after 15 minutes

INTERPRETATION OF RESULTS

Negative result:• The presence of only the single

red/purple colored band in the control window “C” indicates the absence of specific antibodies against Dengue virus or the amount of antibodies is below the detection limit of the test.


Positive result: IgG and IgM• Appearance of two red/purple colored

bands in the test window at region ‘M’ and region ‘G’

• Presence of Dengue virus specific IgM and IgG antibodies

• Acute secondary infection

Positive result: IgM• Appearance of red/purple colored band

in the test window at region ‘M’• Presence of Dengue virus specific IgM

antibodies• Acute primary infection


Positive Result: IgG• Appearance of red/purple colored band in

the test window at region ‘G’• Presence of Dengue virus specific IgG

antibodies• Acute secondary infection


Invalid result• If after 15 minutes no band is visible

either in the test or control window• The test should be repeated with a

new test card


LIMITATION

Limited to the detection of antibodies against Dengue viruses in serum/ plasma.

Test should be repeated with fresh collected samples if negative results were achieved while clinical symptoms are indicative of Dengue virus.

LIMITATION

A definitive clinical diagnosis should not be based on the results of a single test but should rather be made by a clinician after all clinical findings have been evaluated.

Repeatable reactive specimens should be conformed by another qualified test.

Documents

Dengue Duo Rapid Test