Dengue Virus

Serology
Testing
40% of the world’s population is at risk of dengue infection

Focus Diagnostics has been a leader in the development of infectious disease

immunology assays for more than 25 years. Our Dengue DxSelect™ and Dengue
Dx™ Rapid tests reflect the tradition of quality, reliability and consistency expected
by our customers around the world.

Dengue fever (DF) is the most prevalent mosquito-borne viral illness in the world –
endemic in more than 100 countries, with 2.5 billion people at risk for transmission.
The CDC estimates that there are 50 to 100 million cases of DF and several
hundred thousand cases of dengue hemorrhagic fever (DHF), causing more than
25,000 deaths annually. DF and DHF are most prevalent in tropical and subtropical
areas where there is limited public health infrastructure for mosquito control: Africa,
Asia, Mexico, and Central and South America.
 Dengue Virus Serology Testing

Dengue Serology Testing

Dengue viruses are comprised of four closely related serotypes: DEN-1,
DEN-2, DEN-3, and DEN-4. Infection with one serotype does not provide
Dengue is spread by the
protective immunity to the others, and a secondary infection is more likely Aedes aegypti mosquito,
to result in dengue hemorrhagic fever (DHF). a day-biting mosquito that
prefers to feed on humans
and breeds in standing
The onset of dengue symptoms is marked by the presence of dengue NS1 water.

antigen in the patient’s serum. NS1 is a glycoprotein that is common to all In Asia, dengue is spread
from the Aedes albopictus,
dengue serotypes and can be used to detect either primary or secondary
which has similar breeding
infections in the earliest stages. Serology testing for dengue virus-specific and feeding habits to the
antibodies, types IgG and IgM, can be useful in confirming primary or Aedes aegypti mosquito.

secondary diagnosis. IgM is produced approximately 5 days after infection in

both primary and secondary infections, while IgG is produced about 2 to 4
weeks after onset of primary infection and almost immediately after onset of a
secondary infection.
 Dengue Virus Serology Testing

Dengue Virus IgG and IgM Capture DxSelect™ ELISA Kits

The Dengue DxSelect™ IgM Capture and IgG ELISA kits are designed for optimal performance and
cost efficiency. Each kit utilizes inactivated dengue virus types 1-4 and contains 96 breakaway wells
to give laboratories the flexibility to set up runs based on volume requirements, improve turnaround
time with reduced incubation requirements, and eliminate sample pre-treatment.

Dengue Virus IgG DxSelect™ Performance Summary

Sensitivity and specificity for the Dengue Virus IgG DxSelect™ ELISA kit was assessed through well
characterized sera. This sera was drawn from patients exhibiting dengue fever (DF) or dengue hemorrhagic
fever (DHF) symptoms within 1 to 16 days of onset and were previously confirmed as infected with dengue
virus by ELISA, hemagglutination inhibition (HI), and/or PCR.

Dengue Virus IgG DxSelect™ ELISA Sensitivity Dengue Virus IgG DxSelect™ ELISA Specificity
Condition Sensitivity 95% CI Condition Specificity 95% CI
DF 98% (49/50) 89.4 - 99.9% Overall 93% (253/271) 89.7 - 96.0%
DHF 93% (27/29) 77.2 - 99.2%

Overall 96% (76/79) 89.3 - 99.2%

Dengue Virus IgM Capture DxSelect™ Performance Summary

Sensitivity and specificity for the Dengue Virus IgM Capture DxSelect™ ELISA kit was assessed through well
characterized sera. This sera was drawn from patients exhibiting dengue fever (DF) or dengue hemorrhagic
fever (DHF) symptoms within 1 to 16 days of onset and were previously confirmed as infected with dengue
virus by ELISA, hemagglutination inhibition (HI), and/or PCR.

Dengue IgM Capture DxSelect™ ELISA Sensitivity

Dengue IgM Capture DxSelect™ ELISA Sensitivity With Primary, Secondary, and Old Infection Sera*
Condition Sensitivity 95% CI Condition Sensitivity 95% CI
DF 96% (48/50) 86.3 - 99.5% Low IgM 97% (29/30) 82.8 - 99.9%
DHF 96% (25/26) 80.4 - 99.9% Primary Infection 100% (10/10) 69.2 - 100%
Overall 96% (73/76) 88.9 - 99.9%
Secondary Infection 90% (9/10) 55.5 - 99.8%

Old Infection 7% (1/14) 0.2 - 33.9%

Dengue IgM Capture DxSelect™ ELISA Specificity Overall excluding

96% (48/50) 86.3 - 99.5%
Old Infection
Condition Specificity 95% CI
Overall 77% (49/64) 64.3 - 86.2%
Overall 97% (296/306) 94.1 - 98.4%
*The overnight incubation method was used to perform the assay.
 Dengue Virus Serology Testing

Dengue Dx™ Rapid Tests

The Dengue Dx™ NS1 Antigen and IgG/IgM Rapid tests detect primary or secondary infections in 15
minutes using whole blood, plasma, or serum samples. These easy-to-use rapid strip tests detect all
four dengue serotypes and are practical for both point of care and laboratory testing.

Dengue Dx™ Test Interpretation

A positive result will not change once it has been established within 15-20 minutes. In order to prevent
incorrect results, test results should not be interpreted after 20 minutes.

Days After Onset 1-7 Days 8-14 Days All

NS1 Antigen + + – or + – or + –
IgG/IgM –/+ +/– +/+ +/– –/–
Primary Secondary Primary Secondary No dengue
Interpretation
Infection Infection Infection Infection infection

Dengue Dx™ Performance Summary

The Dengue Dx™ IgG/IgM test was compared to the hemagglutination inhibition (HI)
test and showed good correlation. Specimens used in the Dengue Dx™ NS1 Antigen
Rapid test were confirmed with Dengue RT-PCR and/or Viral Culture.

Dengue Dx™ IgG/IgM Rapid Test

Dengue Dx™ RT-PCR and Viral Culture
Specificity
IgG/IgM Positive Negative
POSITIVE 93 9 91.2%

NEGATIVE 20 180 90%

Dengue Dx™ NS1 Antigen Rapid Test

Dengue Dx™ RT-PCR and Viral Culture
Specificity
NS1 Antigen Positive Negative
POSITIVE 104 3 92.8%

NEGATIVE 8 186 98.4%

 Dengue Virus Serology Testing

Dengue DxSelect™ and Dengue Dx™ Kits Detect All Stages of Infection
NS1 Antigen
Primary Infection Secondary Infection Common to all dengue serotypes and can be used
to detect either primary or secondary infections.
Antigen & Antibody Level

IgG
Primary Infection
IgM antibodies appear approximately 5 days after the
onset of symptoms, followed by IgG at about 14 days
post-onset. IgM levels peak after 1 to 2 weeks, but
NS1 Ag NS1 Ag
IgG
may be elevated for 2 to 3 months after illness.

Secondary Infection
IgM IgM IgG rises rapidly within 1 to 2 days of symptoms and
often exceeds previous levels; IgM may not appear
for up to 20 days and may be undetectable in 20-30%
Onset of symptoms Onset of symptoms
of secondary infections.

Ordering Information
Catalog Number Description Quantity

EL1500G CE Dengue Virus IgG DxSelect™ 96

EL1500M CE Dengue Virus IgM Capture DxSelect™ 96

RT1510 CE Dengue Dx™ NS1 Antigen Rapid Test 25

RT1500GM CE Dengue Dx™ IgG/IgM Rapid Test 25

Learn more about our products on our Web site: www.focusdx.com

For additional information contact Focus Diagnostics Customer Service at:

+1-562-240-6500 or fax +1-562-240-6510.

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DxSelect are the trademarks of Focus Diagnostics.
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