What is Dengue?Dengue is a mosquito-born infection with symptoms

similar to those of Malaria, that typically occurs in trop-

ical and/or sub-tropical areas such as Africa or Asia and

Latin American countries. In the past years Dengue

became a global threat by expanding from beforemen-

tioned areas to the US and Europe. In 2012, the islands

of Madeira in Portugal were challenged by an outbreak

of the disease with more than 2.000 reported cases.

Currently, according to WHO estimations, more than

2.5 billion persons or 40% of the global population is at

risk for a Dengue infection, 50–100 million cases are re-

ported annually, the disease is endemic in 100 countries.

Although there is no vaccine or specific treatment to an

infection with Dengue fever, it is massively important to

immediately get medical care by healthcare profession-

als once you received the diagnosis. This reduces the

mortality risk noticeably.

Typical Symptoms Sudden high fever, headaches, pain behind the eyes, joint

and muscle pain

Diagnosis by Besurence Besurence Dengue is a reliable diagnostic test kit for a

first dignosis of an eventual Dengue infection. The test

can be used without any additional laboratory equip-

ment, hence can be performed anywhere at all times

and indicates the result immediately.

Besurence Dengue – 15 minutes that can save your life

99.3%ACCURACY

MADE IN AUSTRIA

15MIN

professional use

Test Procedure1. Get your

blood sample. 2. Add your sample and the provided diluent to the

sample well of the test cassette.3. Wait 5–15

minutes.4. Read results.

S

T

C

10 s

10 s

Positive

pregnancy

Negative Invalid

T

C

T

C

T

C

T

C

S

T

C

10 AM – 8 PM

ovulation

dengue

5 min

5 min

15 min

Positive Negative Invalid

T

C

T

C

T

C

T

C

T

C

T

C

DV IgM Positive

C T2 T1

DV IgG Positive

Negative

Invalid

DV IgM Positive

malaria

3 drops into the „S“ well

gluten

Positive

Negative

Invalid

5 minT C

T C

T C

S T C

helicobacter pylori

HIV

5µl finger-tip blood into the „S“ well

3 drops of sample diluent into the „D“ well

15 min

S

5 µl

step 1

step 2

3 ×

D

PF Positive

C T2 T1

PV Positive

Negative

Invalid

PF & PV Positive

Invalid

1 ml finger-tip blood into the „S“ well

2 drops of sample diluent into the „D“ well

S

1 ml

step 1

step 2

2 ×

D

30 µl finger-tip blood into the „S“ well

50 µl of sample diluent into the „D“ well

15 min

S

30 µl

step 1

step 2

50 µl

D

Positive

C T

Positive

Negative

Invalid

Invalid

3 drops into the „S“ well Positive

Negative

Invalid

5 minT C

T C

T C

S T C

Besurence GmbH, Hoyosgasse 5, 1040 Vienna, Austria, office@besurence.com, www.besurence.com

1795 C

1805 C

656 C

PANTONE

15 - 100 - 100 - 0

6 - 0 - 0 - 3

15 - 100 - 100 - 31

CMYK

204 - 7 - 30

157 - 16 - 25

238 - 244 - 248

RGB

Rapid diagnostic tests – made in Austria

Product Specifications Test cassette can be used with wholeblood/serum/

plasma specimen

Qualitative detection of antibodies to dengue

Time to result: 15 minutes

Sensitivity: 99.1%

Specifity: 99.5%

4–30 °C for 24 months

Stability DengueBesurence Dengue was clinically tested for its stability.

Reports have shown that – as long as the product is kept

in its aluminium pouch – the test kits keep their quality

and functionality even when stored at ambient temper-

atures between 0–45 °C for months. Nonetheless, it is

explicitly recommended to abide by the quoted storage

temperatures at all times.

Performance Characteristics Sensitivity

The analytical sensitivity of Besurence Dengue is 1:8.

Analytical SpecificityBesurence Dengue is specific in its clinical usage. The fol-

lowing substances, when spiked in both positive and neg-

ative specimens, did not interfere with the test results.

Substance Concentration

Treponema Pallidum (+) +

HIV (+) +

HAV (+) +

HBsAg (+) +

HCV (+) +

HEV (+) +

Rheumatoid Factor (+) +

Triglyceride (TG) +

Total bilirubin (TBil) +

Diagnostic Sensitivity and SpecificityBesurence Dengue has correctly identified a panel of

specimens. Besides, a side by side comparison study was

conducted using the test with a leading commercially

available predicate Dengue (IgM / IgG) Test. Testing was

performed with total of 1005 clinical samples.

Clinical Accuracy of Besurence Dengue

Predicate Test

(Positive)

Predicate Test

(Negative)

Total

Besurence Dengue (Positive)

447(a) 3 (b) 450

Besurence Dengue (Negative)

4 (c) 551(d) 555

Total 451 554 1005

Diagnostic Sensitivity (Positive agreement):a/ a+c) = 447/451= 99.1%Diagnostic Specificity (Negative agreement):d/(b+d) = 551/554 = 99.5%Total agreement:(a+d)/(a+b+c+d) = (447+551)/1005 = 99.3%

Repeatability and ReproducibilityThree batches of Besurence Dengue were used and

10  cassettes of each lot were tested with Dengue IgG

and IgM antibodies enterprise reference. Result is sum-

marized in the following table.

Concentration Lot 1 Lot 2 Lot 3 Precision

P N P N P N

0 0 10 0 10 0 10 100%

Con. of Dengue IgG 1:4

10 0 10 0 10 0 100%

Con. of Dengue IgM 1:4

10 0 10 0 10 0 100%

P: Positive N: Negative

References

1. U.S. Department of Health and Human services. Biosafety in mi-crobiological and Biomedical Laboratories. HHS Publication (NIH) 88-8395. Washington: U.S. Government Printing Office, May 1988.

2. World health Organization. Laboratory Biosafety manual. Geneva. World health organization, 1983.

3. National Committee for clinical laboratory Standards. Protection of Laboratory Workers from Infectious Disease Transmitted By Blood, Body Fluids, and tissue: Tentative Guideline. NCCLS Document M29-T. Villanova, PA: NCCLS, 1989.

4. Ranjit S, Kissoon N. “Dengue hemorrhagic fever and shock syn-dromes”. Pediatr. Crit. Care Med, July 2010.

5. Chen LH, Wilson ME. “Dengue and chikungunya infections in travel-ers”. Curr. Opin. Infect. Dis. 23 (5): 438–44, October 2010.

6. Rodenhuis-Zybert IA, Wilschut J, Smit JM. “Dengue virus life cycle: viral and host factors modulating infectivity”. Cell. Mol. Life Sci. 67 (16): 2773–86, (August 2010).

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