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Dengue Rapid Test ARIA SOLUTION FOR POCT DENGUE MANAGEMENT Aria RAPID TEST REGISTERED FACILITY There are four dengue virus serotypes (DENV-1, DENV-2, DENV-3 and DENV-4) that cause human infection. Infection with one serotype of DENV provides immunity to that serotype for life, but doesn’t provide protective immunity to the other serotypes. Dengue infection results in illness ranging from mild and asymptomatic to life-threatening forms of dengue hemor- rhagic fever (DHF) and dengue shock syndrome (DSS). DENGUE INFECTION Dengue NS1 antigen, IgM and IgG are the most effective biomarkers for the detection of dengue infection status. . . . . . . . . . . . . . . . . . . . Dengue IgG/IgM Combo Rapid Test R0061C | Serum/Plasma/Whole Blood Detects and differentiates dengue IgG and IgM antibodies Highly sensitive to all 4 serotypes and their isolates Overall agreement (vs EIA): IgG 99.1%, IgM 98.7% Whole blood specimen allows testing at the point of care, saving crucial time Passed MOH registration evaluations in Asia and Latin America No cross-reaction to 17 common diseases, such HIV, HCV, HBV, CHIK, Malaria, Typhoid No interference with common substances 24 month shelf life at 2-30°C storage Dengue Ag Rapid Test R0063C | Serum/Plasma/Whole Blood Detects NS1 antigen from all 4 serotypes and their isolates Whole blood specimen alllows testing at the point of care, saving crucial time Sensitivity 100%; Specificity 100% (vs a commercial Dengue Ag RDT) Passed MOH registration evaluations in Asia and Latin America No cross-reaction to 17 common diseases, such HIV, HCV, HBV, CHIK, Malaria, Typhoid No interference with common substances 24 month shelf life at 2-30°C storage Duo Dengue Ag-IgG/IgM Combo Rapid Test R0062C | Serum/Plasma/Whole Blood Early-stage primary infection: Ag positive Late-stage primary infection: IgM, and/or IgG positive Recent infection: IgG positive Acute secondary infection: Ag and IgG positive and/or IgM Positive D De Den Den en en eng gu gu gu gue gue ue g g ID ID Dengue C ID M G C T C T Ag-IgG/IgM D De Deng Deng Deng engu u ue ue ue e G/I G/I IgG/I IgG IgM Co gM Co gM Co gM Co M C Com mbo mbo C C M M G G G G G Dengue IgG/IgM Combo C M G IgG/IgM Den De Den en en ngue gue gue gue ue e A Ag Ag C C T T T Dengue Ag C T Ag Combination of IgG/IgM and NS1 tests to provide a full spectrum of dengue infection at either: ARIA RAPID TESTS BY CTK IgG/IgM Ag 20 minutes 20 minutes IgG IgG IgM NS1 IgM titre Secondary Infection Primary Infection NS1 Days Onset of symptoms 0 10 20 30 40 50 0 10 20 30 40 50 IgG cutoff IgM cutoff

Dengue Rapid Test · 2018-09-26 · rhagic fever (DHF) and dengue shock syndrome (DSS). DENGUE INFECTION ... Specificity 100% (vs a commercial Dengue Ag RDT) Passed MOH registration

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Dengue Rapid TestARIA SOLUTION FOR POCT DENGUE MANAGEMENT

Aria RAPID TESTREGISTEREDFACILITY

There are four dengue virus serotypes (DENV-1, DENV-2, DENV-3 and DENV-4) that cause human infection. Infection with one serotype of DENV provides immunity to that serotype for life, but doesn’t provide protective immunity to the other serotypes.

Dengue infection results in illness ranging from mild and asymptomatic to life-threatening forms of dengue hemor-rhagic fever (DHF) and dengue shock syndrome (DSS).

DENGUE INFECTION

Dengue NS1 antigen, IgM and IgG are the most effective biomarkers for the detection of dengue infection status.

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Dengue IgG/IgM Combo Rapid TestR0061C | Serum/Plasma/Whole Blood

Detects and differentiates dengue IgG and IgM antibodies Highly sensitive to all 4 serotypes and their isolatesOverall agreement (vs EIA): IgG 99.1%, IgM 98.7%Whole blood specimen allows testing at the point of care, saving crucial timePassed MOH registration evaluations in Asia and Latin AmericaNo cross-reaction to 17 common diseases, such HIV, HCV, HBV, CHIK, Malaria, TyphoidNo interference with common substances24 month shelf life at 2-30°C storage

Dengue Ag Rapid Test R0063C | Serum/Plasma/Whole Blood

Detects NS1 antigen from all 4 serotypes and their isolatesWhole blood specimen alllows testing at the point of care, saving crucial timeSensitivity 100%; Specificity 100% (vs a commercial Dengue Ag RDT)Passed MOH registration evaluations in Asia and Latin AmericaNo cross-reaction to 17 common diseases, such HIV, HCV, HBV, CHIK, Malaria, TyphoidNo interference with common substances24 month shelf life at 2-30°C storage

Duo Dengue Ag-IgG/IgM Combo Rapid Test R0062C | Serum/Plasma/Whole Blood

Early-stage primary infection: Ag positive Late-stage primary infection: IgM, and/or IgG positiveRecent infection: IgG positive Acute secondary infection: Ag and IgG positive and/or IgM Positive

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Combination of IgG/IgM and NS1 tests to provide a full spectrum of dengue infection at either:

ARIA RAPID TESTS BY CTK

IgG/IgM Ag

20 minutes

20 minutes

IgG

IgG

IgMNS1

IgM

titre

Secondary InfectionPrimary Infection

NS1

Days

Ons

et o

f sym

ptom

s

0 10 20 30 40 50 0 10 20 30 40 50

IgG cutoff

IgM cutoff

ARIA-MK-FLR-R0061 Rev 4.0

CTK Biotech, Inc.

10110 Mesa Rim RoadSan DIego, CA 92121, USAwww.ctkbiotech.com

T +1 858 457 8698F +1 858 535 1739E [email protected]

Full Range of Products for Dengue management at CTK

Dengue ReagentsMab Anti-Dengue Pan NS1 Antibody Pab Anti-Dengue Pan NS1 AntibodyDengue Type 1 NS1 ProteinDengue Type 2 NS1 ProteinDengue Type 3 NS1 Protein DengueType 4 NS1 Protein

Dengue humanized IgM Antibody Dengue humanized IgG AntibodyDengue Type 1 Envelope ProteinDengue Type 2 Envelope ProteinDengue Type 3 Envelope Protein Dengue Type 4 Envelope Protein

Aria ELISA Tests

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Dengue Ag ELISA CE | E0312 Detects NS1 for all 4 serotypes or isolatesHigher sensitivity than the leading Ag ELISADetects NS1 as low as 0.3 ng/mL, no hook effect up to 0.1 mg/mL2 month open vial stability 18 month shelf life at 2-8°C storage

Dengue IgM ELISA CE | E0310 IgM capture ELISA to ensure high specificityDetects IgM for all 4 serotypes or isolatesComparable accuracy to the leading IgM ELISA 2 month open vial stability 18 month shelf life at 2-8°C storage

Dengue IgG ELISA CE | E0311IgG capture ELISA to ensure high specificity Detects IgG for all 4 serotypes or isolatesComparable accuracy to the leading IgG ELISA 2 month open vial stability 18 month shelf life at 2-8°C storage

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Positivia Dengue Rapid Test External Control Kits

Dengue Ag Rapid Test External Control Kit | C0063 Lyophilized control rendering high stability at 2-30°C, allows for simultaneous transport and storage with the rapid test Serotype-specific individual control components allow test sensitivity to be assessed for each individual serotype

Dengue IgG/IgM Rapid Test External Control Kit | Coming soon The first-of-its-kind dengue antibody test control on the market Non-biohazardous Lyophilized control rendering high stability at 2-30°C, allows for simultaneous transport and storage with the rapid test

As a leading discoverer, developer, and manufacturer of IVDs for tropical diseases, CTK is proud to offer a complete line of products for the management of dengue infection:

RAPID TESTS: For all healthcare settings ELISA KITS: To confirm rapid test result and for high-throughput setting RAPID TEST EXTERNAL CONTROL KITS: To verify product quality and test procedure REAGENTS: For research & development

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