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OnSite Leishmania Ab Rapid Test (Strip)Leishmania IgG / IgM Rapid Test

A Leading Product On Market by Using CTK Licensed Patented Antigen

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• 300,000 new cases and over 20,000 deaths annually

• 90% in：o Indian subcontinent, such as

Bangladesh, India, Nepalo Sudano Ethiopia o Brazil

• Transmitted by the sandfly

Visceral Leishmaniasis (VL)

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• Fever

• Weight loss

• Affects spleen, liver, and bone marrow

• Nearly always Fatal if not treated

Clinical Feature of V. Leishmaniasis

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Diagnostic Methods of V. Leishimaniasis

Methods Specimen Test Time RemarksMicroscopydetects amastigote

Splenic aspirate, liver biopsy or bone marrow biopsy

≥ 30 min • Invasive procedure to obtain specimen•Requires skilled technician•Accuracy depends on the microscopist•Amastigotes may be scant and difficult to view

Culturedetects amastigote

Splenic aspirate, bone marrow biopsy

10-21 days • Invasive procedure to obtain specimen•Undetectable since the amastigote stage can

transform into the promastigote stage

Serodiagnosisdetects Ab

DAT* Serum, plasma Over night •Dilute specimens prior to assaying•Need microtitration plates & incubator• Slight variations in reading result

IFA** Serum, plasma ≥ 1 hour •Dilute specimen prior to assaying•Requires fluorescence microscope• Cross reacts with Trypanosoma cruzi

ELISA Serum, plasma ≥ 1 hour • Trained technician•Requires incubator and ELISA reader• IgG/IgM tested separately

Rapid Tests

Serum, plasma, whole blood

15 min •No equipment required•Minimal training• Irrespective of parasite stage

*DAT: Direct Agglutination Test **IFA: Immunofluorescence Assay

Rapid Test is the simplest diagnostic method

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OnSite Leishmania Rapid Test kitsTwo Formats Meet Different Needs

OnSite Leishmania Ab Rapid Test• Strip • Serum/Plasma• Detect Abs• Cost effective

OnSite Leishmania IgG/IgM Rapid Test• Cassette• Serum/Plasma/Whole Blood• Detect and differentiate IgG and IgM• High accuracy

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OnSite Leishmania Rapid Test kitsUtilize rK39 for Better Performance

CTK Licensed patented rK39 antigen from IDRI to make the product • With excellent performance• More sensitive than rKE16 based product• WHO qualified

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OnSite Leishmania Ab Rapid Test (strip)Simple Procedure, Fast Result, Cost Effective

Catalog # R0122S

Intended use Qualitatively detects anti-VLby using rk39 antigen

Specimen type Serum/Plasma

Reading time 15 minutes

Equipments No

Training minimal

Shelf life 18 months

Package size 50 tests

Control lineTest line

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5 μL of specimen 2 drops of sample diluent 15 minutes

OnSite Leishmania Ab Rapid Test (strip)Simple, Rapid Procedure

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Only C line is developed

OnSite Leishmania Ab Rapid Test (strip)Clear, Easy-To-Read Result

Negative

PositiveBoth C and T line are developed

No C line is developedInvalid

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● A total 200 samples from susceptible subjects were tested by the OnSite Leishmania Ab Rapid Test and by a reference Kalazar Ab rapid test

OnSite Leishmania Ab Rapid Test

Reference Positive Negative TotalPositive 31 0 31Negative 0 169 169

Total 31 169 200Relative Sensitivity: 100%, Relative Specificity: 100%, Overall Agreement: 100%

OnSite Leishmania Ab Rapid Test (strip)Excellent Performance Comparing To Competitor

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• WHO evaluation series• Sensitivity, specificity and reproducibility

OnSite Leishmania Ab Rapid Test (strip)Leading Product On Market

Parameter Sensitivity(n=250)

Specificity(n=249)

Average Score(Highest 18)

OnSite 99.6%(97.8-99.9%)

96.8%(93.8-98.4%)

13.5

Participant A 92.8%(88.9-95.4%)

99.2%(97.1-99.8%)

9.9

Participant B 98.8%(96.5-99.6%)

97.6%(94.8-98.9%)

11.0

Participant C 99.6%(97.8-99.9%)

96.0%(92.8-97.8%)

11.8

Participant D 100%(97.9-100%)

100%(97.8-100%)

10.9

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OnSite Leishmania Ab Rapid Test (strip)Leading Product on Market

ParameterProportion positive results among cases

(n=20)

Proportion Negative results among cases

(n=4)

Proportion Invalid results (n=24)

4℃ 37℃ 45℃ 4℃ 37℃ 45℃ 4℃ 37℃ 45℃

OnSite 100% 100% 100% 100% 100% 100% 0% 0% 0%Participant A 95% 90% 90% 100% 100% 100% 0% 0% 0%Participant B 100% 100% 0% 100% 100% 100% 0% 0% 100%Participant C 100% 100% 100% 100% 100% 100% 0% 0% 0%

• WHO evaluation series• Heat Stable

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OnSite Leishmania Rapid Test KitsThe Right Choice for You

• Non-invasive

• High accuracyo sensitivity >99.6%o specificity > 96.8%

• WHO qualified o Average score: 13.5 (highest 18)

• Simple procedure, fast result with minimal training requirement

• Low cost

• Strip or cassette format, wide-ranging specimen (S/P/WB)

• More product availableo Leishmania Ab ELISA Kit

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Technical Support

Contact Info.:10110 Mesa Rim Rd. San Diego, CA 92121 USAEmail Address: tech@ctkbiotech.com Telephone: 1 (858) 457-8698Fax: 1 (858) 535-1739

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THANK YOU

QUALITY . INNOVATION . SIMPLICITY