OnSite Leishmania Ab Rapid Test (Strip) Leishmania IgG / IgM Rapid Test A Leading Product On Market by Using CTK Licensed Patented Antigen

300,000 new cases and over 20,000 deaths annually 90% in ： o Indian subcontinent, such as Bangladesh, India, Nepal o Sudan o Ethiopia o Brazil Transmitted by the sandfly Visceral Leishmaniasis (VL)

Fever Weight loss Affects spleen, liver, and bone marrow Nearly always Fatal if not treated Clinical Feature of V. Leishmaniasis

Diagnostic Methods of V. Leishimaniasis MethodsSpecimenTest TimeRemarks Microscopy detects 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 Culture detects amastigote Splenic aspirate, bone marrow biopsy days Invasive procedure to obtain specimen Undetectable since the amastigote stage can transform into the promastigote stage Serodiagnosis detects Ab DAT*Serum, plasmaOver 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 ELISASerum, 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

STRAEGIC PARTNER OnSite Leishmania Rapid Test kits Two 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

OnSite Leishmania Rapid Test kits Utilize 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

OnSite Leishmania Ab Rapid Test (strip) Simple Procedure, Fast Result, Cost Effective Catalog # R0122S Intended useQualitatively detects anti-VL by using rk39 antigen Specimen typeSerum/Plasma Reading time15 minutes EquipmentsNo Trainingminimal Shelf life18 months Package size50 tests Control line Test line

5 μL of specimen 2 drops of sample diluent 15 minutes OnSite Leishmania Ab Rapid Test (strip) Simple, Rapid Procedure

Only C line is developed OnSite Leishmania Ab Rapid Test (strip) Clear, Easy-To-Read Result Negative Positive Both C and T line are developed No C line is developed Invalid

●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 ReferencePositiveNegativeTotal Positive310 Negative0169 Total Relative Sensitivity: 100%, Relative Specificity: 100%, Overall Agreement: 100% OnSite Leishmania Ab Rapid Test (strip) Excellent Performance Comparing To Competitor

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% ( %) 96.8% ( %) 13.5 Participant A 92.8% ( %) 99.2% ( %) 9.9 Participant B 98.8% ( %) 97.6% ( %) 11.0 Participant C99.6% ( %) 96.0% ( %) 11.8 Participant D100% ( %) 100% ( %) 10.9

OnSite Leishmania Ab Rapid Test (strip) Leading Product on Market Parameter Proportion positive results among cases (n=20) Proportion Negative results among cases (n=4) Proportion Invalid results (n=24) 4℃4℃ 37 ℃ 45 ℃ 4℃4℃ 37 ℃ 45 ℃ 4℃4℃ 37 ℃ 45 ℃ OnSite100% 0% Participant A95%90% 100% 0% Participant B100% 0%100% 0% 100% Participant C100% 0% WHO evaluation series Heat Stable

OnSite Leishmania Rapid Test Kits The Right Choice for You Non-invasive High accuracy o 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 available o Leishmania Ab ELISA Kit

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