OnSite Malaria Rapid Test

Current Malaria Diagnostic Methods Detection of Advantage Disadvantage Thick smear microscope Parasites Detects 10-20 parasites /uL Golden standard Need good microscope Prone to human errors Rapid Ag test Parasite specific antigen Detects 100-200 parasites/ uL Simple procedure, less errors Be used at any place, any time The most popular screening test Need to bring the sensitivity up to 10-50 parasites /uL Rapid Ab test Antibodies to malaria parasites Be used to track malaria infection history: blood donor screening; vaccine candidate screening Can not differentiate current or past infection ELISA Ab test Antibodies to malaria infection Molecular diagnosis Malaria gene Very sensitive To be used by researcher now Expensive equipments Well trained lab tech No product on market

Malaria Ag Rapid Test on Market Malaria parasite specific LDH antibody by Dr. Makler Pf HRP-II antibody by S. African institute Aldolase antibody Pv LDH Pf LDH Pan LDH Pf LDH Pv LDH HRP-II Pan LDH HRP-II Aldolase HRP-II Aldolase Pf-LDH Popular The most popular Least popular HRP-II Clone C1-13 cross-reacts to high concentration of LDH Majority tests use Dr. Makler’s clones Supply security issue due to acquisition !

About Dr. Makler An American doctor studied blood viscosity ended to spend his rest of career in malaria diagnosis Discovered malaria specific LDH Generated dozes of malaria parasite specific LDH antibody Licensed antibodies to “Optimal” manufacturer - Optimal was dominated the malaria Ag rapid test on market for a while Breakdown the deal with “Optimal” - Malaria Ag rapid test can be made by many other manufacturers! Sold the antibodies to a major malaria Ag test manufacturer in 2011! Supply can be interrupted at any time Price can be up at any time Many companies and distributors are at the mercy of “the new owner”

Why it is difficulty to make malaria antibody? LDH is not a stable protein No resource of native antigens Most recombinant protein conformation are quite different than the native protein Many companies tried, failed to replace Makler’s antibody

CTK’s Advantage Have E.Coli, insect, and mammalian express system to fit variant needs Newly improved monoclonal antibody system generates high affinity antibody in 2 months Newly improved polyclonal antibody system generates high affinity antibody in 2 months

CTK Solution Has made a specific anti HRP-antibody that dose not cross react to LDH Has just developed LDH antibody

CTK Test WHO Evaluation Result Overview Round 1 Missed Pf –HRP Rapid Test: Met request WHO procurement list Round 2 A new chemical used in conjugate pad Round 3 Pf - Pan Ag Rapid Test Pf - Pv Ag Rapid Test False positive Round 4 Pf - Pan Ag Rapid Test Pf - Pv Ag Rapid Test Result Pending In a 200 case field study: specificity is > 95%

CTK – A Complete Resource of Malaria Reagents Recombinant Pf & Pv antigen for Ab detection Pf-MSP-1 antigen Pv-MSP-1 antigen Malaria Ab ELISA RecombiLISA Malaria Pf Ab ELISA* RecombiLISA Malaria Pv Ab ELISA* * Under development OnSite Pf - Pv Ag Rapid Test OnSite Pf - Pan Rapid Test OnSite Pf Rapid Test Malaria Ag Rapid Test Positivia HRP-II control Positivia Pf-LDH control Positivia Pv-LDH control Positivia Aldolase control Malaria Ag Test Control

CTK -the only supply for your needs in combating malaria To make tests To diagnose malaria To test product quality To monitor malaria eradication To screen malaria vaccine candidate

Smear Test False Result Low density of parasites less skillful technician Confusion with bacterial, fungi, dirt cell debris False Positive Poor microscope quality Poor blood film preparation Not sufficient fields checked False Negative Poor staining Less skillful technician Confusion with bacterial, fungi, dirt cell debris Errors in species identification

Rapid Test False Result False Positive RF & heterophile antibody Low parasite density Mutation of HRP-II gene Unknown inhibitor in blood False Negative Errors in species identification Cross reaction of antibody used

Early Diagnosis for a better life Together, we grow Athenese Dx & CTK

Together, we grow Athenese Dx & CTK Athenese DX contact information: Module # 407 & 408, 4th Floor, Ticel Bio Park II, No. 5, CSIR Road, Taramani, Chennai - 600113, TamilNadu, India. Together, we grow Athenese Dx & CTK

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