OnSite Malaria Rapid Test

Current Malaria Diagnostic MethodsMethod 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

• Simple procedure, less errors • Be used at any place, any time• 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

Be used to track malaria infection history: blood donor screening; vaccine candidate screening

Can not differentiate current or past 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

Pv LDH

HRP-II

Aldolase

HRP-II

Pan LDH

Pf LDH

Pan LDH

HRP-II

Aldolase

Pf-LDH

Majority tests use Dr. Makler’s clones Supply security issue due to acquisition !

HRP-II Clone C1-13 cross-reacts to high concentration of LDH

The most popular Least popularPopular

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

Round 2

Round 3

Round 4

Missed

Pf –HRP Rapid Test: • Met request• WHO procurement list

Pf - Pan Ag Rapid Test Pf - Pv Ag Rapid Test

False positive A new chemical used in conjugate pad

Pf - Pan Ag Rapid Test Pf - Pv Ag Rapid Test

Result Pending

In a 200 case field study: specificity is > 95%

Recombinant Pf & Pv antigen for Ab detection

Malaria Ab ELISA

Malaria Ag Rapid Test

Malaria Ag Test Control

Positivia HRP-II control Positivia Pf-LDH control Positivia Pv-LDH control Positivia Aldolase control

OnSite Pf - Pv Ag Rapid Test OnSite Pf - Pan Rapid Test OnSite Pf Rapid Test

RecombiLISA Malaria Pf Ab ELISA* RecombiLISA Malaria Pv Ab ELISA*

Pf-MSP-1 antigen Pv-MSP-1 antigen

CTK – A Complete Resource of Malaria Reagents

* Under development

To make tests To diagnose malaria

To test product qualityTo monitor malaria eradication

To screen malaria vaccine candidate

CTK -the only supply for your needs in combating malaria

Smear Test False Result

False Positive

False Negative • Poor microscope quality• Poor blood film preparation• Not sufficient fields checked

• Low density of parasites • less skillful technician • Confusion with bacterial, fungi, dirt cell debris

Errors in species identification

• Poor staining • Less skillful technician • Confusion with bacterial, fungi, dirt cell debris

Rapid Test False Result

False Positive

False Negative

Errors in species identification

RF & heterophile antibody

• Low parasite density • Mutation of HRP-II gene• Unknown inhibitor in blood

Cross reaction of antibody used

Together, we grow Athenese Dx & CTK

Early Diagnosis for a better life

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.

Athenese DX contact informationRegistered Office

Ticel ManufacturingBGB Manufacturing San Diego R&D office