OnSite HEV Rapid Test

Acute viral hepatitis Transmitted via fecal-oral route Jaundice in 50% cases Clinical symptoms Supportive therapeutics

Hepatitis A and Hepatitis E

SimilaritiesBut they are different diseases!

Different Viral Family

ssRNA picornavirusSingle serotype worldwideVaccine is available

ssRNA hepevirus1 serotype, 4 genotypesVaccine is being developed

Hepatitis A Virus Hepatitis E Virus

Different Transmission Routes

Close personal contact household contact homosexual in men child day care centers

Contaminated food, water infected food handlers raw shellfish

Rarely by blood exposure intravenous drug use blood transfusion

Contaminated food and water

Rarely from person to person

Hepatitis A Hepatitis E

Possible zoonotic transmission

Different Incubation Times

15-60 days, average 50 days 15-45 days, average 30 days

Hepatitis A Hepatitis E

Different Population

Symptomatic infection is common

in young adults between 15-40 yrs

The most common acute viral hepatitis.

Affects all age groups, Particularly common in children & young adults

Found primarily in Asian, Africa and South America

Hepatitis A Hepatitis E

Asymptomatic or atypical infection seen mostly in children

Genotype 1: 15-35 yrs Genotype 3-4: Japanese >60 yrs Genotype 1-2: human Genotype 3-4: human & animal

Different Disease Course

1-2% fatality rate, but could go up to 75% with chronic liver disease 20% in the 3rd trimester pregnant women up to 33% of premature infants

Self limiting, no reports of chronic status

Complications: Fulminant hepatitis Cholestatic hepatitis Relapsing hepatitis

0.4% fatality rate

HAV and HEV co-infection in young children may lead to LIVER FAILURE

Complications: Fulminant hepatitis Hepatic cirrhosis in these with immuno- compromised conditions

Self limiting, chronic status in these with immuno-compromised conditions

Mild illness

Mild illness in most cases

Hepatitis A Hepatitis E

Different IgM Generation Time

Appears in the 1st week of infection Peaks at 4 weeks Detectable up to 2-3 months

Appears in the 2nd week of infection Peaks at 7 weeks Detectable up to 4 months

Hepatitis A Hepatitis E

IgM detection is the most common specific diagnostics

Current Clinical Status of HAV and HEV

HEV is often under diagnosed or misdiagnosed: HAV is the most common acute viral hepatitis Lack of awareness of the differences between HEV and HAV Lack of awareness = Diagnostic kits are unavailable, in particular,

HEV test kits are not well-known on the market

Differential diagnosis of HEV and HAV will save lives

HEV is more severe than HAV in high risk groups & requires prompt action to prevent disease progression

HAV and HEV co-infection in young children may lead to liver failure!

CTK Biotech Offers

Easy to use screening kits OnSite HAV IgM Rapid Test kit OnSite HEV IgM Rapid Test kit

Complimenting confirmation kits HAV IgM ELISA kit RecimbilisA HEV IgM ELISA kit

To aid in differential diagnosis of HEV and HAV

OnSite HAV IgM Rapid Test Procedure

1 drop ofspecimen

1 drop ofsample diluent

Resultin 15 minutes!

CE

As easy as “1-2-3” Minimal training required No equipment needed Fast and reliable result in 15 minutes Can be used in any setting

OnSite HAV IgM Rapid Test CE

Test Result Interpretation

NegativeNo HAV Infection

PositiveCurrent infection or late stage of infection

InvalidRepeat test

OnSite HAV IgM Rapid Test CE

CTK HAV IgM Rapid Test

Reference Positive Negative Total

Positive 21 1 22

Negative 0 178 178

Total 21 179 200

Performance

Only 15 minutes to get results…. Relative sensitivity: 95.5% Relative specificity: 100%

CTK HAV IgM ELISA Kit CE

Catalog: E0100ADAPTABLE TO AUTOMATED SYSTEMS

CTK HAV IgM ELISA kit CE

CTK HAV IgM ELISA

Reference Positive Negative Total

Positive 39 0 39

Negative 0 361 361

Total 39 361 400

Performance

Only 70 minutes to get results…. Relative sensitivity: 100% Relative specificity: 100%

OnSite HEV IgM Rapid Test CE

Catalog: R0095C

OnSite HEV IgM Rapid Test Procedure

1 drop ofspecimen

1 drop ofsample diluent

Resultin 15 minutes!

CE

As easy as “1-2-3” Minimal training required No equipment needed Fast and reliable results in 15 minutes Can be used in any setting

OnSite HEV IgM Rapid Test Result

Test Result Interpretation

NegativeNo HEV Infection

PositiveCurrent infection or late stage of infection

InvalidRepeat test

OnSite HEV IgM Rapid Test CE

CTK HEV IgM Rapid Test

Reference Positive Negative Total

Positive 314 6 320

Negative 6 734 740

Total 320 740 1060

Performance

Only 15 minutes to get results…. Relative sensitivity: 98.1% Relative specificity: 99.2%

RecombiLISA HEV IgM ELISA Kit CE

Catalog: E0105ADAPTABLE TO AUTOMATED SYSTEMS

RecombiLISA HEV IgM ELISA kit CE

CTK HEV IgM ELISA

Reference Positive Negative Total

Positive 25 0 25

Negative 0 375 375

Total 25 375 400

Performance

Only 75 minutes to get results…. Relative sensitivity: 100% Relative specificity: 100%

Final Messages to Doctors

HAV and HEV seem similar BUT are clinically different

HEV could be life threatening and requires prompt action to prevent disease progression

HEV is often under diagnosed or misdiagnosed

Differential diagnosis of HEV and HAV is clinically significant

Final Messages to Doctors

OnSite HAV IgM Rapid Test Cat: R0090C

For easy, on site screening & differentiation of HAV & HEV

Order CTK Biotech’sOnSite HEV IgM Rapid Test Cat: R0095C

Final Messages to Doctors

HAV IgM ELISA kit Cat: E0100C

For further confirmation & differentiation of HAV & HEV

Order CTK Biotech’s

HEV IgM ELISA kit Cat: E0105C

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.