OnSite HEV Rapid Test

Hepatitis A and Hepatitis E But they are different diseases! Similarities Acute viral hepatitis Transmitted via fecal-oral route Jaundice in 50% cases Clinical symptoms Supportive therapeutics

Different Viral Family Hepatitis A Virus Hepatitis E Virus ssRNA picornavirus Single serotype worldwide Vaccine is available ssRNA hepevirus 1 serotype, 4 genotypes Vaccine is being developed

Different Transmission Routes Hepatitis A Hepatitis E Contaminated food, water infected food handlers raw shellfish Contaminated food and water Rarely from person to person Close personal contact household contact homosexual in men child day care centers Possible zoonotic transmission Rarely by blood exposure intravenous drug use blood transfusion

Different Incubation Times Hepatitis A Hepatitis E 15-60 days, average 50 days 15-45 days, average 30 days

Different Population Hepatitis A Hepatitis E Symptomatic infection is common in young adults between 15-40 yrs Affects all age groups, Particularly common in children & young adults Genotype 1: 15-35 yrs Genotype 3-4: Japanese >60 yrs Genotype 1-2: human Genotype 3-4: human & animal The most common acute viral hepatitis. Asymptomatic or atypical infection seen mostly in children Found primarily in Asian, Africa and South America

Different Disease Course Hepatitis A Hepatitis E Mild illness Mild illness in most cases Complications: Fulminant hepatitis Hepatic cirrhosis in these with immuno- compromised conditions Complications: Fulminant hepatitis Cholestatic hepatitis Relapsing hepatitis 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 0.4% fatality rate Self limiting, no reports of chronic status Self limiting, chronic status in these with immuno-compromised conditions HAV and HEV co-infection in young children may lead to LIVER FAILURE

Different IgM Generation Time Hepatitis A Hepatitis E 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 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 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! Differential diagnosis of HEV and HAV will save lives

CTK Biotech Offers To aid in differential diagnosis of HEV and HAV 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 of specimen 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 1 drop of sample diluent Result in 15 minutes!

OnSite HAV IgM Rapid Test CE Test Result Interpretation Negative No HAV Infection Positive Current infection or late stage of infection Invalid Repeat test

OnSite HAV IgM Rapid Test CE CTK HAV IgM Rapid Test Reference Positive Negative Total 21 1 22 178 179 200 Performance Only 15 minutes to get results…. Relative sensitivity: 95.5% Relative specificity: 100%

CTK HAV IgM ELISA Kit CE Catalog: E0100 ADAPTABLE TO AUTOMATED SYSTEMS

CTK HAV IgM ELISA kit CE Performance CTK HAV IgM ELISA Reference Positive Negative Total 39 361 400 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 of specimen 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 1 drop of sample diluent Result in 15 minutes!

OnSite HEV IgM Rapid Test Result Test Result Interpretation Negative No HEV Infection Positive Current infection or late stage of infection Invalid Repeat test

OnSite HEV IgM Rapid Test CE Performance CTK HEV IgM Rapid Test Reference Positive Negative Total 314 6 320 734 740 1060 Only 15 minutes to get results…. Relative sensitivity: 98.1% Relative specificity: 99.2%

RecombiLISA HEV IgM ELISA Kit CE Catalog: E0105 ADAPTABLE TO AUTOMATED SYSTEMS

RecombiLISA HEV IgM ELISA kit CE Performance CTK HEV IgM ELISA Reference Positive Negative Total 25 375 400 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 For easy, on site screening & differentiation of HAV & HEV Order CTK Biotech’s OnSite HAV IgM Rapid Test Cat: R0090C OnSite HEV IgM Rapid Test Cat: R0095C

Final Messages to Doctors For further confirmation & differentiation of HAV & HEV Order CTK Biotech’s HAV IgM ELISA kit Cat: E0100C HEV IgM ELISA kit Cat: E0105C

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