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1 Hepatitis Overview
4 SD HBV Portfolio
5 SD HCV Portfolio
▪ Hepatitis A (HAV)
▪ Hepatitis B (HBV)
▪ Hepatitis C (HCV)
▪ Hepatitis D (HDV) (Delta)
▪ Hepatitis E (HEV)
Type
▪ “Acute” - Self-limited disease, 90% adult can recovery
▪ “Chronic” - Carrier, chronic active hepatitis B, hepatitis B
cirrhosis
Vaccination
▪ Majority of people get lifelong protection
- at least 12 years protection
▪ Population approximately
4.026 Billion (1)
▪ HBsAg Prevalence 1.9 -
5.26% - Equates to
approximately 140 Million
▪ 25% with Chronic Hep B
infection
▪ Only 1-10% aware of
their infection
▪ 126 Million people
unaware of their infection
Source - https://simple.wikipedia.org/wiki/List_of_Asian_countries_by_population.
China N. Korea
30 M 0.2 M
Europe
Americas 18 M
14 M S. Korea
Middle East 0.8 M
16 M
Africa Japan
28 M 3M
India
18 M
Indonesia
9M
Australia
0.2 M
Sourced from: 4 World Health Organization (WHO) Guidelines for the Screening, Care and Treatment of Persons with Hepatitis C Infection. April 2014.
Figure adapted from:
5. Lavanchy, D. (2010) Evolving epidemiology of hepatitis C virus.
EXTERNAL USE. NOT FOR PRINT OR DISTRIBUTION. 9
Hepatitis C Virus
Virus
An envelope, single stranded
positive sense RNA including:
▪ Structural genes at the 5' end
▪ Non-structural genes at the
3' end
HCV antibody nonreactive HCV antibody reactive HCV RNA detected HCV RNA not detected
Interpretation
1. If HCV RNA testing is not feasible and person tested is not immunocompromised, do follow-up testing for HCV antibody to demonstrate seroconversion. If the person
tested is immunocompromised, consider testing for HCV RNA.
2. It is recommended before initiating antiviral therapy to retest for HCV RNA in a subsequent blood sample to confirm HCV RNA positivity.
3. If the person tested is suspected of having HCV exposure within the past 6 months, or has clinical evidence of HCV disease, or if there is concern regarding the handling
or storage of the test specimen. EXTERNAL USE. NOT FOR PRINT OR DISTRIBUTION. NOT FOR PRINT OR DISTRIBUTION. 12
WHO- HBV Screening Recommendations
General population Recommended that all adults have routine access to HBsAg serological
Testing testing in settings with a ≥2% or ≥5% HBsAg seroprevalence in the
general population.
Routine testing in pregnant HBsAg serological testing be routinely offered to all pregnant women in
women antenatal clinics
HBs Ag Anti-HBs Ag
Serological Test
Cat# Product Specimen
Target Type
▪ SD BIOLINE Anti-HBs Ag
• Indicator of
previous Detection Limit Sensitivity
exposure to HBV : 30mlU/ml : 91.7%
• Acquired from Specificity
successful : 98.9%
vaccination
▪ SD BIOLINE HBe Ag
Indicator of
Monitoring Sensitivity
presence of HBV the effectiveness : 95.5%
of HBV treatment Specificity
: 98.6%
CONFIDENTIAL | 19
EXTERNAL USE. NOT FOR PRINT OR DISTRIBUTION.
SD BIOLINE HBV Products Procedures
▪ Sensitivity : 100%
▪ Specificity :99.4%
▪ 24months at 1-30°C
▶ Recombinant HCV capture antigen as Core, NS3,
NS4 and NS5 3rd generation method