Contents

1 Hepatitis Overview

2 Hepatitis B and C Overview

3 Alere Hepatitis C Portfolio & Products

4 SD HBV Portfolio

5 SD HCV Portfolio

6 ALERE Portfolio Performance Summary

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 What is Hepatitis?

▪ Hepatitis is a medical condition defined by the

inflammation of the liver and characterized by the
presence of inflammatory cells in the tissue of the
organ
▪ There are 5 viruses known to affect the liver and
cause Hepatitis: HAV, HBV, HCV, HDV (Delta),
Hepatitis E virus (HEV).
▪ Hepatitis A and E are typically caused by
ingestion of contaminated food or water.
▪ Hepatitis B, C and D are typically caused by
contact with contaminated blood or body fluids.
▪ About 1.45 million people die each year from
causes related to Viral Hepatitis B and C
▪ There are two chronic and serious forms:
1. Hepatitis B
2. Hepatitis C

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 Viral Hepatitis

There are five viruses known to affect the

liver and cause hepatitis

▪ Hepatitis A (HAV)
▪ Hepatitis B (HBV)
▪ Hepatitis C (HCV)
▪ Hepatitis D (HDV) (Delta)
▪ Hepatitis E (HEV)

▪ Two chronic and serious forms: hepatitis

B and hepatitis C.
▪ Several drugs are now on the market to
treat hepatitis B,
▪ Highly effective oral HCV drugs
available but expensive Source: Shutterstock

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HBV and HCV - Overview

Parameter HBV HCV

Genome dsDNA ssRNA

Incubation Period 2-6 months 15-150 days

Transmission Blood borne Blood borne
Carrier State Adult: 6-10% 50-70%
Child: 25-50%
Infant: 70-90%
Chronic Hepatitis 5-10% of acute >50%
infection
Hepatocellular 1-2% 1-2%
Mortality
Vaccination Available Not

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Hepatitis B Overview

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Hepatitis B Virus (Dane particle)

Type
▪ “Acute” - Self-limited disease, 90% adult can recovery
▪ “Chronic” - Carrier, chronic active hepatitis B, hepatitis B
cirrhosis

Progression to Chronic after infected by HBV:

▪ Perinatal period: 90-95%
▪ Childhood: 20%
▪ Adult: 10%

Vaccination
▪ Majority of people get lifelong protection
- at least 12 years protection

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 Hepatitis B burden is Asia Pacific

▪ 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.

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Hep B Infection timeline of Markers

Adapted from: Chronic HBV Diagram https://en.wikipedia.org/wiki/File:Chronic_HBV_Diagram-Vector.svg

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Hepatitis-C Overview

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 Hepatitis C Incidence

Estimated number of chronically infected individuals (2010) 5

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.
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 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

5’----- C E1 E2/NS1 NS2 NS3 NS4 NS5 ----- 3’

Structural Genes Non-structural Genes

Figure adapted from: 1. Shah, K.B. et al. Hepatitis C Virus Genome.

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Hepatitis C Ab Testing

Hepatitis C Virus – Diagnosis

Antibody Test Development History
HCV Antibody
First Generation Second Generation Third Generation
Tests
• Remarked
improvement in
• Limited sensitivity sensitivity and • Improved sensitivity
Performance
and specificity specificity • Shorten the window
• To avoid nonspecific
cross-reactivity
• Core
• Core
• NS3
Reagents • NS4 • NS3
• NS4
• NS4
• NS5

Window Period • 3-4 months • 8-12 weeks • 6-10 weeks

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 HCV Test Interpretation Table
Outcome

HCV antibody reactive, HCV antibody reactive,

Test

HCV antibody nonreactive HCV antibody reactive HCV RNA detected HCV RNA not detected
Interpretation

No HCV antibody Presumptive HCV

Current HCV infection No current HCV infection
detected infection

No further action required in

most cases.
A repeatedly reactive
Sample can be reported If distinction between true
result is consistent with
as nonreactive for HCV Provide person tested positivity and biologic false
Further Action

current HCV infection, or

antibody. No further action with appropriate positivity for HCV antibody
past HCV infection that
required. If recent HCV counseling and link is desired, and if sample is
has resolved, or biologic
exposure in person tested person tested to repeatedly reactive in the
false positivity for HCV
is suspected, test for HCV medical care and initial test, test with another
antibody. Test for HCV
RNA.1 treatment.2 HCV antibody assay.
RNA to identify current
infection.
In certain situations3 follow
up with HCV RNA testing
and appropriate counseling.
Adapted from: Getchell, Jane P. et al. (2013) Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report. Testing for HCV Infection: An Update of Guidance
for Clinicians and Laboratorians. Weekly Vol. 62 No. 18. 19-20.

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
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 WHO- HBV Screening Recommendations

Testing approach Recommendations*

and population

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

Focused testing in most Recommended testing to the following:

affected Populations
1. Adults and adolescents from populations most affected by HBV
infection
2. Adults, adolescents and children with a clinical suspicion of chronic
viral hepatitis
3. Sexual partners, children and other family members, and close
household contacts of those with HBV infection
4. Health-care workers

Blood donors screening of blood donors should be mandatory.

* WHO GUIDELINES ON HEPATITIS B AND C TESTING December 2016

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 WHO- HCV Screening Recommendations

Testing approach Recommendations*

and population

• Adults and adolescents from populations most affected by HCV

infection2 (ie. who are either part of a population with high HCV
Focused testing seroprevalence or who have a history of exposures and/or high-risk
in most affected behaviours for HCV infection)
populations
• Adults and children with a clinical suspicion of chronic viral hepatitis3
(ie.symptoms, signs, laboratory markers).

In settings with a ≥2% or ≥5%4 HCV antibody seroprevalence in the

General population
general population it is recommended that all adults have access to and
testing be offered HCV serological testing

This approach may be applied to specific identified birth cohorts of older

Birth cohort testing persons at higher risk of infection6 and morbidity within populations that
have an overall lower general prevalence.

* WHO GUIDELINES ON HEPATITIS B AND C TESTING December 2016

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Alere HBV Portfolio- SD Bioline

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SD Hepatitis B Products Portfolio

HBs Ag Anti-HBs Ag

Serological Test
Cat# Product Specimen
Target Type

Anti-HBs Antibody against Hepatitis B Serum,

01FK20 Device
Ag surface antigen Plasma

Anti-HBs Antibody against Hepatitis B Multi- Serum,

[Device] [Multi-Device] [Strip] 01FK21
Ag surface antigen Device Plasma

Anti-HBs Antibody against Hepatitis B Serum,

Serological Test 01FK22 Strip
Cat# Product Specimen Ag Fast surface antigen Plasma
Target Type

Hepatitis B surface Serum,

01FK10 HBsAg Device
antigen Plasma

Hepatitis B surface Multi- Serum,

01FK11 HBs Ag
antigen Device Plasma HBe Ag
Hepatitis B surface Serum,
01FK12 HBs Ag Fast Strip
antigen Plasma
Serological Test
Hepatitis B surface Serum, Cat# Product Specimen
01FK10W HBs Ag WB Device Target Type
antigen Plasma, WB
Hepatitis B Envelop Serum,
Hepatitis B surface Multi- Serum, 01FK30 Hbe Ag Device
01FK11W HBS Ag WB antigen Plasma
antigen Device Plasma, WB

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Meaning of Marker and Feature

▪ SD BIOLINE HBs Ag and SD BIOLINE HBs Ag WB

Earliest Indicator Detection Limit Sensitivity : 100%

of Acute HBV : 1ng/ml Specificity : 100%
infection Evaluated by WHO

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Meaning of Marker and Feature

▪ 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

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Meaning of Marker and Feature

▪ SD BIOLINE HBe Ag

Indicator of
Monitoring Sensitivity
presence of HBV the effectiveness : 95.5%
of HBV treatment Specificity
: 98.6%

CONFIDENTIAL | 19
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SD BIOLINE HBV Products Procedures

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SD Hepatitis B Products

▪ SD BIOLINE HBs Ag Evaluation Data – WHO

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SD Hepatitis B Products

▪ SD BIOLINE HBs Ag Evaluation Data - CDC

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HCV Portfolio- SD HCV

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 Alere HCV Portfolio- SD BIOLINE HCV

▶ One step immunochromatographic assay

▶ Test for the qualitative detection of antibodies

specific to HCV in human WB, serum or plasma

▪ Sensitivity : 100%
▪ Specificity :99.4%
▪ 24months at 1-30°C
▶ Recombinant HCV capture antigen as Core, NS3,
NS4 and NS5  3rd generation method

▶ Specimen : Serum, Plasma, Whole blood 10uL

▶ Evaluated by & WHO PQ

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SD BIOLINE HCV Products Procedures

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