¿Diagnostico temprano? Infección aguda o crónica LIAISON® Hepatitis Line es la solución

1. Hepatitis and Retrovirus
Hepatitis Virus
From challenges to solutions
FOR OUTSIDE THE US AND CANADA ONLY
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2. Early diagnosis? Acute or chronic infection?
LIAISON®
Hepatitis Line is the Solution
Outbreaks of epidemic jaundice were known in both Greek and Roman times, but today viral hepatitis continues
to be a disease of major significance in terms of morbidity and mortality. The symptoms of hepatitis vary consid-
erably from one individual to another, even when the same causative agent is involved. Because the symptoms
are not specific to the causative agent, it is impossible to distinguish among the various causative agents of
hepatitis based on clinical symptoms alone. Serological testing is then required. A definitive diagnosis of viral
hepatitis is only achievable by the use of viral-specific hepatitis tests. Viral hepatitis assays detect the presence
of specific viral antigens and /or antibodies in serum or plasma and the physician uses these results to diagnose,
screen and monitor a hepatitis infection.
Hepatitis A
Hepatitis B
Most frequent patterns
Total
anti-HAV
IgM
anti-HAV
AST/
ALT
Subject susceptible to
HAV
- - -
Acute HAV infection + + +
Recent HAV infection + - +
Non-HAV hepatitis - - +
Past HAV infection,
immunization ,
past vaccination
+ - -
Acute infection
1 2 3 5
4
0
Anti-HAV
IgM anti-HAV
ALT
Acute infection
Incubation Convalescence
Months after exposure
Jaundice
Symptoms
Acute infection
Convalescence
Prodromic phase
HBsAg
HBeAg Anti-HBs
Anti-HBe
IgM anti-HBc
Anti-HBc
Acute infection
1 2 3 4 5 6 7 8 9 10
Months after exposure
Chronic infection
Anti-HBe
1 2 3 4 2 4 6 8 10
IgM anti-HBc
HBsAg
HBeAg
Anti-HBc
Months Years after exposure
Most frequent patterns
HBsAg Anti-HBs
IgM
anti-HBc
Total
anti-HBc
HBeAg Anti-HBe
HBV-
DNA
Viral activity (mainly wild virus) + - + + + - +
Viral activity (mainly pre-core minus variant) + - + + - +/- +
Resolving acute HBV hepatitis + - + + - +/- -
Healthy carrier + - - + - +/- -
“Core window” - - + + - - -
Post-natural infection immunization - + - + - +/- -
Post-vaccination immunization - + - - - - -
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3. Confidence in Your Results
DiaSorin LIAISON®
HEPATITIS LINE
to achieve high safety for diagnosis and monitoring with
Excellent seroconversion sensitivity
High sensitivity in the recognition of viral variants and mutants
High specificity
High precision and measuring range
Fast response
LIAISON®
HEPATITIS Specificity and Sensitivity Performance
LIAISON®
HEPATITIS A
Test Diagnostic Specificity Diagnostic Sensitivity Analytical Sensitivity
Anti-HAV 487 Specimens / 99,8% 300 Clinical Samples / 99.0%
18 mIU/mL
(WHO 1998 - 2nd IS)
Anti HAV IgM 691 Specimens / 100% 143 Clinical Samples / 97.9% -
LIAISON®
HEPATITIS B
Test Diagnostic Specificity Diagnostic Sensitivity Analytical Sensitivity
HBsAg
5059 BD / 99.88%
1040 HS / 99.52%
526 SS / 100%
0.018 PEI U/mL
0.025 IU/mL NIBSC
code 00/588 CTS 2009
0.10 ng/mL Ag HBs (SFTS)
Anti-HBe 1249 HS / 99.44% 531 SS / 99.25%
0.076 PEI U/mL
(HBe Ref. S82)
Anti-HBc
5002 BD / 99.86%
701 HS / 99.00%
618 SS / 100%
< 0.60 PEI U/mL
(HBc Ref. M82)
HBc IgM 1567 HS / 99.87% 361 SS / 99.44%
20.3 PEI U/mL
(HBc Ref. S84)
Anti-HBs 1186 HS / 99.66% 556 SS / 100%
1.5 mIU/mL WHO 2md IS
(2008)
Anti-HBs II 573 HS / 99,8% 794 SS / 99.5%
Prospective samples
< 1 mIU/mL WHO 2md IS
(2008)
HBeAg 1728 HS / 99.54% 197 SS / 99.49% 0.1 PEI U/mL (HBe Ref A82)
BD = Blood Donors HS = Hospitalized Samples SS = Selected Samples
Excellent Mutant HBsAg Detection with LIAISON®
HBsAg Assay
The sensitivity performance for HBsAg mutant detection
was assayed in different studies with large panels of
HBsAg mutants, including a significant number of natural
and recombinant mutants, with single - or multiple-point
mutations. The studies showed that the assay is capable
of detecting mutants, including the most frequent G145R
mutant.
T.D. Ly et al., Journal of Clinical Microbiology, July 2006, Vol. 44, No.7, p. 2321-2326
T.D. Ly, Journal of Medical Virology, Sept 2007, Vol. 79, S1, p. S37-S41
Chen et al., Proc. Natl. Acad. Sci., 1996, 93: 1997-2001
HBsAg S-Mutants
Wild-Type gly at 145 Mutant arg at 145
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4. DiaSorin S.p.A.
Via Crescentino
13040 Saluggia (VC) - Italy
Tel. +39.0161.487526
Fax: +39.0161.487670
www.diasorin.com
E-mail: info@diasorin.it
DiaSorin LIAISON®
HEPATITIS LINE
committed to better technology
MAIN FEATURES for reliable data
Number of tests: 100 Tests for LIAISON®
HBsAg, Anti-HBs, Anti-HBs II, Anti-HBc, HBeAg,
Anti-HBe, Anti-HAV, HAV IgM
50 Tests for LIAISON®
HBc IgM
Reagents: Unique selection of monoclonal antibodies and recombinant DNA
technology
Label: Isoluminol derivative
Method: CLIA
Assay Format: Qualitative for LIAISON®
HBsAg, Anti-HBc, HBc IgM, Anti-HBe, Anti-HAV
and HAV IgM
Quantitative for LIAISON®
Anti-HBs and Anti-HBs II (dynamic range 5-1000 mIU/mL),
Anti-HBs Plus and Anti-HBs II Plus (dynamic range 5-90,000 mIU/mL) and HBeAg
(0-110 PEI U/mL)
Sample Type: Serum and Plasma
FLEXIBILITY for safe, quick and accurate results
Throughput: 90-180 tests/h
Time to first results: 35-50 minutes
Ready-to-use reagent cartridge
Reagent stability on board: 8 weeks
Calibration Stability: 4 weeks
Sample volume: 0-150 μL
References
http://www.cdc.gov/hepatitis/index.htm
V. Thibault et al., J. Clin. Virol., 50 (2011) 297-302
* Contact your local DiaSorin sales representative for availability in your country
M0870004055/D
12159
0512
Hepatitis and Retrovirus
Ordering information
LIAISON®
HBsAg (code 310100)
HBsAg Confirmatory Test (code 310110)
LIAISON®
Anti-HBc (code 310130)
LIAISON®
HBc IgM (code 310140)
LIAISON®
Anti-HBs II (code 310220)*
LIAISON®
Anti-HBs (code 310120)*
LIAISON®
HBeAg (code 310150)
LIAISON®
Anti-HBe (code 310160)
LIAISON®
Anti-HAV (code 310170)
LIAISON®
HAV IgM (code 310180)
LIAISON®
Anti-HBs II Plus (code 310230)*
LIAISON®
Anti-HBs Plus (code 310190)*
Product availability subject to required regulatory approval
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