hcv diagnosis. features of hepatitis c virus infection incubation periodaverage 6-7 weeks range 2-26...
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HCV Diagnosis
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Features of Hepatitis C Virus InfectionFeatures of Hepatitis C Virus Infection
Incubation periodIncubation period Average 6-7 Average 6-7 weeksweeks
Range 2-26 Range 2-26 weeksweeks
Acute illness (jaundice)Acute illness (jaundice) Mild (Mild (<<20%)20%)
Case fatality rateCase fatality rate LowLow
Chronic infectionChronic infection 75%-85%75%-85%
Chronic hepatitisChronic hepatitis 70% (most asx)70% (most asx)
CirrhosisCirrhosis 10%-20%10%-20%
Mortality from CLDMortality from CLD 1%-5%1%-5%
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Chronic Hepatitis C Factors Promoting Progression or Severity
• Increased alcohol intake
• Age > 40 years at time of infection
• HIV co-infection
• ?Other– Male gender– Other co-infections (e.g., HBV)
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Serologic Pattern of Acute HCV Infection with Recovery
Symptoms +/-
Time after Exposure
Tit
eranti-HCV
ALT
Normal
0 1 2 3 4 5 6 1 2 3 4YearsMonths
HCV RNA
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Serologic Pattern of Acute HCV Infection with Progression to Chronic Infection
Symptoms +/-
Time after Exposure
Tit
eranti-HCV
ALT
Normal
0 1 2 3 4 5 6 1 2 3 4YearsMonths
HCV RNA
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Estimated Incidence of Acute HCV InfectionUnited States, 1960-1999
0
20
40
60
80
100
120
140
1960 1965 1970 1975 1980 1985 1989 1995 1999
Year
New
Inf
ecti
ons
/100
,000
Decline intransfusion recipients
Decline in injection drug users
Source: Hepatology 2000;31:777-82; Hepatology 1997;26:62S-65S
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Transmission of HCV
• Percutaneous – Injecting drug use– Clotting factors before viral inactivation– Transfusion, transplant from infected donor – Therapeutic (contaminated equipment,
unsafe injection practices)– Occupational (needlestick)
• Permucosal– Perinatal– Sexual
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Sources of Infection forPersons with Hepatitis C
Sexual 15%
Other* 5%
Unknown 10%
Injecting drug use 60%
Transfusion 10%(before screening)
*Nosocomial; Health-care work; Perinatal
Source: Centers for Disease Control and Prevention
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Posttransfusion Hepatitis C
0
5
10
15
20
25
30
1965 1970 1975 1980 1985 1990 1995 2000
Year
% o
f Rec
ipie
nts I
nfec
ted
All volunteer donors
HBsAg
Donor Screening for HIV Risk Factors
Anti-HIV
ALT/Anti-HBc
Anti-HCV
Improved HCV Tests
Adapted from HJ Alter and Tobler and Busch, Clin Chem 1997
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HCV Testing Routinely Recommended
• Ever injected illegal drugs• Received clotting factors made before 1987• Received blood/organs before July 1992 • Ever on chronic hemodialysis• Evidence of liver disease
• Healthcare, emergency, public safety workers after needle stick/mucosal exposures to HCV-positive blood
• Children born to HCV-positive women
Based on increased risk for infection
Based on need for exposure management
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Routine HCV Testing Not Recommended(Unless Risk Factor Identified)
• Health-care, emergency medical, and public safety workers
• Pregnant women
• Household (non-sexual) contacts of HCV-positive persons
• General population
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HCV Counseling
• Prevent transmission to others– Direct exposure to blood– Perinatal exposure– Sexual exposure
• Refer to support group
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Preventing HCV Transmission to Others
• Do not donate blood, body organs, other tissue or semen
• Do not share items that might have blood on them– personal care (e.g., razor, toothbrush)– home therapy (e.g., needles)
• Cover cuts and sores on the skin
Avoid Direct Exposure to Blood
HCV Counseling
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Mother-to-Infant Transmission of HCV
• Postexposure prophylaxis not available• No need to avoid pregnancy or breastfeeding
– Consider bottle feeding if nipples cracked/bleeding
• No need to determine mode of delivery based on HCV infection status
• Test infants born to HCV-positive women– Consider testing any children born since woman
became infected– Evaluate infected children for CLD
HCV Counseling
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History of HCV Testing
• First tests licensed by the Food and Drug Administration in 1990
• Since 1990 new versions of these and other FDA- approved anti HCV tests have been used for– Clinical Diagnosis of HCV– Screening of asymptomatic persons
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Testing Rationale
• Testing for HCV infection by using anti-HCV is performed for
1) Clinical diagnosis of patients with signs or symptoms of liver disease
2) Management of occupational and perinatal exposures
3) Screening asymptomatic persons to identify HCV-infected persons who should receive counseling and related to the persons tested is often lacking, and even persons with risk factors for HCV infection might be at sufficiently low enough risk for infection that there screening tests could be falsely positive (e.g. health care professionals-risk but low prevalence)
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HCV Infection Testing AlgorithmHCV Infection Testing Algorithmfor Diagnosis of Asymptomatic Personsfor Diagnosis of Asymptomatic Persons
EIA for Anti-EIA for Anti-HCVHCV
Negative (non-reactive)
STOP
Positive (repeat reactive)
OR
RIBA for Anti-HCVRIBA for Anti-HCVRT-PCR for HCV
RNA
Negative
STOPAdditional Laboratory Additional Laboratory Evaluation (e.g. PCR, Evaluation (e.g. PCR,
ALT)ALT)
Negative PositiveIndeterminate
Medical Medical EvaluationEvaluation
Positive
Negative PCR, Normal ALT
Positive PCR, Abnormal ALT
Source: MMWR 1998;47 (No. RR 19)
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Approved Testing Kits
• Comprised of – Two enzyme immunoassays (EIA)
• Abbot HCV EIA 2.0 • ORTHO HCV Version 3.0 ELISA
– One enhanced chemiluminescence immunoassay (CIA)
• VITROS
• All of the above immunoassays use HCV-encoded recombinant antigens
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Available Supplemental Tests
• Tests include– Serologic anti-HCV assay
• Nucleic acid test (NAT)– Qualitative detection of HCV-RNA
» AMPLICOR Version 2» COBAS AMPLICOR Version 2
• Recombinant immunoblot assay (RIBA)
The Laboratory used determines the type of test performed
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Interpreting Antibody to Hepatitis C Virus (anti-HCV)
Test Results
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Anti-HCV -Positive
• Defined as1) Anti-HCV screening test positive*
AND
Recombinant immunoblot assay (RIBA)-positive
OR
Nucleic acid test (NAT) – positive
*Interpretation of screening immunoassasy test results based on criteria provided by the manufacturer
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Anti-HCV -Positive
2) anti-HCV screening test positive, NAT- negative, RIBA- positive
– An anti-HCV positive result indicates past or current HCV infection.
• An HCV RNA-positive result indicates current (active) infection BUT the significance of a single HCV RNA-negative result is unknown; it does not differentiate intermittent viremia from resolved infection
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Anti-HCV-Positive
• All anti-HCV positive persons should receive – Counseling– Undergo medical evaluating, including additional
testing for the presence of virus and liver disease• Anti-HCV testing usually does not need to be repeated
after a positive anti-HCV result has been confirmed
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Anti-HCV -Negative
• Defined as:1) Anti-HCV screening test negative*
OR2) Anti-HCV screening test positive, RIBA-
negative
OR3) Anti-HCV screening test positive, NAT-
negative, RIBA-negative
*Interpretation of screening immunoassasy test results based on criteria provided by the manufacturer
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Anti-HCV- Negative
• An anti-HCV person is considered uninfected
• No further evaluation or follow-up for HCV is required, unless recent infection is suspected or other evidence exists to indicate HCV infection
• Abnormal liver enzyme levels in an immuno-compromised person
• A person with no other etiology for their liver disease
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Anti-HCV- Indeterminate
• Defined as:
Anti-HCV screening test positive, RIBA- indeterminate
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Anti-HCV- Indeterminate
• An indeterminate anti-HCV result indicates that the HCV antibody status cannot be determined– Can indicate a false positive anti HCV
screening test result, the most likely interpretation among those at low risk for HCV infection; such persons are HCV RNA-negative
– Can occur as a transient finding in a recently infected person who is in the process of seroconversion: such persons usually are HCV RNA -positive
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Anti-HCV- Indeterminate
– Can be persistent finding among persons chronically infected with HCV; such persons usually are HCV RNA -positive
• If NAT is not performed, another sample should be collected for repeat anti-HCV testing (> 1 month later)
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Signal to Cutoff Ratios
• Analysis of enzyme immunoassay and chemiluminescence assay data indicates that s/co ratios can be used to predict supplemental test-positive results
• A specific s/co ratio can be identified for each test that would predict a true antibody-positive result (as defined by the results of supplemental testing) ≥95% of the time, regardless of the anti-HCV prevalence or characteristics of the population being tested.
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Screening test kit name Manufacturer Assay Format
Signal-to-cut—off ratio predictive of a true
positive ≥ 95% of the time
Ortho HCV Version 3.0 ELISA Test System
OrthoEIA
(Enzyme Immunoassay)≥ 3.8
Abbott HCV EIA 2.0 AbbottEIA
(Enzyme Immunoassay)≥ 3.8
VITROS Anti-HCV OrthoCIA
(Chemiluminescennt Immunoassay)
≥ 8.0
AxSYM Anti-HCV AbbottMEIA
(Microparticle Immunoassay)≥ 10.0
Architect Anti-HCV AbbottCMIA
(Chemiluminescent Microparticle Immunoassay)
≥ 5.0
Advia Centaur HCV BayerCIA
(Chemiluminescennt Immunoassay)
≥ 11.0
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