CSTE Position Statement(s)
All hepatitis C virus cases in each classification category should be > 36 months of age, unless known to have been exposed non-perinatally.
One or more of the following:
- Jaundice, OR
- Peak elevated total bilirubin levels ≥ 3.0 mg/dL, OR
- Peak elevated serum alanine aminotransferase (ALT) levels >200 IU/L,
The absence of a more likely diagnosis (which may include evidence of acute liver disease due to other causes or advanced liver disease due to pre-existing chronic Hepatitis C virus (HCV) infection or other causes, such as alcohol exposure, other viral hepatitis, hemochromatosis, etc.)
Confirmatory laboratory evidence:
- Positive hepatitis C virus detection test: Nucleic acid test (NAT) for HCV RNA positive (including qualitative, quantitative, or genotype testing), OR
- A positive test indicating presence of hepatitis C viral antigen(s) (HCV antigen)
Presumptive laboratory evidence:
- A positive test for antibodies to hepatitis C virus (anti-HCV)
Epidemiologic LinkageNo epidemiologic linkage is required for case classification.
Criteria to Distinguish a New Case from an Existing CaseA new acute case is an incident case that is over the age of 36 months and has not previously been reported meeting case criteria for chronic hepatitis C or for whom there is laboratory evidence of re-infection. Cases under the age of 36 months should be classified under the Perinatal HCV Position Statement (17-ID-08) unless the exposure mode is not perinatal (e.g., healthcare acquired).
All jurisdictions are encouraged to track negative HCV viral detection tests to document both spontaneous clearance of infection or sustained viral response to HCV treatment. Cases that have evidence of having cleared the infection at time of initial report or are considered false positive should not be reported to CDC.
Acute cases determined via anti-HCV test conversion do not need to have a positive HCV viral detection test reported to be considered confirmed acute cases.
A new probable acute case may be reclassified as confirmed acute if a positive HCV viral detection test is reported in the same reporting year (e.g. prior to CDC closing reporting for the calendar year).
Collection of risk history data is recommended for probable and confirmed acute HCV cases. Timing of risk history data to collect ranges from 2 weeks to 12 months prior to symptom onset or diagnosis. The time frame to employ depends on the method of classification (e.g. if a case meets clinical criteria and has a positive HCV detection test, a risk history time frame of 2 weeks to 6 months prior to onset should be used; for a case classified via anti-HCV test conversion or HCV RNA test conversion, 2 weeks to 12 months prior to onset should be considered).
If evidence indicating resolution of infection is received after a confirmed acute case has been reported to CDC, the case report does not need to be modified as it was a confirmed case at the time of initial report. However, negative HCV viral detection test results received on confirmed acute case, subsequent to an initial positive result, should be appended to case reports, as feasible, and considered for the purpose of data analysis by each jurisdiction.
For probable acute cases, the presence of a negative HCV viral detection test result, in the absence of criteria that would allow for confirmation, indicates that a case should not be classified as probable acute and should not be reported to CDC.A confirmed acute case may be classified as a confirmed chronic case if a positive HCV viral detection test is reported one year or longer after acute case onset. A confirmed acute case may not be reported as a probable chronic case (i.e. HCV antibody positive, but with an unknown HCV viral detection test). For purposes of incidence and prevalence calculations, confirmed acute and chronic HCV cases should be counted.
- A case that meets clinical criteria and has presumptive laboratory evidence, AND
- Does not have a hepatitis C virus detection test reported, AND
- Has no documentation of anti-HCV or HCV RNA test conversion within 12 months,
- A case that meets clinical criteria and has confirmatory laboratory evidence, OR
- A documented negative HCV antibody followed within 12 months by a positive HCV antibody test (anti-HCV test conversion) in the absence of a more likely diagnosis, OR
- A documented negative HCV antibody OR negative hepatitis C virus detection test (in someone without a prior diagnosis of HCV infection) followed within 12 months by a positive hepatitis C virus detection test (HCV RNA test conversion) in the absence of a more likely diagnosis,
1. Kuo G, Choo Q-L, Alter HJ, Gitnick GL, Redeker AG, Purcell RH, Miyamura T, Dienstag JL, Alter MJ, Stevens CE, et al. An Assay for Cirulating Antibodies to a Major Etiologic Virus of Human Non-A, Non-B Hepatitis. Science 1989;244(4902):362-4