CSTE Position Statement(s)
An illness with discrete onset of any sign or symptom consistent with acute viral hepatitis (e.g., fever, headache, malaise, anorexia, nausea, vomiting, diarrhea, and abdominal pain),
(a) jaundice, OR
(b) a peak elevated serum alanine aminotransferase (ALT) level >200 IU/L during the period of acute illness.
Laboratory Criteria for Diagnosis
- A positive test for antibodies to hepatitis C virus (anti-HCV)
- Hepatitis C virus detection test:
- Nucleic acid test (NAT) for HCV RNA positive (including qualitative, quantitative or genotype testing)
- A positive test indicating presence of hepatitis C viral antigen(s) (HCV antigen)*
* When and if a test for HCV antigen(s) is approved by FDA and available.
Criteria to Distinguish a New Case from an Existing Case
A new acute case is an incident acute hepatitis C case that meets the case criteria for acute hepatitis C and has not previously been reported. A new probable acute case may be re-classified as confirmed acute case if a positive NAT for HCV RNA or a positive HCV antigen(s) test is reported within the same year. A confirmed acute case may be classified as a confirmed chronic case if a positive NAT for HCV RNA or a positive HCV antigen 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 RNA NAT or antigen status).
States and territories may choose to track resolved hepatitis C cases in which spontaneous clearance of infection or sustained viral response to treatment are suspected to have occurred before national notification or are known to have occurred after national notification as a confirmed or probable case to CDC.
- A case that meets clinical criteria and has a positive anti-HCV antibody test, but has no reports of a positive HCV NAT or positive HCV antigen tests,
- Does not have test conversion within 12 months or has no report of test conversion.
- A case that meets clinical criteria and has a positive hepatitis C virus detection test (HCV NAT or HCV antigen),
- A documented negative HCV antibody, HCV antigen or NAT laboratory test result followed within 12 months by a positive result of any of these tests (test conversion).