Hepatitis C laboratory tests

Diagnosis
The diagnosis of "hepatitis C" is rarely made during the acute phase of the disease because the majority of people infected experience no symptoms during this phase of the disease. Those who do experience acute phase symptoms are rarely ill enough to seek medical attention. The diagnosis of chronic phase hepatitis C is also challenging due to the absence or lack of specificity of symptoms until advanced liver disease develops, which may not occur until decades into the disease.

Chronic hepatitis C may be suspected on the basis of the medical history (particularly if there is any history of IV drug abuse or inhaled substance usage such as cocaine), a history of piercings or tattoos, unexplained symptoms, or abnormal liver enzymes or liver function tests found during routine blood testing. Occasionally, hepatitis C is diagnosed as a result of targeted screening such as blood donation (blood donors are screened for numerous blood-borne diseases including hepatitis C) or contact tracing.

Hepatitis C testing begins with serological blood tests used to detect antibodies to HCV. Anti-HCV antibodies can be detected in 80% of patients within 15 weeks after exposure, in >90% within 5 months after exposure, and in >97% by 6 months after exposure. Overall, HCV antibody tests have a strong positive predictive value for exposure to the hepatitis C virus, but may miss patients who have not yet developed antibodies (seroconversion), or have an insufficient level of antibodies to detect. While uncommon, a small minority of people infected with HCV never develop antibodies to the virus and therefore, never test positive using HCV antibody screening.

Anti-HCV antibodies indicate exposure to the virus, but cannot determine if ongoing infection is present. All persons with positive anti-HCV antibody tests must undergo additional testing for the presence of the hepatitis C virus itself to determine whether current infection is present. The presence of the virus is tested for using molecular nucleic acid testing methods such as polymerase chain reaction (PCR), transcription mediated amplification (TMA), or branched DNA (b-DNA). All HCV nucleic acid molecular tests have the capacity to detect not only whether the virus is present, but also to measure the amount of virus present in the blood (the HCV viral load). The HCV viral load is an important factor in determining the probability of response to interferon-based therapy, but does not indicate disease severity nor the likelihood of disease progression.

In people with confirmed HCV infection, genotype testing is generally recommended. There are six major genotypes of the hepatitis C virus, which are indicated numerically (e.g., genotype 1, genotype 2, etc.). HCV genotype testing is used to determine the required length and potential response to interferon-based therapy.

Laboratory Diagnosis

 * HCV Enzyme-linked immunosorbent assay (ELISA)
 * Positive within 4-10 weeks after infection
 * False negatives can occur with HIV infection, chronic renal failure, cryos
 * HCV RNA
 * Polymerase chain reaction (PCR) highly sensitive for confirming viremia
 * Predicts response to therapy but not risk of progression

There are several blood tests that can be done to determine if you have been infected with HCV. Your doctor may order just one or a combination of these tests. The following are the types of tests your doctor may order and the purpose for each:

a) Anti-HCV (antibody to HCV)

EIA (enzyme immunoassay) or CIA (enhanced chemiluminescence immunoassay) Test is usually done first. If positive, it should be confirmed RIBA (recombinant immunoblot assay) A supplemental test used to confirm a positive EIA test Anti-HCV does not tell whether the infection is new (acute), chronic (long-term) or is no longer present. b) Qualitative tests to detect presence or absence of virus (HCV RNA) c) Quantitative tests to detect amount (titer) of virus (HCV RNA)

A single positive PCR test indicates infection with HCV. A single negative test does not prove that a person is not infected. Virus may be present in the blood and just not found by PCR. Also, a person infected in the past who has recovered may have a negative test. When hepatitis C is suspected and PCR is negative, PCR should be repeated.



==Recommendations for Diagnosis of Acute and Chronic HCV Infection: AASLD Practice Guidelines 2009 == 1. Patients suspected of having acute or chronic HCV infection should ﬁrst be tested for anti-HCV (Class I, Level B.)

2. HCV RNA testing should be performed in:


 * a) Patients with a positive anti-HCV test (Class I, Level B)


 * b) Patients for whom antiviral treatment is being considered, using a sensitive quantitative assay (Class I, Level A)


 * c) Patients with unexplained liver disease whose anti-HCV test is negative and who are immunocompromised or suspected of having acute HCV infection (Class I, Level B).

3. HCV genotyping should be performed in all HCV-infected persons prior to interferon-based treatment in order to plan for the dose and duration of therapy and to estimate the likelihood of response (Class I, Level A)

Follow-up testing for health care personnel exposed to HCV-positive blood

 * For the source, perform baseline testing for anti-HCV.
 * For the person exposed to an HCV-positive source, perform baseline and follow-up testing, including
 * baseline testing for anti-HCV and ALT activity AND
 * follow-up testing for anti-HCV (e.g., at 4–6 months) and ALT activity. If earlier diagnosis of HCV infection is desired, testing for HCV RNA may be performed at 4–6 weeks.
 * Confirmation by supplemental anti-HCV testing of all anti-HCV results reported as positive by enzyme immunoassay.