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{{Hepatitis C}}
{{Hepatitis C}}
{{CMG}}
{{CMG}} ; '''Associate Editor(s)-In-Chief:''' {{JA}}
==Overview==
==Overview==
The laboratory diagnosis of hepatitis C infection is first by documenting positive serologies (Anti-HCV antibodies) followed by HCV RNA quantification by PCR to determine the viral load and differentiate chronic infection from remission.
The laboratory diagnosis of hepatitis C infection is first made by documenting positive [[serology|serologies]] (anti-HCV antibodies), followed by HCV RNA quantification by PCR or NAT to determine the viral load and to differentiate chronic infection from remission.


== Serologies and HCV RNA ==
==Serologies and HCV RNA==
The diagnosis of HCV is rarely made during the acute phase given that the majority of people infected are asymptomatic during this phase of the disease. Chronic hepatitis C may be suspected on the basis of the [[medical history]] (particularly if there is history of IV drug abuse or inhaled substance usage such as cocaine), a history of piercings or [[tattoo]]s, unexplained symptoms, or abnormal liver enzymes or liver function tests found during routine blood testing.
The diagnosis of HCV is rarely made during the acute phase given that the majority of individuals infected are asymptomatic during this phase of the disease. Chronic hepatitis C may be suspected on the basis of the [[medical history]] (particularly if there is the history of [[intravenous|IV]] or intranasal drug use), a history of piercings or [[tattoo]]s, unexplained symptoms, or abnormal levels of [[liver function test]]s found during routine blood testing.


Hepatitis C testing begins with [[serology|serological]] blood tests used to detect antibodies to HCV. Overall, HCV antibody tests have a strong [[positive predictive value]] for exposure to the hepatitis C virus, but may miss patients who have not had [[seroconversion]].<ref name="aasld2014">AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed July 27, 2014.</ref> As anti-HCV antibodies indicate exposure to the virus, but cannot determine active infection, all patients with positive anti-HCV antibody tests must undergo HCV RNA quantification to determine the viral load. The HCV viral load is an important factor in determining active disease and probability of response to therapy. It does not indicate disease severity nor the likelihood of disease progression. In people with confirmed HCV infection, genotype testing is recommended. HCV genotype testing is used tailor therapeutic regimen.<ref name="who">World Health Organization (WHO) 2014. Guidelines for the screening, care and treatment of persons with hepatitis C infection.http://www.who.int/hiv/pub/hepatitis/hepatitis-c-guidelines/en/. Accessed online on July 24,2014.</ref>
Hepatitis C testing begins with [[serology|serological]] blood tests used to detect antibodies against HCV in the majority of cases. Overall, anti-HCV antibody tests have a strong [[positive predictive value]] for exposure to the hepatitis C virus, but may miss patients who have not yet had [[seroconversion]].<ref name="aasld2014">AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed July 27, 2014.</ref><ref name="pmid29703790">{{cite journal |vauthors=Cacoub P, Desbois AC, Comarmond C, Saadoun D |title=Impact of sustained virological response on the extrahepatic manifestations of chronic hepatitis C: a meta-analysis |journal=Gut |volume=67 |issue=11 |pages=2025–2034 |date=November 2018 |pmid=29703790 |doi=10.1136/gutjnl-2018-316234 |url=}}</ref> As anti-HCV antibodies indicate exposure to the virus, but cannot determine active infection, all patients with positive anti-HCV antibody tests must undergo HCV RNA quantification by nucleic acid amplification (NAT) via [[polymerase chain reaction]] (PCR) to determine the viral load. The HCV viral load is an important factor in determining active disease and the probability of response to therapy. It is not associated with disease severity or the likelihood of disease progression.


=== Laboratory tests ===
Rarely, HCV RNA quantification is performed without prior anti-HCV antibody testing. This is only indicated in patients who have a known past history of cleared HCV infection with previous [[seroconversion]] and in [[immunocompromised]] patients.


Among individuals with confirmed HCV infection, genotype testing is recommended. HCV genotype testing is used tailor therapeutic regimen.<ref name="who">World Health Organization (WHO) 2014. Guidelines for the screening, care and treatment of persons with hepatitis C infection.http://www.who.int/hiv/pub/hepatitis/hepatitis-c-guidelines/en/. Accessed online on July 24,2014.</ref>
===Laboratory Tests===
* '''HCV Enzyme-linked immunosorbent assay (ELISA)'''
* '''HCV Enzyme-linked immunosorbent assay (ELISA)'''
*:* Positive within 4-10 weeks after infection
*:* Positive within 4-10 weeks after infection
*:* False negatives can occur with HIV infection, chronic renal failure, cryos
*:* False negatives can occur with [[HIV]] infection, [[chronic renal failure]], and [[cryoglobulinemia]]
* '''HCV RNA'''
* '''HCV RNA'''
*:* Polymerase chain reaction (PCR) highly sensitive for confirming viremia
*:* PCR highly sensitive for confirming viremia
*:* Predicts response to therapy but not risk of progression
*:* Predicts response to therapy but not risk of progression


A single positive PCR test indicates infection with HCV. Negative tests require retesting especially in cases with high clinical suspicion.
A single positive PCR test indicates infection with HCV. Negative tests usually do not require re-testing, except in cases with high clinical suspicion.


[[File:HCV infection diagnosis.JPG|900px|center]]
[[File:HCV infection diagnosis.JPG|900px|center|thumb|Source: https://www.cdc.gov/]]
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==Follow-up testing for health care personnel exposed to HCV-positive blood==
==Follow-up Testing for Healthcare Personnel Exposed to HCV-positive Blood==
*For the source, perform baseline testing for anti-HCV.
*For the source, perform baseline serological testing using anti-HCV antibodies.
*For the person exposed to an HCV-positive source, perform baseline and follow-up testing, including
*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
**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.
**follow-up testing for anti-HCV and ALT activity at approximately 4–6 months after exposure. If earlier diagnosis of HCV infection is desired, testing for HCV RNA may be performed at 4–6 weeks after exposure
*Confirmation by supplemental anti-HCV testing of all anti-HCV results reported as positive by enzyme immunoassay.
*Confirmation by supplemental HCV RNA testing for all positive anti-HCV results


==References==
==References==
{{Reflist|1}}
{{Reflist|2}}
 
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Latest revision as of 23:13, 12 June 2021

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] ; Associate Editor(s)-In-Chief: Javaria Anwer M.D.[2]

Overview

The laboratory diagnosis of hepatitis C infection is first made by documenting positive serologies (anti-HCV antibodies), followed by HCV RNA quantification by PCR or NAT to determine the viral load and to differentiate chronic infection from remission.

Serologies and HCV RNA

The diagnosis of HCV is rarely made during the acute phase given that the majority of individuals infected are asymptomatic during this phase of the disease. Chronic hepatitis C may be suspected on the basis of the medical history (particularly if there is the history of IV or intranasal drug use), a history of piercings or tattoos, unexplained symptoms, or abnormal levels of liver function tests found during routine blood testing.

Hepatitis C testing begins with serological blood tests used to detect antibodies against HCV in the majority of cases. Overall, anti-HCV antibody tests have a strong positive predictive value for exposure to the hepatitis C virus, but may miss patients who have not yet had seroconversion.[1][2] As anti-HCV antibodies indicate exposure to the virus, but cannot determine active infection, all patients with positive anti-HCV antibody tests must undergo HCV RNA quantification by nucleic acid amplification (NAT) via polymerase chain reaction (PCR) to determine the viral load. The HCV viral load is an important factor in determining active disease and the probability of response to therapy. It is not associated with disease severity or the likelihood of disease progression.

Rarely, HCV RNA quantification is performed without prior anti-HCV antibody testing. This is only indicated in patients who have a known past history of cleared HCV infection with previous seroconversion and in immunocompromised patients.

Among individuals with confirmed HCV infection, genotype testing is recommended. HCV genotype testing is used tailor therapeutic regimen.[3]

Laboratory Tests

  • HCV Enzyme-linked immunosorbent assay (ELISA)
  • HCV RNA
    • PCR highly sensitive for confirming viremia
    • Predicts response to therapy but not risk of progression

A single positive PCR test indicates infection with HCV. Negative tests usually do not require re-testing, except in cases with high clinical suspicion.

Source: https://www.cdc.gov/


Follow-up Testing for Healthcare Personnel Exposed to HCV-positive Blood

  • For the source, perform baseline serological testing using anti-HCV antibodies.
  • 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 and ALT activity at approximately 4–6 months after exposure. If earlier diagnosis of HCV infection is desired, testing for HCV RNA may be performed at 4–6 weeks after exposure
  • Confirmation by supplemental HCV RNA testing for all positive anti-HCV results

References

  1. AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed July 27, 2014.
  2. Cacoub P, Desbois AC, Comarmond C, Saadoun D (November 2018). "Impact of sustained virological response on the extrahepatic manifestations of chronic hepatitis C: a meta-analysis". Gut. 67 (11): 2025–2034. doi:10.1136/gutjnl-2018-316234. PMID 29703790.
  3. World Health Organization (WHO) 2014. Guidelines for the screening, care and treatment of persons with hepatitis C infection.http://www.who.int/hiv/pub/hepatitis/hepatitis-c-guidelines/en/. Accessed online on July 24,2014.

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