Anti-HCV (Anti-Hepatitis C virus antibodies)
Detection of antibodies to Hepatitis C virus.
|Reporting Name||Available separately||Always performed|
|HCV RNA PCR||YES||NO|
Indications for Testing
Detection of total antibodies to hepatitis C virus.
Anti-HCV should be ordered as a screen for acute, past or chronic hepatitis C infection (see Special Instructions):
Acute hepatitis screen (unknown etiology)
Chronic hepatitis screen (unknown etiology)
Previous hepatitis exposure (unknown etiology)
For a child born of an HCV-infected mother
HCV serology is not reliable during infancy because passively transferred maternal antibody may persist for up to 18 months. Therefore serology performed at 12 – 18 months of age is the primary diagnostic test. In special situations of heightened anxiety a single HCV RNA PCR test at a minimum of two months is recommended.
Special Instructions and Forms
Chemiluminescent Microparticle Immunoassay (CMIA)
non-A, non-B Hepatitis
Serology: Suitable specimens are individual samples (human sera or EDTA/heparinized/citrated plasma) obtained by standard laboratory techniques.
Container/Tube: Serum separator (SST) or Plain Red-top tube(s)
Specimen Volume: 5 mL of whole blood
Separate plasma or serum within 6 hours and store at 2-8°C and transport on ice packs within 7 days.
Specimen Minimum Volume
*The samples should be stored for not more than 7 days at 2-8°C.
**For longer delay, freeze at -20°C or below and transport on dry ice.
Reject Due To
|Specimens other than||Serum|
Detection of antibodies to Hepatitis C virus.
Hepatitis C virus (HCV) infection is diagnosed employing an initial screening for anti-HCV antibodies. The presence of anti-HCV antibodies is indicative of previous or current HCV infection. Determination of active infection is required as >50% of infected, anti-HCV-REACTIVE, patients spontaneously clear the virus. Clearance usually occurs within 14 weeks of exposure, most patients clear the virus within 12 weeks. All anti-HCV REACTIVE specimens are subjected to HCV RNA PCR to determine if circulating virus is present.
HCV antibodies are usually not detected during the first 2 months following infection and are almost always detectable by the late convalescent stage (4-6 months after onset) of infection. These antibodies do not neutralize the virus, and they do not provide immunity against re-infection. Loss of HCV antibodies may occur several years following resolution of infection.
Evolution of HCV infection markers over time.
Most infected people are asymptomatic with onset of disease being insidious. Symptoms range from anorexia, fatigue, fever, myalgia, nausea and vomiting progressing to jaundice. More than 50% of those infected will develop chronic HCV infection. Of those chronically infected about half will develop cirrhosis or cancer of the liver.
Hepatitis C virus (HCV) is an RNA virus of the Flaviviridae family, previously known as NANB hepatitis, which is spread predominantly by parenteral routes. An estimated 170 million people are infected worldwide, and HCV infection is now the leading cause for liver transplantation in the United States because of its propensity to cause chronic liver disease, cirrhosis, and hepatocellular carcinoma.
HCV is recognized as the cause of most cases of post-transfusion hepatitis and is a significant cause of morbidity and mortality worldwide. HCV infection has been reported in virtually every country where it has been carefully evaluated, suggesting that HCV, unlike HIV, has a long-standing global distribution. Occurrence of HCV worldwide is directly related to the prevalence of people who routinely share injection equipment. Approximately 250,000 Canadians are infected with HCV. In Newfoundland and Labrador in 2006 there were 90 cases of HCV reported with a calculated incidence rate of 17.8 per 100,000. The risk factor most commonly reported is injection drug use.
Despite the value of serologic tests to screen for HCV infection, several limitations of serologic testing exist:
1. There may be a long delay (up to 6 months) between exposure to the virus and the development of detectable HCV antibodies.
2. False-reactive screening test results can occur.
3. A reactive screening test result does not distinguish between past (resolved) and chronic HCV infection.
4. Serologic tests cannot provide information on clinical response to anti-HCV therapy.
Unfortunately, HCV serology is not reliable during infancy because passively transferred maternal antibody may persist for up to 18 months. Therefore, serology performed at 12 – 18 months of age is the primary diagnostic test (with the test repeated at 18 months of age, if it is still REACTIVE before that age).
REACTIVE: A reactive anti-HCV antibody screen may suggest past or recent infection. Confirmation with HCV PCR or anti-HCV LIA required (autoreflex).
NON-REACTIVE: A non-reactive result does not exclude early active infection. If clinically indicated submit a follow-up specimen. Most cases of true HCV infection show seroconversion at 4 – 6 months post exposure. If early acute (seronegative) HCV is suspected HCV RNA PCR may be ordered to detect viremia.
See Special Instructions for PHL recommended diagnostic approach to hepatitis.
(Canadian Pediatric Society Position Statement, 2008)
Abbott. 2009. Abbott Architect System, Anti-HCV: package insert. Abbott Diagnostics Division, Wiesbaden, Germany.
Curry, M. P., and Chopra, S. 2010. Acute Viral Hepatitis, p. 1577-1592. In Mandell, D., Bennett, J. E., and Dolin, R. Principles and practice of infectious diseases, 7th ed., vol. 2. Churchill Livingstone, Elsevier, Philadelphia, PA.
Ray, S. C., and D. L. Thomas. 2010. Hepatitis C, p. 2157-2185. In Mandell, D., Bennett, J. E., and Dolin, R. Principles and practice of infectious diseases, 7th ed., vol. 2. Churchill Livingstone, Elsevier, Philadelphia, PA.
Scott, J. D., and Gretch, D. R. 2007. Hepatitis C and G Viruses, p. 1437-1452. In Murray, P. R., Baron, E. J., Jorgensen, J. H., Landry, M. L., and Pfaller, M. A. Manual of Clinical Microbiology, 9th ed., vol. 2. ASM Press, American Society for Microbiology, Washington, DC.
Sherman, M., S. Shafran, K. Burak, et al. 2007. Management of chronic hepatitis C: Consensus guidelines. Can J Gastroenterol 21:25C-34C.
Infectious Disease and Immunization Committee, Canadian Pediatric Society. 2008. Vertical transmission of the hepatitis C virus: Current knowledge and issues. Pediatr Child Health. 03(6):529-534.
|Status||Days||Analytic Time||Maximum Laboratory Time||Specimen Retention|
|Routine||Mon, Tue, Fri||7h||72h||1 month|
The ARCHITECT Anti-HCV assay is a two-step immunoassay, using chemiluminescent microparticle immunoassay (CMIA) technology, for the qualitative detection of anti-HCV in human serum and plasma. In the first step, sample, recombinant HCV antigen coated paramagnetic microparticles and Assay Diluent are combined. Anti-HCV present in the sample binds to the HCV coated microparticles. After washing, anti-human acridinium-labeled conjugate is added in the second step. Following another wash cycle, Pre-Trigger and Trigger Solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of anti-HCV in the sample and the RLUs detected by the ARCHITECT i* System optics. The presence or absence of anti-HCV in the specimen is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from a previous ARCHITECT Anti-HCV calibration. If the chemiluminescent signal in the specimen is greater than or equal to the cutoff signal, the specimen is considered reactive for anti-HCV.
Architect Anti-HCV assay is Health Canada Licensed, 2001.
Performing Laboratory Location
Newfoundland & Labrador Public Health Laboratory