Hepatitis C virus (HCV) by PCR

Test code: S0045 - Ultrasensitive qualitative detection of hepatitis C virus by reverse transcription real time polymerase chain reaction

(ELISA test for Hepatitis B antibodies: A0009)

Hepatitis C virus (HCV) is member of the Flaviviridae family and is the major causative agent of parenterally transmitted non-A, non-B hepatitis worldwide. Genetic analysis of this virus led to the discovery of six major genetic groups (genotypes 1-6) and multiple minor genetic groups (subtypes 1a, 1b, 2a, 2b, etc.). To date, chimpanzees represent the only appropriate animal model for studying HCV infection, as they are easily infected with human hepatitis C virus and develop acute or chronic hepatitis (Farci and Purcell, 1993; Schlauder et al., 1991). HCV infection in other wild or captive non-human primates is still controversial and the possibility of such infection cannot be ruled out (Korzaya et al., 2002; Peli et al., 2002).

Diagnostic tests currently available either detect direct antibodies to HCV (anti-HCV) or HCV RNA. Anti-HCV indicates prior exposure to HCV but does not distinguish between cleared and active infection. An additional immunoassay such as RIBA may confirm the status of infection, but such immunoassays have a high indeterminate rate. Detection of HCV RNA by reverse transcription PCR offers a more rapid, sensitive and specific method for diagnosis of active HCV infection.

Utilities:

• Confirm the disease causing agent
• Ensure that animal colonies are free of Hepatitis C
• Early prevention of spread of this virus among a colony
• Minimize personnel exposure to this virus
• Safety monitoring of biological products and vaccines that derive from primates

References:
Farci, P. and Purcell, R.H. (1993) Hepatitis C virus: natural history and experimental models. In: Zuckerman AJ, Thomas HC, eds. Viral hepatitis: scientific basis and clinical management. Edinburg, UK: Churchill Livingstone, 241-267.
Korzaya, L.I., Lapin, B.A., Keburiya, V.V. and Chikobava, M.G. (2002) Spontaneous infection of lower primates with hepatitis C virus. Bull Exp Biol Med. 133:178-181.
Peli, A., Scagliarini, A., Cinotti, S. and Martinelli, G.N. (2002) Seropositivity to HCV in Macaca fascicularis. New Microbiol. 25:231-234.
Schlauder, G.G., Leverenz, G.J., Amann, C.W., Lesniewski, R.R. and Peterson, D.A. (1991) Detection of the hepatitis C virus genome in acute and chronic experimental infection in chimpanzees. J Clin Microbiol 29: 2175-2179.

Specimen requirement: 1 ml whole blood in EDTA (purple top) or ACD (yellow top) tube, or 1 ml plasma or serum, shipped overnight at room temperature; or 1 ml frozen plasma or serum, shipped frozen.

For specimen types other than those listed here, please call to confirm specimen acceptability and shipping instructions.

For all specimen types, if there will be a delay in shipping, or during very warm weather, refrigerate specimens until shipped and ship with a cold pack unless more stringent shipping requirements are specified. Frozen specimens should be shipped so as to remain frozen in transit. See shipping instructions for more information.

Turnaround time: 2 business days

Methodology: Qualitative reverse transcription real time PCR

Normal range: Nondetected