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Pseudonyms: HCV, jaundice, sexually transmitted disease, STD, bloodborne disease
TURNAROUND TIME: 8 days
TESTING METHODOLOGY:
The viral RNA is detected by real-time TaqMan RT-PCR amplification with a co-amplified internal control and has been defined with a lower limit of detection of 12 IU/mL. The assay is targeted at a highly conserved region of the viral RNA that provides for the detection of all common HCV genotypes (1 through 6). This is an FDA approved test.
SPECIMEN REQUIREMENTS:
- Collect: Prefer 5ml whole blood in an EDTA tube which will then be processed to obtain serum or plasma.
- Min. Collection:2.0 mL whole blood.
- Transport: Separated serum or plasma is sent frozen to the main laboratory. The serum should be stored frozen within 24 hours of collection.
- Stability: Ambient: up to 24 hours.
- Unacceptable Conditions: Frozen or severely hemolyzed blood. Clotted blood.
Contact the Molecular Laboratory at 918-502-1721 to obtain further information.
INTERPRETATIVE DATA:
Incidence: 1 in 50 in the United States but in other at-risk populations, such as the military, prison and drug users, the incidence can be 5 to10-fold higher. Only 25% of those infected are symptomatic. The remainder of the infected population are clinically unrecognized but the chronic infection can lead to eventual cirrhosis (20%) and death (5-7%). A significantly higher rate (3-4%) of unrecognized HCV infections are found in the baby boomer generation (1945-1963) which has resulted in a recommendation to screen this population for HCV.
Disease Characteristics: HCV symptoms can include mild flu-like symptoms, weakness and jaundice. Chronically infected but asymptomatic individuals have a significant risk of liver complications including cirrhosis of the liver, liver cancer, liver failure and death. In the chronically affected population the first indications of the condition may be abnormal liver enzyme/function values.
Reference Values:
Abnormal range >= 1.08 log IU/ mL (>=12 IU/mL)
Normal range <1.08 log IU/ mL (< 12 IU/mL)
Normal range <1.08 log IU/ mL (< 12 IU/mL)
Test Ranges:1.08 Log IU/ mL to 8.0 Log IU/ mL (12 IU/ mL to 10 8 IU/mL)
Related Tests: HBV quantitation by PCR ; Hepatitis C Genotyping by PCR
Clinical Sensitivity: 99%
Analytical Sensitivity: 99%
Indications for Testing
- To monitor the status of a known HCV infection and the response to anti-viral therapy.
- To monitor individuals after successful anti-viral therapy for recurrence of an active infection.
- Persistent mild flu
- Known exposure to hepatitis
- Suspicion of chronic hepatitis (abnormal liver enzymes)
ADDITIONAL RESOURCES:
CDC Recommendations : http://www.cdc.gov/vaccines/pubs/surv-manual/chpt22-lab-support.html