APTIMA^® HCV RNA Qualitative Assay
Amplified assay for the detection of hepatitis C virus (HCV) RNA in human plasma or serum

Disease Overview:
Nearly four million persons in the United States are infected with hepatitis C virus (HCV). Approximately 35,000 new cases are diagnosed each year. A major issue is most cases - approximately 85% - become chronic resulting in hepatitis C accounting for the leading cause of chronic liver disease, cirrhosis, and liver cancer in the United States, as well as the number one indication for liver transplantation.

Who are the patients at risk to develop chronic HCV infection and develop this progressive liver disease? These are the individuals, who were exposed to blood products before the development of hepatitis C testing, individuals who intermittently used or continue to use intravenous drugs or inhale cocaine, and individuals with chronic renal failure on dialysis. These individuals have a high risk of HCV exposure either through blood products used to treat the complications of chronic renal failure or because of contamination in dialysis units. Incarcerated individuals, many of whom have used drugs in the past, have a high prevalence for HCV infection. Occupational exposure to blood products is a potential mode of exposure, and individuals who receive organ or tissue grafts from HCV-positive donors through transplant are also exposed to the virus. Finally, individuals who have participated in body piercing and tattooing may be exposed through these activities.

It is critical when evaluating patients with hepatitis C to measure HCV RNA levels. The roles of diagnostic testing are to identify patients with viral hepatitis infection, to measure previous exposure to the HCV, to differentiate active from inactive infection and resolved infection, and to assess response to therapy both during and after treatment.

Use:
The APTIMA HCV Assay is an in vitro nucleic acid amplification assay for the detection of HCV RNA in human plasma or serum. The APTIMA HCV Assay is indicated for use with fresh or frozen specimens from the following populations:
• Individuals with antibody evidence of HCV infection with evidence of liver disease
• Individuals suspected to be actively infected with HCV with antibody evidence
• Individuals at risk for HCV infection with antibodies to HCV
Detection of HCV RNA is evidence of active HCV infection.

Summary:
The APTIMA HCV Assay is a sensitive and specific assay that incorporates an internal control as an additional check to prevent false-negatives. The assay detects all the major groups 1 – 6 and subtypes in viral isolates and patient samples. Finally, the APTIMA HCV Assay is able to detect active versus resolved infection.


References:

1. APTIMA HCV RNA Qualitative Assay Package Insert; 500237 Rev. B
2. www.cdc.gov
3. Clinical Care Options
4. HCV RNA Detection by TMA during the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis, C. Morishima et al. Hepatology Vol. 44, No. 2, 2006

		APTIMA HCV RNA Qualitative Assay Description: An in vitro nucleic acid assay for use from the following population: • Individuals with antibody evidence of HCV infection with evidence of liver disease • Individuals suspected to be actively infected with HCV with antibody evidence • Individuals at risk for HCV infection with antibodies to HCV Detection of HCV RNA is evidence of active HCV infection   PI / MSDS 100 Tests #2179
		APTIMA HIV-1 and HCV Auto Detect Reagents Description: Detection reagents used on the LEADER HC+ Luminometer. With bioburden testing.   PI / MSDS 1000 Tests (2*500) #2162
		APTIMA Auto Detect Reagents Description: Detection reagents used on the LEADER HC+ Luminometer. With bioburden testing.   PI / MSDS #1048
		APTIMA HCV Proficiency Panel Description: Panel is to be used for assessing proficiency in laboratory testing procedures.   PI / MSDS #2161