中国丙型肝炎防控现状分析报告.ppt

/all/info-progress/show-33623_35.html 派罗欣HCV Global Slide Kit * * This is an algorithm suggested by the Centers for Disease Control for testing for HCV infection. The diagnosis of HCV infection can be made by detecting either anti-HCV antibodies or HCV RNA using RIBA or reverse transcriptase polymerase chain reaction (RT-PCR). Acute or chronic HCV infection in a patient with a positive EIA test should be confirmed by a qualitative HCV RNA assay with a lower limit of detection of 50 IU/mL or less (approximately 100 viral genes/mL). However, confirmation may be unnecessary in a patient who has evidence of liver disease and obvious risk factors for HCV. The FDA-approved manual and semiautomated, qualitative HCV PCR assays have a lower limit of detection of 50 to 100 IU/mL. More recently, a transcription-mediated amplification assay has been developed with a lower limit of detection on the order of 5 to 10 IU/mL, but it has yet to be approved for use by the FDA. The specificity of these assays for detecting HCV RNA exceeds 98%. A single positive qualitative assay for HCV RNA confirms active HCV replication, but a single negative assay does not exclude viremia and may reflect only a transient decline in viral level below the level of detection of the assay. A follow-up qualitative HCV RNA should be performed to confirm the absence of active HCV replication. Once HCV infection is confirmed, repeat testing using a qualitative assay with a limit of detection of 50 IU/mL or less is not helpful in the management of untreated patients, except for determining whether an acute infection has resolved spontaneously. Until future studies determine whether the sustained virologic response (SVR) will be sustained over the long term following successful antiviral treatment, periodic measurements of HCV RNA may need to be performed. * Over the past 2 decades, there has been substantial improvement in treatment outcomes for chronic HCV-1 infection. Interferons (IFN) are produced by th