Advanced Technology Laboratory, Chemistry, Molecular Diagnostics

Hepatitis C Antibody Reporting Change

The Spectrum Health Laboratory is now reporting all Hepatitis C Antibody results as Negative or Positive only. (Hepatitis C Antibody, Screening; Hepatitis C Antibody, Diagnostic) The separate Low Positive result category has been eliminated.

The Laboratory has changed to a new Hepatitis C Antibody reagent which no longer includes the Low Positive result category in its product labeling (the FDA approved instructions which laboratories are required to follow). The Low Positive category was defined on the basis of old guidelines which indicated that results above a defined S/CO (signal/cutoff) value were considered to have a 95% or greater probability of being true positives and did not require RIBA confirmation. The RIBA confirmatory test has not been available for several years now. Current guidelines are that all positive Hepatitis C Antibody tests should be confirmed with a HCV RNA test. The Spectrum Health laboratory reflexes all positive antibody results to this test. A positive HCV RNA following a positive antibody result should be considered indicative of active HCV infection, and may be used as a baseline for antiviral therapy.

 

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