Table 2 Definitions of key analytical performance terms used in defining hepatitis C virus RNA VL titer measurements based on guidelines [28]
Result | Definition |
|---|---|
Target not detect | HCV RNA is not detected, no observable PCR amplification or detection |
LLOQ | Lowest HCV RNA titer within the test's dynamic range that is quantifiable and accurate |
LOD | Lowest amount of analyte in a sample that can be detected (e.g. Detection of HCV RNA ≥95% by Hit Rate or PROBIT analysis) |
ULOQ | The highest HCV RNA titer result within the test's dynamic range that is quantifiable and accurate |