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Table 3 The results and interpretations that are reported by manufacturers of commercial hepatitis C virus RNA VL tests

From: Molecular diagnostics in the management of chronic hepatitis C: key considerations in the era of new antiviral therapies

Titer result (IU/mL) Reported results Results interpretation*
"Target not detected" or "Not detected" Results are reported as "HCV RNA not detected". Ct value for HCV is above the limit for the assay or no Ct value for HCV is obtained.
Less than the Lower Limit of Quantification (LLOQ) Results are reported as "HCV RNA detected, less than [ LLOQ ] IU/mL HCV RNA". Calculated IU/mL is below the dynamic range of the assay.
Titer is within the linear range of the test Results are reported as "[ number ]
IU/mL, HCV RNA detected".
Calculated results are quantifiable within the dynamic range of the test (e.g.greater than or equal to the LLOQ and less than or equal to ULOQ, results)
Greater than the upper limit of quantification (ULOQ) Results are reported as "greater than [ ULOQ ] IU/mL HCV RNA". Calculated results are above the dynamic range of the assay.
  1. * Ct = crossing point or crossing threshold, the value in which the PCR amplification is detected (sigmoidal curve)
  2. HCV: Hepatitis C virus. LLOQ: Lower limit of quantification. ULOQ: Upper limit of quantification.