Limit of Detection (LoD) by Genotype

The assay limits of detection (LoD) were estimated for each HCV genotype (1a, 1b, 2, 3, 4, and 5). For each genotype, a single HCV specimen was diluted in HCV negative human plasma as well as in human serum to make panels containing the following HCV concentrations: 1000, 500, 250, 100, and 25 IU/mL.

Each panel member was tested with a minimum of 2 replicates per run, with 2 runs per day, for 4 or 5 days and with 2 Abbott RealTime HCV Genotype II Amplification Reagent lots, for a total of 40 measurements. The results for each HCV genotype in plasma and serum are summarized in Table 3.

Table 3. Abbott RealTime HCV Genotype II - Limit of Detection Summary Limit of Detection Estimates (IU/mL) Sample Type

Plasma

Serum

HCV Genotype 1a 1b 2 3 4 5 100 100 500 500 500 250 100 25 500 500 100 100

The limit of detection of the Abbott RealTime HCV Genotype II assay is 500 IU/mL.