* Denotes analysis based upon samples tested with m2000rt results: 1, 1a, 1b, 1/1a, and 1/1b.
** Three out of 110 subtype 1a samples were identified as genotype 1 only but not as subtype 1a.
*** One vendor identified subtype 1b sample was excluded from analysis because it was identified by sequencing as genotype 1 only. Two out of 58 remaining subtype 1b samples were identified as genotype 1 but not as subtype 1b.
**** Genotype 4 was detected in all 28 samples. Genotype 1 was also detected in 3 of the samples, which could not be resolved due to 2-way cross-reactivity.
‡ Denotes analysis based upon genotypes 1, 2, 3, 4, 5, and 6 combined.
The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for determining the genotype(s) of hepatitis C virus (HCV) in plasma and serum from HCV-infected individuals. The Abbott RealTime HCV Genotype II assay detects genotypes 1, 2, 3, 4, 5, and 6, and subtypes 1a and 1b through the use of genotype-specific fluorescent-labeled oligonucleotide probes. The Abbott RealTime HCV Genotype II is not for screening blood, plasma serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection.
1. Abbott RealTime HCV Genotype II [package insert]. Abbott Laboratories, 2013.