Table 1. Ability of the different molecular methods tested in this study to correctly identify HCV subtypes 1a and 1b in a series of 500 patients infected by one or the other of these subtypes.
| Assay | Trugene HCV 5′NC Genotyping Assay | INNO-LiPA HCV 1.0 | INNO-LiPA HCV 2.0 | Abbott RealTime HCV Genotype II assay | |
| Manufacturer | Siemens Medical Solutions Diagnostic | Innogenetics | Innogenetics | Abbott Molecular | |
| Method | Sequence analysis of the 5′NCR followed by sequence comparison | Reverse hybridization targeting the 5′NCR | Reverse hybridization targeting the 5′NCR and the core-coding region | Real-time PCR assay targeting the 5′NCR and NS5B-coding region | |
| All samples | Subtype 1a * (N = 237), n/N (%) | 183/237 (77.2%) | 167/237 (70.5%) | 231/237 (97.5%) | 220/236** (93.2%) |
| Subtype 1b * (N = 263), n/N (%) | 238/263 (90.5%) | 240/263 (91.3%) | 253/263 (96.2%) | 232/261** (88.9%) | |
| Samples that could be PCR-amplified only | Subtype 1a * , n/N (%) | 183/235(77.9%) | 167/236 (70.8%) | 231/232 (99.6%) | 220/236 (93.2%) |
| Subtype 1b * , n/N (%) | 238/258 (92.2%) | 240/260 (92.3%) | 253/255 (99.2%) | 232/259 (89.6%) | |
Correct identification with the different techniques tested is shown for all samples, and for samples that could be amplified by PCR in the assay.
*
The correct HCV genotype 1 subtype was identified by means of direct sequence analysis of a portion of the NS5B gene followed by phylogenetic analysis, the reference method.
**
In one 1a case and two 1b cases, not enough serum volume was available for testing in the Abbott RealTime HCV Genotype II assay.