ViroSeqTM | TRUGENE® | |
---|---|---|
US FDA approved CE marked |
Yes | Yes |
HIV-1 subtype | FDA approved for subtype B, but may also work for non-B | FDA approved for subtype B, but may also work for non-B |
Viral load | >2.000 copies/ml, but may also work for 500-1000 copies/ml. | >500-1000 copies/ml. |
Plasma Volume | ≥0.5 ml | ≥0.2 ml |
Coverage | Pro: positions 1 to 99 RT: positions 1 to 335 |
Pro: positions 4 to 99 RT: positions 38 to 248 |
Cross-contamination control | UNG system (destroys PCR amplicons containing dUTP) | Built-in Genetic Fingerprint for sequence analysis |
Labour intensiveness | Moderately high | High |
Sequence data analysis | Experience needed | Semi-automatic |
Instrument Maintenance cost | Expensive | Moderate |
Sequence data analysis software | System specific | System specific |
Resistance Report | Yes | Yes |
Workflow | PCR& Sequencing purification steps 3 days for results | No purification 2 days for results |
Biosafety requirement | BSL II cabinet | BSL II cabinet and specific chemical disposal requirement |
Biohazard waste generated | Moderate | High, including specific requirement for handling chemical waste |
Labour intensiveness (sequence detection) | Moderate, batch run | High, individual patient sequence run |
Cost-effectiveness consideration for use | Surveillance and medium-to-large population-based genotyping services | Small-to-medium patient genotyping services |
No. tests/kit | 48 | 30 |