Table 8.: Technical, Complexity, Biosafety and Cost-Effectiveness Aspects Related to Commercial Tests Available for Resistance Testing

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