Table 1.
Lower limit of quantitation, upper limit of quantitation, sample input volume, and processing volume of the four cobas HBV assays*.
| Platform* | Quantitative standard control (type) |
Linear range | Workflow | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LLOQ (IU/ml) |
ULOQ (IU/ml) |
Sample processing volume (µl) |
Type of sample prep | Maximum walk away time (h) |
Sample processing time$ (h) | Hands on time per 8 h shift (h) | Detection time (h) |
Interventions per 8 h (n) |
Time to first results [h (n)] | Throughput in 8 h (n) |
||
| HPS/CTM | Competitive | 29 | 1.1E + 08 | 500 | Manual | 3 | 2 | 2.5 | 3 | N/A | 5 (48) | 96 |
| CAP/CTM | Competitive | 20 | 1.7E + 08 | 650 | Automated | 2.5 | 2 | 0.5 | 3 | 4 | 5.5 (96) | 96 |
| cobas 4800 | Noncompetitive | 10 | 1.0E + 09 | 200 or 400 | Automated | 2.7 | 3 | 0.5 | 1.5 | 5 | <5 (96) | 192 |
| cobas 6800 | Noncompetitive | 10 | 1.0E + 09 | 200 or 500 | Automated | 8 | 1.5 | 0.5 | 1.5 | 3 | <3.5 (96) | 384 |
| cobas 8800 | Noncompetitive | 10 | 1.0E + 09 | 200 or 500 | Automated | 4 | 1.5 | 1 | 1.5 | 4‡ | <3.5 (96) | 960 |
Corresponding assays for each platform: COBAS TaqMan HBV test for use with the High Pure System (HPS/CTM); COBAS AmpliPrep/COBAS TaqMan HBV v2 test using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer (CAP/CTM); cobas HBV test for use on the cobas 4800 System (cobas 4800); cobas HBV test for use on the cobas 6800/8800 Systems (cobas 6800/8800).
Sample processing time includes sample extraction and purification and polymerase chain reaction setup.
Extra waste removal step compared with cobas 6800.
HBV, hepatitis B virus; LLOQ, lower limit of quantitation; ULOQ, upper limit of quantitation.