TABLE 1.
Limits of detection of the plasma separation card for cobas HIVb
| Concn (copies/ml) | No. of valid samplesa | No. of reactive samples | Detection rate (%) |
|---|---|---|---|
| 1,971.1 | 62 | 62 | 100.0 |
| 1,925.3 | 63 | 63 | 100.0 |
| 1,358.1 | 62 | 62 | 100.0 |
| 985.5 | 63 | 62 | 98.4 |
| 962.6 | 63 | 62 | 98.4 |
| 679 | 63 | 59 | 93.7 |
| 657 | 63 | 59 | 93.7 |
| 641.8 | 63 | 57 | 90.5 |
| 452.7 | 63 | 52 | 82.5 |
| 328.5 | 63 | 47 | 74.6 |
| 320.9 | 63 | 46 | 73.0 |
| 226.3 | 62 | 49 | 79.0 |
| 164.3 | 63 | 36 | 57.1 |
| 160.4 | 63 | 35 | 55.6 |
| 113.2 | 63 | 38 | 60.3 |
| 0 | 63 | 0 | 0.0 |
| 0 | 63 | 0 | 0.0 |
| 0 | 63 | 0 | 0.0 |
a
Some sample sizes were <63 due to an insufficient number of spots. Data for limit of detection analysis for CAP/CTM are not shown.
b
Limit of detection by probit analysis (95% hit rate), 790.2 copies/ml. 95% confidence interval (CI), 658.9 to 1,003.6 copies/ml. Lowest panel member with ≥95% reactive rate, 962.6 copies/ml 98.4% (62/63); 95% CI = 91.5 to 100.0%; lower one-sided 95% CI = 92.7%.