Table 3.
Summary of Qualitative Performance for EBV Viral Load Testing
| EBV – Commercial panel - Single replicate of each dilution at each site | |||||
| Number of replicates | |||||
| Expected (log10 copies/ml) | Negative | Positive* | Quantifiable | Mean (log10 copies/ml) | Range (log10 copies/ml) |
| 0 | 5 | ||||
| 3 | 1 | 3 | 1 | 2.27 | |
| 4 | 1 | 4 | 3.17 | 2.00–3.76 | |
| 5 | 5 | 4.04 | 3.07–4.88 | ||
| 6 | 5 | 5.27 | 4.23–5.77 | ||
| 7 | 5 | 6.29 | 5.29–6.75 | ||
| EBV – WHO International Standard, Three replicates of each dilution at each site** | |||||
| Expected IU/ml (log10 IU/ml) | Negative | Positive* | Quantifiable | Mean (log10 copies/ml) | Range (log10 copies/ml) |
| 0 | 14 | ||||
| 10 (1) | 10 | 4 | |||
| 100 (2) | 4 | 7 | 3 | 2.44 | 2.01–3.16 |
| 1000 (3) | 4 | 10 | 3.38 | 2.37–3.75 | |
| 10,000 (4) | 14 | 4.16 | 3.45–4.69 | ||
| 100,000 (5) | 14 | 5.21 | 4.55–5.73 | ||
| 1,000,000 (6) | 14 | 6.18 | 5.46–6.67 | ||
**
Protocol 4 only 2 replicates;
*
Positive but below the reportable range