TABLE 3.
Overall specificity analysis for the Elecsys HTLV-I/II and Abbott Architect rHTLV-I/II assays in routine diagnostic samples
| Parametera | Elecsys HTLV-I/II serum | Abbott Architect rHTLV-I/II serum |
|---|---|---|
| No. of samples | ||
| Total | 2,399 | 2,399 |
| Negative | 2,336 | 2,336 |
| With ≥1 s/co | ||
| IRpos | 66 | 68 |
| IRfpos | 4 | 7 |
| RRpos | 66 | 68 |
| RRfpos | 4 | 7 |
| No. of samples with HTLV-1/2 immunoblot assay result/total no. tested | ||
| Positive | 59/66 | 59/68 |
| Indeterminate | 3/66 | 2/68 |
| Negative | 4/66 | 7/68 |
| % specificity IR ≥ 1 s/co | 99.83 | 99.70 |
| 95% confidence limit (two-sided, IR ≥ 1) | 99.56–99.95 | 99.38–99.88 |
| % specificity RR ≥ 1 s/co | 99.83 | 99.70 |
| 95% confidence limit (two-sided, RR ≥ 1) | 99.56–99.95 | 99.38–99.88 |
a
Total, number of analyzed samples; negative, number of true-negative samples (excluding indeterminate, positive, and false-negative samples); IR, initially reactive; IRpos, initially reactive sample, including true-positive samples; IRfpos, initially reactive sample, not including true-positive samples; RR, repeatedly reactive; RRpos, repeatedly reactive sample, including true-positive samples; RRfpos, repeatedly reactive sample, not including true-positive samples; s/co, signal/cutoff ratio.