TABLE 2.
Summary of test reagent sensitivity and specificity
| Testing reagent | TP | FP | FN | TN | Sensitivity | 95% CrI | Specificity | 95% CrI | PLR | NLR |
|---|---|---|---|---|---|---|---|---|---|---|
| All agents, combined | 5 | 27 | 88 | 458 | 0.03 | 0.00–0.08 | 0.98 | 0.95–1 | 2.75 | 0.99 |
| Either mRNA vaccine agent | 3 | 8 | 11 | 95 | 0.2 | 0.01–0.52 | 0.97 | 0.9–1 | 4.75 | 0.84 |
| mRNA‐1273 vaccine (Moderna) | 2 | 6 | 1 | 27 | 0.59 | 0.08–0.98 | 0.76 | 0.01–1 | 2.3 | 0.52 |
| BNT162b2 vaccine (Pfizer‐BioNTech) | 1 | 2 | 10 | 68 | 0.1 | 0.00–0.38 | 0.99 | 0.94–1 | 1.3 | 0.92 |
| Polyethylene Glycol a | 1 | 11 | 45 | 240 | 0.02 | 0.00–0.07 | 0.99 | 0.96–1 | 2 | 0.99 |
| Polysorbate b | 1 | 8 | 32 | 123 | 0.03 | 0.00–0.11 | 0.97 | 0.91–1 | 1.5 | 0.99 |
| Sensitivity analysis (all agents, combined) | TP | FP | FN | TN | Sensitivity | 95% CI | Specificity | 95% CrI | ||
|---|---|---|---|---|---|---|---|---|---|---|
| 1st dose anaphylaxis patients included in the study | 5 | 26 | 82 | 435 | 0.03 | 0.00–0.09 | 0.98 | 0.95–1 | 6.5 | 0.89 |
| No 1st dose anaphylaxis patients included in the study | 0 | 0 | 10 | 10 | 0.07 | 0.00–0.45 | 0.98 | 0.76–1 | 2.5 | 0.97 |
| Graded challenge allowed | 4 | 15 | 45 | 197 | 0.08 | 0.01–0.23 | 0.97 | 0.9–1 | 1.4 | 0.98 |
| No graded challenge allowed | 1 | 11 | 47 | 248 | 0.01 | 0.00–0.06 | 0.99 | 0.96–1 | 2 | 0.99 |
| Premedication allowed | 0 | 11 | 54 | 183 | 0.00 | 0.00–0.03 | 0.98 | 0.93–1 | 0.5 | 1 |
| No premedication allowed | 5 | 15 | 38 | 280 | 0.09 | 0.01–0.25 | 0.98 | 0.94–1 | 3.67 | 0.92 |
| Predictive only of 2nd dose anaphylaxis | 2 | 26 | 12 | 433 | 0.11 | 0.01–0.32 | 0.98 | 0.95–1 | 6.5 | 0.89 |
Abbreviations: CrI, credible interval; FN, false negative; FP, false positive; NLR, negative likelihood ratio; PLR, positive likelihood ratio; TN, true negative; TP, true positive.
a
Inclusive of any molecular weight polyethylene glycol tested.
b
Inclusive of any polyoxyethylene group number tested.