TABLE 3.
Clonality testing results of the TRG1 clonality assay and 3 novel multiplex clonality assays targeting the TRG, TRD, and TRB loci using lymphoma and non‐lymphoma cases
| TRG1 | TRG2 | TRD | TRB | TRG2 + TRD | TRG2 + TRB | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Total | ve+ | ve− | ve+ | ve− | ve+ | ve− | ve+ | ve− | |||
| Lymphoma | 89 | 79 | 10 | 85 | 4 | 56 | 33 | 71 | 18 | ||
| Nonlymphoma | 35 | 0 | 35 | 1 | 34 | 0 | 35 | 0 | 35 | ||
| Sensitivity | 88.8% (80.3‐94.5%) a | 95.5% (88.9‐98.8%) | 62.9% (52.0‐72.9%) | 79.8% (69.9‐87.5%) | 98.3% | 99.1% | |||||
| Specificity | 100% (90.0‐100%) a | 97.1% (85.0‐99.9%) | 100% (90.0‐100%) | 100% (90.0‐100%) | 97.1% | 97.1% | |||||
Note: Test ve+: electrophoresis profiles had a clonal rearrangement or a clonal rearrangement with a polyclonal background. Test ve−: electrophoresis profiles had a polyclonal rearrangement, a pseudoclonal rearrangement or no amplification. Sensitivity = true positive/ (true positive + false negative). Specificity = true negative/(true negative + false positive).
Abbreviations: TRG1, original TRG assay; TRG2, new multiplex TRG assay.
a
95% confidence interval.