Table 3.
Analytic validity of UGT1A1 testing for genotypes involving the *28 variant
| Analytic
|
||||||
|---|---|---|---|---|---|---|
| Sensitivitya |
Specificitya |
|||||
| Source | N | Test method | Referent method | *28/*28 | *28/*1 | *1/*1 |
| Monaghan19 | 12 | Radioactive PCR | Sequencing | 4/4 | 5/5 | 3/3 |
| Pirulli40 | 40 | DHPLC | Sequencing | 19/19 | 8/8 | 13/13 |
| Hasegawa39 | 60 | Invader (RUO) | Sequencing | 4/4 | 11/11 | 42/42b |
| Invader32 | 212 | Invader (IVD) | Sequencing | 30/30 | 109/109 | 73/73 |
| All | 324 | 57/57 | 133/133 | 131/131 | ||
| Overall estimate (95% confidence interval) | 100% (98–100%) | 100% (97–100%) | ||||
a
Test result/referent result.
b
Does not include three sample failures.