TABLE 2.
Performance of antibody detection kits (compared with the gold standard reference method) currently in clinical use, according to recent reportsa
| Test | Gold standard method | Sensitivity (%) | Specificity (%) | PPV (%) | NPV (%) | Accuracy (%) | Reference(s) |
|---|---|---|---|---|---|---|---|
| H. pylori IgG EIA test kit (Rapid Labs, Ltd., Little Bentley, Essex, United Kingdom) | RUT | 90.5 | 39.6 | 52.1 | 85.2 | 61 | 131 |
| E-plate Eiken H. pylori Antibody II (Eiken Chemical Co., Ltd., Tokyo, Japan) | UBT | 97.4 | 76.3 | 91.5 | 91.8 | 91.6 | 145 |
| H. pylori IgG Seiken (Denka Seiken Co., Ltd., Tokyo, Japan) | UBT | 99.4 | 74.6 | 91.1 | 97.8 | 92.5 | 145 |
| GastroPanel (Biohit Oyj, Helsinki, Finland) | Histology | 74.7 | 95.6 | 91 | 86 | 160, 161 | |
| Unified GastroPanel (Biohit Oyj, Helsinki, Finland) | Histology | 93.8 | 88.9 | 93.8 | 88.9 | 165 | |
| URINELISA (Otsuka Pharmaceuticals Co., Ltd., Tokyo, Japan) | UBT or SAT | 86.5 | 85.8 | 167 | |||
| Rapirun (Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan) | Culture alone or histopathology and RUT combined | 86.2 | 90.8 | 80.6 | 93.7 | 89.4 | 171 |
| gabControl H. pylori (gabmed GmbH, Cologne, Germany) | UBT | 91.4 | 76.7 | 65.3 | 94.9 | 174 | |
| Eiken H. pylori antibody (Eiken Chemical Co., Ltd., Tokyo, Japan) | UBT | 98.1 | 78.0 | 92.1 | 93.9 | 92.5 | 145 |
| H. pylori Latex Seiken (Denka Seiken Co., Ltd., Tokyo, Japan) | UBT | 98.1 | 71.2 | 89.9 | 93.3 | 90.6 | 145 |
| Pyloriset Dry (Orion Diagnostica, Espoo, Finland) | 95 | 82 | 181 | ||||
| RecomLine H. pylori IgG (Mikrogen Diagnostik, Germany) with 6 antigens | Histology | 98.3 | 95.5 | 146 | |||
| RecomLine H. pylori IgG (Mikrogen Diagnostik, Germany) with 4 antigens | Histology | 96.1 | 20.9 | 69.7 | 73.7 | 191 |
a
PPV, positive predictive value; NPV, negative predictive value.