TABLE 6.
Performance of norovirus antigen enzyme immunoassays
| Study reference | Test | Study location(s) | Case context | Population(s) | Sensitivity (%) | Specificity (%) | Reference method (reference[s]) |
|---|---|---|---|---|---|---|---|
| 363 | IDEIAa | UK | Outbreak | Not specified | 55.5 | 98.3 | Conventional RT-PCR (180, 364) |
| 365 | IDEIA | USA | Outbreak, sporadic | Pediatric, adult | 39.0 | 100.0 | Conventional RT-PCRd |
| SRSV(II)-ADb | 80.0 | 69.0 | |||||
| 193 | Ridascreenc | Germany | Outbreak, sporadic | Pediatric, adult | 34.6 | 65.3 | Nested RT-PCR (366) |
| 367 | Ridascreen | Australia | Outbreak | Not specified | 47.0 | 71.0 | Conventional RT-PCR (368) |
| 369 | IDEIA | Australia | Outbreak | Not specified | 66.0 | 85.0 | Conventional RT-PCR (368) |
| 370 | IDEIA | Netherlands | Not specified | 38.0 | 96.0 | Conventional RT-PCR (189) | |
| Ridascreen | 36.0 | 88.0 | |||||
| 371 | Ridascreen | Venezuela | Sporadic | Pediatric | 60.0 | 97.5 | Conventional RT-PCR (364) |
| 372 | IDEIA | Canada | Outbreak | Pediatric, adult | 60.6 | 100.0 | Compositee |
| Ridascreen | 80.3 | 100.0 | |||||
| 172 | IDEIA | European | Sporadic | Not specified | 46.2 | 95.7 | Conventional RT-PCRf |
| IDEIA | Multicenter | Outbreak | 65.9 | 95.7 | |||
| Ridascreen | Sporadic | 31.6 | 99.5 | ||||
| Ridascreen | Outbreak | 55.3 | 97.1 | ||||
| 373 | IDEIA | Spain | Sporadic | Pediatric | 76.9 | 85.9 | Conventional RT-PCR (189, 374) |
| Ridascreen | 59.0 | 73.1 | |||||
| 171 | IDEIA | USA, UK | Sporadic | Pediatric, adult | 59.0 | 93.3 | Compositeg |
| Outbreak | 58.7 | 88.9 | |||||
| 375 | IDEIA | Brazil | Sporadic | Pediatric | 45.0 | 100.0 | Real-time/conventional RT-PCR (184, 198) |
| Ridascreen | 63.0 | 100.0 | |||||
| 213 | IDEIA | Hungary | Sporadic | Pediatric, adult | 78.9 | 100.0 | Compositeh |
| 376 | Ridascreeni | Brazil | Sporadic | Pediatric, adult | 49.5 | 93.9 | Conventional RT-PCR (377) |
| Outbreak | 87.9 | 83.8 | |||||
| 378 | Ridascreeni | Brazil | Sporadic | Pediatric | 92.0 | 83.3 | Conventional RT-PCR (377) |
| 379 | Ridascreeni | Germany | Sporadic | Not specified | 77.0 | 96.0 | Compositej |
| 380 | Ridascreeni | Italy | Sporadic | Pediatric, adult | 40.0 | 96.0 | Real-time RT-PCR (116) |
Oxoid Ltd, Hampshire, United Kingdom.
Denka Seiken Co. Ltd., Tokyo, Japan.
R-Biopharm, Darmstadt, Germany.
RT-PCR primers were not specified.
At least 2 positive test results by RT-PCR (88), electron microscopy, and 2 enzyme immunoassays are considered a true-positive result.
Multiple RT-PCR assays were utilized in this study (76).
Utilizes a diagnostic algorithm (171) that takes into account electron microscopy, conventional RT-PCR/bidirectional sequencing (131, 184, 211, 381), and real-time RT-PCR (202).
At least 1 positive real-time RT-PCR test result by Argene Calici/Astrovirus Consensus (bioMérieux, Marcy l'Etoile, France) and SmartNorovirus (Cepheid, Sunnyvale, CA) is considered a true-positive result.
The third-generation Ridascreen Norovirus assay was used in this study.
At least 2 positive real-time RT-PCR test results by SmartNorovirus (Cepheid, Sunnyvale, CA), Ridagene Norovirus LC (R-Biopharm, Darmstadt, Germany), and an assay developed at the Robert Koch Institute (195) are considered a true-positive result.