POCKIT™ Central Norovirus GI and POCKIT™ Central Norovirus GII are in vitro diagnostic1 molecular assays intended for use with POCKIT™ Central system. These two assays, targeting the ORF1/ORF2 junction region, are for qualitative detection of norovirus GI and GII, respectively, in liquid or soft stool from patients suspected of norovirus infection. The assays are intended to aid in the diagnosis of norovirus infection.
1Not U.S. FDA cleared or approved yet.
| Overall agreement…………………………………………100% (CI95%, 97.4% to 100%) |
| Positive agreement ………………………………………..100% (CI95%, 94.9% to 100%) |
| Negative agreement ………………………………………100% (CI95%, 94.9% to 100%) |
*Compared to a norovirus GI real-time PCR assay
| Overall agreement…………………………………………96.3% (CI95%, 93.0% to 99.6%) |
| Positive agreement ………………………………………..93.3% (CI95%, 86.0% to 100%) |
| Negative agreement ……………………………………….98.0% (CI95%, 94.4% to 100%) |
*Compared to a norovirus GII real-time PCR assay
| Reagent |
|---|
| Product Name | cat. No. | Specifications |
| POCKIT™ Central Norovirus GI | apcri-113 | 24 tests/set including: - Extraction Cartridges - Norovirus GI Reagent Cartridges - Norovirus GI Internal Control |
| POCKIT™ Central Norovirus GII | apcri-114 | 24 tests/set including:
- Extraction Cartridges - Norovirus GII Reagent Cartridges - Norovirus GII Internal Control |
| Instrument |
|---|
| Product Name
| Cat.No.
| Specifications
|
| POCKIT™ Central Nucleic Acid Analyzer | apcc-1i | Throughput: 1-8 samples |