THÔNG TIN MÔ TẢ
In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® Influenza Screen & Type RT-PCR Kit 1.5 has received a new product number and Global Trade Item Number (GTIN). The new product number reflects the desired change in regulatory status. All other product characteristics as well as the product performance remain unchanged. The kit is chemically identical to its already existing counterpart and contains the same kit components.
Products not FDA cleared or approved. Kits not available in all countries.
The AltoStar® Influenza Screen & Type RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of influenza A virus, influenza B virus and influenza A (H1N1)pdm09 virus specific RNA in human respiratory swab specimens. It is intended to be used as an aid for diagnosis of influenza A, influenza B and influenza A (H1N1)pdm09 virus infection.
Key features
- Detection and differentiation of influenza A virus, influenza A (H1N1)pdm09 virus and influenza B virus specific RNA
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in copies/ml
Limit of detection (LoD)
| LoD influenza A virus | 370 copies/ml |
| LoD influenza A (H1N1)pdm09 virus | 241 copies/ml |
| LoD influenza B virus | 478 copies/ml |
Sample types
The following sample type is validated for use with the AltoStar® Influenza Screen & Type RT-PCR Kit 1.5:
- Human respiratory swab specimens
Other workflows
The AltoStar® Influenza Screen & Type RT-PCR Kit 1.5 can be used with compatible workflows (manual or automated). Real-time PCR instruments that have been validated for use with the AltoStar® Influenza Screen & Type RT-PCR Kit 1.5 are:
- CFX96™ Deep Well Dx System (Bio-Rad)
- CFX96™ Dx System (Bio-Rad)
- ABI Prism® 7500 SDS (Applied Biosystems)
- LightCycler® 480 Instrument II (Roche)
- QuantStudio™ 5 Real-Time PCR System (Applied Biosystems)
- Rotor-Gene® Q5/6 plex Platform (QIAGEN)
The AltoStar® Influenza Screen & Type RT-PCR Kit 1.5 can be used with nucleic acid extraction systems other than the AltoStar® AM16. Alternative procedures used for nucleic acid extraction have to be validated by the user.
