In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® Adenovirus 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.
Intended use
The AltoStar® Adenovirus PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human adenovirus (HAdV) specific DNA in human plasma and whole blood. It is intended to be used as an aid for diagnosis of HAdV infection and for the monitoring of the HAdV load in individuals with HAdV infection.
Specifications
Key features
- Detection and quantification of human adenovirus (HAdV) specific DNA
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in copies/ml
Limit of detection (LoD)
| LoD plasma | 141 copies/ml |
| LoD whole blood | 382 copies/ml |
Sample types
The following sample types are validated for use with the AltoStar® Adenovirus PCR Kit 1.5:
- Human EDTA plasma
- Human citrate plasma
- Human EDTA whole blood
- Human citrate whole blood
Other workflows
The AltoStar® Adenovirus 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® Adenovirus 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® Adenovirus 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.
