In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® CMV 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 licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.
Intended use
The AltoStar® CMV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of cytomegalovirus (CMV) specific DNA in human plasma, whole blood and urine. It is intended to be used as an aid for diagnosis of CMV infection and for monitoring of the CMV load in individuals with CMV infection.
Specifications
Key features
- Detection and quantification of cytomegalovirus (CMV) specific DNA
- CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in IU/ml
Limit of detection (LoD)
| LoD plasma | 215 IU/ml |
| LoD whole blood | 305 IU/ml |
| LoD urine | 711 IU/ml |
Sample types
The following sample types are validated for use with the AltoStar® CMV PCR Kit 1.5:
- Human EDTA plasma
- Human citrate plasma
- Human EDTA whole blood
- Human citrate whole blood
- Human urine
Other workflows
The AltoStar® CMV 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® CMV 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® CMV 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.
