In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® HHV-6 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.
Key features
- Detection, differentiation and quantification of human herpesvirus 6A (HHV-6A)
and human herpesvirus 6B (HHV-6B) specific DNA - CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in IU/ml
Limit of detection (LoD)
| LoD plasma (HHV-6A) | 249 IU/ml |
| LoD plasma (HHV-6B) | 134 IU/ml |
| LoD whole blood (HHV-6A) | 1,112 IU/ml |
| LoD whole blood (HHV-6B) | 653 IU/ml |
Sample types
The following sample types are validated for use with the AltoStar® HHV-6 PCR Kit 1.5:
- Human EDTA plasma
- Human citrate plasma
- Human EDTA whole blood
- Human citrate whole blood
Other workflows
The AltoStar® HHV-6 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® HHV-6 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® HHV-6 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.
