In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® alpha Herpesvirus 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® alpha Herpesvirus PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2) and varicella-zoster virus (VZV) specific DNA in human cutaneous and mucocutaneous swab specimens. It is intended to be used as an aid for diagnosis of HSV-1, HSV-2 and VZV infection.
Specifications
Key features
- Detection and differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2)
and varicella-zoster virus (VZV) specific DNA - CE-IVD marked in vitro diagnostic test
- Analytical sensitivity reported in copies/ml
Limit of detection (LoD)
| LoD HSV-1 | 26 copies/ml |
| LoD HSV-2 | 37 copies/ml |
| LoD VZV | 91 copies/ml |
Sample types
The following sample types are validated for use with the AltoStar® alpha Herpesvirus PCR Kit 1.5:
- Human cutaneous swab specimens in universal transport medium
- Human mucocutaneous swab specimens in universal transport medium
Other workflows
The AltoStar® alpha Herpesvirus 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® alpha Herpesvirus PCR Kit 1.5 are:
- CFX96™ Deep Well Dx System (Bio-Rad)
- CFX96™ Dx System (Bio-Rad)
- ABI Prism® 7500 SDS (Applied Biosystems)
- QuantStudio™ 5 Real-Time PCR System (Applied Biosystems)
- Rotor-Gene® Q5/6 plex Platform (QIAGEN)
The AltoStar® alpha Herpesvirus 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.
