Intended use
The AltoStar® HSV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection, differentiation and quantification of herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) specific DNA in human plasma. It is intended to be used as an aid for diagnosis of HSV infection and for monitoring of the HSV-1 and HSV-2 load in individuals with HSV infection.
| LoD plasma (HSV-1) | 34 copies/ml |
| LoD plasma (HSV-2) | 73 copies/ml |
The following sample types are validated for use with the AltoStar® HSV PCR Kit 1.5:
Human EDTA plasma
Human citrate plasma
The AltoStar® HSV 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® HSV 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® HSV 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.
In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® HSV 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.
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altona Diagnostics GmbH
Mörkenstr. 12
22767 Hamburg, Germany