AltoStar®HHV-6 PCR Kit 1.5

Specifications 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.

The AltoStar® HHV-6 PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection, differentiation and quantification of human herpesvirus 6A (HHV-6A) and human herpesvirus 6B (HHV-6B) specific DNA in human plasma and whole blood. It is intended to be used as an aid for diagnosis of HHV-6 infection and for monitoring of the HHV-6A and HHV-6B load in individuals with HHV-6 infection.