AltoStar®JCV PCR Kit 1.5

Specifications Key features Detection and quantification of JC virus (JCV) specific DNA CE-IVD marked in vitro diagnostic test Analytical sensitivity reported in IU/ml Limit of detection (LoD) LoD plasma 3.6 IU/ml Sample types The following sample types are validated for use with the AltoStar ® JCV PCR Kit 1.5: Human EDTA plasma Human citrate plasma Other workflows The AltoStar ® JCV 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 ® JCV 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 ® JCV 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® JCV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of JC virus (JCV) specific DNA in human plasma. It is intended to be used as an aid for diagnosis of JCV infection and for monitoring of the JCV load in individuals with JCV infection.