AltoStar®HAV RT-PCR Kit 1.5

Specifications Key features Qualitative detection of hepatitis A virus (HAV) specific RNA CE-IVD marked in vitro diagnostic test Analytical sensitivity reported in IU/ml Limit of detection (LoD) LoD plasma 6.31 IU/ml Sample types The following sample types are validated for use with the AltoStar ® HAV RT-PCR Kit 1.5: Human EDTA plasma Human citrate plasma Other workflows The AltoStar ® HAV RT-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 ® HAV RT-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 ® HAV RT-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® HAV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of hepatitis A virus (HAV) specific RNA in human plasma. It is intended to be used as an aid for diagnosis of HAV infection.