AltoStar®BKV PCR Kit 1.5

• Specifications:

  Specifications Key features Detection and quantification of BK virus (BKV) specific DNA CE-IVD marked in vitro diagnostic test Analytical sensitivity reported in IU/ml Limit of detection (LoD) LoD plasma 66 IU/ml LoD whole blood 105 IU/ml LoD urine 21 IU/ml Sample types The following sample types are validated for use with the AltoStar ® BKV PCR Kit 1.5: Human EDTA plasma Human citrate plasma Human EDTA whole blood Human citrate whole blood Human urine Other workflows The AltoStar ® BKV 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 ® BKV 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 ® BKV 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.

• Certification:

  CE-IVD

• Applications:

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

• Shipping Conditions:

  Dry ice