AltoStar® BKV PCR Kit 1.5

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.

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.

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