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Home / AltoStar® / AltoStar® BKV PCR Kit 1.5
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AltoStar® BKV PCR Kit 1.5

Intended use

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 EDTA and citrate plasma, human EDTA and citrate whole blood and human 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.

The results generated with the AltoStar® BKV PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings.

The AltoStar® BKV PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques and in vitro diagnostic procedures.

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

 

For use with

The AltoStar® BKV PCR Kit 1.5 can be used with compatible workflows. The following real-time PCR instruments have been validated for use with the AltoStar® BKV PCR Kit 1.5:

 

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)

 

* according to Regulation (EU) 2017/746 (IVDR).

Order No
AS0031543
Rxns
96
Transportation
Dry ice
Regulatory status
CE-IVD

Products not FDA cleared or approved. Kits not available in all countries.

Manuals AltoStar® BKV PCR Kit 1.5
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Associated documents AltoStar® BKV PCR Kit 1.5
Download
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Manuals AltoStar® BKV PCR Kit 1.5
Language
AltoStar® BKV PCR Kit 1.5 - DE
Language: German
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - EN
Language: English
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - ES
Language: Spanish
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - FR
Language: French
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - IT
Language: Italian
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - PL
Language: Polish
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - PT
Language: Portuguese
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - VI
Language: Vietnamese
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - CS
Language: Czech
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - RO
Language: Romanian
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
Associated documents AltoStar® BKV PCR Kit 1.5
Language
Type of document
AltoStar® BKV PCR Kit 1.5 - DE - DoC
Language: German
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - EN - DoC
Language: English
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - FR - DoC
Language: French
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® BKV PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD