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Home / AltoStar® / AltoStar® EBV PCR Kit 1.5

AltoStar® EBV PCR Kit 1.5

Intended use

The AltoStar® EBV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of Epstein-Barr virus specific DNA in human EDTA and citrate plasma and human EDTA and citrate whole blood.

It is intended to be used as an aid for diagnosis of EBV infection and for monitoring of the EBV load in individuals with EBV infection.

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

The AltoStar® EBV 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 Epstein-Barr virus (EBV) specific DNA
  • CE-IVD* marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

 

Limit of detection (LoD)

LoD plasma 195 IU/ml
LoD whole blood 320 IU/ml

 

Sample types

The following sample types are validated for use with the AltoStar® EBV PCR Kit 1.5:

 

Human EDTA plasma

Human citrate plasma

Human EDTA whole blood

Human citrate whole blood

 

For use with

The AltoStar® EBV PCR Kit 1.5 can be used with compatible workflows. The following real-time PCR instruments have been validated for use with the AltoStar® EBV 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
AS0131543
Rxns
96
Transportation
Dry ice
Regulatory status
CE-IVD

Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.

Manuals AltoStar® EBV PCR Kit 1.5
Associated documents AltoStar® EBV PCR Kit 1.5
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Manuals AltoStar® EBV PCR Kit 1.5
Language
AltoStar® EBV PCR Kit 1.5 - DE
Language: German
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - EN
Language: English
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - ES
Language: Spanish
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - FR
Language: French
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - IT
Language: Italian
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - NO
Language: Norwegian
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - PL
Language: Polish
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - PT
Language: Portuguese
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - VI
Language: Vietnamese
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - CS
Language: Czech
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - RO
Language: Romanian
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
Associated documents AltoStar® EBV PCR Kit 1.5
Language
Type of document
AltoStar® EBV PCR Kit 1.5 - DE - DoC
Language: German
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - EN - DoC
Language: English
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - FR - DoC
Language: French
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® EBV PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD