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AltoStar® CMV PCR Kit 1.5

Intended use

The AltoStar® CMV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of cytomegalovirus (CMV) 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 CMV infection and for monitoring of the CMV load in individuals with CMV infection.

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

The AltoStar® CMV 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 cytomegalovirus (CMV) specific DNA
  • CE-IVD* marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

 

Limit of detection (LoD)

LoD plasma 215 IU/ml
LoD whole blood 305 IU/ml
LoD urine 711 IU/ml

 

Sample types

The following sample types are validated for use with the AltoStar® CMV 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® CMV PCR Kit 1.5 can be used with compatible workflows. The following real-time PCR instruments have been validated for use with the AltoStar® CMV 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
AS0021543
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® CMV PCR Kit 1.5
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Associated documents AltoStar® CMV PCR Kit 1.5
Download
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Manuals AltoStar® CMV PCR Kit 1.5
Language
AltoStar® CMV PCR Kit 1.5 - DE
Language: German
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - EN
Language: English
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - ES
Language: Spanish
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - FR
Language: French
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - IT
Language: Italian
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - PT
Language: Portuguese
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - VI
Language: Vietnamese
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - PL
Language: Polish
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - CS
Language: Czech
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - RO
Language: Romanian
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
Associated documents AltoStar® CMV PCR Kit 1.5
Language
Type of document
AltoStar® CMV PCR Kit 1.5 - DE - DoC
Language: German
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - EN - DoC
Language: English
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - FR - DoC
Language: French
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® CMV PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD