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Home / Products / AltoStar / AltoStar® Adenovirus PCR Kit 1.5

AltoStar® Adenovirus PCR Kit 1.5

Intended use

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

Specifications

Key features

  • Detection and quantification of human adenovirus (HAdV) specific DNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in copies/ml

 

Limit of detection (LoD)

LoD plasma 141 copies/ml
LoD whole blood 382 copies/ml


Sample types

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

 

Human EDTA plasma

Human citrate plasma

Human EDTA whole blood

Human citrate whole blood

 

Other workflows

The AltoStar® Adenovirus 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® Adenovirus 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® Adenovirus 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.

Order No
AS0301543
Rxns
96
Transportation
Dry ice
Regulatory status
CE-IVD

In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® Adenovirus PCR Kit 1.5 has received a new product number and Global Trade Item Number (GTIN). The new product number reflects the desired change in regulatory status. All other product characteristics as well as the product performance remain unchanged. The kit is chemically identical to its already existing counterpart and contains the same kit components.

 

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

Manuals AltoStar® Adenovirus PCR Kit 1.5
Associated documents AltoStar® Adenovirus PCR Kit 1.5
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Manuals AltoStar® Adenovirus PCR Kit 1.5
Language
AltoStar® Adenovirus PCR Kit 1.5 - DE
Language: German
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - EN
Language: English
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - IT
Language: Italian
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - ES
Language: Spanish
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - FR
Language: French
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - PT
Language: Portuguese
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - VI
Language: Vietnamese
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - PL
Language: Polish
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - CS
Language: Czech
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
Associated documents AltoStar® Adenovirus PCR Kit 1.5
Language
Type of document
AltoStar® Adenovirus PCR Kit 1.5 - DE - DoC
Language: German
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - EN - DoC
Language: English
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - FR - DoC
Language: French
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® Adenovirus PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD