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Home / Products / AltoStar / AltoStar® HHV-6 PCR Kit 1.5

AltoStar® HHV-6 PCR Kit 1.5

Intended use

The AltoStar® HHV-6 PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection, differentiation and quantification of human herpesvirus 6A (HHV-6A) and human herpesvirus 6B (HHV-6B) specific DNA in human plasma and whole blood. It is intended to be used as an aid for diagnosis of HHV-6 infection and for monitoring of the HHV-6A and HHV-6B load in individuals with HHV-6 infection.

Specifications

Key features

  • Detection, differentiation and quantification of human herpesvirus 6A (HHV-6A)
    and human herpesvirus 6B (HHV-6B) specific DNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

 

Limit of detection (LoD)

LoD plasma (HHV-6A) 249 IU/ml
LoD plasma (HHV-6B) 134 IU/ml
LoD whole blood (HHV-6A) 1,112 IU/ml
LoD whole blood (HHV-6B) 653 IU/ml

 

Sample types

The following sample types are validated for use with the AltoStar® HHV-6 PCR Kit 1.5:

 

Human EDTA plasma

Human citrate plasma

Human EDTA whole blood

Human citrate whole blood

 

Other workflows

The AltoStar® HHV-6 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® HHV-6 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® HHV-6 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
AS0311543
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® HHV-6 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® HHV-6 PCR Kit 1.5
Associated documents AltoStar® HHV-6 PCR Kit 1.5
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Manuals AltoStar® HHV-6 PCR Kit 1.5
Language
AltoStar® HHV-6 PCR Kit 1.5 - DE
Language: German
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - EN
Language: English
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - ES
Language: Spanish
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - FR
Language: French
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - IT
Language: Italian
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - NO
Language: Norwegian
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - PT
Language: Portuguese
Date: 2022-03
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
Associated documents AltoStar® HHV-6 PCR Kit 1.5
Language
Type of document
AltoStar® HHV-6 PCR Kit 1.5 - DE - DoC
Language: German
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - EN - DoC
Language: English
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - FR - DoC
Language: French
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® HHV-6 PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD