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Home / AltoStar® / AltoStar® alpha Herpesvirus PCR Kit 1.5
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AltoStar® alpha Herpesvirus PCR Kit 1.5

Intended use

The AltoStar® alpha Herpesvirus PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2) and varicella-zoster virus (VZV) specific DNA in human cutaneous and human mucocutaneous swab specimens.

It is intended to be used as an aid for diagnosis of HSV-1, HSV-2 and VZV infection.

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

The AltoStar® alpha Herpesvirus 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 differentiation of herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2)
    and varicella-zoster virus (VZV) specific DNA
  • CE-IVD* marked in vitro diagnostic test
  • Analytical sensitivity reported in copies/ml

 

Limit of detection (LoD)

LoD HSV-1 26 copies/ml
LoD HSV-2 37 copies/ml
LoD VZV 91 copies/ml


Sample types

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

 

Human cutaneous swab specimens in universal transport medium

Human mucocutaneous swab specimens in universal transport medium

 

For use with

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

 

CFX96™ Deep Well Dx System (Bio-Rad)

CFX96™ Dx System (Bio-Rad)

ABI Prism® 7500 SDS (Applied Biosystems)

QuantStudio™ 5 Real-Time PCR System (Applied Biosystems)

Rotor-Gene® Q5/6 plex Platform (QIAGEN)

 

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

Order No
AS0081543
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® alpha Herpesvirus PCR Kit 1.5
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Associated documents AltoStar® alpha Herpesvirus PCR Kit 1.5
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Manuals AltoStar® alpha Herpesvirus PCR Kit 1.5
Language
AltoStar® alpha Herpesvirus PCR Kit 1.5 - DA
Language: Danish
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - DE
Language: German
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - EN
Language: English
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - ES
Language: Spanish
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - FR
Language: French
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - IT
Language: Italian
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - PT
Language: Portuguese
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - PL
Language: Polish
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - VI
Language: Vietnamese
Date: 2025-12
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
Associated documents AltoStar® alpha Herpesvirus PCR Kit 1.5
Language
Type of document
AltoStar® alpha Herpesvirus PCR Kit 1.5 - DE - DoC
Language: German
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - EN - DoC
Language: English
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - FR - DoC
Language: French
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD
AltoStar® alpha Herpesvirus PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2026-02-26
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD