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Home / AltoStar® / AltoStar® HAV RT-PCR Kit 1.5
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AltoStar® HAV RT-PCR Kit 1.5

Intended use

The AltoStar® HAV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of hepatitis A virus (HAV) specific RNA (genotypes I – III) in human EDTA and citrate plasma. It is intended to be used as an aid for diagnosis of HAV infection.

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

The AltoStar® HAV RT-PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques and in vitro diagnostic procedures.

Specifications

Key features

  • Qualitative detection of hepatitis A virus (HAV) specific RNA
  • CE-IVD* marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

 

Limit of detection (LoD)

LoD plasma 6.31 IU/ml


Sample types

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

 

Human EDTA plasma

Human citrate plasma

 

For use with

The AltoStar® HAV RT-PCR Kit 1.5 can be used with compatible workflows. The following real-time PCR instruments have been validated for use with the AltoStar® HEV RT-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
AS0241543
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® HAV RT-PCR Kit 1.5
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Associated documents AltoStar® HAV RT-PCR Kit 1.5
Download
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Manuals AltoStar® HAV RT-PCR Kit 1.5
Language
AltoStar® HAV RT-PCR Kit 1.5 - DE
Language: German
Date: 2025-12
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - EN
Language: English
Date: 2025-12
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - ES
Language: Spanish
Date: 2025-12
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - FR
Language: French
Date: 2025-12
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - IT
Language: Italian
Date: 2025-12
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - PT
Language: Portuguese
Date: 2025-12
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - PL
Language: Polish
Date: 2025-12
Panel: Bloodborne infections
Regulatory status: CE-IVD
Associated documents AltoStar® HAV RT-PCR Kit 1.5
Language
Type of document
AltoStar® HAV RT-PCR Kit 1.5 - DE - DoC
Language: German
Date: 2026-02-26
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - EN - DoC
Language: English
Date: 2026-02-26
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2026-02-26
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - FR - DoC
Language: French
Date: 2026-02-26
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2026-02-26
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HAV RT-PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2026-02-26
Panel: Bloodborne infections
Regulatory status: CE-IVD