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

Intended Use

The AltoStar® HDV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of hepatitis D virus (HDV) specific RNA in human EDTA plasma and serum. It is configured for use with the CFX96™ Deep Well Dx System (Bio-Rad) in combination with the AltoStar® Automation System AM16, the AltoStar® Purification Kit 1.5 and the AltoStar® Internal Control 1.5.

The AltoStar® HDV RT-PCR Kit 1.5 is intended to be used for viral load monitoring in individuals with HDV infection.

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

The AltoStar® HDV 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

  • Detection and quantification of hepatitis D virus (HDV) specific RNA
  • Detection of genotypes 1 to 8 in human EDTA plasma and serum
  • Quantification Standards calibrated against the 1st  WHO International Standard for HDV RNA (PEI code: 7657/12)
  • CE-IVD marked* in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

 

Limit of detection (LoD)

  • LoD human EDTA plasma 1.12 IU/ml
  • LoD human serum at least 1.12 IU/ml

 

Sample types

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

Human EDTA plasma

Human serum

 

For use with

AltoStar® Automation System AM16 / AltoStar® Connect Software
AltoStar® Purification Kit 1.5
AltoStar® Internal Control 1.5
CFX96™ Deep Well Dx System (Bio-Rad)

 

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

Order No
AS0401543
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® HDV RT-PCR Kit 1.5
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Associated documents AltoStar® HDV RT-PCR Kit 1.5
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Manuals AltoStar® HDV RT-PCR Kit 1.5
Language
AltoStar® HDV RT-PCR Kit 1.5 - DE
Language: German
Date: 2025-05
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - EN
Language: English
Date: 2025-05
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - ES
Language: Spanish
Date: 2025-05
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - HU
Language: Hungarian
Date: 2025-05
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - IT
Language: Italian
Date: 2025-05
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - PL
Language: Polish
Date: 2025-05
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - PT
Language: Portuguese
Date: 2025-05
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - RO
Language: Romanian
Date: 2025-05
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - FR
Language: French
Date: 2025-05
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - VI
Language: Vietnamese
Date: 2025-05
Panel: Bloodborne infections
Regulatory status: CE-IVD
Associated documents AltoStar® HDV RT-PCR Kit 1.5
Language
Type of document
AltoStar® HDV RT-PCR Kit 1.5 - EN
Language: English
Date: 2026-02
Regulatory status: CE
AltoStar® HDV RT-PCR Kit 1.5 - DE - DoC
Language: German
Date: 2025-10-29
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - EN - DoC
Language: English
Date: 2025-10-29
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2025-10-29
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - FR - DoC
Language: French
Date: 2025-10-29
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2025-10-29
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HDV RT-PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2025-10-29
Panel: Bloodborne infections
Regulatory status: CE-IVD