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

AltoStar® HCV RT-PCR Kit 1.5

Intended use

The AltoStar® HCV RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human hepatitis C virus (HCV) specific RNA (genotypes 1 to 6) in human EDTA plasma and serum. The AltoStar® HCV RT-PCR Kit 1.5 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® HCV RT-PCR Kit 1.5 is intended to be used for viral load monitoring in HCV infection.

Specifications

Key features

  • Detection and quantification of hepatitis C virus (HCV) specific RNA
  • Detection of genotypes 1 to 6 in human EDTA plasma and serum
  • Quantification Standards calibrated against the 5th WHO International Standard for HCV NAT
    (NIBSC code: 14/150)
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in IU/ml

 

Limit of detection (LoD)

LoD human EDTA plasma 11.1 IU/ml
LoD human serum at least 11.1 IU/ml


Sample types

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

 

Human EDTA plasma

Human serum

 

 

Order No
AS0211513
Rxns
96
Transportation
Dry ice
Regulatory status
CE-IVD

The AltoStar® RT-PCR Kits 1.5 are developed for the simultaneous testing of pathogens by harmonized cycling conditions and enabling the identification of clinical pathogen using the AltoStar® Molecular Diagnostic Workflow. The AltoStar® HCV RT-PCR Kit 1.5 is designed for reliable viral load monitoring of HCV infected patients.

 

Product not licensed with Health Canada and not FDA cleared or approved. Kit not available in all countries.

Manuals AltoStar® HCV RT-PCR Kit 1.5
Associated documents AltoStar® HCV RT-PCR Kit 1.5
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Manuals AltoStar® HCV RT-PCR Kit 1.5
Language
AltoStar® HCV RT-PCR Kit 1.5 - DE
Language: German
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV RT-PCR Kit 1.5 - EN
Language: English
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV RT-PCR Kit 1.5 - ES
Language: Spanish
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV RT-PCR Kit 1.5 - FR
Language: French
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV RT-PCR Kit 1.5 - IT
Language: Italian
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV RT-PCR Kit 1.5 - PL
Language: Polish
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV RT-PCR Kit 1.5 - PT
Language: Portuguese
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV RT-PCR Kit 1.5 - VI
Language: Vietnamese
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD
Associated documents AltoStar® HCV RT-PCR Kit 1.5
Language
Type of document
AltoStar® HCV PCR Kit 1.5 - DE - DoC
Language: German
Date: 2022-05-24
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV PCR Kit 1.5 - EN - DoC
Language: English
Date: 2022-05-24
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2022-05-24
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV PCR Kit 1.5 - FR - DoC
Language: French
Date: 2022-05-24
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2022-05-24
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2022-05-24
Panel: Bloodborne infections
Regulatory status: CE-IVD
AltoStar® HCV RT-PCR Kit 1.5 - DE - Certificate - 1
Language: German
Date: 2022-05-13
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - DE - Certificate - MDC - 1
Language: German
Date: 2022-05-23
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - EN - Certificate - 2
Language: English
Date: 2022-05-13
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - EN - Certificate - MDC - 2
Language: English
Date: 2022-05-23
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - EN - Reference - 1
Language: English
Date: 2019-01
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - ES - Certificate - 4
Language: Spanish
Date: 2022-05-13
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - ES - Certificate - MDC - 4
Language: Spanish
Date: 2022-05-23
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - FR - Certificate - 3
Language: French
Date: 2022-05-13
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - FR - Certificate - MDC - 3
Language: French
Date: 2022-05-23
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - IT - Certificate - 6
Language: Italian
Date: 2022-05-13
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - IT - Certificate - MDC - 6
Language: Italian
Date: 2022-05-23
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - PT - Certificate - 5
Language: Portuguese
Date: 2022-05-13
Panel: Bloodborne infections
AltoStar® HCV RT-PCR Kit 1.5 - PT - Certificate - MDC - 5
Language: Portuguese
Date: 2022-05-23
Panel: Bloodborne infections