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AltoStar^® HBV PCR Kit 1.5

Intended use

The AltoStar^® HBV PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of human hepatitis B virus (HBV) specific DNA (genotypes A to H) in human EDTA plasma.

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

Specifications

Key features

Detection and quantification of hepatitis B virus (HBV) specific DNA
Detection of genotypes A to H in human EDTA plasma
Quantification Standards calibrated against the 4^th WHO International Standard for HBV DNA for nucleic acid amplification techniques (NIBSC code: 10/266)
CE-IVD marked in vitro diagnostic test
Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD human EDTA plasma

10.2 IU/ml

Sample types

The following sample type is validated for use with the AltoStar^® HBV PCR Kit 1.5:

Human EDTA plasma

Order No

AS0201513

Rxns

Transportation

Dry ice

Regulatory status

CE-IVD

The AltoStar^® 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^® HBV PCR Kit 1.5 is designed for reliable viral load monitoring of HBV infected patients.

Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.

Manuals AltoStar^® HBV PCR Kit 1.5

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Associated documents AltoStar^® HBV PCR Kit 1.5

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Manuals AltoStar^® HBV PCR Kit 1.5

Language

AltoStar® HBV PCR Kit 1.5 - DE
Language: German
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - EN
Language: English
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - ES
Language: Spanish
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - FR
Language: French
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - IT
Language: Italian
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - PT
Language: Portuguese
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - VI
Language: Vietnamese
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - PL
Language: Polish
Date: 2021-10
Panel: Bloodborne infections
Regulatory status: CE-IVD

Associated documents AltoStar^® HBV PCR Kit 1.5

Language

Type of document

AltoStar® HBV PCR Kit 1.5 - DE - DoC
Language: German
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - EN - DoC
Language: English
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - FR - DoC
Language: French
Date: 2022-05-18
Panel: Transplant & Immunocompromised
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HBV PCR Kit 1.5 - DE - Certificate - 1
Language: German
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - EN - Certificate - 2
Language: English
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - FR - Certificate - 3
Language: French
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - ES - Certificate - 4
Language: Spanish
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - PT - Certificate - 5
Language: Portuguese
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - IT - Certificate - 6
Language: Italian
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - DE - Certificate - MDC - 1
Language: German
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - EN - Certificate - MDC - 2
Language: English
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - FR - Certificate - MDC - 3
Language: French
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - ES - Certificate - MDC - 4
Language: Spanish
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - PT - Certificate - MDC - 5
Language: Portuguese
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - IT - Certificate - MDC - 6
Language: Italian
Date: 2022-05-13
Panel: Bloodborne infections

AltoStar® HBV PCR Kit 1.5 - EN - Reference - 1
Language: English
Panel: Bloodborne infections

AltoStar^® HBV PCR Kit 1.5

Specifications

Key features

Limit of detection (LoD)

Sample types

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