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AltoStar^® HIV RT-PCR Kit 1.5

Intended use

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

Specifications

Key features

Detection and quantification of human immunodeficiency virus type 1 (HIV-1) specific RNA
Detection of group M, N and O in human EDTA plasma
Quantification Standards calibrated against the 4^th WHO International Standard for HIV-1 RNA
(NIBSC code: 16/194)
CE-IVD marked in vitro diagnostic test
Analytical sensitivity reported in IU/ml

Limit of detection (LoD)

LoD human EDTA plasma

30.0 IU/ml

Sample types

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

Human EDTA plasma

Order No

AS0221513

Rxns

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 pathogens using the AltoStar^®Molecular Diagnostic Workflow. The AltoStar^® HIV RT-PCR Kit 1.5 is designed as a dual target assay for reliable viral load monitoring of HIV infected patients.

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

Manuals AltoStar^® HIV RT-PCR Kit 1.5

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Associated documents AltoStar^® HIV RT-PCR Kit 1.5

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Manuals AltoStar^® HIV RT-PCR Kit 1.5

Language

AltoStar® HIV RT-PCR Kit 1.5 - DE
Language: German
Date: 2022-02
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - EN
Language: English
Date: 2022-02
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - ES
Language: Spanish
Date: 2022-02
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - FR
Language: French
Date: 2022-02
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - IT
Language: Italian
Date: 2022-02
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - PL
Language: Polish
Date: 2022-02
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - PT
Language: Portuguese
Date: 2022-02
Panel: Bloodborne infections
Regulatory status: CE-IVD

Associated documents AltoStar^® HIV RT-PCR Kit 1.5

Language

Type of document

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

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

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

AltoStar® HIV RT-PCR Kit 1.5 - FR - DoC
Language: French
Date: 2022-05-18
Panel: Bloodborne infections
Regulatory status: CE-IVD

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

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

AltoStar® HIV RT-PCR Kit 1.5 - DE - Certificate - 1
Language: German
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - EN - Certificate - 2
Language: English
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - FR - Certificate - 3
Language: French
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - ES - Certificate - 4
Language: Spanish
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - PT - Certificate - 5
Language: Portuguese
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - IT - Certificate - 6
Language: Italian
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - DE - Certificate - MDC - 1
Language: German
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - EN - Certificate - MDC - 2
Language: English
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - FR - Certificate - MDC - 3
Language: French
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - ES - Certificate - MDC - 4
Language: Spanish
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - PT - Certificate - MDC - 5
Language: Portuguese
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - IT - Certificate - MDC - 6
Language: Italian
Date: 2022-05-13
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar® HIV RT-PCR Kit 1.5 - EN - Reference - 1
Language: English
Date: 2021
Panel: Bloodborne infections
Regulatory status: CE-IVD

AltoStar^® HIV RT-PCR Kit 1.5

Specifications

Key features

Limit of detection (LoD)

Sample types

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