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Home / AltoStar® / AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

AltoStar® SARS-CoV-2 RT-PCR Kit 1.5

Intended use

The AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA in human respiratory swab specimens. It is intended to be used as an aid for diagnosis of SARS-CoV-2 infection.

 

The assay is available in two different configurations.

 

Find out more about the current altona SARS-CoV-2 test kits reactivity analyses in response to mutations.

Specifications

Key features

  • Detection of lineage B-betacoronavirus (B-βCoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA
  • CE-IVD marked in vitro diagnostic test
  • Analytical sensitivity reported in PFU/ml

 

Limit of detection (LoD)

LoD E gene 0.025 PFU/ml
LoD S gene 0.014 PFU/ml


Sample types

The following sample type is validated for use with the AltoStar® SARS-CoV-2 RT-PCR Kit 1.5:

 

Human respiratory swab specimens

 

 

Other workflows

The AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 can be used with compatible workflows (manual or automated). Real-time PCR instruments that have been validated for use with the AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 are:

 

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)

 

The AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 can be used with nucleic acid extraction systems other than the AltoStar® AM16. Alternative procedures used for nucleic acid extraction have to be validated by the user.

 

Regulatory status
CE-IVD

 

 

 

Order No
AS0821543
Rxns
96
Transportation
Dry ice
Order No
AS0821547
Rxns
1200
Transportation
Dry ice

In the course of the application of “Regulation (EU) 2017/746” (IVDR) on May 26, 2022, the AltoStar® SARS-CoV-2 RT-PCR kits have received a new product number and Global Trade Item Number (GTIN). The new product numbers reflect the desired change in regulatory status. All other product characteristics as well as the product performances remain unchanged. The kits are chemically identical to their already existing counterparts and contain the same kit components.

Manuals AltoStar® SARS-CoV-2 RT-PCR Kit 1.5
Associated documents AltoStar® SARS-CoV-2 RT-PCR Kit 1.5
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Manuals AltoStar® SARS-CoV-2 RT-PCR Kit 1.5
Language
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - DE
Language: German
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - EN
Language: English
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - ES
Language: Spanish
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - FR
Language: French
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - IT
Language: Italian
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - PL
Language: Polish
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - PT
Language: Portuguese
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - DE
Language: German
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - EN
Language: English
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - ES
Language: Spanish
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - FR
Language: French
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - IT
Language: Italian
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - PT
Language: Portuguese
Date: 2021-10
Panel: Respiratory infections
Regulatory status: CE-IVD
Associated documents AltoStar® SARS-CoV-2 RT-PCR Kit 1.5
Language
Type of document
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - DE - DoC
Language: German
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - EN - DoC
Language: English
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - ES - DoC
Language: Spanish
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - FR - DoC
Language: French
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - IT - DoC
Language: Italian
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 - PT - DoC
Language: Portuguese
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - DE - DoC
Language: German
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - EN - DoC
Language: English
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - ES - DoC
Language: Spanish
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - FR - DoC
Language: French
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - IT - DoC
Language: Italian
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 (1200 rxns) - PT - DoC
Language: Portuguese
Date: 2022-05-18
Panel: Respiratory infections
Regulatory status: CE-IVD