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.
| LoD E gene | 0.025 PFU/ml |
| LoD S gene | 0.014 PFU/ml |
The following sample type is validated for use with the AltoStar® SARS-CoV-2 RT-PCR Kit 1.5:
Human respiratory swab specimens
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.
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.
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altona Diagnostics GmbH
Mörkenstr. 12
22767 Hamburg, Germany