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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



RealStar SARS-CoV-2 RT-PCR Kit

Manufactured by Altona Diagnostics, Germany - altona-diagnostics.com 

Device identification number
22
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Comments
Instructions for Use at: https://altona-diagnostics.com/files/public/Content%20Homepage/-%2002%20RealStar/MAN%20-%20CE%20-%20EN/RealStar%20SARS-CoV-2%20RT-PCR%20Kit%201.0_WEB_CE_EN-S03.pdf
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
Time
minutes
LOD
1.00E-01 PFU/ml for both targets, the S gene and the E gene
Positive control
Positive Control contains both targets, B-?CoV and SARS-CoV-2. Internal control.
Negative control
Negative control, not specified
Analytical Sensitivity
Expressed as LoD
Analitical Specificity
Ensured by the thorough selection of the oligonucleotides checked by sequence comparison analysis against publicly available sequences (B-?CoV, target E gene; SARSCoV-2, target S gene).
Throughput
Single tubes
Notes
https://altona-diagnostics.com/en/products/reagents-140/reagents/realstar-real-time-pcr-reagents/realstar-sars-cov-2-rt-pcr-kit.html

Related Scientific Literature

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements