SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method)
Manufactured by Shenzhen Lifotronic Technology Co. Ltd., China - http://en.lifotronic.com
Device identification number
2613
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
This kit is used for in vitro qualitative detection of SARS-CoV-2 in respiratory specimens including oropharyngeal swab, sputum, bronchoalveolar lavage fluid and nasopharyngeal swab. Primer sets and FAM labeled probe are designed for specific detection of ORF1ab gene of SARS-CoV-2, VIC labeled probe for N gene of SARS-CoV-2. Human RNase P gene extracted concurrently with the test sample provides an internal control to validate nucleic extraction procedure and reagent integrity. Probe targeting human RNase P gene is labeled with CY5.
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Measurement
Qualitative
Detection Principle
Fluorescence
LOD
100 cpm (cpm)
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