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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

REALQUALITY RQ-SARS-CoV-2

Manufactured by AB ANALITICA, Italy - www.abanalitica.com 

Device identification number
2091
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual, Semi-automated
Target
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
Coronaviruses (HCoV), MERS-CoV, SARS-CoV
Commercial Status
Commercialised
Last Update
2021-05-27 01:35:19 CET
Comments
Kit for detection of RdRp and S genes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by one-step Real-Time RT PCR; Specimens: Nasopharyngeal swab Oropharyngeal swabs; Target: S, RdRP genes and endogenous Internal Control; No cross-reactivity confirmed with other respiratory pathogens including SARS, MERS and SARS-related viruses; Diagnostic specificity = 100% Diagnostic sensitivity = 100% Accuracy = 100%
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
100 minutes
LOD
3.57 cpr
Positive control
Positive control SARS-CoV-2 (DNA containing part of the SARS-CoV-2 genome and RNaseP gene)
Clinical Sensitivity
98.1 %
Clinical Specificity
100 %
Type of antigen
S, RdRP genes

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