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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

REALQUALITY ABFlu-CoV-2

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

Device identification number
2092
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Fully automated (robot), Manual
Target
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
Influenza A, Influenza A H1N1, Influenza B, Influenza B Yamagata
Commercial Status
Commercialised
Last Update
2021-05-27 01:41:20 CET
Comments
Kit for identification of the respiratory viruses severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Influenza A and Influenza B by one-step Real-Time RT PCR; Specimens: Nasopharyngeal swab Oropharyngeal swabs; Target: RdRp and N genes for SARS-CoV-2; M gene for Influenza A and B and endogenous Internal Control; No cross-reactivity confirmed with other respiratory pathogens including SARS, MERS and SARS-related viruses; Diagnostic specificity SARS-CoV-2 99.6% Influenza A virus 100% Influenza B virus 100% Diagnostic sensitivity SARS-CoV-2 99% Influenza A virus 98.6% Influenza B virus 100% Accuracy SARS-CoV-2 99.5% Influenza A virus 99.5% Influenza B virus 100%
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
100 minutes
LOD
7.71 cpr (SARS-CoV-2 7.71 cpr Influenza A 7.87 cpr Influenza B 4.35 cpr)
Positive control
Positive control ABFlu-CoV2 (DNA containing part of the Influenza A, Influenza B and SARS-CoV-2 geno
Accuracy
99.5 %
Clinical Sensitivity
99 %
Clinical Specificity
99.6 %

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