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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



REALQUALITY SARS-CoV-2 5G

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

Device identification number
3121
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual, Semi-automated
Target type
Nucleic acid
Targets
nucleocapsid protein, ORF1ab polyprotein, spike protein,
Specimen
Nasopharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2022-06-14 05:01:17 CET
Comments
Kit for detection of RdRp, N and S genes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by one-step Real-Time RT PCR; Specimens: Nasopharyngeal swab; Target: N, S, RdRP genes and endogenous Internal Control; No cross-reactivity confirmed with other respiratory pathogens including SARS, MERS and SARS-related viruses;
Assay Type
Nucleic acid-PCR
Subcategory
Other
Method
RT-PCR
Measurement
Qualitative
Time
70 minutes
Subclass
Multiple
LOD
4.1 cpr
Positive control
Positive control SARS-CoV-2 (DNA containing part of the SARS-CoV-2 genome and RNaseP gene)
Clinical Sensitivity
99 %
Clinical Specificity
100 %
Throughput
96 samples per run

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