Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Quantivirus SARS-CoV-2 Variants Detection Kit

Manufactured by Diacarta Inc., United States - https://www.diacarta.com/ 

Device identification number
3034
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Microplate
Target type
Nucleic acid
Targets
ORF1ab polyprotein/gene, spike protein/gene
Specimen
Deep (cough) sputum, Nasal aspirate, Nasal aspiration, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus, SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
G614G, L452R, K417T, N501Y, T478K, K417N, ORF1ab and Rp
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
100% sensitivity and 100% Specificity for delta and Omicron
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
250 minutes
Subclass
JRC-S
LOD
100 copies/ml
Positive control
100 % (PPV)
Negative control
100 % (NPV)
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
Higher than 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