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 Antigen Rapid Test

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

Device identification number
3001
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Polyclonal
Targets
non-structural protein NSP1, non-structural protein NSP2, non-structural protein NSP3, non-structural protein NSP4, non-structural protein NSP5
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, 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), Rhinovirus A, Rhinovirus B, SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
whole N protein as the antigen target and multiple epitope (polyclonal antibody)
Lineages detected
B.1.1.529 (Omicron), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
2000 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
11.76 % (6 out of 51)
Precision
Evaluated
Accuracy
100 % (PPV)
Accuracy
92 % ( NPV)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
88.24 % (95% CI: 76-95%)
Clinical Specificity
100 % (95% CI: 94-100%)
Type of antigen
Nonstructural protein NS3

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