ARISTA™ COVID-19 Antigen Rapid Test
Manufactured by ARISTA Biotech Pte. Ltd., Singapore - www.aristabio.com
Device identification number
1926
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza B, 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) Type A, Rhinovirus, SARS-CoV
Pathogens detected
SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
ARISTA™ COVID-19 Antigen Rapid Test is targeting at the RNA binding domain of the nucleocapsid protein by a pair of monoclonal antibodies. The antibodies and respective epitopes used are: COV19-ps-Mab117: 74-105aa COV19-PS-MAb41: 44-175aa
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
ARISTA has conducted a verification study using recombinant nucleocapsid protein of the Omicron variant (B.1.1.529) and B.1.640. The results show that ARISTA™ COVID-19 Antigen Rapid Test remain fully capable in detecting the N-protein of the Omicron variant as well as the wildtype SARS-CoV-2 and the Delta Variant with similar sensitivity (LoD: 100 pg/ml).
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0.6 %
Precision
Evaluated
Accuracy
99.82 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.4 %
Clinical Specificity
100 %
Type of antigen
Nucleocapsid protein
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