SARS-COV-2 Nucleocapsid (N) Antigen Rapid Test Cassette
Manufactured by LiClear Biotech (Hangzhou) Co., Ltd, China - www.accleargenlabs.com
Device identification number
3973
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
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), Enterovirus A71 (EV-A71), Influenza A H3N2, Influenza B, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
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
Sandwich
Detection Principle
Colloidal gold
LOD
2000 TCID50/ml
Analytical Sensitivity
90 %
Analytical Specificity
100 %
False positives
0 %
False negatives
10 %
Accuracy
97.32 %
Clinical Sensitivity
90 %
Clinical Specificity
100 %
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