Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit (Immunochromatography)
Manufactured by Vacure Prelab Medical Technology Co. Ltd., China
Device identification number
2041
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal 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, Influenza B, MERS-CoV, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus
Lineages detected
B.1.617.1 (Kappa)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
CE registration number: RPS/921/2021 CE registration date: 04/05/2021 CE registration area: Spanish AUTHORIZED REPRESENTATITVE IN THE EUROPEAN COMMUNITY: CMC Medical Devices & Drugs S.L
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
15 minutes
Subclass
Sandwich
LOD
1000 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.53 %
False negatives
1.68 %
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.32 %
Clinical Specificity
99.47 %
Type of antigen
Nucleoprotein
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