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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AQUILAVIE ® SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold)

Manufactured by Aquila Healthcare Limited, Hong Kong S.A.R - www.aquilavie.com 

Device identification number
5727
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Epstein-Barr Virus (EBV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Varicella Zoster Virus (VZV)
Pathogens detected
Adenovirus 3, Adenovirus 7, Epstein-Barr Virus (EBV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Varicella Zoster Virus (VZV)
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
A.23.1, AT.1, 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.1.526.1, B.1.526.2, B.1.616, 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), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-10-25 10:05:24 CET
Assay Type
Other (Immunochromatography-Antigen)
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other (Extraction kit, Sample Collection Device, Transport Kit)
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Other (Immunochromatography)
LOD
1.5 TCID50/ml (1.5×10^2 TCID50/mL - As "Value", we can put numbers and not symbols. Therefore, we have included the complete value and correct Unit information in this box for Additional info(numbers and symbols))
Calibration
Not evaluated
Analytical Sensitivity
1.5 % (1.5×10^2 TCID50/mL - As "Value", we can put numbers and not symbols.Furthermore,the system does not allow us to amend the "Unit"(we can only select "%").Thus,we have included the complete value and correct Unit information in this box for Additional info)
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
0.88 %
False negatives
12.97 %
Precision
Evaluated
Accuracy
93.7 %
Robustness
Not evaluated
Clinical Sensitivity
87.03 %
Clinical Specificity
99.12 %

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