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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Andlucky™ COVID-19 Antigen Rapid Test

Manufactured by Zhejiang Anji Saianfu Biotech Co., Ltd, China - www.reopentest.com 

Device identification number
1296
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Lab-based
Physical Support
Cassette, Strip
Target type
Antigen
Targets
ORF1ab polyprotein, ORF1b polyprotein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2021-09-30 09:30:27 CET
Comments
more information please visit www.seinofy.com
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colorimetry
LOD
116 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.88 % (3/340)
Fn
3 % (7/228)
Precision
Evaluated
Accuracy
98.24 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.93 %
Clinical Specificity
99.12 %
Type of antigen
ORF1b 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