Skip to main content
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 (RAT)
Yes
Format
Lab-based
Physical Support
Cassette, Strip
Target type
Antigen
Targets
ORF1ab polyprotein, ORF1b polyprotein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Beta Coronavirus OC43 (HCoV-OC43), SARS-CoV
Lineages detected
A.23.1, AT.1, 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
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
0.88 % (3/340)
False negatives
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