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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Green Spring SARS-CoV-2 Antigen-Rapid test-Set

Manufactured by Shenzhen Lvshiyuan Biotechnology Co. Ltd., China - https://www.lsybt.com/ 

Device identification number
2109
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV), SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Dear colleagues, we have removed the saliva sample method from our test and the data of the sensitivity and specificity are from the newest performance evaluation. Thank you very much for the update! Best regards, Anna Zhu
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
400 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 0 of 210 (100% specificity)
False negatives
3.23 % (5 of 155 (96.77% sensitivity))
Precision
Evaluated
Accuracy
98.63 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.77 % (Antigen)
Clinical Specificity
100 % (Antigen)
Type of antigen
Nucleoprotein
Type of antigen
Nucleocapsid 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