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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

GLINE-2019-nCoV Ag Saliva

Manufactured by SHENZHEN YHLO BIOTECH Co. Ltd., China - http://www.szyhlo.com 

Device identification number
1893
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Saliva
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
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
The GLINE-2019-nCoV Ag Saliva has obtained CE marking, and its clinical performance verification and analytical performance verification has also been completed.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
LOD
425 TCID50/ml
Analysis of cross reactivity
Evaluated
False positives
0 % (0 out of 123)
False negatives
5.2 % ((26 out of 500))
Robustness
Evaluated
Clinical Sensitivity
95.27 % ( (95%CI: 93.15%-96.89%))
Clinical Specificity
100 % ( (95%CI: 97.05%-100%))
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