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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography)

Manufactured by Guangdong Longsee Biomedical Co. Ltd., China - www.longseemed.com 

Device identification number
1216
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cartridge, Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, 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.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This update is mainly for nasopharyngeal and oropharyngeal swab sensitivity and specificity data.Meanwhile ,nasal swab data are added.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
600 TCID50/ml (Nasopharyngeal swab)
LOD
600 TCID50/ml (Oropharyngeal swab)
LOD
593 TCID50/ml (Nasal swab)
Analysis of cross reactivity
Evaluated
False positives
0.28 % (Nasopharyngeal swab)
False positives
0.32 % (Nasal swab)
False positives
0.28 % (Oropharyngeal swab)
False negatives
4.49 % (Nasopharyngeal swab)
False negatives
5.85 % (Nasal swab)
False negatives
4.78 % (Oropharyngeal swab)
Precision
Evaluated
Accuracy
97.5 % (Oropharyngeal swab)
Accuracy
97.6 % (Nasal swab)
Accuracy
97.64 % (Nasopharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.51 % (Nasopharyngeal swab)
Clinical Sensitivity
95.22 % (Oropharyngeal swab)
Clinical Sensitivity
94.15 % (Nasal swab)
Clinical Specificity
99.72 % (Oropharyngeal swab)
Clinical Specificity
99.68 % (Nasal swab)
Clinical Specificity
99.72 % (Nasopharyngeal swab)
Type of antigen
Nucleocapsid protein
Notes
Rapid diagnostic test Colloidal Gold

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