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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test

Manufactured by Hangzhou Clongene Biotech Co., Ltd, China - http://en.clongene.com/ 

Device identification number
1363
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2 B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
A prospective clinical study conducted in Greece from Nov. 2021 to Feb. 2022, the performance of COVID-19 Antigen Rapid Test was evaluated by detection of 626 nasopharyngeal swab specimens, setting a RT-PCR detection of nasopharyngeal specimens as comparator. The test showed a sensitivity of 95.5% (n=150/157, 95%CI: 91.1%-97.8%) and a specificity of 100% (n=469/469, 95%CI: 99.2%-100%). A genotyping analysis on unselected 88 PCR-positive specimens identified 31 cases of Omicron infection, those comparator PCR Ct values ranged from 10.5 to 31.1 (7/31 at Ct >25) and all of which were positive by COVID-19 Antigen Rapid Test. Thus, the test performance is not affected by Omicron variant.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
TCID50/ml 570 TCID50/mL
Crossreactivity
Evaluated
Fp
% 0%
Fn
% 4%
Precision
Evaluated
Accuracy
99.1 % (Nasopharyngeal swab)
Accuracy
99.1 % (Nasal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % (Nasopharyngeal swab)
Clinical Sensitivity
95.5 % (Nasal swab)
Clinical Specificity
100 % (Nasopharyngeal swab)
Clinical Specificity
100 % (Nasal swab)
Type of antigen
Nucleocapsid protein
Notes
antigen_epi AA95-175

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