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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

Manufactured by Shenzhen Huian Biosci Technology Co., Ltd., China - www.huiantech.com 

Device identification number
2414
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV) Type A, Rhinovirus
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.617.2 (Delta), P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
All samples used in RT-PCR as a comparative method were nasopharyngeal swab specimens, and the sample collection for the SARS-CoV-2 Antigen Test Kit was carried out according to the instructions for use of the test
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
150 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.9 % (Nasal swab)
Fp
0.9 % (Nasopharyngeal swab)
Fn
5.4 % (Nasal swab)
Fn
5 % (Nasopharyngeal swab)
Precision
Evaluated
Accuracy
97.6 % (Nasal swab)
Accuracy
99.7 % (Nasopharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.6 % (Nasal swab)
Clinical Sensitivity
95 % (Nasopharyngeal swab)
Clinical Specificity
99.1 % (Nasal swab)
Clinical Specificity
99.1 % (Nasopharyngeal swab)
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