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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 Detection Kit (Colloidal Gold)

Manufactured by Zhuhai Lituo Biotechnology Co., Ltd, China - www.lituo.com.cn 

Device identification number
1957
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Hepatitis B Virus (HBV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
A.23.1 B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 P.1 (Gamma),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Updated on 12th July 2021. PEI positive evaluation.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
428 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.41 %
Fn
1 %
Precision
Evaluated
Accuracy
99.42 % (NP swab: )
Accuracy
98.87 % (Nasal swab: )
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99 % (NP swab )
Clinical Sensitivity
96.12 % (Nasal swab (CT<= 33))
Clinical Specificity
99.59 % (NP swab )
Clinical Specificity
100 % (Nasal swab (CT<= 33))
Type of antigen
Nucleoprotein
Notes
The microbial interference and endogenous interference study are also evaluated.

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