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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 Rapid Test Kit (Fluorescence Immunochromatography)

Manufactured by BIOHIT HealthCare (Hefei) Co., Ltd, China - www.biouhan.com 

Device identification number
1286
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Anterior nasal swab
Pathogens detected
Adenovirus, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2021-10-28 04:37:08 CET
Comments
This test is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Fluorescence
LOD
40 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
0 %
Precision
Evaluated
Accuracy
97.92 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.04 %
Clinical Specificity
98.94 %
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