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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 Quantitative Assay Kit (Enzyme-linked Immunoassay)

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

Device identification number
1293
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Plasma, Serum
Pathogens detected
Adenovirus, Chlamydia Pneumoniae, Influenza A, Influenza B, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2021-11-10 11:09:57 CET
Comments
This kit is used for quantitative detection of SARS-CoV-2 nucleocapsid protein (N protein) in human serum or plasma.
Assay Type
Immuno-Antigen
Rapid Diagnostic
No
Reader Required
Yes
Subcategory
Other
Method
ELISA
Measurement
Quantitative
Time
75 minutes
Subclass
Sandwich, Double
LOD
2.97 (pg/mL)
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
0 %
Precision
Evaluated
Accuracy
99.33 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.05 %
Clinical Specificity
100 %
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