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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 Test (Fluorescence Immunochromatography)-Blood

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

Device identification number
2693
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cartridge, Cassette, Chip, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), 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, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Varicella Zoster Virus (VZV)
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hepatitis B Virus (HBV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Varicella Zoster Virus (VZV)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This rapid kit is used for the quantitative detection of SARS-CoV-2 nucleocapsid protein antigen in human serum, plasma (heparin, dipotassium EDTA, and sodium citrate), and fingertip blood with the supporting Fluorescent Immunoassay Analyzer. Antigen epitope information: N‐terminal domain (NTD; 46 –176 aa) C‐terminal domain (CTD; 247–364 aa).
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Semiquantitative
Time
16 minutes
Subclass
Sandwich
Detection Principle
Fluorescence
LOD
8.92 (pg/mL)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
98.69 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.63 %
Clinical Specificity
99.72 %
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