Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

BOH-180 Fluorescent Immunoassay Analyzer

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

Device identification number
2694
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cassette, Chip, Lateral flow
Target type
Antibody, Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
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, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Varicella Zoster Virus (VZV)
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)
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
BOH-180 is a small bench top analyzer intended to be used with cassette-based immunofluorescent IVD assays manufactured by Biohit Healthcare (Hefei) Co., Ltd.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Quantitative
Time
1 minutes
Subclass
Other ()
Detection Principle
Fluorescence
LOD
12.69 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
98.71 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.12 %
Clinical Specificity
99.6 %
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