Respiratory 13 Pathogen Antigen Test Kit(Colloidal Gold Chromatographic Immunoassay)
Manufactured by Shenzhen Microprofit Biotech Co. Ltd., China - www.microprofit-bio.com
Device identification number
25672
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, 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-2
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Other (Mycoplasma Pneumoniae, L.p, S.p, S.aureus, Kpn), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2025-01-08 09:26:47 CET
Comments
Submission ID: 25670
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
12 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
49 TCID50/ml
Calibration
Evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
%
False negatives
7.07 %
Precision
Evaluated
Accuracy
100 %
Robustness
Evaluated
Clinical Sensitivity
92.93 % (97.48%(RhV); 98.08%(PIV); 96.82%(Influenza A);97.47%(Influenza B);98.72%(RSV); 98.06%(ADV); 98.04%(hMPV);95.00%(S.p); 93.08%(S.aureus); 94.92%(L.p); 93.57%(M.P);96.32%(Kpn))
Clinical Specificity
100 % (98.68%(RhV); 98.75%(PIV); 99.55%(Influenza A);100%(Influenza B);100%(RSV); 100%(ADV); 100%(hMPV);99.19%(S.p); 97.14%(S.aureus); 97.89%(L.p); 95.89%(M.P);98.57%(Kpn))
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