Humasis COVID-19 Ag Test
Manufactured by Humasis Co. Ltd., South Korea - http://www.humasis.com/en/
Device identification number
1263
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein, spike protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), 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) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Other
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.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2023-03-30 10:56:38 CET
Comments
[Contents] ● Test devices packaged individually in aluminum pouch (25tests/box) ● Disposable test tube with extraction buffer (25ea/box) ● Filter cap (25ea/box) ● Sterilized swabs for specimen collection (25ea/box) ● Instructionsfor use (1ea) [Storage] Room temperature (2~30℃)
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
32 TCID50/ml (5 x 100.8 TCID50/mL)
Calibration
Not evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
%
False negatives
%
Precision
Evaluated
Accuracy
98.3 % (Nasal swab)
Robustness
Not evaluated
Clinical Sensitivity
91.9 % (Nasal swab)
Clinical Sensitivity
90.48 % (Nasal swab)
Clinical Sensitivity
90.2 % (Nasopharyngeal swab)
Clinical Specificity
99.7 % (Nasal swab)
Clinical Specificity
100 % (Nasal swab)
Clinical Specificity
100 % (Nasopharyngeal swab)
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