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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

STANDARD F COVID-19 Ag FIA

Manufactured by SD BIOSENSOR Inc., South Korea - https://www.sdbiosensor.com/ 

Device identification number
344
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid 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, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV
Pathogens detected
Beta Coronavirus HKU1 (HCoV-HKU1)
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.1.429 (Epsilon), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), Other (Omicron (BA.1, BA.2, BA.3, BA.4.1, BA.5, BA.2.75, BF.7, BF.14, BJ.1, BQ.1.1, BA.4.6, BA.2.75.2, BA.2.12.1, BA.5.1, BA.5.2, BA.2.3.20, XBB, BA.2.10, BM.1.1.1, BS.1, BQ.1, BA.4.4, BA.5.2.6, BN.1, CH.1.1, CJ.1, XBF, XBB.1, XBB.1.5, XBC)), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2023-03-27 03:24:21 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Fluorescence
LOD
202.87 TCID50/ml (NP Swab)
LOD
153.89 TCID50/ml (Nasal Swab)
Calibration
Evaluated
Analytical Sensitivity
92.86 % (NP Swab 104/102 (95% CI: 86.54 – 96.34%))
Analytical Specificity
99.63 % (NP Swab 536/538 (95% CI: 98.65 – 99.90%))
Analysis of cross reactivity
Evaluated
False positives
0.37 % (2/538 (NP Swab))
False positives
% 0/100 (Nasal Swab)
False negatives
7.14 % (8/112 (NP Swab))
False negatives
5.77 % (3/52 (Nasal Swab))
Precision
Evaluated
Accuracy
100 % (according to the precision study)
Robustness
Evaluated
Clinical Sensitivity
92.86 % (NP Swab 104/102 (95% CI: 86.54 – 96.34%))
Clinical Sensitivity
94.23 % (Nasal Swab - 49/52 (95% CI : 84.05% - 98.79%))
Clinical Specificity
99.63 % (NP Swab 536/538 (95% CI: 98.65 – 99.90%))
Clinical Specificity
100 % (Nasal Swab 100/100 (95% CI : 96.38% - 100.00%))

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