STANDARD Q COVID-19 Ag Test 2.0
Manufactured by SD BIOSENSOR Inc., South Korea - http://sdbiosensor.com/xe/
Device identification number
24758
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, 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, Influenza B Victoria, Influenza B Yamagata, 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 A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV
Pathogens detected
Other (N/A)
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 (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 05:02:17 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
14.6 TCID50/ml (NP swab)
LOD
13 TCID50/ml (NS swab)
Calibration
Evaluated
Analytical Sensitivity
99 % (NP Swab)
Analytical Specificity
99.75 % (NP Swab)
Analysis of cross reactivity
Evaluated
False positives
1 samples (Negative Antigen: 401 out of 402 (NP))
False negatives
1 samples (Positive Antigen: 99 out of 100 (NP))
Precision
Evaluated
Accuracy
100 % (according to the precision data)
Robustness
Evaluated
Clinical Sensitivity
99 % (NP Swab)
Clinical Sensitivity
95.8 % (NS swab)
Clinical Specificity
99.75 % (NP Swab)
Clinical Specificity
100 % (NS 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