NADAL® GX COVID-19 Ag Test
Manufactured by Nal von minden GmbH, Germany - https://www.nal-vonminden.com/
Device identification number
4062
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal 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), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Other (Influenza A H7N9-Virus, Adenovirus Typ 1, Adenovirus Typ 2, Adenovirus Typ 5, Adenovirus Typ 55, Legionella pneumophila Bloomington-2, Legionella pneumophila 82A3105, Streptococcus pneumoniae 475298 [Maryland (D1) 6B-17], Streptococcus pneumoniae 178 [Pol), 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, SARS-CoV, SARS-CoV-2
Pathogens detected
SARS-CoV, 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.1.427 (Epsilon), 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), P.1 (Gamma), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-09-20 02:26:19 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other (Lateral flow rapid test)
Method
Immunochromatography
Measurement
Qualitative
Time
17 minutes
Subclass
Sandwich
Detection Principle
Other (Colored particles (polystyrene microspheres))
LOD
75.5 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
100 % (Above the limit of detection (75.5 TCID50/ml))
Analytical Specificity
100 % (For all tested potentially cross reacting organisms except SARS-CoV)
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
2.58 %
Precision
Evaluated
Accuracy
99.32 %
Robustness
Not evaluated
Clinical Sensitivity
97.42 %
Clinical Specificity
99.99 %
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