TARGETINGONE® SARS-CoV-2 Antigen Test
Manufactured by TargetingOne Technology (Beijing) Corporation, China - http://www.targetingone.com/en/CompanyProfile/index.aspx
Device identification number
3066
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Latex
Target type
Antigen
Antibody type
Polyclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 Antigen Test is used for in vitro qualitative detection of the SARS-CoV-2 N antigen in human nasal secretions. Antigen testing is generally conducted in the acute infection period, that is, within 7 days of the onset of symptoms. Positive results from the antigen test can be used for early triage and rapid management of patients with suspected infections. However, a positive result only indicates the presence of SARS-CoV-2 N antigen in the sample, and cannot be used as a basis for the diagnosis of SARS-CoV-2 infection. Negative results do not rule out SARS-CoV-2 infection and may not be used as the sole basis for treatment and disease management decisions. Further nucleic acid testing should be performed for both antigen positive and negative results in the suspected population. SARS-CoV-2 Antigen Test is used for latex immunochromatography for the detection of SARS-CoV-2 N antigen in human nasal secretions. The SARS-CoV-2 monoclonal antibody 2 is fixed in the detection zone (T line) of the nitrocellulose (NC) membrane,and a Goat anti-mouse polyclonal antibody is fixed in the quality control zone (C line) of the NC membrane. A mixture of SARS-CoV-2 monoclonal antibody 1 labeled with red latex was immobilized on a fiberglass membrane.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
100 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.98 %
False negatives
12.26 %
Precision
Evaluated
Accuracy
96.69 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
87.74 % (Antigen)
Clinical Specificity
99.02 % (Antigen)
Type of antigen
Nucleocapsid protein
Notes
field_variants_detected B.1.604
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