SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT
Manufactured by ZET medikal tekstil dis tic Ltd. sti, Turkey - www.zetmedikal.com/en
Device identification number
2226
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A H1N1
Pathogens detected
Influenza A H1N1
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
A.23.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.616, B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-09-30 09:55:48 CET
Comments
Intended Use:The SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT is an immunochromatographic test kit, which contains specific antibodies for qualitative detection of (Covid-19) SARS COV-2 antigen in human nasal swab samples. This test kit is used to detect the SARS-CoV-2 N-protein antigen that occurs in the acute phase of an infection. The SOFTEC SARS COV-2 COVID-19 ANTIGEN TEST KIT can be used in symptomatic and asymptomatic people for lay users.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
N.A.
Detection Principle
Colloidal gold
LOD
2300 AU
Analysis of cross reactivity
Evaluated
False positives
2.27 % (3/132)
False negatives
0.4 % (1/248)
Precision
Evaluated
Accuracy
98.6 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.7 %
Clinical Specificity
99.5 %
Type of antigen
Nucleocapsid protein
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