SARS-CoV-2 Antigen Rapid Self-test Kit (Colloidal Gold)
Manufactured by SHENZHEN REETOO BIOTECHNOLOGY CO. LTD, China - http://www.reetoo.com.cn/
Device identification number
5738
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Mumps Virus (MuV), Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Mumps Virus (MuV), Respiratory Syncytial V (RSV), Rhinovirus
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-10-31 09:11:51 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
200 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
90 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
0.25 %
False negatives
3.96 %
Precision
Evaluated
Accuracy
99 %
Robustness
Evaluated
Clinical Sensitivity
96.04 %
Clinical Specificity
99.75 %
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