COVID-19 Antigen Rapid Test For Self Test
Manufactured by Eternal Material Co.,Ltd., Taiwan ROC - https://www.eternal-group.com/Home/EngIndex
Device identification number
3453
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
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus
Information on antigen epitope targeted by the antibodies used in the design of the device
SARS-CoV-2 (Wuhan strain) N protein
atgtctgataa tggaccccaa aatcagcgaa atgcaccccg cattacgtttggtggaccct cagattcaac tggcagtaac cagaatggag aacgcagtgg ggcgcgatcaaaacaacgtc ggccccaagg tttacccaat aatactgcgt cttggttcac cgctctcactcaacatggca aggaagacct taaattccct cgaggacaag gcgttccaat taacaccaatagcagtccag atgaccaaat tggctactac cgaagagcta ccagacgaat tcgtggtggtgacggtaaaa tgaaagatct cagtccaaga tggtatttct actacctagg aactgggccagaagctggac ttccctatgg tgctaacaaa gacggcatca tatgggttgc aactgagggagccttgaata caccaaaaga tcacattggc acccgcaatc ttgctaacaa tgctgcaatcgtgctacaac ttcctcaagg aacaacattg ccaaaaggct tctacgcaga agggagcagaggcggcagtc aagcctcttc tcgttcctca tcacgtagtc gcaacagttc aagaaattcaactccaggca gcagtaaacg aacttctcct gctagaatgg ctggcaatgg cggtgatgctgctcttgctt tgctgctgct tgacagattg aaccagcttg agagcaaaat gtctggtaaaggccaacaac aacaaggcca aactgtcact aagaaatctg ctgctgaggc ttctaagaagcctcggcaaa aacgtactgc cactaaagca tacaatgtaa cacaagcttt cggcagacgtggtccagaac aaacccaagg aaattttggg gaccaggaac taatcagaca aggaactgattacaaacatt ggccgcaaat tgcacaattt gcccccagcg cttcagcgtt cttcggaatgtcgcgcattg gcatggaagt cacaccttcg ggaacgtggt tgacctacac aggtgccatcaaattggatg acaaagatcc aaatttcaaa gatcaagtca ttttgctgaa taagcatattgacgcataca aaacattccc accaacagag cctaaaaagg acaaaaagaa gaaggctgatgaaactcaag ccttaccgca gagacagaag aaacagcaaa ctgtgactct tcttcctgctgcagatttgg atgatttctc caaacaattg caacaatcca tgagcagtgc tgactcaactcaggcctaa
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.429 (Epsilon), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Capture
Detection Principle
Colloidal gold
LOD
1255.9 TCID50/ml
Analytical Sensitivity
97.73 %
Analytical Specificity
98.67 %
False positives
1.33 %
False negatives
2.27 %
Accuracy
94.54 %
Clinical Sensitivity
81.05 %
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