Uni-Gold SARS_CoV-2 Antigen Test
Manufactured by Trinity Biotech plc, Ireland - www.trinitybiotech.com
Device identification number
3152
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, 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, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Please send any questions regarding clarifications to micheal.roche@trinitybiotech.com
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
1.3 ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.05 % (Prospective study: False positives 2/189)
False negatives
1.07 % (CT<32 = 1/93)
False negatives
0 % CT<28 = 0/77
Precision
Not evaluated
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
98.9 % (CT<32 92/93 )
Clinical Sensitivity
100 % (CT<28 = 77/77)
Clinical Specificity
98.9 % (187/189 - Antigen)
Type of antigen
Nucleocapsid protein
Notes
antigen_epi Monoclonals are mouse IgM, one recognises the conformational epitope, the other the linear epitope
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