Celltrion DiaTrust ™– Covid-19 Ag Rapid Test
Manufactured by Humasis Co. Ltd., South Korea - http://www.humasis.com/en/
Device identification number
2635
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Celltrion DiaTrustTM COVID-19 Ag Rapid Test is designed for qualitative detection of SARS-CoV-2 antigens in nasopharyngeal and nasal swab specimen of symptomatic patients suspected of COVID-19 [ MATERIAL COMPOSITION ] ● Monoclonal antibody to SARS-CoV-2 Nucleocapsid ● Monoclonal antibody specific to RBD of SARS-CoV-2 Spike Protein ● Goat anti-mouse IgG Celltrion DiaTrust COVID-19 Ag Rapid Test: Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use. EUA Number: EUA210190
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Other ()
LOD
32 TCID50/ml (5 x 100.8 TCID50/mL)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
Unknown
False negatives
Unknown
Precision
Evaluated
Accuracy
Unknown
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
92 %
Clinical Specificity
100 %
Type of antigen
Other
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