Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab)
Manufactured by BMT Diagnostics, Israel - www.bmtdiagnostics.com
Device identification number
1605
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Throat swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
no info on website about preformance
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
1000 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.43 % (3 of 123)
False negatives
1.23 % (1 of 81)
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.4 %
Type of antigen
nucleoprotein
Notes
Rapid diagnostic test Dipstick
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