ThEA DSS-F1
Manufactured by RAM THz Solutions GmbH, Germany - www.ramthzsolutions.com
Device identification number
3120
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cartridge, Chip
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Influenza A H1N1, Influenza B, Mycoplasma Pneumoniae, Rhinovirus, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The ThEA product successfully introduces a new approach in medical diagnostics for direct detection of SARS-CoV-2 virions in biological samples. The product is to be operated by a trained Healthcare Professional (HCP); however, the ThEA product does not require any laboratory infrastructure or additional equipment and can be used at the point of care or near point-of-care. The ThEA product introduces a unique advantage of eliminating the need for biochemical reagents or any system calibration or control sample. The ThEA product utilizes a disposable diagnostic sensor stick to which the sample is applied using the swab. The measurement is done using ThEA RapiDx THz analyzer, and the process takes less than 30 seconds. The entire process from sample collection to results is achieved within two minutes. This method will enable mass testing in high traffic environments such as airports and stadiums adding a new powerful tool to have a quicker and more efficient response in reducing the spread of the virus.
Assay Type
Other ()
Self Test
No
Reader Required
Yes
Method
Other ()
Measurement
Qualitative
Time
1 minutes
Subclass
Other ()
LOD
40 - Cycle threshold (CT)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5/345
False negatives
5/101
Precision
Evaluated
Accuracy
97.8 (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.1 (Antigen)
Clinical Specificity
98.6 (Antigen)
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