Trueline COVID-19 Ag Rapid Test
Manufactured by TP Medicare GmbH, Germany - www.tp-medicare.de/
Device identification number
1497
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
False positives
0 % 0 of 21
False negatives
2.7 % (1 of 37)
Accuracy
98.1 %
Clinical Sensitivity
93.8 %
Clinical Specificity
100 %
Type of antigen
nucleocapside
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