BTMED
Manufactured by Biotrack B.V., Netherlands - www.biotrack.nl
Device identification number
1597
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
30 minutes
LOD
0.49 cpu
Positive control
130 samples positive by RT-PCR and mild to severe symptomatic
Negative control
361 samples negative by RT-PCR and mild symptomatic
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
96.9 %
Clinical Specificity
98.6 %
Notes
Automated lab-based, near-POC NAT or POC NAT
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