Covid-19 PCR
Manufactured by Dynamic Code AB, Sweden - https://www.dynamiccode.com/
Device identification number
2550
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Microplate
Specimen
Anterior nasal swab, Nasal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, 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.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
The sampling kit is CE-marked and the analysis is performed in a laboratory inspected by SWEDAC (ISO17025).
Assay Type
Unknown
Subcategory
Sample collection device
Method
RT-PCR
Measurement
Semiquantitative
Time
90 minutes
LOD
0.005 TCID50/ml
Analytical Sensitivity
96 %
Analytical Specificity
99 %
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