geneMAP 2019-nCoV (SARS-CoV-2) Detection Kit
Manufactured by Genmark Saglik Urunleri, Turkey - www.genmark.com.tr
Device identification number
1222
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.25727
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
46 minutes
LOD
200 copies/ml
Positive control
Synthetic Nucleic Acid (Ultramer)
Negative control
RNase Free Water
Analytical Sensitivity
95 %
Analytical Specificity
98 %
Clinical Sensitivity
95 %
Clinical Specificity
98 %
Throughput
96 samples per run
Notes
manual or automated
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