geneMAP 2019-nCoV (SARS-CoV-2) Rapid Detection Kit
Manufactured by Genmark Saglik Urunleri, Turkey - www.genmark.com.tr
Device identification number
1059
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
Rapid Diagnostic
No
Method
RT-PCR
Time
75 minutes
LOD
1000 cpm
Positive control
Synthetic Nucleic Acid (Ultramer)
Negative control
V (Virus Transport Medium)
Analytical Sensitivity
98 %
Analytical Specificity
100 %
Clinical Sensitivity
96 %
Clinical Specificity
98 %
Throughput
96 samples/run
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