SMARTROL™ 2019-nCoV Detection Kit v1
Manufactured by Genecast Co. Ltd., South Korea - https://igenecast.com/
Device identification number
2840
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Sputum
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), 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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Detects 4 target genes in SARS-CoV-2 accurately and quickly. Applied Uracil-DNA N-glycosylase (UNG) system, No more carry-over contamination. Able to detect new variant OMICRON, as well as major variants that are found so far (Alpha, Beta, Gamma, Delta, etc.)
Assay Type
Nucleic acid-PCR
Reader Required
No
Method
RT-PCR
Measurement
Qualitative
Time
120 minutes
LOD
95 %
Positive control
Mixture of RdRP, S, N, E and RNase P plasmids
Negative control
Nuclease-Free Water
Analytical Sensitivity
100 %
Clinical Sensitivity
100 % (100)
Clinical Specificity
100 % (100)
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