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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Allplex 2019-nCoV assay

Manufactured by Seegene Inc., South Korea - www.seegene.com/ 

Device identification number
348
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
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
110 minutes
LOD
100 copies/ml
Positive control
yes
Negative control
yes
Analytical Specificity
tested negative with 61 species of microorganisms.
Clinical Sensitivity
100 % ((49/49) [95% CI: 92.75% - 100.00%],)
Clinical Specificity
94 % ((94/100) [95% CI: 87.40% - 97.77%])
Throughput
single tubes
Notes
http://www.seegene.com/assays/allplex_2019_ncov_assay#

Related Scientific Literature

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