Coronavirus disease 2019(COVID-19) Multiplex Detection Kit, nCoV-OM
Manufactured by MiCo Biomed Co. Ltd., South Korea - www.micobiomed.com/
Device identification number
2797
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Strip
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This Real-time PCR kit is a real-time Reverse Transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab specimens from individuals who are suspected of COVID-19. Saliva samples can also be tested, and saliva should be collected using the Veri-Q saliva collection kit (MiCo BioMed, Cat No. 7K401). Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
120 minutes
Subclass
JRC-S
LOD
273.8 cpm (ABI7500)
LOD
126.1 cpm (CFX96)
Positive control
SARS-CoV-2 Positive Control Material
Negative control
Nuclease Free Water
Analytical Sensitivity
95 %
Analytical Specificity
95 %
Clinical Sensitivity
99.36 %
Clinical Specificity
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