MutaPLEX® Coronavirus Real-Time-RT-PCR-Kit
Manufactured by Immundiagnostik AG, Germany - www.immundiagnostik.com
Device identification number
2014
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Mid-turbinates swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
MutaPlex Coronavirus Real-Time-RT-PCR-Kit was developed for the simultaneous in vitro detection of RNA of novel coronavirus and subgenus Sarbecovirus extracted from biological specimens. The simultaneous detection of 3 target sequences(RdRP-Gen, S-Gen and E-Gen) also increases the diagnostic safety in case of mutations of the target sequence.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Quantitative
Time
65 minutes
Subclass
JRC-S
LOD
One copy
Positive control
yes with 10,000 copies per PCR
Negative control
yes, including internal control
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
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