MutaPLEX® CoV-2 MUT real time RT-PCR Kit
Manufactured by Immundiagnostik AG, Germany - www.immundiagnostik.com
Device identification number
1850
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
Comments
The values for analytical and clinical sensitivity and specificity require strict adherence to the procedures described in the IFU. Test description The MutaPLEX® CoV-2 MUT real time RT-PCR Kit (Immundiagnostik AG, cat. No. KG193196) is an assay for the genotyping of SARS-CoV-2. There are 4 specific mutations in the spike protein, that can be detected by the real time RT-PCR: del69/70, del241-243, N501Y and H655Y. Combinations of the 4 different mutations are needed to identify the specific lineage of SARS-CoV-2. Lineage B.1.1.7 (UK variant): del69/70, N501Y Lineage B.1.351 (South Africa, ZA, variant): del241/243, N501Y Lineage P.1 (Brazil, BRA, variant): H655Y, N501Y
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Quantitative
Time
70 minutes
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