CoviDetect™ COVID-19 Multiplex RT-qPCR Assay
Manufactured by PentaBase, Denmark - https://pentabase.com/
Device identification number
2915
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based, Semi-automated
Physical Support
Microplate, Microtiter plate
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), MERS-CoV, SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Accurate diagnosis of SARS-CoV-2 is important in individuals suspected of a respiratory infection. The CoviDetect™ COVID-19 Multiplex RT-qPCR Assay is a molecular in vitro diagnostic assay based on PentaBase’s highly sensitive technology to identify the presence of SARS-CoV-2 RNA in individuals. The assay is provided in a multiplex format, which means that one sample from a patient can be analyzed in one tube.
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
RT-PCR
Measurement
Qualitative
Time
80 minutes
Subclass
JRC-S
LOD
cpr 5-20 cpr for N1 and N2 combined depending on the cycler machine
Positive control
Positive controls (20 copies/μl). 200 μl should be added during the RNA extraction procedure.
Negative control
Added to the assay. 200 μl should be added during the RNA extraction procedure.
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples per run
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