Coronavirus Disease 2019 Real Time PCR Kit
Manufactured by MedicalSystem Biotechnology Co. Ltd., China - https://en.nbmedicalsystem.com/en/
Device identification number
2051
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Microplate
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Reader Required
No
Method
RT-PCR
Measurement
Qualitative
Time
120 minutes
LOD
500 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
99.25 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Specificity
100 %
Notes
target RNA
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