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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

DiaPat-CoV-50

Manufactured by mosaiques diagnostics GmbH, Germany - https://www.diapatshop.de/en/p/cov-50-test-molecular-detection-of-the-course-of-complications-of-a-covid-19-disease 

Device identification number
2407
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
As you suggested in our mail exchange, we provide here a test to predict the severe Covid-19 courses after SARS-CoV-2 infection. The LOD for the detection of the biomarker peptides in urine is 1.5 fmol.
Assay Type
Unknown
Subcategory
Transport kit
Method
Other ()
Measurement
Other ()
Time
1440 minutes
LOD
1.5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
27 %
False negatives
15 %
Precision
Evaluated
Accuracy
82 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
85 %
Clinical Specificity
73 %
Type of antigen
Other

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