SARS-CoV-2 MONLABTEST
Manufactured by MONLAB SL, Spain - www.monlab.com
Device identification number
1961
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
LoD: Detection limit value (typical) of SARS-CoV-2 is 1.00 ng/mL of SARS-CoV-2 recombinant protein or 1x103 TCID50/mL of 2019nCoV/USA-WA1/2020
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
1 ng/mL
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.4 %
False negatives
7.1 %
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.9 %
Clinical Specificity
99.6 %
Type of antigen
Nucleoprotein
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