MSP SARS-CoV-2 Antigen Schnelltest
Manufactured by MSP bodmann GmbH, Germany - www.mspbodmann.com
Device identification number
2532
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
MSP SARS-CoV-2 Antigen Schnelltest is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
1.51 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.52 % (Oropharyngeal)
False positives
0.33 % (Nasopharyngeal)
False positives
0.52 % (Nasal)
False negatives
1.32 % (Oropharyngeal)
False negatives
1.22 % (Nasopharyngeal)
False negatives
1.32 % (Nasal)
Precision
Evaluated
Accuracy
98.78 % (Nasopharyngeal)
Accuracy
98.68 % (Oropharyngeal)
Accuracy
98.68 % (Nasal)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.33 % (Nasopharyngeal)
Clinical Sensitivity
96.69 % (Oropharyngeal)
Clinical Sensitivity
96.69 % (Nasal)
Clinical Specificity
99.48 % (Oropharyngeal)
Clinical Specificity
99.67 % (Nasopharyngeal)
Clinical Specificity
99.48 % (Nasal)
Type of antigen
Nucleocapsid protein
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