Covid-19 Slide Test
Manufactured by HGH Desinfections und Cosmetique GmbH, Austria - www.hgh-group.at/
Device identification number
1958
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Detects SARS-CoV-2 S antigen and SARS-CoV-2 N antigen
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Other ()
Time
15 minutes
LOD
1.25 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
93 % ((95%CI:83%-95%))
False negatives
100 % ((95%CI:93%-100%))
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 %
Clinical Specificity
100 %
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