Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SCREEN TEST COVID-19 SALIVA

Manufactured by SCREEN ITALIA S.r.l., Italy - www.screenitalia.it 

Device identification number
1847
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Saliva, Sputum
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
* LOD: According to the study shown above, the lowest concentration that still led to a 100% detection rate was 100 TCID50/mL of inactivated SARS-COV-2 (Swab). Conclusion: Minimal detection limits of COVID-19 Antigen Rapid Test is 100pg/ml for recombine COVID-19 protein and 100TCID50/mL for inactivated SARS-COV-2.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Other
LOD
0 AU 0
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
2.15 % (2 on 93)
Fn
0.96 % (10 on 313)
Precision
Evaluated
Accuracy
97 % ((95% CI*: 94.9%~98.5%))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
90.1 % ((95% CI*:82.5%~95.1%))
Clinical Specificity
99.3 % ((95% CI*: 97.7%~99.9%))
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