SMARAPIDTEST
Manufactured by APLUS Diagnostics Laboratuvar San.Tic.A.S. - www.aplustbd.com
Device identification number
1344
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antibody, Antigen
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
03/24/2021 04:30
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
15
Fp
5 2 out of 40 samples of Gold standard reagent
Fn
2.5 2 out of 80 samples of Gold standard reagent
Accuracy
96 %
Clinical Sensitivity
95 %
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0.1 0.1
Calibration
not evaluated
Crossreactivity
evaluated
Fp
1.47 % 1 out of 68 samples of Gold standard reagent
Fn
10.1 % 10 out of 99 samples of Gold standard reagent
Precision
not evaluated
Accuracy
98 % IgG
Accuracy
93 % IgM
Reproducibility
not evaluated
Robustness
evaluated
Clinical Sensitivity
97 % IgG
Clinical Sensitivity
87 % IgM
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