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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SMARAPIDTEST

Manufactured by APLUS Diagnostics Laboratuvar San.Tic.A.S., Turkey - 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 type
Antibody, Antigen
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
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