SMARAPIDTEST
Manufactured by A PLUS DIAGNOSTICS LAB.SAN.TIC.A.S., Turkey - www.aplustbd.com
Device identification number
1344
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody, Antigen
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
15
False positives
5 (2 out of 40 samples of Gold standard reagent )
False negatives
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
Analysis of cross reactivity
Evaluated
False positives
1.47 % (1 out of 68 samples of Gold standard reagent )
False negatives
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