LFA COVID-19 IgG & IgM Rapid Test Device
Manufactured by Spartacus-Biomed, France - www.spartacus-biomed.fr
Device identification number
2186
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Peripheral blood, Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Additional and Independent validation by the French Reference Center (Pasteur Institute Paris) Validated by the French National Agency of Health product (ANSM) and Health Authorities (HAS). Referenced on the French Ministry of Health website for COVID (https://covid-19.sante.gouv.fr/tests) Registered by the Ministry of Health in Spain and Portugal.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
1
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % IgG
False positives
1 % IgM
False negatives
1 % IgG
False negatives
2 % IgM
Precision
Evaluated
Accuracy
96 % IgG
Accuracy
96 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % IgG
Clinical Sensitivity
92 % IgM
Clinical Specificity
100 % IgG
Clinical Specificity
100 % IgM
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