LooK SPOT 2
Manufactured by Laipac Technology Inc., Canada - www.laipac.com
Device identification number
2368
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab
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
LooK SPOT 2 can screen 500+ people in one hour by using SPEED mode. LooK SPOT 2 uses AI Cloud to validate the test result and provide traceability in real time. Patients can receive test certificates on their phones in real time.
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
1 minutes
LOD
129000 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 % (Limited to less than 2%)
False negatives
2 % (Limited to less than 2%)
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.4 %
Clinical Specificity
98.3 %
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