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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

LooK SPOT

Manufactured by Laipac Technology Inc., Canada - www.laipac.com 

Device identification number
1667
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
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
Low-cost LooK SPOT to read over thousands of tests. Look SPOT access AI Cloud for the diagnosis of the images and it provides consistent test results including low positive cases. Under SPEED mode, it can provide test results within 30 seconds.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
1 minutes
Subclass
Other ()
Detection Principle
Colorimetry
LOD
129000 TCID50/ml
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