cue health
Manufactured by cue health Inc., United States - cuehealth.com
Device identification number
2655
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cartridge
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Digital connectivity to mobile health app
Assay Type
Unknown
Reader Required
Yes
Subcategory
Other ()
Method
Digital-PCR
Measurement
Semiquantitative
Time
20 minutes
LOD
60000 AU
Positive control
Yes
Negative control
Yes
Analytical Sensitivity
99.5 %
Analytical Specificity
100 %
Clinical Sensitivity
98.7 %
Clinical Specificity
97.8 %
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