nCoVega Saliva-Based Rapid Antigen COVID19 Test
Manufactured by Kaya17 Inc., United States - www.kaya17.com
Device identification number
2779
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Target type
Antigen
Targets
spike protein
Specimen
Saliva
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
over 600 subjects in 4 external clinical trials
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Sample collection device
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Other ()
LOD
20 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
No food or drink 30 min prior to giving sample to avoid false positives
False negatives
Assay has high sensitivity and no Hook Effect so avoids false negatives
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99 %
Clinical Specificity
99 %
Type of antigen
Spike protein
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