ZEKMED LUNA Ag Antigen Rapid Test Kit
Manufactured by ZEKMED Ltd., United Kingdom - https://zekmed.com
Device identification number
2842
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), 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
Accuracy: (98+210)/ (98+0+2+210) *100%=99.35% (95%CI* 97.58% to 99.43%) Pe= (100*98+210*212)/ (310*310) =0.557 Kappa:( P0 - Pe)/(1-pe) =0.992
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
400 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
0 AU
Precision
Evaluated
Accuracy
99.35 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 % (Antigen)
Clinical Specificity
100 % (Antigen)
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