Lumipulse G SARS-CoV-2 Ag
Manufactured by Fujirebio Inc., Japan - https://www.fujirebio.com
Device identification number
2124
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Automated, Fully automated (robot), Lab-based
Physical Support
Cartridge
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus, SARS-CoV
Lineages detected
A.23.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.616, B.1.617.2 (Delta), P.1 (Gamma), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.fujirebio.com/en/products-solutions/lumipulse-g-sars-cov2-ag
Assay Type
Immuno-Antigen
Rapid Diagnostic
No
Self Test
No
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
25 minutes
Subclass
Sandwich
LOD
2.95 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
see IFU
False negatives
see IFU
Precision
Evaluated
Accuracy
97.5 % (Precision: ≤ 2.5% (total %CV))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.6 % (NPS: 95% CI: 93.3-99.2% (124/127) ; Ct-value <30)
Clinical Sensitivity
100 % (NSP: 95%CI: 95.8-100.0% (87/87) ; Ct-value <25)
Clinical Specificity
99.3 % (Nasopharyngeal swab: (95% CI: 97.8-99.7%) (397/400) )
Type of antigen
Nucleocapsid 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