ESPLINE SARS-CoV-2
Manufactured by Fujirebio, Japan - https://www.fujirebio.com/en
Device identification number
2147
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV) Type A, Rhinovirus
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
ESPLINE SARS-CoV-2 is a cassette-style assay using a simple procedure without any special instruments. SARS-CoV-2 can be detected within 30 minutes.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
30 minutes
Subclass
Enzyme-linked
LOD
50 PFU/mL ((Viral Copy equivalent = 1.09 x 10 exp5 copies/ml))
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % Specificity = 100% (n=644, no false positives)
False negatives
12.2 % (Sensitivity = 87.8% (n=98, Ct<33))
Precision
Evaluated
Accuracy
98.3 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
87.8 % ( (n=98, Ct<33))
Clinical Specificity
100 %
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