Elecsys® Anti-SARS-CoV-2 S
Manufactured by ROCHE Diagnostics, Germany - https://diagnostics.roche.com/
Device identification number
2160
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based
Physical Support
Cartridge
Target type
Antibody
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Varicella Zoster Virus (VZV)
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
The Elecsys Anti SARS CoV 2 S assay uses a recombinant antigen representing the receptor-binding domain (RBD) of the Spike protein in a double-antigen sandwich assay format. Other pathogens tested for cross-reactivity are: Borrelia burgdorferi; E. coli; Neisseria gonorrhoeae; HEV; HTLV; Listeria; Measles; Parvovirus B19; Plasmodium falciparum; Rubella;; Toxoplasma gondii; Enterovirus; Haemophilus influenza B; Candida albicans; Chlamydia trachomatis; Legionella;
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
18 minutes
Subclass
Sandwich, Double
LOD
0.4 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.8 % ( (95% CI: 98.1 99.3))
Clinical Specificity
99.98 % ( (95% CI: 99.91 100))
Type of antigen
receptor-binding domain (RBD) of the 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