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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Elecsys® Anti-SARS-CoV-2

Manufactured by ROCHE Diagnostics, Germany - https://diagnostics.roche.com/ 

Device identification number
882
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)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Mumps Virus (MuV), 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 assay uses a recombinant antigen representing the nucleocapsid (N) protein in a double-antigen sandwich assay format. OTher pathogens tested for cross-linking Borrelia burgdorferi; E. coli; Neisseria gonorrhoeae; HEV; HTLV; Listeria; Measles; Parvovirus B19; Plasmodium falciparum; Rubella;; Toxoplasma gondii;
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
18 minutes
Subclass
Sandwich, Double
Detection Principle
Chemiluminescence
LOD
0
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.5 % ( (95% CI: 97-100%) (≥14 days after PCR confirmation))
Clinical Specificity
99.8 % ((95% CI: 99.69-99.88%))
Type of antigen
Nucleocapsid N-protein
Notes
Preliminary assessment indicates that the mutations within the described variants are not expected to affect the clinical interpretation of samples measured with the Elecsys® Anti-SARS-CoV-2 S assay.

Related Scientific Literature

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