COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2156

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Automated, Lab-based

Physical Support

Cartridge

Target type

Antigen

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab

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

Elecsys SARS CoV 2 Antigen is an immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) in nasopharyngeal, oropharyngeal and nasal swab samples from patients with signs and symptoms suggestive of COVID 19, or known or suspected exposure to SARS CoV 2. The test is intended as an aid in the diagnosis of SARS CoV 2 infection. The Elecsys SARS CoV 2 Antigen assay uses monoclonal antibodies directed against the SARS CoV 2 nucleocapsid protein in a double-antibody sandwich assay format for the detection of SARS CoV 2 in upper respiratory tract specimens. Specimen collection and preparation: Nasopharyngeal, oropharyngeal and nasal specimens, collected using flocked or polyester-tipped swabs, placed in 3 mL of COPAN Universal Transport Medium (UTM-RT™), BD™ Universal Viral Transport (UVT), Viral Transport Media (VTM, prepared according to CDC SOP#: DSR 052 05), or sterile saline (0.9% NaCl). For quality control, use PreciControl SARS CoV 2 Antigen. antigen_epi N-terminal domain; C-terminal domain

Assay Type

Immuno-Antigen

Rapid Diagnostic

No

Self Test

No

Reader Required

Yes

Method

CLIA

Measurement

Qualitative

Time

18 minutes

Subclass

Sandwich, Double

LOD

22.5 TCID50/ml (in UTM/VTM)

LOD

37.5 TCID50/ml (in sterile saline)

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

Precision

Evaluated

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

94.5 % (95% CI: 90.4-97.2 - Nasopharyngeal swab)

Clinical Sensitivity

96.8 (95% CI: 88.8-99.6% - Nasal swab)

Clinical Sensitivity

94.5 (95% CI: 90.4-97.2 - Oropharyngeal swab)

Clinical Specificity

99.9 % (95% CI: 99.6-100)

Type of antigen

Nucleocapsid protein

Notes

https://diagnostics.roche.com/global/en/products/params/elecsys-sars-cov-2-antigen-test.html