COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2478

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Fully automated (robot)

Physical Support

Cartridge

Target type

IgG

Specimen

Plasma, Serum

Cross-reactivity (pathogens tested)

SARS-CoV

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 Antibody assay is intended for testing: (a) health-care workers at risk of COVID-19 infection to verify whether or not they might be positive for potentially neutralizing anti Spike/RBD antibodies. (b) normal population for epidemiology studies on presence of potential “protective” Antibodies to SARS-CoV-2 Spike/RBD; (c) PCR-negative infected individuals, successfully recovered from infection, to assure presence of potentially neutralizing antibodies; (d) human donors, recovered from COVID-19 infection, positive for anti-Spike/RBD antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (e) vaccinated individuals to assure a reliable positive immunization with development of anti Spike/RBD antibodies

Assay Type

Immuno-Antibody

Method

CLIA

Measurement

Quantitative

Time

23 minutes

Detection Principle

Chemiluminescence

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0 % No false positive reaction was observed

False negatives

0 % No false reactivity was found

Precision

Evaluated

Accuracy

100 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98 %

Clinical Specificity

98 %

Type of antigen

Other (Spike protein, RDB protein)