COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2456

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Manual

Physical Support

Microplate

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

Enzyme ImmunoAssay (ELISA) for the determination of IgG antibodies to COVID-19 Spike antigens in human plasma and sera. The IgG 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 IgG; (b) normal population for epidemiology studies on presence of potential “protective” IgG to COVID-19 Spike antigens; (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 IgG 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 IgG antibodies

Assay Type

Immuno-Antibody

Method

ELISA

Measurement

Quantitative

Time

105 minutes

LOD

2 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0 % None

False negatives

0 % None

Precision

Evaluated

Accuracy

100 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

100 %

Clinical Specificity

98 %

Type of antigen

Spike 1&2