COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2462

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 inhibition activity of RBD-ACE2 binding induced by antibodies to SARS-CoV-2 in human plasma and sera. The assay is intended for: (a) Confirmation of anti RBD antibodies neutralizing activity in patients positively recovered from COVID-19 showing antibodies to RBD/Spike; (b) Testing human donors, recovered from COVID-19 infection, positive for anti-RBD/Spike antibodies for the generation of hyperimmune plasma, as a possible immunotherapeutic approach to the disease; (c) Screening of vaccinated individuals to assure a reliable positive and efficient immunization with development of high titer neutralizing anti RBD/Spike IgG antibodies.

Assay Type

Immuno-Antibody

Method

ELISA

Measurement

Quantitative

Time

115 minutes

LOD

2 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0 % No false positive reactions were observed

False negatives

0 % No false negative result was found

Precision

Evaluated

Accuracy

100 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

100 %

Clinical Specificity

100 %

Type of antigen

Other