COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2383

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Cartridge

Target type

Antibody, IgA, IgG, IgM

Specimen

Plasma, Serum, Whole blood

Cross-reactivity (pathogens tested)

SARS-CoV

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

INTENDED USE: REVEALCOVID-19TM Total Antibody Test is an in vitro diagnostic test for the qualitative detection of total antibodies to the specific SARS-CoV-2 antigens in human serum, plasma and whole blood samples collected in certified laboratories and/or by the healthcare workers at the point-of-care. DEVICE DESCRIPTION: REVEALCOVID-19TM Total Antibody Test is a manually performed, visually interpreted Rapid Vertical Flow® (RVF) immunoassay that detects total antibodies to SARS-CoV-2, the causative agent of COVID-19 disease, in human serum, plasma and venipuncture whole blood. REVEALCOVID-19TM Total Antibody Test consists of a Test Cartridge, an InstantGold Cap, and two (2) vials of pre-aliquoted universal buffer solutions. Test Cartridge consists of two plastic casings (top and bottom) that snap together to securely hold the reactive nitrocellulose membrane overlaid on top of the absorbent pad. The Test Zone of the membrane is coated with a combination of synthetic proteins that correspond to the conserved regions of the SARS-CoV-2 nucleocapsid protein (N), thus, allowing the capture of SARS-CoV-2 antibodies. As a procedural/reagent control, Protein A is immobilized in a designated area (Control Zone) on the nitrocellulose membrane to allow a non-specific capture of Ig antibodies. InstantGold cap, which contains proprietary Protein A/L colloidal gold conjugates, enables the visualization of the aforementioned antigen – antibody immunocomplexes formed on the reactive membrane. Universal buffer solutions are proprietary formulations of ionic and non-ionic detergents in Tris-buffered saline that serve four main functions: a) lysis of blood cells in whole blood specimens; b) optimization of the interactions between capture antigens on the test membrane and antibodies present in the specimen; c) reduction of non-specific binding to the membrane; d) reconstitution of the colorimetric detection agent in the InstantGold Cap.

Assay Type

Immuno-Antibody

Reader Required

No

Method

Immunoassay

Measurement

Qualitative

Time

3 minutes

Subclass

Capture

LOD

20 AU

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

3.22 % (Plasma: 1/37 (PPA = 97.1%))

False positives

0 % Serum: 0/31 (PPA = 100%)

False positives

3.22 % (Whole Blood: 1/37 (PPA = 97.1%))

False negatives

1.61 % (Plasma: 2/124 (NPA = 98.1))

False negatives

0.91 % (Serum: 1/110 (NPA = 99.0%), )

False negatives

0 % Whole Blood: 0/37 (NPA = 100%)

Precision

Evaluated

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98.5 %

Clinical Specificity

98.7 %

Type of antigen

Other