COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2283

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cartridge

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Saliva

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

Our device is equipped with dual targeting system. One sensor is coated with monoclonal antibody to SARS-CoV-2 nucleocapsid protein and another with monoclonal antibody to SARS-CoV-2 spike protein. During testing SARS-CoV-2 antigens possibly present in the specimen react with the bio receptor antibody nanoparticles present in the test. . This immunological reaction results in a digital electrical signal that is recognized by the systems software on the mobile app which results in a plus (+) sign on mobile app indicating a positive result.. If the antigens are not present in the specimen, no digital electrical signal is generated which appears as a minus (-) sign on the app indicating a negative result.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Method

Immunoassay

Measurement

Qualitative

Time

2 minutes

Subclass

Other ()

LOD

100 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.83 % (When 120 negative samples were tested, 1 sample showed false positive result)

False negatives

1.8 % (When 111 positive samples were tested, 2 samples showed false negative result)

Precision

Evaluated

Accuracy

98.7 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98.2 %

Clinical Specificity

99.17 %

Type of antigen

Nucleocapside protein