COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2531

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Cassette

Target type

Antibody

Specimen

Plasma, Serum, Whole blood

Cross-reactivity (pathogens tested)

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus, Varicella Zoster Virus (VZV)

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

None.

Assay Type

Immuno-Antibody

Reader Required

Yes

Method

Immunochromatography

Measurement

Quantitative

Time

15 minutes

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

3.3 %

False negatives

8.4 %

Precision

Evaluated

Accuracy

94.8 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

91.6 %

Clinical Specificity

96.7 %

Type of antigen

Spike protein