COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2673

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Near POC / POC

Physical Support

Cassette

Target

Antigen

Specimen

Anterior nasal swab, Mid-turbinates swab, Nasopharyngeal swab

Pathogens detected

Adenovirus, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV

Lineages detected

B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.526 (USA), B.1.617.1 (India), B.1.617.2 (India), B.1.621 (Colombia), P.1 (Japan/Brazil), C.37 (Peru), B.1.526.2 (USA),

Commercial Status

Commercialised

Last Update

2021-10-11 10:53:07 CET

Comments

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Assay Type

Immuno-Antigen

Reader Required

No

Method

Immunochromatography

Measurement

Qualitative

Time

10 minutes

Subclass

Sandwich

LOD

140.6 TCID50/ml

Calibration

Evaluated

Crossreactivity

Evaluated

Fp

0 AU

Fn

5 AU

Precision

Evaluated

Accuracy

99.9 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

95 %

Clinical Specificity

100 %

Type of antigen

Nucleocapsid protein