COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2150

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Near POC / POC

Physical Support

Lateral flow

Target type

Antigen

Specimen

Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, 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, SARS-CoV, Varicella Zoster Virus (VZV)

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The M&D 2019-nCoV Antigen Test Kit is a rapid and convenient lateral flow immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid protein from nasopharyngeal swab samples obtained from individuals suspected of COVID-19 by their healthcare provider within five-seven days of symptom onset and /or epidemiological criteria. The rapid test device is for professional use only and is intended to be used as an aid in the diagnosis of SARS-COV-2 infection.

Assay Type

Immuno-Antigen

Method

Immunochromatography

Time

15 minutes

Subclass

Membrane-based

LOD

1 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

8.47 %

False negatives

0 %

Precision

Evaluated

Accuracy

98.11 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

91.53 %

Clinical Specificity

100 % (（Antigen）)

Type of antigen

Nucleoprotein