COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2164

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Manual, Near POC / POC

Physical Support

Card, Cassette, Lateral flow, Strip

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

SARS-CoV

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

The product is used for the qualitative detection of SARS-COV-2 infection. No instrument required. It can be used for the screening of early infected patients and asymptomatic patients. The test can be performed at the patient’s medical facility (POC – point of care-conditions). The negative result cannot rule out novel coronavirus infection, and it can not be used alone as a basis for treatment and disease management decisions.The positive result of the antigen test can be used for early triage and rapid management of suspected infected people, but the positive result only indicates the presence of the novel coronavirus N-Protein (Nucleocapsid) in the sample, and cannot be used as the basis for the diagnosis and exclusion of pneumonia caused by the novel coronavirus. It should be combined with nucleic acid testing, imaging and other diagnostic information, medical history, and contact history to determine the status of infection. Coronavirus belongs to the order Nidoviridae, and the coronavirus family is divided into three genera of α ,β, and γ. α and β are only pathogenic to mammals, and γ mainly causes bird infections. COV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through fecal or oral routes.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

Yes

Subcategory

Validity test kit

Method

Immunoassay

Measurement

Qualitative

Time

10 minutes

Subclass

Sandwich, Double

Detection Principle

Colloidal gold

LOD

100 TCID50/ml

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.67 %

False negatives

0.5 %

Precision

Evaluated

Accuracy

99.45 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

99.33 %

Clinical Specificity

99.5 %

Type of antigen

Nucleocapsid protein