COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3087

CE Marking

✓Yes

HSC common list (RAT)

×No

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV)

Pathogens detected

Influenza A, Influenza B, SARS-CoV

Lineages detected

B.1.1.529 (Omicron)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

Shenzhen AIVD Biotech Inc.，founded in 2014, is a high-tech enterprise specializing in the development, production and service of in vitro diagnostic reagents, which is composed of a team of "one thousand" professors from the Organization Department of the Central Committee of the COMMUNIST Party of China and experts with rich R&D experience. The company owns 5 invention patents. The company has invested a lot of resources in the production of materials for in vitro diagnostic reagents, reagent production and technical services for the whole product system. It has a strong R&D and production capacity, and its products sell around all over the word. With the continuous expansion of the market, the output and output value have been increasing year by year, and the company has been rated as a high-tech enterprise by Shenzhen for many years.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Method

Immunoassay

Time

15 minutes

Detection Principle

Colloidal gold

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

1.18 %

False negatives

7 %

Precision

Evaluated

Accuracy

95.91 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

93 %

Clinical Specificity

98.82 %

Type of antigen

Nucleocapsid protein