COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2834

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Card

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Nasal swab, Oropharyngeal swab, Saliva

Cross-reactivity (pathogens tested)

SARS-CoV

Pathogens detected

Influenza A

Type of Antigen (in case of Antigen-based)

Nucleocapsid protein

Lineages detected

B.1.1.529 (Omicron), B.1.617.2 (Delta)

Commercial Status

Commercialised

Last Update

2022-10-26 05:17:51 CET

Comments

Shenzhen Aivd Biotechnology Co., LTD., 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

Self Test

No

Reader Required

Yes

Subcategory

Other (Antigen Detection Kit)

Method

Other (Latex Lateral Flow)

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich

Detection Principle

Other (Latex Lateral Flow)

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

1.3 AU

False negatives

7.7 AU

Precision

Evaluated

Accuracy

99.2 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98.52 %

Clinical Specificity

98.87 %

Type of antigen

Nucleocapsid protein