COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1815

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Near POC / POC

Physical Support

Lateral flow

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Anterior nasal swab, Nasal swab

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text And we have attached the MHRA registration certificate. Also the registration in Germany, registration in Italy, registration in Portugal and so on.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Method

Immunochromatography

Measurement

Qualitative

Time

20 minutes

Detection Principle

Colorimetry

LOD

320 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.2 %

False negatives

3.6 %

Precision

Evaluated

Accuracy

99.03 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

96.4 %

Clinical Specificity

99.8 %

Type of antigen

Nucleoprotein