COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2685

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasopharyngeal swab

Lineages detected

A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.617.2 (Delta), P.1 (Gamma), P.2 (Zeta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

COVID-19 ANTIGEN RAPID TEST was tested with the following viral strains, no cross-reaction was observed at the following concentrations: Adenovirus type 3 3.16 x 10^4 TCID50/ml Influenza B 3.16 x 10^6 TCID50/ml Adenovirus type 7 1.58 x 10^5 TCID50/ml Human Rhinovirus 2 2.81 x 10^4 TCID50/ml Human Coronavirus OC43 1 x 10^6 TCID50/ml Human Rhinovirus 14 1.58 x 10^6 TCID50/ml Human Coronavirus 229E 5 x 10^5 TICID50/ml Human Rhinovirus 16 8.89 x 10^6 TCID50/ml Human Coronavirus NL63 1 x 10^6 TICID50/ml Masern-Virus 1.58 x 10^4 TCID50/ml Human Coronavirus HKU1 1 x 10^6 TICID50/ml Mumps-Virus 1.58 x 10^4 TCID50/ml MERS COV Florida 1.17 x 10^4 TICID50/ml Parainfluenza virus 2 1.58 x 10^7 TCID50/ml Influenza A H1N1 3.16 x 10^5 TCID50/ml Parainfluenza virus 3 1.58 x 10^8 TCID50/ml Influenza A H3N2 1 x 10^5 TCID50/ml Respiratory syncytial virus 8.89 x 10^4 TCID50/ml Hangzhou Alltest Biotech CO., Ltd is the contract OEM manufacturer of COVID-19 Antigen Rapid Test which is already on the Common list of rapid antigen tests (JRC Device ID 1257).

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Membrane-based

LOD

100 TCID50/ml

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

N.A.

False negatives

N.A.

Precision

Evaluated

Accuracy

99.6 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

93.4 %

Clinical Specificity

99.9 %

Type of antigen

Nucleocapsid protein