COVID-19 In Vitro Diagnostic Medical Device – detail

2019-nCoV Ag Rapid Test Kit – REF: CY-F006-AG25

Manufactured by Huachenyang (Shenzhen) Technology Co. Ltd., China – https://www.chenyanglobal.com 

Device identification number

1748

CE Marking

✓Yes

HSC common list (RAT)

×No

Physical Support

Cassette

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasal swab, Nasopharyngeal swab, Saliva

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

LOD

50 U/ml

Analysis of cross reactivity

Evaluated

False positives

6.6 % (4 false positives out of 61 tests)

False negatives

0.22 % (1 false negatives out of 449 tests)

Precision

Evaluated

Accuracy

99.02 %

Reproducibility

Evaluated

Robustness

Not evaluated

Clinical Sensitivity

96.67 %

Type of antigen

Nucleoprotein

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark.