COVID-19 In Vitro Diagnostic Medical Device - detail | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

AnyLab COVID-19 Ag Test Kit

Manufactured by Z Biotech Inc., South Korea - http://zetbio.com/

Device identification number

2599

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Manual

Physical Support

Other

Target

IgG, IgM, IgA

Specimen

Nasal swab, Nasopharyngeal swab, Saliva

Pathogens detected

Adenovirus, Adenovirus 3, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV

Lineages detected

B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.427 (USA), B.1.526 (USA), B.1.617.1 (India), B.1.617.2 (India), P.1 (Japan/Brazil),

Commercial Status

Last Update

2021-09-02 10:40:11 CET

Comments

None

Assay Type

Immuno-Antigen

Reader Required

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

LOD

805 AU

Calibration

Evaluated

Crossreactivity

Evaluated

Not Applicable

Precision

Evaluated

Accuracy

98 % ( (Antigen))

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

90.9 % ( (Antigen))

Clinical Specificity

96.9 % ( (Antigen))

Type of antigen

Nucleocapsid protein

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. Acknowledgements