COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2658

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Near POC / POC

Physical Support

Card, Strip

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Anterior nasal swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, Varicella Zoster Virus (VZV)

Pathogens detected

Varicella Zoster Virus (VZV)

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

Our product "SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal " has obtained the EC Notified Body Certificate (CE1434) with EC Certificate No. 1434-IVDD-016/2022, comply with requirements of Annex III(Section 6) to Directive 98/79/EC.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

Yes

Reader Required

No

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich, Double

Detection Principle

Colloidal gold

LOD

50000 copies/ml

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

0.22 % (A total 450 negative samples are tested, and 1 subject is tested false positive by the kit.)

False negatives

3.8 % (A total 105 positive samples are tested, and 4 subjects are tested false negative by the kit.)

Precision

Evaluated

Accuracy

99.1 % (97.91% to 99.61%)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

96.19 % (90.61% to 98.51%)

Clinical Specificity

99.78 % (98.75% to 99.96%)

Type of antigen

Nucleocapsid protein