COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2800

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Card, Lateral flow

Target type

Antigen

Antibody type

Monoclonal

Targets

non-structural protein NS6, non-structural protein NSP6

Specimen

Nasopharyngeal 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

SARS-CoV

Information on antigen epitope targeted by the antibodies used in the design of the device

The COVID-19 Antigen Rapid Test Kit is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. The test uses SARS-CoV-2 antibody (test line T) and goat anti-mouse IgG (control line C) immobilized on a nitrocellulose strip. The burgundy-colored conjugate pad contains colloidal gold conjugated to anti- SARS-CoV-2 antibody conjugated with colloid gold (SARS-CoV-2 conjugates) and mouse IgG-gold conjugates.

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The principle of the kit is based on the nucleocapsid protein of SARS- CoV-2,and the performance is not affected by mutations in SARS- Cov-2 spike glycoprotein antigens.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

Yes

Subcategory

Sample preparation

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich, Double

Detection Principle

Colloidal gold

LOD

9.65 TCID50/ml

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

not allowed

False negatives

Improper operation procedures, below limits detection, mutant strains, disease stage

Precision

Evaluated

Accuracy

97.57 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

96.19 %

Clinical Specificity

99.01 %

Type of antigen

Nonstructural protein NS6