COVID-19 Ag Rapid Test Kit (Colloidal Gold)

The COVID-19 Ag Rapid Test Kit (Colloidal Gold) is an in vitro immunochromatographic method for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from flocked nasopharyngeal (NP) swabs or nasal (NS) swabs of individuals suspected of COVID-19.

The COVID-19 Ag Rapid Test Kit (Colloidal Gold) uses the double antibody sandwich method to legally detect the novel coronavirus antigen in nasopharyngeal swabs or oropharyngeal swabs. It is designed to assist in the rapid diagnosis of SARS-COV-2 infection.

Components: 1 swab, 1 extraction buffer, 1 test cassette/test

Certifications: CE 2934/Thai FDA/ISO 13485

CE 2934 & Thai FDA Certified

HCY’s COVID-19 Ag rapid test kit (colloidal gold) belongs to the self-test category according to the IVDD (98/79/EC) in vitro diagnostic device directive. The CE 2934 certificate was obtained only after Notify Body, which meets the EU requirements, intervened to conduct a strict technical review and test on our products and proved that the covid-19 antigen rapid test kits are safe, clinically reliable, and in compliance with international technical specifications.

Product Details

The self-test COVID-19 Ag rapid test kit is to identify SARS-CoV-2 nucleocapsid antigen that is generally detectable in upper respiratory samples during the acute phase of infection.

The detection area (T) on the plain film is pre-coated with an anti-2019-nCoV monoclonal antibody, and finally, a red reaction line is formed in the T area. If the sample does not contain the 2019-nCoV antigen, a red reaction line cannot be formed in the T zone.

• Sensitivity: 96.15% (100/104), confirmed positive cases compared to the nucleic acid amplification test.
• Specificity: 99.78% (448/449), confirmed negative cases compared to the nucleic acid amplification test.
• Cross-reactivity: There is no cross-reactivity with influenza A virus, influenza B virus, adenovirus, Coxsackie virus, ECHO virus, and enterovirus; no cross-reactivity with Chlamydia pneumoniae, Mycoplasma pneumoniae, Chlamydia psittaci, and Chlamydia trachomatis; no cross-reactivity with Acinetobacter baumannii, Bordetella pertussis, Candida albicans, Escherichia coli, Haemophilus influenzae and Neisseria gonorrhea.

Application: 

For suspicious patients with symptoms, mild symptoms, or even without symptoms, also for testing people with close contact with infected patients and people under quarantine control.