ISO 13485 SARS-CoV-2 Rapid Antigen Swab Test Kit Class III iiLO

iiLO SARS-CoV-2 Rapid Antigen Swab Test Kit Self Test Class III Certification CE2934 ISO:13485

iiLO Antigen Swab Test Kits SARS-CoV-2 Testing European self-test versions Class III 1 Test/Box

The antigen detection test of NewGene makes use of saliva as the sample and is therefore a non-invasive rapid test. The COVID-19 Antigen Detection Kit is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibody against the nucleocapsid protein of SARS-CoV-2. The reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. With this method there a just a few drops of saliva and extraction buffer needed and the results show in 15 minutes. The test does not have to be performed by a trained person. It can be used by everyone, including private use.

Description

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

Date sheet

Advantages of Antigen Rapid Test

Although the development cycle of antigen detection is relatively long, its
1. Sensitivity and specificity are higher than antibody detection
2. The pathogen can be detected at the initial stage of infection
3. Short TAT and simple operation.
4. No professional technicians and equipment are required, and the test can be completed in 15 min.
5. Home use.
6. Personal test.