iiLO SARS-CoV-2 Rapid Antigen Swab Test Kit Self Test Class III Certification CE2934 ISO:13485 Europe
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
| Shelf Life | 2 Years |
| Brand Name | iiLO |
| Certification | CE ISO:13485 |
| Instrument CI | Class III |
| Model number | Antigen Test Set |
| Specimen | Swab |
| Size | 70mm |
| Material | Plastic |
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.
Materials Provided
| Components | Main Ingredients | Loading quantity (Specification) |
| 1 Tests/Set | 5 Tests/Set | 10 Tests/Set |
| Detection Card | Test strip containing SARS-CoV-2 monoclonal antibody, Anti-mouse IgG polyclonal antibody | 1 pcs | 5 pcs | 10 pcs |
| Sample Extraction Solution | 0.02 M PB, 0.5M NaCl, 0.1% Tween 20 | 0.5mL*1 | 0.5mL*5 | 0.5mL*10 |
| Sample Extraction Tube | 1 pcs | 5 pcs | 10 pcs |
| Dropper | 1 pcs | 5 pcs | 10 pcs |
| Nasopharyngeal Swab | 1 pcs | 5 pcs | 10 pcs |
Interpretation Of Test Results
1. This set contains quality control process, when the pink/purple reaction line appears in the C zone, it indicates the correct and effective operation. C line is the prerequisites to see if the test is valid. If the C line does not show color, regardless of whether the T line shows color or not, the test is invalid, and it is recommended to retest.
2. The detection results ofthe set are interpreted according to the following table.
| C Line | T Line | Result |
| Pink/purple | Pink/purple | Positive |
| Pink/purple | Colorless | Negative |
| Colorless | Whether color is visible or not | Invalid test, retest
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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.
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ISO 13485 SARS-CoV-2 Rapid Antigen Swab Test Kit Class III IiLO Europe Images
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