SARS-CoV-2 Antigen Rapid Test Device (Saliva)
INTENDED USE
The SARS-CoV-2 Antigen Rapid Test device is a rapid visual immunoassay for the qualitative, presumptive detection of SARS-CoV-2 antigens form Nasal swabs specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute SARS-CoV-2 virus infection.
PRINCIPLE
The detection of SARS-COV-2 adopts the principle of double antibody sandwich method and colloidal gold immunochromatography to qualitatively detect SARS-COV-2 antigen in human Nasopharyngeal swabs, Nasal swab, Saliva, etc., with two highly specific and highly sensitive SARS-COV-2 N antigen monoclonal antibodies, wherein monoclonal antibody I is a capture antibody, fixed in the detection area on the NC membrane, monoclonal antibody II is a colloidal gold-labeled antibody, sprayed on the binding pad, and the NC membrane quality control area C is coated with goat anti-chicken IgY antibody. The double antibody sandwich method is used in the detection area, and the antigen-antibody reaction is used in the quality control area, combined with colloidal gold immunochromatography technology to detect the SARS-COV-2 in the human body. During detection, the sample is chromatographed under the capillary effect. If the tested sample contains SARS-COV-2, the gold-labeled SARS-COV-2 N antigen monoclonal antibody I combines with SARS-COV-2 to form a complex, and combines with the a SARS-COV-2 N antigen monoclonal antibody II fixed at the detection line during the chromatography process, which will form the "Au-antibody I-N antigen- antibody II" sandwich, so that a purple band appears in the detection area (T); Otherwise, no magenta bands appear in the detection area (T). Regardless of whether there is a SARS-COV-2 antigen in the sample, the complex will continue to be chromatographed up to the control area (C), and a purple band appears when reacting with the goat anti- chicken IgY.
The purple-red band presented in the control area (C) is a standard for judging whether the chromatographic process is normal, and also serves as an internal control standard for reagents.
PROCEDURE
Bring tests, and/or controls to room temperature (15-30°C) before use.
1.Remove the test from its sealed pouch, and put the device into your mouth, let saliva fully infiltrate the device.
2.When you see the C line colored. Take the device out of your mouth. Put the lid on, and wait 10 minutes to read the result.
As the test begins to work, color will migrate across the membrane. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
PERFORMANCE CHARACTERISTICS
Of the 110 confirmed SARS-CoV-2 positive cases .5 were Delta and 5 were Omicron. 450 SARS-CoV-2 Negative samples, of which 300 non-infected individuals, Samples containing other interfering and cross-reactive respiratory pathogens from 50 cases. Negative Samples from 100 hospitalized cases. Detailed test results are presented in table below.
Table 1: Saliva Sample vs. PCR Results
| Relative Sensitivity: 90.91% (83.92%~95.55%) Relative Specificity: 100% (99.18%~100.0%) Overall Agreement: 98.21% (96.74%~99.14%) *95% Confidence Interval | SARS-CoV-2 antigen Rapid Test | ||||
+ | - | Total | |||
PCR | + | 100 | 10 | 110 | |
- | 0 | 450 | 450 | ||
560 | |||||
