Test principle
The Rapid COVID-19 Antigen Test is a membrane-based rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 antigens in human nasopharyngeal and nasal swab samples. During the test, the SARS-CoV-2 antigens contained in the sample react with the antibody-coated nanoparticles contained in the test strip. As a result, the mixture migrates chromatographically by capillary action along the test strip.
If the sample contains SARS-CoV-2 antigens, they will bind to SARS-CoV-2 antibodies contained in the test line region (T) and generate a colored line on the test strip, resulting in indicates a positive result. If antigens are not present in the sample, no colored line will appear in the test line region (T), indicating a negative result. As a procedural control, a colored line will always appear in the control line region (C), indicating that the test procedure was successful and that the test components functioned as intended.
The Rapid COVID-19 Antigen Test is aimed at health professionals with the aim of supporting them in the management of COVID-19 emergencies, by receiving rapid results on the health status of their patients:
- standards of high sensitivity and specificity, compared to a PCR methodology;
- safe and accurate results in just 15 minutes;
- easy to use and read.
Why use a COVID-19 antigen test?
The use of a Rapid COVID-19 Antigen Test allows detecting the presence of SARS-CoV-2 antigens in our body and taking initial preventive isolation measures in order to reduce the spread of the virus. As stated by Mina et al. in the New England Journal of Medicine, due to the consistently high incidence of COVID-19 cases around the world, there is a great need for accurate and reliable diagnostic devices that are easy to use and have a rapid response, to enable operations frequent testing.
Constant and high incidence of COVID-19 cases worldwide, there is a great need for accurate and reliable diagnostic devices that are easy to use and have a rapid response, which has been developed to facilitate the diagnosis and traceability of the newly infected people: antigen testing.
How does the test work?
- Collect the nasal sample with the swab provided. Roll it gently into both nostrils and pull it out. Alternatively, collect the nasopharyngeal sample by inserting the swab into the nasal cavity and holding it parallel to the palate. Gently rub and roll it up and take it out;
- Insert the swab into the extraction buffer and swirl it for about 10 seconds. Remove the swab while squeezing the sides of the test tube to extract as much liquid as possible;
- Apply 3 drops of the extracted sample to the sample well. Wait 15 minutes and read the results. After 20 minutes, the results are no longer reliable.
Interpretation of results
Positive result: two colored lines appear, one in the control line region (C) and one in the test line region (T). This result means that the test has identified the presence of SARS-CoV-2 antigens.
Negative result: one colored line appears in the Control region (C) and none in the test region (T).
Invalid result: the control line does not appear. An insufficient amount of diluent or an incorrect procedure is the most likely reasons for the absence of the control line. If the problem persists, contact your local dealer.
The rapid COVID-19 antigen test will only indicate the presence of SARS-CoV-2 antigens in the sample and should not be used as the sole criterion for the diagnosis of SARS-CoV-2 infections. Results obtained from this test should be considered in evaluations resulting from other laboratory tests.
