COVID-19 Antigen Rapid Test

Published on 06/11/2020

Find out how the test works.

COVID-19 Antigen Rapid Test

COVID-19 Antigen Rapid Test is a rapid device for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal and nasal. For professional in-vitro use only.

Are you interested in buying our COVID-19 Antigen Rapid Test kit? Please write to info@primahometest.com for further information.

Principle of the Test

COVID-19 Antigen Rapid Test is a rapid membrane-based lateral flow immunoassay for the qualitative detection of SARS-CoV-2 antigens in human nasopharyngeal and nasal swab specimens. During the test, any SARS-CoV-2 antigens contained in the sample react with the antibody-coated nanoparticles contained in the reactive test strip. As a result, the blend migrates chromatographically by capillary action along the reactive strip.
If the specimen contains SARS-CoV-2 antigens, these will bind to SARS-CoV-2 antibodies contained in the (T) Test line region and generate a colored line on the test strip, indicating a positive result. If the antigens are not present in the specimen, no colored line will appear in the (T) Test line region, indicating a negative result. As a procedural control, a colored line will always appear in the (C) Control line region, indicating the test procedure has been performed properly and that test components have worked as intended.

COVID-19 Antigen Rapid Test is addressed to healthcare professionals with the aim to support them in COVID-19 emergency management, by receiving prompt results on the health status of their patients:
- high Sensitivity and Specificity standards, when compared to a PCR Methodology;
- safe and accurate results in only 15 minutes;
- easy to use and to read.

Why using a COVID-19 antigen test?

The use of a COVID-19 Antigen Rapid Test allows to detect the presence of SARS-CoV-2 antigens in our body and to take initial precautionary 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 constant high incidence of COVID-19 cases worldwide, there is a high need for accurate and reliable diagnostic devices that are easy to use and have a prompt response, in order to enable frequent testing operations. Constant high incidence of COVID-19 cases worldwide, there is a high need for accurate and reliable diagnostic devices that are easy to use and have a rapid response, have been developed, in order to facilitate the diagnosis and traceability of newly infected people: the antigen tests.
Since the transmission of the SARS-CoV-2 virus seems to occur days after exposure, when the viral load reaches its peak, the frequency of testing is increasingly important in order to slow down the spread of the pandemic, as shown in Figure 1.

Figure 1

The criteria expressed in Figure 1 could be defined as a surveillance method, intended to reduce the number of people affected by SARS-CoV-2 and give rapid results, in order to minimize the asymptomatic spread. This surveillance approach cannot be performed using the standard PCR technique because, after collection, PCR samples usually require transport to specialised laboratories run by experts, this in turn requires one or more days for the results, creates a bottleneck and is expensive.

How does the Test work?

View the video Tutorial and follow the procedure:

A) Collect the nasal sample using the provided swab. Gently roll it into both nostrils and take it out. Alternatively, collect the nasopharyngeal sample by inserting the swab in the nasal cavity and holding it parallel to the palate. Gently rub and roll it and take it out;
B) Insert the swab into the extraction buffer and rotate it for about 10 seconds. Remove the swab while squeezing the sides of the test tube in order to extract as much liquid as possible;
C) Apply 3 drops of the extracted specimen into the sample well. Wait 15 minutes and read the results. After 20 minutes the results are no longer reliable.

Results interpretation

Positive Result: Two coloured lines appear, one in the Control line region (C) and another in the Test line region (T). This result means that the test has identified the presence of SARS-CoV-2 antigens.

Negative Result: A coloured line appears in the Control (C) region and none in the Test (T) region.

Invalid Result: The Control line does not appear. An insufficient quantity of diluent or an incorrect procedure are the most likely reasons for the absence of the Control line. If the problem persists contact your local distributor.

COVID-19 Antigen Rapid Test will only indicate the presence of SARS-CoV-2 antigens in the specimen and should not be used as the sole criterion for the diagnosis of SARS-CoV-2 infections. The results obtained with this test should be considered on the evaluations resulting from other laboratory tests.

Bibliography

1. European Centre for Disease Prevention and Control, Disease background of COVID-19 (https://www.ecdc.europa.eu/en/2019-ncov-background-disease)

2. WHO Director-General’s opening remarks at the media briefing on COVID-19 - 11 March 2020 (https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020)

3. Centers for Disease Control and Prevention, Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html)

4. Mina M.J., Parker R., Larremore D. B., “Rethinking Covid-19 Test Sensitivity — A Strategy for Containment”, NEJM, 2020, doi: 10.1056/NEJMp2025631 https://www.nejm.org/doi/full/10.1056/NEJMp2025631

5. https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-point-of-care-immunodiagnostictests-for-covid-19

6. European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020. https://www.ecdc.europa.eu/en/covid-19/latest-evidence/diagnostic-testing. Accessed July 2020