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What is the sensitivity and specificity of the COVID-19 Antigen Rapid Test Kit?

Time:2021-07-12 16:22

It is well known that the methods used to diagnose COVID-19 at this stage are nucleic acid assays and IgG / IgE antibody assays. The establishment of rapid and accurate specific assays is important to control the outbreak, and antigen and antibody detection reagents have the potential to achieve high throughput screening of the virus. Then the next one to share is antigen detection.
Antigen detection, on the other hand, can be done by testing various types of samples to look for protein molecules on the surface of the virus. This method allows for faster results and also allows for initial rapid screening of COVID-19 in various types of samples.
1. The detection process of COVID-19 antigen detection kit
2. Operation of COVID-19 antigen test kit
The Abbexa COVID-19 Antigen Assay Kit operates as a qualitative lateral flow immunochromatographic assay for the detection of SARS-CoV-2 antigen in human pharynx, nasal and nasopharyngeal swabs.
The kit contains a monoclonal antibody against SARS-CoV-2 / COVID-19, which is coupled to gold-labeled nanoparticles that capture any SARS-CoV-2 antigen present in the sample. a SARS-CoV-2 specific monoclonal antibody (detection antibody) is coated in the detection region on a nitrocellulose membrane, which binds to the previously formed antigen-antibody The antibody binds to the previously formed antigen-antibody complex and forms a colored detection line due to the gold nanoparticles, and the quality control area at the top of the dark box confirms the success of the test.
3. How long does it take to get the results?
Within 10 minutes.
4. How do I interpret the results?
The reading should show 1 line of color in the C area (quality control area), a purple line next to the T area (test area) indicates a positive result, and a faint line is also considered a positive result.
1. Positive C and T areas: the user is infected or reinfected with coronavirus.
2. Positive C zone and negative T zone: the user is not infected with coronavirus or has been recently infected and does not provide sufficient antigen.
3. C-zone negative, T-zone positive or negative: the test is invalid, please retest with a new cassette.
If the test result is negative.
1. The virus may not have been encountered or may have been encountered recently and there is not yet enough antigen to be detected by the rapid test kit.
If needed, a nucleic acid test can be performed to assist in confirming infection with the virus.
COVID-19 antigen test kit details
5. Specificity and sensitivity
Sensitivity and specificity of COVID-19 Antigen Rapid Test Kit: 31 swabs were selected from those positive for SARS-CoV-2 infection by RT-PCR and 127 swabs were selected from those negative for SARS-CoV-2 infection and tested with COVID-19 Antigen Rapid Test Kit (abx294181). abx294181 showed 28 positive results out of 31 positive PCR samples and 126 negative results out of 127 negative PCR samples.
Sensitivity: 28/31=90.32%
Specificity: 126/127=99.21%
Cross-reaction assay.
The kit has been validated to be non-cross-reactive with the following pathogens.