Rapid Test for the Quick Detection of SARS-CoV-2 Antigen

Affidea collaborates with the most reliable manufacturers in the US and Europe, offering an in vitro diagnostic rapid test for the qualitative detection of the SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab samples from individuals who meet the clinical and/or epidemiological criteria for COVID-19. These manufacturers are FDA (EUA) approved, have CE-IVD certification, and have received emergency use authorization (EUA) from the World Health Organization (WHO).

The rapid test reliably and quickly tests individuals suspected of having SARS-CoV-2, with results ready in 15-20 minutes, enabling informed treatment decisions. The test is conducted by taking a nasopharyngeal swab under conditions of complete safety in specially designed areas. The antigen test accurately checks individuals with known exposure to infected patients with SARS-CoV-2, providing quick answers about the infection status.

It should be conducted within the first 7 days from the onset of symptoms, as the sensitivity of the method decreases after the 7th day. In case of a negative result and worsening of the patient’s symptoms, confirmation with a PCR genome detection test is recommended.

With consistency and responsibility in the effort to limit the spread of the SARS-CoV-2 coronavirus and protect public health, we have taken emergency measures to operate our Diagnostic Centers to better serve examinees at Affidea Diagnostic Centers. For this reason, we are adjusting the operating hours of our Diagnostic Centers regarding the conduct of preventive diagnostic tests against Covid-19 (SARS-CoV-2 detection test using the Real Time PCR method and rapid antigen detection test – Rapid Test).

Based on clinical studies, the SARS-CoV-2 antigen (Ag) test has a sensitivity of 93.3% (95% CI: 83.8-98.2%) and a specificity of 99.4% (95% CI: 97.0-100%). Clinical samples were determined as positive or negative using an RT-PCR reference method, which is the reference method. Samples included in the study had a presumed exposure to COVID-19 or had presented symptoms between the 1st and 7th day.

Generally, antigen tests have high specificity, although they are not as sensitive as molecular tests that amplify viral DNA or RNA sequences to show the presence of the virus in a sample. Therefore, to compensate for the potential decrease in the sensitivity of an antigen test, negative results should be analyzed alongside additional patient factors, such as COVID-19 exposure history, clinical symptoms, and additional test results, to help guide the patient’s diagnosis and subsequent treatment.

In any case, you should have immediate communication with your attending physician.