FDA EUA Approved Rapid COVID-19 Antigen Tests

FDA EUA approved Rapid COVID-19 antigen Test

Since the first outbreak of the Coronavirus Disease 2019 (COVID-19), the need for an efficient testing strategy was required. The demand for reagents and materials required to facilitate molecular tests created an interest in affordable and less time-consuming testing alternatives.  To effectively end the spread of the virus, systematic screening using the rapid COVID-19 antigen test was introduced.

For a very long time, testing for COVID-19 in individuals was done in CLIA (Clinical Laboratory Improvement Amendment) laboratories. Samples for molecular tests had to be transported to the lab, from where more time was required to load them into the analyzer for the results to be obtained. The introduction of the rapid COVID-19 antigen test made testing more affordable, available, and fast.

Antigen tests that fall under the US Food and Drug Administration’s Emergency Use Authorization are the most popular in the world due to the agency’s strict standards when it comes to medical devices. Different from Coronavirus molecular (RT-PCR) tests, which detect the virus’s genetic material, COVID-19 antigen tests that detect specific protein on the surface of SARS-CoV-2.

After the introduction of diagnostic tests for COVID-19 antibodies, scientists and developers went ahead and started building rapid diagnostic tests for the detection of SARS-CoV-2 antigens. Medical device developers yielded to the demand for a rapid test that does not need the use of an analyzer. These testing cards have a similar design to that of a pregnancy test.

Rapid COVID-19 antigen tests are important additions to the number of diagnostic tests that can provide results in minutes. People can now know whether they have the virus or not without waiting for days or sometimes weeks. Healthcare providers and patients can now fight the pandemic together in almost real-time.

The best thing about using rapid COVID-19 tests is the testing time, in less than 15 minutes your test results will be ready for interpretation.  These immunochromatographic assays use lateral flow technology when diagnosing COVID-19 or active coronavirus infection. The design of a rapid antigen test makes it simple and efficient in detecting the presence of the SARS-CoV-2 virus. 

The process of using a rapid COVID-19 antigen test requires the collection of mucus samples from the nose or throat. They are then placed on the testing card and a reagent is added. The specimen on the swabs can be used directly from the patient or it can come from a collected nasopharyngeal swab stored inside a BD universal transport media.

Rapid COVID-19 antigen tests are designed for use in point-of-care or patient care settings such as emergency rooms, schools, or the doctor’s office. The FDA has authorized the use of this Point of Care (POC) antigen test in patients suspected of having contacted SARS-CoV-2. According to FDA and antigen test manufacturers, these special kits are ideal for use within five days to one week of symptom onset.

According to the FDA, the rapid COVID-19 antigen test is categorized as an in vitro diagnostic test, and it should only be used under the Emergency Use Authorization (EUA).  Most of these testing kits are only available by prescription.  Under the EUA, these tests and critical medical devices can be accessed during an emergency or when there are no adequate, approved, and available testing options.

Rapid COVID-19 antigen tests are used for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in individuals suspected of coronavirus.  During the acute phase of the infection, positive results indicate the presence of viral antigens.  Positive results obtained from rapid COVID-19 antigen kits are usually highly accurate. The tests can be very specific but not as sensitive as molecular tests.

When the COVID-19 antigen test results are negative, you will need the patient’s history, clinical observations, or epidemiological information to confirm this type of status.  Since negative results are presumptive, so a confirmation test through molecular assay is crucial.  If the patient shows symptoms of COVID-19 but the antigen test shows a negative result, then a molecular test is required.

You need to be proficient in performing COVID-19 tests in point of care settings for you to use a POC rapid antigen test.  We are talking about medical professionals, clinical laboratory personnel, and trained operators.  Individuals who think that they have coronavirus disease 2019 (COVID-19) and need to get a test to verify are advised to contact their health care providers as soon as possible.

If you are looking to make large orders of Rapid COVID-19 antigen test kits online, approved by the FDA under EUA, then you can do that right now from Rapid Connect Medical. We can supply quantities as large as 10,000,000 kits or more. Please contact our sales team for more information on how to make large and cost-effective orders from Rapid Connect Medical.

We have access to reliable test kits that can be sent to countries around the world. Our test kits are high in sensitivity and specificity. All of our products carry the FDA EUA Authorization and are backed by the research of the CDC, WHO, and university scientific studies. Our products are based on findings and guidance that helps protect the public and help the person using it know their status of infection or not.

By knowing the probability of spreading the virus and knowing infectious diagnostics can help end the global spread of Covid-19. By helping identify infected individuals, the proper response can be initiated and performed by medical professionals. These antigen tests are easy to administer with a nasal or throat saliva sample from the persons being tested. False positive report rates are confirmed low.

his test also is easy to collect samples and doesn’t require testing tools or complex certified lab facilities to diagnose the outcomes. You can help keep outbreaks in your organizations, school or country to a minimum. We offer fast shipping methods for our antibody test kits at an affordable rate. You can order test kits online at https://rapidconnectmedical.com/

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Stop the Spread – Test Yourself Now

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