CareStart™ Covid-19 Rapid Antigen Test: What it is and how it works

As the SARS COVID-19 virus has swept throughout the world it has exposed a number of weaknesses in our global healthcare settings. The medical community was not prepared for a virus that was not only incredibly virulent, but also fast-spreading. One of the most critical actions that has been required has been the ability to have widespread testing with faster results. CareStart™ has created a COVID-19 Rapid Antigen Test designed for qualified medical professionals that can provide results in ten minutes for symptomatic patients as part of their point of care services. To assist in reducing transmission during a pandemic, fast infection testing results is a requirement. Released by the FDA as part of the EUA (Emergency Use Authorizations), the CareStart COVID-19 Rapid Antigen Test is a convenient way to get testing results quickly and efficiently.

The goal of any testing procedure in a pandemic is to recognize potential infection quickly as a major step in stopping the spread of the virus and institute treatment procedures.

Why Rapid Tests?

In the initial stages of COVID-19 testing processes, healthcare professionals were required to give a symptomatic patient a referral for testing approval at a local COVID-19 testing facility. The test appointment could take days with lab supplied results taking as long as a week. Any patient that was infected with COVID-19 could continue to transmit the virus. As the process became more streamlined, patients could set up their own same-day appointments with lab results in as few as 2-5 days. Convenience and accessibility was more common in urban settings but were far from easy for those that lived in smaller towns and in rural locations. This is completely unacceptable in a pandemic condition and contributed to the methods of infection and transmission.

An additional loophole in the beginning was that testing was required in the first seven days of symptoms and since the entire process could take longer than seven days, many patients infected with COVID-19 had progressed to more severe symptoms and were required to be hospitalized. Without quick and efficient testing and results, COVID-19 infection became a domino effect that has caused hundreds of thousands of deaths and millions with the virus.

While some countries in the world had adopted wearing masks when they had the flu or a cold, not all countries accepted this as a personal responsibility. The problematic adoption and practice of wearing a medical mask and social distancing has led to massive COVID-19 transmission situations, which compounded the requirement for the development of COVID rapid testing.

CareStart™ COVID-19 Rapid Antigen Test Qualifications

Medical professionals are reassured by the Access Bio, Inc. CareStart COVID-19 Antigen Test that has been approved by the FDA for emergency use. This is a lateral flow immunochromagraphic assay test created to detect extracted SARS-CoV-2 nucleocapsid protein antigens via nasopharyngeal swab specimens from individuals that are symptomatic and whose healthcare providers suspect they may have COVID-19.

In February, 2020, the Secretary of Health and Human Services (HHS) made a declaration that “circumstances justified the authorization of emergency use” for tests that test and diagnose COVID-19. Under this declaration, the tests, drugs, and devices designed as medical countermeasures could be used to study and meet the needs of the public during these emergency conditions. EUAs (Emergency Use Authorizations) empowered public health experts to enhance the response to public health threats with medical countermeasures that are FDA (Food and Drug Administration) regulated during these emergency conditions.

CareStart™ COVID-19 Rapid Antigen Test: Healthcare Professionals Only

There is a requirement for a planned and coordinated strategy to take control of COVID-19 so that transmission is reduced. CareStart™ COVID-19 Rapid Antigen Test brings the process to the individual patient at point of care. Only qualified and approved members of the medical profession and those operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation will have access to the COVID-19 Rapid Antigen Tests. The testing doesn’t require any additional instruments or lab equipment and can be done within a medical environment so that testing results occur in a period of ten minutes.

Explanation of the Various COVID-19 Tests

The scientific community has learned a lot during the spread of COVID-19 and this knowledge has launched a few different types of tests for the purpose of COVID-19 diagnosis. Antigen tests are designed to detect the virus proteins, molecular tests (aka PCR tests or diagnostic tests) can detect the virus’ genetic material. While PCR tests are more sensitive, a negative result doesn’t rule out infection and may require additional PCR testing.

CareStart™ Q&A for Medical Professionals and Patients

No other global pandemic in history had the kind of misinformation and disinformation influence as COVID-19. As scientists tried to adjust to new and updated data, the internet poured incorrect advice that added to the chaos and pain already being experienced. There has been a critical and distinct need for clarity so that both patients and members of the medical community could address this virus head-on.

CareStart™ has been on the forefront in understanding the kind of questions and concerns for COVID-19 rapid testing. Moving forward and overcoming this virus includes tackling some of the hard questions and answering truthfully.

For Healthcare Providers, CareStart™ has created a fact sheet to inform of the significant known and potential risks and benefits of the emergency use of the CareStart™ COVID-19 Antigen test that requires a nasal swab.

For patients, CareStart has designed a fact sheet that contains information that medical providers can supply to patients to help understand the risks and benefits of using the COVID-19 Antigen test for the diagnosis of COVID-19 using a simple nasal swab.