FaStep® Covid-19 Point-of-care Antibody Test: What it is and how it works

The COVID-19 pandemic has made the global scientific community reel with reality of the overwhelming condition of the virus. The fact that viruses have been able to survive throughout the millennia meant that medical professionals had to take drastic steps in understanding and overtaking the spread of transmission.

While COVID-19 fast testing is a first important layer in the battle, it was just as critical to find out who has the virus and those that have survived it. This requires an ability to check for the antibodies that are created by the human body due to infection. The study of antibodies plays a priority role in research, vaccine development, and patient treatment. To address the need for fast and efficient antibody testing, the Assure FaStep® COVID-19 Point-of-care Antibody Test has been developed for use by healthcare professionals in point-of-care settings through whole blood, serum, and plasma.

FaStep® Covid-19 Point-of-care Antibody Test- Defined:

Antibody identification is very complex due to the variations in the body’s response to COVID-19. FaStep® COVID-19 Point-of-care antibody test has been designed as a three-step process to identity the:

  • SARS-CoV-2 IgG antibody that is produced in the later stages of infection and can be a key indicator of prior or recent infection.
  • SARS-Co-V-2 IgM antibody which is an acute phase marker and the body’s first antibody produced by the immune system as a response to an infection.
  • Differentiate by monitoring seroconversion and immunological status of the patient by providing IgG and IgM specific results.

Through use of a single drop of blood, or 5uL of serum or plasma, the results if the FaStep® COVID-19 Point-of-Care antibody test can confirm current or past exposure to COVID-19 and act to provide information that complements molecular studies.

Healthcare Professionals Only – at Point-of-Care

Winning a war against a microscopic virus that has the ability to mutate requires a multifaceted approach and should only be used and monitored by trained scientific experts. A first step strategy can include CareStart™ COVID-19 Rapid Antigen Test to ascertain whether a symptomatic patient has COVID-19 with the addition of FaStep® COVID-19 Point-of-Care antibody test for confirmation of antibodies in determining whether a patient has or had the virus. The use of FaStep® COVID-19 Point-of-care antibody test and CareStart™ COVID-19 Rapid Antigen Test is only for healthcare professionals in a point-of-care environment. 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 CareStart ™COVID-19 Rapid Antigen Tests and FaStep® COVID-19 Point-of-care antibody tests.

CDC Antibody Testing Guidelines for COVID-19

When a virus, bacteria, parasite or fungus invades the body, there is a creation of y-shaped proteins that are specialized to bind to the invader in a kind of “lock-and-key” style. Antibodies are released from the cells and hunt out the invaders and mark them for destruction. This process triggers a series of events that destroy the invader. Antibodies are referred to as part of the “adaptive immune system” which is the area of the immune system that recognizes and eliminates specific pathogens.

Information about COVID-19 has been rapidly changing, and the CDC (Center for Disease Control) has created an “interim guidance” for the ways that healthcare providers, laboratories, and staff within the public health verticals should use antibody tests.

  • Antibodies typically develop within 1-3 weeks after the patient has been infected.
  • A positive antibody result can mean that a some point the patient has been exposed to the COVID-19 virus, however, there are instances of false positives when antibodies are not present. Conversely, if a patient tests negative but has virus antibodies present, it is considered to be a false negative.
  • While rare, it should be noted that there have been reports of confirmed and suspect cases of reinfection of the COVID-19 virus.
  • Antibody testing results should not be used as a point of diagnosis for a patient with an active infection.
  • Individuals that have a positive antibody test but don’t have COVID-19 symptoms and haven’t been exposed to anyone that may have COVID-19 are not likely to have a current infection. However, these people should continue to take safety precautions to protect others as well as themselves.
  • Individuals that have a positive antibody test and are either currently sick or have been recently sick or have been exposed to someone that had COVID-19 should comply with the CDC recommendations on caring for themselves and others as well as the timing regarding when it is safe to be around other people again.

To avoid a high level of errors healthcare organizations should choose antibody tests such as FaStep® COVID-19 Point-of-care antibody tests that have a high level of specificity.

Fast Results is Necessary

The ability for viruses to mutate means that there are now multiple COVID-19 variants around the world. The latest variant first found in the United Kingdom is called B.1.1.7 and spreads faster and more easily. Combating the virus equates to a necessity to have widespread COVID rapid testing on all fronts to give healthcare systems the ability to diagnose and treat patients. As a world community we meet and exceed the speed of transmission with FaStep® COVID-19 Point-of-care antibody tests with:

  • Testing results supplied in 15 minutes
  • A simple 3-step procedure requiring the addition of a patient sample, buffer, and then reading the results after a 15 minute duration.
  • Sample versatility that includes whole blood (one drop), serum (5 uL), and plasma (5 uL).

More Covid-19 Information