SARS-CoV-2, the virus responsible for the COVID-19 pandemic has spread at an alarming rate since the first cases were identified in late 2019 in Wuhan, China. The virus can be transmitted from person-to-person in respiratory secretions from symptomatic or asymptomatic individuals. Since the virus was new to the human population and death rates are 10 to 50-fold higher than other respiratory viruses, the pandemic has placed excessive demands on the global healthcare network. Because no vaccines or effective antiviral therapies exist for SARS-CoV-2, efforts to combat this pandemic have been challenging.
Polymerase chain reaction (PCR) tests that detect active SARS-CoV-2 infection are playing an important role in tracking disease spread, while serological tests that detect antibodies against SARS-CoV-2 are now being used to measure past rates of infection and identify individuals that could be immune to COVID-19. However, not all antibodies are created equal and tests that specifically measure antibodies that neutralize SARS-CoV-2 have not been generally available to healthcare providers or patients.
SARS-CoV-2 neutralizing antibodies block binding and entry of the virus into host cells. It is desirable to have high levels of neutralizing antibodies in convalescent plasma used to treat patients fighting COVID-19 so that those antibodies can block the virus from further infecting the host. However, despite convalescing from the disease, not all individuals make high levels of neutralizing antibodies. Therefore, there is a clinical need to measure levels of neutralizing antibodies in COVID-19 convalescent plasma.
In response to these needs, AXIM Biotech has developed a rapid (10-minute) serological diagnostic test that measures SARS-CoV-2 neutralizing antibodies (Nabs). Specifically, it is envisioned that the test may be used for:
1) Measurement of neutralizing antibodies in individuals who have recovered from COVID-19 and/or received a vaccine and to provide an “Immunity Passport” so that they can go back to work and school or participate in social gatherings without risk of infecting others. . The primary goal of any vaccine is to induce neutralizing antibody responses that protect vaccine recipients from infection and subsequent disease. As COVID-19 vaccines begin rolling out to the general public, immunity monitoring is starting to play a critical role in determining whether the vaccine is effective, for how long, and when it is time to get a booster shot. Since vaccines protect each individual for varying amounts of time, immunity monitoring could continue for many years even after widespread vaccination throughout the world. Additionally, measuring neutralizing antibodies in people after vaccination may give a better look at how vaccine responses hold up over time. That way, when levels of neutralizing antibodies eventually dip, researchers will have a sense of when they’re unacceptably low and a revaccination is needed.
2) Screening plasma collected from individuals recovered from COVID-19 so that patients fighting COVID-19 can be treated with plasma containing high levels of Nabs. Additionally, Nabs need to be monitored in patients receiving convalescent plasma so that we learn what is an effective therapeutic dose.
AXIM’s test is different from neutralizing antibody tests currently available because:
- It is specifically testing for neutralizing antibodies, which are those needed to fight COVID-19 within the body
- It can quantitatively measure the amount of neutralizing antibodies a person has
- Patients get their results in just a few minutes
Currently, ImmunoPass is undergoing human clinical trials. In preclinical research, ImmunoPass has already been proven to work with 97.8% accurately in plasma and serum and works on all strains of COVID, so newly-discovered strains will not affect its efficacy. ImmunoPass has shown a significantly better statistical correlation with SARS-CoV-2 neutralization assays than the currently available antibody tests. Since ImmunoPass agrees well with live virus-based assays, it could serve as an effective low-cost alternative to lab-based assays for monitoring large numbers of vaccine recipients for neutralizing antibodies.
PAIRING DIAGNOSTIC EXPERTISE TO
AXIM’s subsidiary Sapphire Biotech is a pioneer in the research and development of diagnostic tools for the early screening of cancer, our researchers have been able to quickly adapt our existing research and products currently under development to create a diagnostic tool that screens for COVID-19 neutralizing antibodies. The need for such an instrument is great as the pandemic continues to plague the worldwide healthcare landscape.
Axim Biotech’s rapid diagnostic test can measure rising and falling levels of neutralizing Antibodies (Nabs) longitudinally. If neutralizing antibodies fall over time and the virus is still circulating (like influenza), individuals might be advised to receive a booster immunization that will re-elevate protective neutralizing antibodies. The company will seek FDA emergency use approval of the device in order to meet the unprecedented demand.
We envision at least two primary uses of this patent pending test. First is the measurement of neutralizing antibodies in Convalescent Plasma (CP) so that patients fighting COVID19 can be treated with CP containing high levels of neutralizing antibodies. Secondly, we envision that vaccine companies will use the test to determine if their vaccine formulation elicits strong neutralizing antibodies and what is the duration and levels of those neutralizing antibodies.
First-Ever Face Mask That Captures and Deactivates SARS-CoV-2 (COVID-19)
As we work together to slow the spread of COVID-19, face masks have become an everyday item. However, most commercially available masks are unable to efficiently filter the tiny aerosols that contain the SARS-CoV-2 virus and, when moist, can actually increase the risk of infection.
Identifying this as a major issue, AXIM developed the first face mask that captures and deactivates SARS-CoV-2, the coronavirus responsible for the ongoing COVID-19 pandemic. AXIM’s novel face mask is designed to provide enhanced protection from infection by capturing the viruses in the face mask filter layer before it reaches or after it exits the user’s respiratory system.
For more information on AXIM’s first-of-its-kind face mask, click below: