COVID-19 DIAGNOSTICS

OVERVIEW

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, Sapphire 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) 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.

2) Vaccine efficacy. The primary goal of any vaccine is to induce neutralizing antibody responses that protect vaccine recipients from infection and subsequent disease.

3) Measurement of neutralizing antibodies in individuals who have recovered from COVID-19 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.

BACKGROUND

PAIRING DIAGNOSTIC EXPERTISE TO
IMMEDIATE NEED

As 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.

Sapphire’s SOLUTION

RAPID TEST

Sapphire 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.

 

APPLICATIONS

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.