Available now, the Covid-19 BioCard™ is an ultra-rapid antibody screen or confirmatory IVD, for healthcare professionals.
The development path
Bio-Diagnostics patented BioCard™ was developed in direct response to the COVID-19 pandemic, with research beginning in February 2020 in our ISO accredited laboratories in the UK.
The BioCard™ utilises the company’s 40 years’ experience in antibody testing and its extensive in vitro diagnosis expertise. Physical adaptations from the established QuickCard technology, combined with specific changes to the biochemistry of the device, have resulted in a robust, accurate and ultra-rapid IgG antibody test indicative of a COVID-19 specific immune response.
Throughout development, the BioCard™ utilised finger prick and venous bloods, and is CE marked and immediately available for delivery throughout Europe and the USA.
In validation, the 3rd generation of the device is capable of providing more accurate results than many other professional laboratory analysers.
The CE marked home bleed kit has been specifically developed for the COVID-19 BioCard™ and is validated for use with the BioCard™ alone.
The combination of the blood drawing kit and a highly accurate test for SARS-COV-2 spike specific antibodies is a powerful combination that can provide rapid results anywhere, including all those Countries and States in which lateral flow devices do not meet with the approval of governing bodies, but the benefits of a POC IVD remain highly desirable.
What is the COVID-19 BioCard?
The Covid-19 BioCard™ is an IgG antibody detection IVD for the specific detection of circulating IgG antibodies to the spike protein of the SARS-CoV-2 virus. The presence of specific IgG to this portion of the SARS-CoV-2 virus is a marker ideally used as a tool to assist in identifying past SARS-CoV-2 infection given it is unique to the SARS-CoV-2 virus.
How accurate is the COVID-19 BioCard™?
Results are more accurate than many laboratory systems and Lateral flow devices. From approximately 250 samples in validation, the BioCard™ attained 99.4% specificity and 100% sensitivity from the latest 3rd generation of the COVID-19 antibody BioCard™.
Able to utilise significantly more blood sample than many other traditional POC devices, enables the device to detect more borderline positive patients, that otherwise may be considered “undetectable” by some laboratory systems and many POC devices.
Children and adults identified by the BioCard™ as having detectable antibodies in March 2020 have continued to maintain their antibodies when retested 4 months later… and counting.
Why establishing evidence of IgG presence is important…
IgG is a convenient longer-term marker bourn from immune cells and is involved in the immune systems’ wider cellular response. Detecting IgG prior to its levels waning is an effective method to demonstrate past natural exposure, and allows a record to be made should it become undetectable.
As early forms of antibodies emerge from immune cells, levels of live virus inversely begin to fall. For COVID-19, insufficient time has passed to prove the inverse relationship is directly linked, without the assumption that the immune system behaves in the same way that it does for the majority of other viruses.
Once patterns of the disease have existed long enough to enable long term study and associated patterns of potential immunity, the presence of IgG may also confirm a wider cellular immune response has taken place, without necessarily directly testing for it.
If IgG does fall away completely in time, attaining a record of its existence prior to it dropping to undetectable levels, enables evidence of an otherwise lost clinical history, and insight of who may prove to have immunity (full or partial), and enable such patients to assume the conclusions of such research.
A positive result on the COVID-19 BioCard™, (but not necessarily other devices using more generic proteins), demonstrates the presence of a specific Ag for COVID-19, almost certainly inferring past infection of SARS-COV-2 has previously occurred.
The reaction seen directly in the test window of the BioCard™ utilises the same mechanism of coupling of an antibody binding to a virus when in-vivo. As part of a wider immune response, this action enables the virus to be “tagged” for cellular neutralisation within the body and directly counteracts the action of a virus. The same binding action in vitro demonstrates the same effect, and thereby strongly suggests resistance exists for a particular infection by the action of specific antibodies present in samples found to be positive. This is the definition of Immunity.
Limitless results in minutes for Healthcare professionals
The sera version of the BioCard™ is intended to be used by competently trained healthcare professionals, ideally utilising venous bleed where possible.
However, the BioCard™ was also specifically validated to also included the use of finger-prick blood draws, for which a specific CE marked home bleed kit now exists for use exclusively with the COVID-19 BioCard™ for limitless testing locations.
As no analysers are required, tests can be performed in clinics, pharmacies, pop-up labs, drive-throughs and other appropriate locations when overseen by healthcare professionals.
Without the need for any processor, specialist equipment or associated wider costs, individual results are available within as little as 3 minutes. Multiple devices can be run concurrently enabling thousands of results to be attained per hour by a small team.
Where large laboratories suffer bottlenecks or require a backup to automation failures, results can be attained on a par with laboratory processors.
Test the world in 5 minutes
The Covid-19 BioCard™ provides a mass screening method with professional quality laboratory results, to differentiate those with Covid-19 specific IgG antibodies from those without. Where best practice is in use, equivocal results are found, or a confirmatory method is required, the Covid-19 BioCard™ is a perfect alternative method to any other.
The technology is continuing to be adapted in parallel to ensure it remains an effective device to combat the global pandemic effectively, should Covid-19 mutate, and existing methods become obsolete.
Test the world in 5 minutes, potentially for anything…
As the BioCard™ can be readily adapted for the testing of virtually any disease.
Creative applications and intelligent usage of results will help societies and economies recover from the consequences of the pandemic.
Used responsibly, in combination with other clinical data wherever possible, the BioCard™ is a highly effective tool, with limitless applications, which can be used at national and international levels, in any setting.
For further information on the Covid-19 BioCard™ please contact us.