BBL is a medical solutions company which utilises its considerable know-how and network of professional connections to assist young companies in commercialising their products and achieving the distribution network they require for their products to be available to the medical field and public. BBL only partners with very select companies and usually operates behind the scenes to support the development and long-lasting viability of these companies. In this unprecedented scenario, however, BBL has decided to become more prominent in the dissemination of information and marketing of the product which its client Pharmact produces. BBL only partners with companies that run ethical business policy and are dedicated to consistently providing products of the highest quality.
The coronavirus (SARS-CoV-2) pandemic of severe acute respiratory syndrome (Corona Virus Disease 2019 = COVID-19) is without doubt one of the greatest challenges to the medical well-being of the planet as well as the socio-economic viability of our societies. The rapid spread of this virus, with the ensuing impact on the population’s health, has been unprecedented and, in its wake, is causing utmost socio-economic upheaval.
In the fight against this pandemic, the detection of the virus and especially the assessment of individuals affected by the virus, whether they have active disease or have come through the infection, is of utmost importance especially when allowing individuals back to work or to regain their normal social activity. BBL has entered into a partnership with Berlin based pharmaceutical company Pharmact, which has developed a high quality rapid SARS-CoV-2 IgM/IgG antibodies detection test, to help develop a global distribution network and scale the production line. At this time, the incredible team of dedicated individuals of Pharmact and BBL are devoting their entire capacity to scaling production and developing a distribution fleet for these much-needed products around the world.
Pharmact is a highly specialised company which, through the exceptional know-how of its medical scientists, has already developed several, very novel, early detection tests for diabetes, myocardial infarction and liver failure. With the development of the COVID-19 pandemic, Pharmact applied its competence and experience in this field to the development of a highly specific antibody test utilising own in-house technology. The CoV-2 Rapid Test is highly specific and reliable. It is manufactured in a way that a detection of antibodies against other viruses is very unlikely so that the test results can be strongly relied upon that an individual has had an infection with the coronavirus. Pharmact has furthermore developed a reading device which enables even the faintest positive traces to be clearly identified, hereby again increasing the accuracy of the test and making the test more widely available to Allied Healthcare professionals conducting these. The specifics of these infections and the way these tests work is outlined in the paragraph below:
An outline of the bodies reaction to a viral infection and how the currently available tests work and what the differences are.
When a virus causes an infection of the body, the presence of the virus is detected by the defence cells in the blood (the so-called white blood cells). These cells are responsible for detecting and eliminating so-called pathogens (bacteria or viruses which infect and damage the body). The body uses proteins called antibodies which the defence cells make to detect the viruses or bacteria. These antibodies have specific shapes which can attach to the surface of a virus and hereby guide the defence cells to these viruses in order to destroy these. These antibodies have an active side which varies according to the different type of virus or substrate they are adhering to and a consistent side which, for practical purposes, is always the same. Much the way an arrow can have different arrowheads, but the shaft and feathers will always be the same. There are different types of these antibodies; a very general type called IgM has an adherence surface which can attach to multiple different types of viruses. This is usually the first type of protein which is active in the defence against a virus, but it is not specific to a type of virus. This protein is found early on in an infection.
Once the body has recognised the specific type of virus through its definitive surface structure, the body then manufactures specific targeted antibodies against exactly this type of virus. These antibodies are called IgG; these turn up later during the infection and indicates that the body has mounted a defence exactly against this type of virus. As there are a very large number of different viruses, being immune against one virus does not mean that one is immune against another virus. This is the underlying principal of vaccination, to expose the body to “dead fragments of a virus” so that it can mount a specific defence with production of the IgG antibodies so that the body is ready to target these viruses if the same virus were to cause an infection again.
The detection of these antibodies is at the core of the rapid coronavirus detection test CoV-2 Rapid Test. Once the infection takes hold, an increase in the IgM antibody levels is usually detected after a few days. After approximately a week, IgG antibody levels become apparent which have been specifically made to target the virus. Once the virus has been defeated, the IgM antibody levels reduce but the IgG antibody levels remain detectable, indicating that an infection has taken place but that, with all likelihood, there is no further active virus present and that the individual may actually be now resistant (immune) to this virus. We do not have scientific evidence as yet that the presence of IgG antibodies in COVID-19 creates immunity against this virus but, from what we know from other infections, this does seem likely. In either case, it would indicate that an individual who only has IgG levels, but no further IgM levels should be safe to re-join society and work without risk of infection of others and in all likelihood, without risk of redeveloping an infection themselves.
CoV-2 Rapid Test detects the presence of these antibodies. Blood from a small prick to the finger is placed on special surfaces (matching the surface of the virus). If antibodies to the virus are present they adhere to this surface. The test contains antibodies used to detect the patient’s antibodies – using the comparison of the arrow, these antibodies detect the inactive side (shaft of the arrow) of the patients antibodies which is embedded in the target (virus). This creates a positive colour signal which indicates the presence of the antibodies. It therefore follows that the most specific tests are those where the surfaces in the test match the most specific areas of the virus – specifically, the most accurate tests are directed against highly specialised areas of the so called spike protein which allows the SARS-CoV2 virus to latch onto human cells. Less specific tests will include regions which are more common to a variety of viruses. When selecting tests, it is therefore very important to assess how specific these tests are as less specific tests could be detecting cross reactions to other previous viral infections and hereby create false positive results leading to the assumption that an infection with SARS-CoV2 had occurred and been survived whereby the results have actually been produced through cross-reaction from an infection to other viruses. The most reliable tests on the market analyse this through testing for false positive results. This leads to a higher demand on the laboratory in the production of these types of tests along with the stringent quality controls.
The nature of immunoassay tests like CoV2-Rapid Test, is that it cannot prove an infection in the very early stages before antibodies against the virus have been produced. In these stages, the best way of proving the presence of a virus is through the direct proof of presence through the so-called PCR test (polymerase chain reaction test). This is the test which is commonly employed through swabs of the throat and detects the actual virus surfaces. These are highly specific and sensitive; however, it usually takes several hours to conduct and requires central laboratories whereas the antibody test can be conducted simply using the test kit in almost any situation with results being delivered in 20 minutes. The PCR test also has restricted value in the late phase of the infection as it may still be positive through the presence of virus fragments whereby these fragments do not any longer consist of a live virus. In an ideal setting, both tests are synergistic and available, and clinicians can choose which to employ.
From a practical point of view, the antibody test is especially useful when screening individuals who have been in quarantine to assess whether they have actually been exposed to the virus and whether they are likely to have built up resistance to this; again, at this time, we do not have scientific proof that the presence of IgG conveys immunity to the virus but it would seem likely. Furthermore, the test is very useful in screening persons when they have early signs of infection, especially in individuals who are mildly symptomatic; here, a positive response would indicate early signs of an infection. The test is also going to be very relevant with the resurgence of the flu season as this test should be able to differentiate between an infection with SARS-CoV2 and an infection with the common flu virus. For the health professionals conducting vaccinations against the flu and hopefully, against SARS-CoV2, this will also provide a very useful tool in the decision-making. In the absence of IgM and only IgG being present, it is also highly unlikely that this individual would still be contagious. This is of great importance to the medical field to allow medical staff to return to hospitals, for any business where the presence of workers in the company interacting with other individuals is important and, of course, for any public service staff such as the police force, rescue services and armed forces.
The challenge that we face globally is to provide the very large volume of tests required for this. At this time, no individual company has the capacity to meet the global demand. It is, therefore, very important that all producing manufacturers adhere to the highest standard and maintain this throughout this challenging period. Pharmact and BBL are committed to providing tests of the highest quality and developing a reliable global distribution network. BBL Healthcare Solutions will furthermore donate 10% of profit to related charitable causes.
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