Blood donation is a selfless act that not only saves lives but also plays a crucial role in advancing medical research and development and diagnosing patients. In the rapidly evolving field of in-vitro diagnostic (IVD) testing, where accurate, reliable, and timely diagnoses are crucial, the availability of high-quality biospecimens is of utmost importance. Blood, being a highly accessible resource, is an invaluable asset for IVD testing and it is estimated that 118.54 million blood donations are collected worldwide each year. In this blog post, we will explore the importance of blood donation for the IVD industry and highlight the multitude of benefits it offers.

Availability of High-Quality Biospecimens

For diagnostic testing, often the entire blood is not utilized. Instead, it is converted into serum or plasma, which are derived from blood but have distinct compositions and uses in the laboratory setting. Plasma, the liquid component of blood, makes up 55 percent of the total blood volume. It is composed primarily of water, but also contains antibodies, coagulation factors, electrolytes, lipids, and proteins necessary for bodily functions. When blood is collected using an anticoagulant such as EDTA, heparin or citrate, and then centrifuged at high rotations, the blood cells and platelets are separated by centrifugal forces, leaving plasma as the upper layer​. In the case of serum, blood is collected without the use of an anticoagulant and allowed to clot at room temperature for 30 minutes. This clotted blood is then centrifuged, leaving a straw-coloured cell-free liquid above the clot known as serum​​.

Serum or Plasma?

Serum and plasma are often preferred over whole blood in diagnostic testing due to their stability and ease of analysis. It is also possible that red and white blood cells and other components in whole blood can interfere with certain assays. While most of the components are the same for both plasma and serum, plasma contains fibrinogen which is absent in serum therefore making plasma suitable for measuring coagulation factors, additional testing related to blood clotting and for some molecular diagnostic tests, such as PCR, without interference from clotting factors. Serum is generally acceptable for most clinical chemistry assays, but not for all for example, potassium and phosphorus levels may be increased in serum due to release from cells/platelets during the clotting process. Serum would be preferred in cases where fibrinogen interferes with the assay.  Ultimately, the choice between plasma and serum depends on the specific testing needs and limitations, which is why diagnostic manufacturers test matched sets i.e., serum and plasma (containing the different anti-coagulants) from the same donor blood lot, to validate the performance of their assay on multiple matrices.

Screening and Diagnosis

One of the critical areas where blood donation significantly contributes is infectious disease screening. Bloodborne pathogens, including HIV, hepatitis B and C, syphilis, and many others, can be detected through serological tests where detection of the antibodies generated by the donor’s immune system in response to the pathogen is diagnostic of the pathogen having been present. The detected antibodies are usually IgG or IgM, and the amount of each of these present can in some cases provide clues as to when the infection took place. By donating blood, individuals provide a valuable resource for creating diagnostic assays that accurately detect and monitor these infections, aiding in timely treatment and prevention.

Monitoring Disease Progression and Treatment Efficacy

Blood samples obtained from donors at different stages of a disease provide a valuable longitudinal perspective. These samples enable healthcare professionals to monitor disease progression, assess treatment efficacy, and personalize patient care. By comparing blood samples over time, medical experts gain insights into how diseases evolve and respond to specific interventions. This knowledge not only helps refine diagnostic methods but also enhances treatment strategies and improves patient outcomes.

Facilitating Research and Development and Enabling Assay Development

Donated blood samples are invaluable resources for advancing medical research, developing innovative diagnostic techniques and validating IVD assay performance. Researchers depend on these biospecimens to investigate the causes, progression, and treatment of various diseases. Blood donations enable scientists to conduct in-depth studies, explore novel biomarkers, and refine diagnostic technologies. These insights contribute to the development of novel IVD assays, allowing for early detection, accurate diagnosis, and personalized treatment strategies. By donating blood, individuals directly contribute to the improvement and expansion of the IVD assay portfolio, empowering healthcare professionals with effective tools to diagnose and monitor diseases with greater precision.

Enhancing Quality Assurance and Test Validation

In-vitro diagnostic tests undergo rigorous validation and quality control processes to ensure accuracy and reliability. Blood donation specimens are used as standardised reference materials and controls, allowing manufacturers to validate the performance of their assays against known standards and laboratories to ensure the performance of the assay over time. By providing biospecimens, blood donors actively participate in the quality assurance processes that underpin the diagnostic testing industry, leading to consistent and trustworthy diagnostic results.

Logical Biological

At Logical Biological we are thankful for the blood donations that enable us to empower the IVD industry by providing a reliable source of human biospecimens. We specialise in the provision of biospecimens from healthy and disease cohorts that are suitable for IVD assay development, validation and the manufacture of control and calibration material. Our biospecimens are collected ethically with donor consent or IRB, as either single donor units or pooled material. Various methods are used to quantify the titre of the samples and provide traceability and donor/ collection information. Material is screened for viruses, and we can provide various plasma anti-coagulants e.g. EDTA, Li-Heparin and citrate. We have a broad range of disease state markers available, so contact us to see how we can support your projects and simplify the sourcing of biospecimens.

Sexually transmitted infection (STI) cases across the world are an ever present and ever-increasing issue, not only to adults but to a foetus. Two diseases of particular importance are HIV and Syphilis (caused by the bacterium Treponema pallidum).

How big a threat are STIs in today’s world?

The most recent figures show that in the US, Syphilis cases have tripled between 2013 and 2018 , which includes 5,726 pregnant women. Between 2008 and 2018 Europe also saw a 50% increase in Syphilis and Canada’s cases have more than doubled. In these high-income countries men are disproportionately  affected, however, in low to middle income countries (LMIC), syphilis is endemic to the general population and makes up over 90% of worldwide case numbers. This also means high numbers of infections in pregnant women, leading to increased cases of congenital Syphilis.

Syphilis is classed as an ulcerative STI, which means it causes genital ulcers. These ulcers facilitate the acquisition of HIV during intercourse, increasing the chance of transmission five-fold. Coinfections of Syphilis and HIV can increase the HIV viral load and HIV can accelerate the natural history of Syphilis. This means that individuals suffering from a coinfection will more frequently develop neurosyphilis than those with syphilis alone. In LMIC countries such as Tanzania, Uganda, and Ethiopia, the number of HIV positive patients with Syphilis are nearly 10%, and in Ghana, it is as high as 14.8%.


What does Syphilis mean for pregnant women?

Globally, Congenital syphilis is the second leading cause of preventable stillbirths and there are a plethora of other complications that can arise from untreated congenital Syphilis, such as severe anaemia, jaundice, and ultimately blindness and deafness. In 2016, the World Health Organisation (WHO) estimated that there were 661,000 infants born with congenital Syphilis, and that approximately 40% of babies born to untreated Syphilis, or an estimated 143,000 infants, will suffer early deaths or stillbirths. This is not to say that this is inevitable, and in fact syphilis can be effectively treated with penicillin if caught early enough. This is why testing pregnant women for these infections is so important.

The World Health Organisation (WHO) ‘Prevention of Mother-to-Child Transmission of HIV/AIDS Program’ (PMTCT) aims to eliminate mother-to-child transmission of HIV and syphilis by providing technical support to member states on the uptake of antenatal services like HIV and Syphilis testing, as well as collecting and analysing regional trends.

In higher income countries, high sensitivity and high specificity tests for HIV and Syphilis are performed in labs and protocols are defined for screening of these diseases. In LMIC’s, there are often limited centralised health services or appropriate lab availability for these kinds of tests and so a point of care (POC) approach is taken, which allows for the collecting of a sample, and testing to be conducted in a single visit. POC tests for HIV have proved successful in LMIC countries, with 70-100% of pregnant women being screened. However, there is a clear deficit for pregnant women being screened for Syphilis, falling short at 40-60%. The high prevalence of syphilis in HIV infected patients indicates that there is a need to increase syphilis testing efforts.

What can be done to bridge the gap between HIV and Syphilis testing rates?

There are several combined HIV/ Syphilis POC rapid diagnostic tests (RTD) which aim to increase the rate of syphilis testing by leveraging existing HIV testing programs. To be successful the combined tests must be affordable, easy to use, and appropriate for a POC scenario. The widespread distribution of these combined tests is cheaper and more efficient than two individual tests and can allow for the early detection and treatment of HIV and Syphilis, saving both pregnant women and their unborn children.

Source: World Health Organization

Tests designed with decentralised testing and POC scenarios in mind can be visually interpreted and are easily used. Storage and distribution are big concerns and so these HIV/ syphilis POC tests are compact, have a 2-year shelf life, and can be stored across a broad temperature range. It is important to understand that these tests are only for initial screening, and if positives come back more specific alternative diagnosis methods should be used.

The importance of dual HIV/ Syphilis POC tests in LMIC’s cannot be understated. These tests are projected to allow for an additional 4.4 million women to be tested, with at least 285,000 Syphilis infections in women to be identified. Ultimately this could lead to 38,000 fewer cases of congenital syphilis, and 51,500 child mortalities being avoided.

HIV/ Syphilis Serum and Plasma from Logical Biological

Logical Biological provide a large portfolio of HIV and syphilis serum and plasma products. Testing can be performed on syphilis serum and syphilis plasma using a wide selection of methodologies including TPHA, ELISA and EIA. Available testing for HIV serum and HIV plasma includes LIA, EIA, PCR (copies/ml), Nucleic Acid Amplification, Western Blot, Ratio CD4/CD8 profiling and Chemiluminescent Immunoassay (ChLIA) (S/CO units).

All serum and plasma specimens can be provided according to your custom specifications and are supplied with demographic information available.

Table: HIV and Syphilis serum and plasma available from Logical Biological

Logical Biological is committed to do what we can to reduce our environmental impact and improve our local environment. With this core value in mind some of our team recently enjoyed a blustery day in Sandwich and Pegwell Bay National Nature Reserve volunteering for the Kent Wildlife Trust.


Covering 615-hectares (1,520-acres), Sandwich and Pegwell Bay is the Kent Wildlife Trusts largest site and is important for breeding, migrating, and wintering birds all year round. It has rich feeding grounds which are a vital stop for migrating birds, some of which cover thousands of miles and come all the way from places like Canada, Russia, and Africa. The area is also home to many internationally important rare plants and animals, such as lizard orchids and sand lizards.


Caption: Sea-buckthorn dominate the dunes above Pegwell bay


Sea-buckthorn, as we discovered, is a spiny, thicket-forming shrub that grows well in the sand dunes. In-fact it grows so well that it has taken over too much of the reserve and needed cutting back and managing. That is where our team of volunteers came in! Our team spent the day cutting back the shrub and litter picking the cleared area, making it ready for sand lizard to bask in the summer sun and highland cattle to graze.

Caption: Logical Biologicals team of volunteers


With the ideal ratio of shrub to dunes being 25:75%, there’s still a way to go, but we definitely made an impact and hope that we played a part in ensuring the vast biodiversity of the area.

Caption: Rubbish and wayward golf balls collected (there’s an adjacent championship links golf course!)


BK polyomovirus (BKV) is a double stranded DNA virus that affects 65-90% of the adult population. Commonly a childhood infection with minimal symptoms, this virus can exist in a latent form in the renal system for a lifetime. Its significance arises if an individual becomes immunocompromised such as for recipients of kidney or bone marrow (stem cell hematopoietic) transplants (HCT). Under these circumstances tests for BKV are essential to prevent haemorrhagic cystitis, ureteral stenosis or nephropathy (BKVN) and organ rejection.


The kidney is the most common type of transplanted organ. There were 2,263 kidney transplant procedures in the UK in 2021/2022 and the US reached a record high of 25,487 in 2021. Bone marrow or stem cell transplant numbers are in the region of almost 5,000 people in the US, 4,000 annually in the UK and over 32,000 across Europe as a whole. With BKV affecting up to 15% of transplant patients and a lack of effective antiviral therapies, post-transplant screening is a key recommendation to manage the reduction of immunosuppression in patients with BKV infections.


BKV Screening

Although a kidney biopsy remains the gold standard for BKVN diagnosis, most testing is currently performed in regional or reference laboratories utilising serum, plasma, EDTA whole blood, or urine samples tested using PCR based tests. When triggered by reduced immunity, BKV reactivation causes decoy cells and viral components to be excreted in urine, viruria, then progresses across the interstitium and within a couple of weeks pass into the capillaries causing viremia.


In HCT patients, BKV testing can help to manage the diagnosis and management of hemorrhagic cystitis, with an antiviral drug. In kidney transplantation, screening for BKV DNA allows for an early intervention generally with a preemptive reduction in immunosuppression. This prevents BKVN development and subsequent graft failure.


A UK study that screened paediatric transplant patients found that 30% of them were BKV viremia positive and BKVN was found in 6.6% of cases 3 months post-transplant. This supports other studies in adults that have seen viruria and viremia from 3 months post-transplant. As a result of this, the current guidelines  for testing start at one month post-transplant, with monthly plasma screening for the first 6 months, then every 3 months until 2 years post-transplant.


 Image: Other kidney disease state serum and plasma available from Logical Biological


BKV Test Standardisation

Disparity in sample type, DNA extraction techniques, primer and probe sequences, and even the BK strain DNA used for the control, can all affect results and potentially produce clinical variability. Attempts at reducing these discrepancies have resulted in a WHO International standard to help reduce inter assay variability.


Introduced in 2016 the 1st WHO International Standard for BKV nucleic acid amplification testing (NAAT) enables worldwide harmonization of results across hospitals and institutions. As clinical laboratories worldwide use assays traceable to the WHO International standard, we will see an increased potential for establishing quantitative BKV DNA load cutoffs that can be used in a clinical setting. There is currently no definitive viral load cutoff associated with nephropathy although guidelines recommend a plasma viral load of ≥10,000 copies/ml as the threshold for clinical intervention in kidney transplantation based on a specificity of 93% for BKVN, some centers have reported that this threshold may underestimate the diagnosis of BKVN and suggest using lower viral load thresholds.


To make matters more complicated there are 12 subtypes/subgroups of BKV. Commercial diagnostic testing often uses genotype I, the Dunlop strain, as the reference sequence for primers and probes. One study looked at using these tests on BK variants and concluded a decrease in the sensitivity for patients with BKV variant infections. They urged caution when interpreting test results and being faced with a clinical discrepancy. Unfortunately, rare subtypes have been shown to be an increased risk factor for BKV induced nephropathy, namely subtypes III and IV.


BKV infections continue to be the predominant clinical issue faced by transplant providers and patients. Screening guidelines have resulted in earlier detection, improved patient outcomes and standardisation is helping reduce inter-assay variability. BKVN is however still a challenge for physicians, especially with no anti-viral currently available for the virus.


BK Virus Serum and Plasma from Logical Biological

Logical Biological provide BK Virus PCR positive serum and BK Virus PCR positive plasma with known values (IU/mL) standardised against the 1st WHO International Standard for BK Virus. We can also offer transplant serum and transplant plasma, and kidney failure samples. All serum and plasma specimens can be provided according to your custom specifications and are supplied with demographic information available.

In the four years since it was founded, Logical Biological has established itself as a go-to company for diagnostic test developers, requiring healthy and diseased human biological material such as serum, plasma, swabs, and saliva, directly from donor centres and blood banks around the world.


Founder and managing director, James Steggles, set up the business after being persuaded by his family and friends to go it alone and put his years of industry experience to work.


With the need to operate from Containment Level 2 laboratory space, James identified the life science park: Discovery Park in the southeast of the UK as the home for his start-up company, Logical Biological.


Speaking from his office in Building 500, James said: “Discovery Park offered the space and the all-important containment facilities, and a welcoming approach that made it easy for us to choose to move here.

James Steggles, Founder and Managing Director, Logical Biological

James Steggles, Founder and Managing Director, Logical Biological


“Since establishing the company at Discovery Park we’ve grown quickly and already moved to bigger offices and labs twice, with another move onsite on the horizon.”


The company’s expertise has helped it establish a global network of partners to help source the human biological material needed by companies involved in the development of disease diagnosis testing.


Logical Biological’s aspiration is to be the company of choice for test developers to partner with their 12-strong team. A further three people are expected to join by the end of the year, maintaining it as one of the UK’s fastest growing companies.


James, who has a PhD in Biochemistry and years of experience in the industry, felt that there was an opportunity to establish a business that offered integrity, reliability, and quality assurance.


“The development of high-quality tests, whether for allergies, auto-immune diseases, cancer, cardiology or infectious diseases, require reliable information gathered from high-quality human material. My experience while working in the industry was that the supply-chain too often failed. I knew that with the right attention to detail, we could do much better,” added James.


His confidence has been well-founded. The company now provides human biomaterial to many globally recognised names and often with multiple projects for each ongoing at any one time. Logical Biological’s approach and expertise is being put to good use by test developers involved in a wide range of clinical areas.


James added: “Covid-19 shone a light on the value of diagnostic tests and how they can support clinicians across many fields, which has stimulated demand for the materials we are perfectly placed to source and supply.


“Repeat business, referrals from existing customers and to potential new ones, has driven our growth. Seeing our work, which is at the start of the development of new tests, come to fruition with the tests being launched into the market, gives all of the team huge satisfaction, and drives us to be even better.”


Logical Biological has benefited from the talent pool that exists in Kent, and specifically in the Discovery Park area.


“The majority of the CVs we receive from potential team members inevitably mention Pfizer which demonstrates the quality of the skills on offer, and the local universities are delivering science graduates to the area.


“We’ve also benefitted from the community of like-minded companies here with shared values, with relationships nurtured by the team on site, and we have developed a strong partnership with at least one other firm at Discovery Park.”


Logical Biological’s offices, with its testing and write-up space, put the team in amongst a community of high-growth companies, many of whom have started and flourished at Discovery Park.


James concluded: “Being among business owners and scientists who are open to collaborate here means that Discovery Park is a great environment in which to grow.


“I am delighted about how great the last four years have turned out. Our success has been built on doing things right through integrity and reliability and an extreme commitment to our customers.”


The team has also benefitted from the work-life balance offered by Discovery Park and living in Kent. James frequently commutes by train from Whitstable to Ramsgate and then cycles to work through Pegwell Bay nature reserve, with the sea air getting the day off to a great start.



The flu season is well and truly upon us, but is it Influenza, RSV or Covid? And does it matter?


The ‘tripledemic’ season of Influenza, COVID-19, and RSV viruses

Influenza A/B, COVID-19 with its variants and respiratory syncytial virus (RSV) are the three largest contenders responsible for respiratory infections globally. The European Centre of Disease prevention and Control and the Pan American Health Organisation have reported unusual infection spikes this year, collectively calling it a ‘triple threat’, and providing a worldwide picture of increased infections.

Global numbers for annual mortality associated with respiratory infections stands at up to 650,000 for influenza and 80,000 for RSV. The relative newness of SARS-COV-2 and its fatalities mean its numbers cannot yet be directly used in comparisons here, needless to say cumulative deaths from COVID-19 are over 6 million and continue to be recorded in great detail. Infections themselves number in the tens to hundreds of millions, some sources even estimate flu infections reach a billion cases annually, leading to between 300,000 and 800,000 hospitalizations in the U.S. alone each year. Australia’s increased flu infections this year have been an important prediction for the Northern Hemisphere flu season to be ready, and that prediction is unfortunately proving accurate.


Influenza, Covid and RSV symptoms are very similar- Is there a need to define which respiratory disease you have?

Covid Flu A/B RSV A/B symptoms

Influenza, SARS-COV-2, and RSV have incredibly similar symptoms and without medical intervention, the same treatment – namely rest, fluids and over the counter relief medication. An average, healthy infected individual will suffer for a week or two, but otherwise make a full recovery.  People suffering moderate to severe symptoms tend to self-impose an element of isolation from others, with awareness of the effectiveness of this as a prevention highlighted in the recent SARS-COV-2 pandemic. Problems arise when the young, old, or immunologically challenged are infected and need medical assistance in their recovery.

Vaccines and antiviral treatments however vary, and there is an increased interest in being able to identify which virus is responsible for specific infections. A test is the only way to be certain of which antiviral medication should be administered as soon as possible after infection.

Table source: CDC, Mayo Clinic


Combined tests offer streamlined workflow for doctors allowing viral specific diagnosis in a single test

Calls for simple, low cost, differential diagnosis combination tests for the three viruses discussed here are growing. Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) or rapid lateral flow tests (LFT) that combine more than one pathogen identifier would enable the testing process to be streamlined, allowing for multiple test results from a single sample. Patient sample collection from one nasopharyngeal or mid-turbinate swab would decrease patient discomfort but also provide a financial saving and optimise clinician’s time.


Different types of combination tests available

Real-time quantitative reverse transcription PCR (rRT-PCR) testing that combines Flu A and B with COVID, is used by the Centres for Disease Control and Prevention to track disease trends. Other clinical combination testing that includes RSV is available for general diagnostic use, are FDA approved and encourage home sample collection. Further available tests, have Emergency Use Authorisation (EUA) from the FDA, but with time and increased demand we may well find more of these tests being approved. Globally companies were swift to produce combination tests for these viral respiratory diseases using TEM-PCR technology. CE-IVD marked RT-PCR and multiplex rRT-PCR tests are already available in European countries and the Middle East.

Laboratory test results are generally available between 24 to 48 hours. As with all tests needing additional equipment for sample processing and analysis, transport and storage facilities have to be considered and can add outlying costs to testing.

A limited number of lateral flow tests combining the three viral components in one test have been developed, although results are available within a 10 minute window, there are separate sample requirements, meaning it may require more than one sample extraction. Other technologies for combination testing include microfluid immunofluorescence assays, combinations remain limited to two viral components. These provide quick results, within 12 minutes, using a specific reader.

Currently there is no reliable, over the counter, rapid lateral flow test that combines these three, allowing quick, cheap testing in a clinical setting or indeed a home test.


Logical Biological Products

At Logical Biological we supply nasopharyngeal/ oropharyngeal/ nasal SARS-CoV-2, Influenza A, Influenza B and RSV swabs available in UTM, Inactivating TM, saline or dry frozen. Negative swabs and COVID-19 / pre-COVID saliva are also available. Typically, our swabs are provided together with a Ct value measured from a ‘companion swab’ taken simultaneously. We also provide serum and plasma samples from individuals infected with SARS-CoV-2, Influenza A/ B, RSV, Streptococcus A, Adenovirus, Parainfluenza and other respiratory infectious diseases.

SARS-CoV-2 Flu A/B RSV A/B products

Table: Products available from Logical Biological

Logical Biological were delighted to exhibit for the first time at MEDICA, in Dusseldorf, Germany from 14 – 17 November 2022.

MEDICA – Leading International Trade Fair

MEDICA 2022 Infographic

MEDICA is one of the largest international events for the IVD Diagnostic industry and Logical Biological was one of over 5,000 exhibitors from over 70 countries . Logical Biological was pleased to see that visitor numbers were up from 2021 to more than 81,000 visitors, a significant increase from the 46,000 visitors that attended in 2021. In fact, MEDICA felt almost back to its pre-Covid self with the share of international visitors totalling 75 percent. European countries topped the visitor numbers, followed by South Korea and the USA. India and North African countries were also represented in large numbers. Many visitors noted that after the long pandemic break, they were happy to be able to talk to exhibitors again.

Logical Biological at MEDICA 2022

For Logical Biological, this was the first time exhibiting at MEDICA. Exhibiting gave us the opportunity to increase awareness within the industry of who Logical Biological are and how we can support and empower IVD manufacturers to develop high performance assays and associated calibrator and control material.

Thanks to some bold back-lit graphics we were a noticeable presence in the UK Gambica area of Hall 1, which enabled us to have many conversations with passing visitors, who we look forward to building working relationships with. Our team of three enjoyed over 30 pre-arranged meetings with customers and suppliers, and many more spontaneous ones. Better still, thanks to the support of Gambica we were able to have 2 meetings simultaneously by utilising the shared meeting area that Gambica offers.

MEDICA is always good way to get an overview of the market, to network and to see what the other companies are doing and where the trends are, this year was no exception. We look forward to attending more trade shows this year and further building the relationships we started at MEDICA.


Logical Biological Products

Logical Biological specialises in provision of human biospecimens, such as serum, plasma, swabs and saliva, all of which are essential components used in IVD tests, their development, calibration and quality control. 

Date of the next MEDICA in Düsseldorf: 13 –16 November 2023

Global vaccine roll out is making progress but with most countries wanting priority status and with a limited supply, how can governments best prioritise those requiring vaccination?

Vaccination strategies

Overall two vaccination strategies are in place: the first concentrates on those at highest risk, the second focuses vaccinations on people most likely to transmit the virus, known as direct and indirect vaccination strategies, respectively. Regardless of vaccine type and manufacturer, there are significant availability issues. Cell division time is a limiting factor in production, and considerations such as vaccine transport, worker health and storage capacity all contribute towards availability issues. Limited stores of reagents and chemicals involved in production have become a problem in the massive upscaling of vaccine production required for the global population.

As of writing, Israel has vaccinated its 9 million population once and is over halfway through the second dosage. The UAE is also high on the list of countries who have nearly managed to complete vaccination and has started its own vaccine manufacture.  


Countries with larger populations have different hurdles. The UK has targeted vaccinations for the old-aged, healthcare workers and those with underlying health conditions, with Norway doing similar. Studies in vaccination strategy suggest prioritising the over 60’s to minimise mortality. However, Indonesia was one of the first countries breaking from this template, focusing on vaccinations to reduce transmissions, namely the working age group 18-59. Indonesia’s population consists of only 10% over 60, whereas the UK is nearer 20%. The UK has vaccinated approximately 60% of its population, with nearly 40 million doses given, whereas the US is making astounding progress with well over 50% of the population having had the first dose; a whopping 185 million doses given. However, the overall picture is one of limited vaccine availability, with only a small proportion of the global population having been vaccinated.

Length of vaccine protection

It is unknown how long the vaccines provides protection for. Research has suggested after an asymptomatic, mild or moderate infection specific T cell immunity may be persist for around 6 months. The CEO of Pfizer has speculated that booster vaccinations for SARS-CoV-2 may be required within 12 months. 

Factors affecting vaccine efficacy:

  • age 
  • underlying health conditions 

Factors affecting vaccination strategy:

  • country specific age structure 
  • infection fatality rate
  • vaccine availability 
  • vaccine efficacy 
  • social distancing/isolation measures
  • seroprevalence

Over a dozen COVID-19 vaccines are currently approved. Types used include inactivated virus, mRNA, non-replicating viral vector and Adenovirus vectors. Whether these contrasting mechanisms provide differing outcomes regarding longevity of protection remains to be seen.  

Serology status

Serology, the study of antibodies in the blood, is relevant to vaccinations as individuals may already carry the antibodies required to fight SARS-CoV-2 through previous infection. If this is the case, should they be lower down the priority list for vaccination?



Hepatitis B Virus (HBV) is a disease known to require susceptibility status prior to vaccination, and therefore serology documentation. However, most vaccinations do not require serology paperwork. With limited supply of SARS-CoV-2 vaccines available it stands to reason the most impactful use of each dose would be given to susceptible individuals and not immune individuals. Modelling studies have advocated prioritising COVID-19 vaccinations by serostatus as well as age. There are clearly additional logistics, complexity and expense involved, and few if any governments have deprioritised citizens for vaccination on the basis of serology or positive PCR tests. Another rational approach that has not caught on would be to provide only a single dose to those who have recovered from SARS-CoV-2 infection; in Ferbruary 2021 it was reported that France intends to give only a single dose to those citizens who have recovered from COVID-19.

A SARS-CoV-2 serology test, or antibody test, is typically a lateral flow test, lab based ELISA or Chemiluminescence Immunoassay designed to detect whether an individual has ever been infected with the virus. Generally SARS-CoV-2 serology tests can detect immunoglobulins: IgG, IgM or a combination of both. There is research to indicate IgA should be included in these serology tests as it may be a more accurate marker than IgM regarding tests taken shortly after an infection. There is much activity taking place within the IVD industry to tailor such tests to areas where they might be useful, for example to develop a test identifying those who have produced adequate antibodies from the vaccine and those who would require a booster.

Time kinetics of antibody response in coronavirus disease 2019 (COVID-19). The illustration demonstrates the relative levels of host immunoglobulins (IgM, IgG, IgA) and SARS-CoV-2 viral load at different stages of COVID-19. Antibody-specific seroconversion occurs when the antibody reaches a detectable level in blood. Disclaimer: This graphic is for illustrative purposes only and does not represent actual levels of each antibody.


As scientists we support the use of serology tests and previous PCR status to inform SARS-CoV-2 vaccine prioritisation in the context of limited vaccine availability, particularly in the young and healthy who are least at risk from the virus .

Logical Biological Products

At Logical Biological we provide serum and plasma from individuals pre- and post-COVID-19 vaccination, as well as SARS-CoV-2 IgG, IgM and IgA positive serum and plasma samples. We also provide SARS-CoV-2, Influenza and RSV swabs and saliva.

Table- Products available from Logical Biological

Logical Biological is delighted to announce the appointment of Stephane Argivier as Non-Executive Director and Board member. Stephane has been involved in IVD and Life Science for the past 23 years, during most of which he has held leadership and executive positions, and built a successful track record of delivering fast and sustained growth with entities ranging from start-ups to multinationals.

Stephane is currently CEO and Board member of MIP Diagnostics, a rapidly growing company with a unique technology expanding the scope of affinity reagent applications & functionalities. Stephane was previously Managing Director at SCIPAC Ltd, a multi-business awards winning company, where he led a successful divestment of the company to the BBI Group on behalf of its shareholders. Stephane stayed with the organisation in various Executive roles for a further 9 years to enable a successful integration to what became BBI Solutions and to set-up a number of new business units, several of which have now reached a significant size. Stephane holds a Masters degree in Business and a degree in Applied Biology.

The appointment comes at a time when Logical Biological has established a strong market position as an ethical, quality focused and reliable source of best-in-industry human biological materials and is now preparing for the next stage of its journey. Dr James Steggles, Managing Director at Logical Biological said, “I am very pleased to welcome Stephane Argivier to the board of Logical Biological. Stephane’s experience in critical IVD reagents, especially within the clinical specimen market, will be extremely valuable as we continue to expand our business operations. We are delighted that Stephane will be joining our board and we look forward to working with him as we continue to build scale and success at Logical Biological”.

Stephane Argivier commented, “I am delighted to be joining Logical Biological at this pivotal time in its business cycle. I am truly impressed with the progress the company has made over the past few years and excited about its future.”



As the pandemic has struck the predicted second wave, public struggles persist with lifestyle restrictions, but our knowledge to identify and fight the virus has significantly progressed.

With tests developed, distributed and administered satisfactorily for most symptomatic sufferers (PCR), and the vaccine roll out for the most vulnerable, science and medicine turn to consider the silent carriers of SARS-CoV-2…the asymptomatic vectors.

The case for rapid antigen testing using Lateral Flow

At present testing generally consists of Polymerase Chain Reaction (PCR ) or Lateral Flow Tests (LFT) also known as rapid or antigen tests. Writing on these previously highlighted the differences and nuances of each. Regarding asymptomatic carriers it would appear that PCR will test positive for a longer period of the infection, even if the individual is not contagious. It can also take a long time to get PCR test results, often days – making them non-suitable for detecting asymptomatic carriers in everyday social settings such as schools. Lateral flow tests are considerably quicker, providing a result in 10-30 minutes, and significantly cheaper as they do not require a laboratory.

Graph – High-Frequency Testing with Low Analytic Sensitivity versus Low-Frequency Testing with High Analytic Sensitivity

Analysis of UK mass lateral flow test events have been beneficial. It is suggested the 60% of people who had “false negative” tests in the Liverpool pilot were not contagious. As the graph shows, PCR sensitivity may be detrimental when considering the effects of extreme and unnecessary self-isolation requirements. Evaluations have shown that lateral flow tests identify 90100% of asymptomatic individuals whose samples go on to provide viable virus in cultured samples. 

Results from an American University mass testing event showed the ability to culture viable virus from a sample means the virus is capable of reinfecting, hence the individual is contagious. This study also used lateral flow tests and showed similar results to the UK. Virus samples collected were able to infect cell cultures in vitro, showing their viability. Good news indeed for identifying individuals who are asymptomatic and infectious.

Repeat testing using lateral flow tests, especially in high transition groups, medical staff, teachers and carers, with a short turn around time, will help reduce transmissions. The cost effectiveness and ease of a lateral flow test makes repeat testing an obvious option.  

Not to rapid test

Evidence from mass testing events (previous blog) has suggested lateral flow tests can miss up to approximately 60% of infected people. In the UK Liverpool study a third of people tested negative even with high viral loads, implying the individuals would be infectious, even if they were asymptomatic. A negative lateral flow test would potentially release this individual into the population to spread the disease, although this assumes positive individuals ignore the guidance to not treat a negative result as a definitive confirmation of COVID-negative status. This scenario shows how important other preventative measures are, such as social distancing and hand washing. Unfortunately Liverpool, whilst providing reams of data, is also, to date (18th Jan 2021), one of the few UK areas with increased cases of the disease, even after all the lockdown measures and mass testing. 

France has recently voiced its concerns over lateral flow tests and have insisted that any non-EU travellers must have a negative RT-PCR test; they will no longer accept a negative lateral flow test as sufficient for entry into France. This will inevitably feed into the public concern over lateral flow test results and cause many issues, not only because at present, certainly in the UK, you only qualify for an RT-PCR test if you are symptomatic. Medicines and Healthcare products Regulatory Agency (MHRA) have raised concerns about using lateral flow tests in UK schools as there is no ‘test-to-enable’, this had led to a pause on testing in UK schools. A test-to-enable would provide definitive results as to the infectiousness of an individual.

Mass testing has been touted as the way out of the crisis since it began. Now we are getting into a position to test everyone how might this affect human behaviour? People are encouraged to act as if they are positive for COVID-19, but the increase in testing means many will have a “negative” test and could decide to ignore social distancing guidance on the basis of it. This had been flagged as a major (hypothetical) problem by some highly-credentialed scientists taking issue with the UK’s lateral flow test testing program.

Most tests need a swab of some kind to collect their sample, exceptions being drooled saliva and blood samples. Sample collection can be uncomfortable but most willingly go through the procedure. Often sample collection is supervised with the individual taking the actual sample. This has implications for correct procedure sample collection, with reports from the Liverpool mass testing suggesting the test performed worse when civilians performed their own test without supervision. For others, who are unwilling or unable to undergo the stress or complexities of testing, the test may fail from the start with inadequate sample collection. As yet lateral flow tests are not readily available without symptoms at home.

Logical Biological’s View

Our view is that lateral flow tests are a cheap and easy test that when performed on a regular basis in certain settings, schools being a prime example, can identify a substantial proportion of infectious individuals, enabling them to be removed quickly from that setting. This would undoubtedly improve the safety of those associating with them in the same setting, allowing the setting to remain open for longer, to the benefit of society. However, in order to maximise the utility of such an approach a minimum test frequency guideline should be defined in each setting. This testing should be frequent, ideally daily.  

Other high risk settings are likely to include meat processing plants, university halls of residence and care homes (staff and visitors). Imagine how much safer you would be as a teacher, parent or care home resident if most asymptomatic people you or your loved ones associated with were identified and self-isolated. This would also cut chains of transmission and reduce strain on health systems. For these reasons many scientists have pushed back against the warnings from researchers with ‘unfounded criticism’ of the lateral flow test.

Currently no test can definitively assess for SARS-CoV-2 infectiousness, and to attain that ideal may take many months/years or may never happen. Heeding the prescient words of Mike Ryan at the outset of the pandemic “perfection is the enemy of the good. Speed trumps perfection”, we are frustrated at resistance from within the scientific community to the use of technologies that, despite their imperfections, are likely to have an enormous benefit to society. 

Logical Biological Products

At Logical Biological we supply nasopharyngeal/oropharyngeal/nasal SARS-CoV-2, FluA and Flu B swabs available in UTM, Inactivating TM, saline or dry frozen. Negative swabs and COVID-19 / pre-COVID saliva are also available. Typically, our swabs are provided together a Ct value measured from a ‘companion swab’ taken simultaneously. We also provide serum and plasma samples from individuals infected with SARS-CoV-2 and other respiratory infectious diseases. Samples from vaccinated individuals can be collected.

Table: Products available from Logical Biological