Robert Bogdan, Author at Logical Biological

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.

Blog Overview

June 12th 2023

Serum & Plasma

Share this blog:

Serum & Plasma Contact Us

Related Blogs

Infectious Diseases Renal Serum & Plasma

BK Virus: What is it and why is it a problem?

March 20th 2023

BK polyomovirus (BKV) is a double stranded DNA virus that affects 65-90% of the adult population. Its significance arises if an individual becomes immunocompromised such as for recipients of kidney or bone marrow (stem cell hematopoietic) transplants (HCT).

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%.

Source: UNAIDS WHO

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