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.

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.

Logical Biological has added Chagas antibody positive plasma to its range having received clearance from the UK government Health & Safety Executive to handle human biological material containing Trypanosoma cruzi, which is the causative agent of Chagas Disease. T. cruzi is a Hazard Group 3 pathogen according to “The Approved List of Biological Reagents”. Hazard Group 3 is defined as follows: “Can cause severe human disease and may be a serious hazard to employees; it may spread to the community, but there is usually effective prophylaxis or treatment available.”

As part of this process, the UK government has reviewed Logical Biological’s key risk assessments and standard operating procedures. Logical Biological has previously received clearance to handle human biological material infected with other Hazard Group 3 organisms such as HIV, Hepatitis B, Hepatitis C, Malaria (Plasmodium falciparum) and Tapeworm (Taenia solium).

You can see the full list of infectious disease materials offered by Logical Biological here.

Logical Biological has received clearance from the UK government Health & Safety Executive to handle human biological material containing Trypanosoma cruzi, which is the causative agent of Chagas Disease. T. cruzi is a Hazard Group 3 pathogen according to “The Approved List of Biological Reagents”. Hazard Group 3 is defined as follows: “Can cause severe human disease and may be a serious hazard to employees; it may spread to the community, but there is usually effective prophylaxis or treatment available.”

As part of this process, the UK government has reviewed Logical Biological’s key risk assessments and standard operating procedures. Logical Biological has previously received clearance to handle human biological material infected with other Hazard Group 3 organisms such as HIV, Hepatitis B, Hepatitis C, Malaria (Plasmodium falciparum) and Tapeworm (Taenia solium).

You can see the full list of infectious disease patient material offered by Logical Biological here. Please contact us for further information on any of our plasma/serum, antigen and monoclonal antibody products for IVD.

All over the planet, women are getting pregnant, over 200 million of them each year. Most of these pregnancies are unintended1. This means two things: a lot of babies, and a lot of surprises. Despite this, some 8% of couples are unable to conceive within two years and are considered infertile. Risk factors for infertility include age, previous medical history (sexually-transmitted diseases, cancer treatment) and obesity. 

Fortunately, a wide-range of fertility treatments are now available, although sadly the cost of such treatment is prohibitive for many. Despite this, for those who can access it fertility treatment does work; in the UK the Human Fertility and Embryology Authority reported ~20,000 births in 2016 from ~68,000 treatment cycles.

Much of the success in fertility treatment stems from the use of medications that seek to address fertility issues in individual patients. While this is welcome news, as the number of fertility treatments increases and their use becomes more widespread there is a need for diagnostic test manufacturers to ensure that the tests they develop give the right results in patients taking fertility drugs.

For example, low levels of Progesterone early in pregnancy can be suggestive of increased risk of miscarriage and ectopic pregnancy. A patient with a low result for Progesterone levels may be treated in order to manage this situation and reduce the likelihood of miscarriage or to confirm and manage an ectopic pregnancy. If such patients are also being treated with Clom1fene – not an unlikely scenario for a patient in the early stages of pregnancy – then it would be important to know that the Progesterone test result is not interfered with by the presence of Clom1fene in the patient. Therefore, there is a need within the disease diagnosis industry for material from patients treated with fertility drugs to ensure that diagnostic tests being developed are not interfered with.

During immunoassay development, diagnostic test manufacturers typically test their assays for specificity. They construct a list of potential cross-reacting molecules, and then spike these on an individual basis into human specimens that do not contain the analyte of interest (e.g. Progesterone). They would then test the specimens in the assay to see if any “Progesterone” was detected, expecting a value of zero if the cross-reactant does not interfere with the assay.

Let’s now review some of the drugs used in fertility, all of which have the potential to interfere with diagnostic assays. Logical Biological can provide plasma and serum from individuals in every stage of pregnancy (0-40 gestation weeks) and those treated with medications covered in this article. Do let us know if this would be of interest to your organisation.

Drugs which stimulate ovulation

Clom1fene* (brand name: Clom1d) – a commonly used drug which stimulates ovulation by causing the pituitary gland to release more Follicle-Stimulating Hormone (FSH) and Luteinising Hormone (LH), which it does by blocking estrogen receptors. This stimulates the growth of an ovarian follicle containing an egg.

Gonadotropins – FSH, LH or human Chorionic Gonadotrophin (hCG) strongly stimulate the ovary directly to mature and release eggs. These hormones can be used individually or in combination and are administered by injection. Brand names of this type of drug include Gonal-F, Follistim AQ, Bravelle, Menopur, Ovidrel and Pregnyl.

Metformin (brand names include Glucophage) is used when insulin is the suspected underlying cause of infertility. Metformin helps improve insulin resistance and thus increases the likelihood of ovulation.

Letrozole (brand name: Fermara) is an aromatase inhibitor, developed for use in treating breast cancer, which also serves to stimulate ovulation by decreasing the amount of testosterone converted to estradiol. This reduces estrogen activity and leads to more FSH secretion.  

Bromocriptine and cabergoline (brand names: Parlodol and Dostinex) are dopamine agonists which can be used where ovulation problems, such as irregular or absent ovulation, are caused by excess production of prolactin by the pituitary gland (hyperprolactinemia).

Drugs which suppress ovulation

Some drugs are actually used by fertility clinics to suppress ovulation. This could be to prevent ovulation before the eggs can be retrieved surgically for IVF use. Gonadotropin-releasing hormone (GnRH) agonists achieve this and examples include ganirelix acetate and cetrorelix acetate. Brand names include Antagon, Ganirelix, Cetrotide and Orgalutran.

Other fertility medications are GnRH agonists. These stimulate FSH and LH production but then cause the body to stop producing them, allowing control of ovulation.  Examples are leuprolide acetate, nafarelin acetate, buserelin and goserelin. These are manufactured under brand names including Lupron, Synarel, Suprecur and Zoladex, which variously may be delivered to the patient by nasal spray, implant or injection.

Other Drugs

Birth control pills (contraceptive pills) may also be used by fertility clinics to enhance response to Clom1d of women with polycystic ovary syndrome. Progesterone may be prescribed for luteal phase defects or recurrent miscarriages. Estrogen may be prescribed to alleviate a symptom of Clom1d, which is a thicker endometrial lining that can interfere with conception.


As technology advances there is a strong trend towards increased uptake of fertility treatments. Diagnostics immunoassay developers should continue to include fertility drugs in their cross-reactivity studies to determine the specificity of their assays.


  1. Global, regional, and subregional trends in unintended pregnancy and its outcomes from 1990 to 2014: estimates from a Bayesian hierarchical model. Bearak J, Popinchalk A, Alkema L, Sedgh G. Lancet Glob Health. 2018 Apr;6(4):e380-e389.

This article should be viewed for general interest purposes only, may not be fully accurate or comprehensive, and should not be considered as medical advice.
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