Debunking Six Common Misconceptions About Biospecimens in IVD Testing

There are many common myths and misunderstandings about biospecimens and how they are applied in in vitro diagnostics (IVD). In this blog post, we’ll separate the myths from the facts to foster a better understanding of biospecimens.

1. Biospecimens

Biospecimens are merely remnant (leftover) samples that are used for research.

Biospecimens and biofluids are widely used in clinical diagnostics, helping to:1 Diagnose diseases  Monitor treatment efficacy Advance medicine Remnant samples are the remains of human biological samples that would otherwise be discarded, collected for clinical care or analysis purposes.2 Some biospecimens are remnants, but others are carefully collected and preserved according to the various needs of the user.1 In addition to confirmatory and exploratory research, these biospecimens are crucial for various stages of in vitro diagnostics test development and validation.1 The quality and integrity of these samples is becoming increasingly valuable to the industry.1

“In order for meaningful progress to occur, the biospecimens used in research must meet the highest technical and ethical standards.”                                                                                                                       - Compton CC, 2014, American Association for Cancer Research3

(Options available in single samples or bulk volumes, standard or customized)

2. Saliva diagnostics

Saliva has little to no value in clinical diagnostics. It has typically not been a valuable tool compared to the other biofluid alternatives.

Saliva has a wide breadth of uses in in vitro testing. It can provide measurements on free hormone levels, can be used for detection of various drugs or illegal substances, is a key source for genetic testing, and is becoming an increasingly valuable tool in infectious disease diagnosis.1  Saliva sample collection is a simple process that’s safer and less invasive than blood collection and, unlike urine collection, it can be done under direct supervision.4

Read more: The Shift to Saliva in Sample Testing

3. Cerebrospinal fluid diagnostics

	Cerebrospinal fluid (CSF) analysis is only useful for diagnosing conditions such as meningitis and encephalitis. Testing of CSF isn’t routine and it’s only analyzed in severe conditions.
	Neurodegenerative biomarkers can appear in the CSF years before the onset of symptoms5 and CSF testing is relatively common.1 CSF analysis is useful – and sometimes essential – for aiding the diagnosis and monitoring of a variety of conditions, such as multiple sclerosis, Alzheimer’s disease and other neurodegenerative diseases.1

4. CSF alternatives for neurology

CSF is the only biospecimen type that is useful for treating and studying neurological conditions. There are no replacements for, or alternatives to, CSF when it comes to neurological conditions.

When it comes to neurological health, the usefulness of new biospecimen types continues to increase daily. Blood and plasma/serum are becoming more useful for diagnosis, as well as for monitoring neurological markers and conditions.1 Beyond that, other unique specimens are bringing value – for example, tears are now aiding in neurodegenerative biomarker research.6 The identification of biomarkers in tears could lead to the development of cost-effective, non-invasive methods of screening, diagnosis and disease monitoring.6 Urine is also being used to analyze neurological disorder-associated metabolites.1

Read more: Tear Biomarkers and Alzheimer’s Disease

5. Vaginal fluid diagnostics

	The clinical value of vaginal fluid is limited to diagnosing infections.
	Vaginal fluid can provide a variety of insights on hormonal status and overall reproductive health. Additionally, changes in vaginal fluid itself can indicate hormonal, menstrual, pregnancy-related or even dietary-related factors – not just infections.1

6. Nasal fluid diagnostics

Nasal fluid and nasal swabs only provide value for common respiratory pathogens like COVID-19. These nasal matrices provide no value outside of infectious disease testing.

Nasal fluid and nasal swabs are useful for a whole spectrum of respiratory infection diagnoses and treatments, while also being useful for diagnosing, treating and researching various allergies or conditions such as sinusitis.1  Beyond this, nasal fluid is being researched for its potential in early-stage diagnosis of neurodegenerative diseases – olfactory dysfunction is an early sign of most of these diseases and research suggests that the olfactory pathway could be one of the first areas to be affected in patients.7 Nasal fluid is also being studied for its potential to detect certain biomarkers associated with head and neck cancers.1

Read more: Seed Amplification Assay of Nasal Swab Extracts for Accurate and Non-Invasive Molecular Diagnosis of Neurodegenerative Diseases

The key roles of biospecimens in in vitro diagnostics

What is IVD and what role do biospecimens play in in vitro testing? 

IVD is a type of testing carried out on samples that have been taken from the human body. IVD can detect diseases or monitor a person’s overall health to help treat or prevent diseases. IVD can also be used in precision medicine, to identify patients likely to benefit from specific treatments.⁸ 

Biospecimen research is critical to understanding and improving human health conditions. These specimens are used to identify and validate clinically relevant biomarkers, including potential prognostic, predictive and diagnostic markers, as well as drug targets.⁹

The importance of biospecimens in test research and development 

Biospecimens play an important role in securing Food and Drug Administration (FDA) approval for IVD tests, particularly through their use during assay validation stages where they help to assess test accuracy, safety and a number of other important performance parameters. It’s important to use consistently high-quality biospecimens to ensure reliable test results.

Biospecimens are also important for the bulk manufacturing of IVD tests, as they can be used to ensure the accuracy and reproducibility of diagnostic devices.

Of late, There is a significant focus on biospecimens and biofluids in areas such as fertility and sexually transmitted infection (STI) testing.^10,11 For example, testing for STIs is done using a sample of blood, urine, saliva or a genital/rectal swab,¹⁰ while blood, semen and urine are analyzed in fertility testing.¹¹ Home testing kits using urine or saliva samples are also available to track ovulation.^12,13 Biospecimens therefore play a major role in human reproductive health.^10-13

Ethical considerations when working with biospecimens

As the need for human biospecimens in medical research continues to grow, it’s become essential to consider the ethical, legal and social implications of biospecimen collection and research. These include respecting the autonomy and privacy of any donor providing a biospecimen.¹⁴

Medix Biochemica offers an extensive range of biospecimens and biologicals for use in the in vitro diagnostics industry. We work closely with a large network of partner clinical sites, hospital labs and collection facilities – as well as directly with an internal donor group – to deliver the specialized biological materials our clients need. 

Our product offerings are highly customizable so we can accommodate a variety of specific sourcing requirements, from demographic to disease state.¹⁵ Our biologicals and technical service teams work to understand customer needs first, in order to make the best suggestions. 

Contact us to discuss your requirements:

References:

1. Expert opinion. Anthony Austin. Global Marketing Manager, Medix Biochemica. October 2024.
2. Remnant samples definition. Law Insider. Accessed October 29, 2024. https://www.lawinsider.com/dictionary/remnant-samples.
3. Compton CC. Abstract ED02-02: ED02-02.
4. Crouch DJ, Day J, Baudys J, et al. Evaluation of saliva/oral fluid as an alternate drug testing specimen. U.S. Department of Justice. February 2005. https://www.ojp.gov/pdffiles1/nij/grants/203569.pdf.
5. Luebke M, Parulekar M, Thomas FP. Fluid biomarkers for the diagnosis of neurodegenerative diseases. Biomarkers in Neuropsychiatry. 2023;8:100062. doi:10.1016/j.bionps.2023.100062.
6. Kaštelan S, Braš M, Pjevač N, et al. Tear biomarkers and Alzheimer’s disease. International Journal of Molecular Sciences. 2023;24(17):13429. doi:10.3390/ijms241713429.
7. Duan S, Yang J, Cui Z, et al. Seed amplification assay of nasal swab extracts for accurate and non-invasive molecular diagnosis of neurodegenerative diseases. Translational Neurodegeneration. 2023;12(1):13. doi:10.1186/s40035-023-00345-1.
8. In vitro diagnostics. Food and Drug Administration. Accessed October 29, 2024. https://www.fda.gov/medical-devices/products-and-medical-procedures/in-vitro-diagnostics.
9. Betsou F. Clinical biospecimens: Reference materials, certified for nominal properties? Biopreservation and Biobanking. 2014;12(2):113. doi:10.1089/bio.2013.0086.
10. What is STI testing & do I need it? Cleveland Clinic. Accessed October 30, 2024. https://my.clevelandclinic.org/health/diagnostics/std-testing.
11. Fertility tests: When’s the right time? Cleveland Clinic. Accessed October 30, 2024. https://my.clevelandclinic.org/health/articles/fertility-test.
12. Ovulation (saliva test). Food and Drug Administration. Accessed October 30, 2024. https://www.fda.gov/medical-devices/home-use-tests/ovulation-saliva-test.
13. Ovulation: Calculating, timeline, pain & other symptoms. Cleveland Clinic. Accessed October 30, 2024. https://my.clevelandclinic.org/health/articles/23439-ovulation.
14. Ethics in biobanking. National Cancer Institute Biorepositories and Biospecimen Research Branch. Accessed October 22, 2024. https://biospecimens.cancer.gov/programs/ethics/.
15. Biospecimens and biomaterials. Medix Biochemica. Accessed October 30, 2024. https://www.medixbiochemica.com/biospecimens-and-biomaterials.