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The alternative.

Portrait Dajana Domik

Unlocking the secrets of saliva.
An alternative to blood-based diagnostics.

Dr. Dajana Domik, Product Manager, Tecan

Blood has been the preferred medium for a wide range of diagnostic tests for decades, overshadowing saliva testing due to concerns regarding sensitivity, specificity and reproducibility. However, significant progress has been made in saliva diagnostics over the years, and the increasing availability of sensitive and robust saliva-based assays is now allowing clinicians to put away their syringes. Tecan offers an extensive range of immunoassays based on luminescence and enzyme-linked immunosorbent assay (ELISA) technologies – including steroid assays for cortisol and sex hormones, as well as tests for melatonin and alpha amylase – that have been specially developed and validated for saliva.

A matter of bioavailability.

Saliva contains various hormones and other biomolecules that can serve as direct or indirect indicators of human health, biochemical imbalances and even certain disease states.1 These analytes are also present in blood, but a key advantage of saliva testing lies in its ability to measure the biological active free fraction.2 Most steroid hormones in the bloodstream are bound to carrier proteins, and are therefore metabolically inactive, with just a small unbound proportion available to exert an effect. In contrast, only free, unbound hormones leave the bloodstream and make their way into saliva via passive diffusion, so saliva testing provides a measure of biologically active hormones.3,4

The ability to measure bioactive hormones is crucial in identifying hormonal imbalances and managing conditions effectively. However, saliva-based assays need to be very sensitive, as saliva contains only low concentrations – between one and five percent – of hormones compared to blood.2 Fortunately, saliva testing has come a long way since the topic was first discussed in scientific literature over 40 years ago,5 with a growing range of ever-more sensitive saliva-based immunoassays on the market today.

The benefits of saliva sampling.

Saliva testing has some way to go before it overtakes traditional analytical methods like blood and urine testing, but it offers several advantages which may make it a favorable choice for clinicians and patients alike, particularly in terms of accuracy and convenience. For instance, while 24-hour urine collection is a valid method for monitoring hormones, it can be inconvenient for patients, and only measures the total amount of a hormone produced, without offering insights into its hourly profile throughout the day. Similarly, studying diurnal variations in cortisol requires multiple blood samples to be taken throughout the day. Unfortunately, blood sampling is invasive and impractical for repeated sampling, and can be a stressful process for patients that are fearful of needles. Any unnecessary anxiety during sample collection can potentially also affect their cortisol levels, skewing results. Saliva testing overcomes these challenges, as it is non-invasive, easily repeatable and can be performed in any setting. Samples can be collected by patients in the comfort of their own homes, allowing for frequent measurements without the necessity of medical supervision.

Efficient sample handling is another area where saliva testing shines. After sample collection, it is crucial to transport the specimen to the laboratory without any deterioration, as this can compromise results. While blood collection tubes are only suitable for short-term storage and transport, saliva samples are easy to handle and transport in collection tubes.

Beyond traditional medicine.

Although saliva testing is both efficient and convenient, its uptake in many clinical settings has been hampered by a lack of knowledge, and the absence of standardized collection and analysis protocols. However, standard operating procedures (SOPs) are now in place regarding sample collection methods – as well as analytical processes – and saliva diagnostics is growing consistently globally based on market trends and experience. It is particularly popular in emerging areas of medicine, such as the ‘wellness’ space, which includes occupational medicine, sports medicine, mental health and sleep disorders.3,4

An individual’s overall wellbeing is affected significantly by hormonal fluctuations, and individuals seeking answers to a range of issues – including stress, mood, memory, energy, weight management and more – often turn to integrative medicine when conventional medicine falls short. Saliva testing offers a simple way to establish baseline hormone levels, serving as a starting point for further investigations. Commonly requested tests include cortisol, estradiol, progesterone, testosterone, and its precursor dehydroepiandrosterone (DHEA). By identifying hormonal imbalances, these tests pave the way to effective solutions for a range of health concerns. Salivary biomarkers have also been found to be helpful in detecting and monitoring mental health conditions – such as depression6 – evaluating circadian rhythms and diagnosing sleep disorders,7 monitoring the outcomes of hormone replacement therapy (HRT) in perimenopausal women,8 and as a benchmark for optimizing recovery and performance in athletes.9,10

Choosing the right assay.

The ongoing expansion of saliva diagnostics into a wide range of application areas would not have been possible without an extensive array of commercially available assays. However, to ensure reliable diagnoses, it is crucial that laboratories choose an assay with demonstrated sensitivity, accuracy, precision, reliability and reproducibility. Tecan has over 40 years of experience in manufacturing immunoassays for hormone testing, and is pioneering assays of exceptional quality to serve a growing saliva research and diagnostics community. For example, FLUIDS iQ in Canada relies on saliva-based immunoassays from Tecan to offer its patients a personalized approach to health and wellness. President and CEO Dr Aron Gonshor explained why Tecan was the company’s provider of choice: “We chose Tecan for its high-quality assays, but the company does more than just supply saliva testing kits. It also offers an independent proficiency testing program to help laboratories safeguard the accuracy and reliability of analytical results.”

Another diagnostic laboratory based in Slovenia, Medicare PLUS, relies on ELISA kits from Tecan to measure more than six separate biological mediators in patient saliva samples. Aleš Koščak, CEO of Medicare PLUS, commented: “The kits are very reliable, consistently performing to the high standards we require, and generating very low CVs (coefficients of variation) of under eight percent. Tecan also runs an independent quality control scheme as an additional service, which allows us to compare the performance of our testing results against other labs, and this is vital to meet our external quality control regulations set by the Ministry of Health.”

Transforming healthcare testing.

Laboratories worldwide rely on Tecan’s luminescence- and ELISA-based saliva immunoassays due to their high analytical sensitivity. Tecan offers a wide range of IVDR certified saliva diagnostic kits*, as well as a fast, reliable and professional service – backed by capable scientific and technical support – to laboratories across the world. These reliable, convenient and effective diagnostic tools are revolutionizing many areas of healthcare testing for patients and medical professionals alike and, ultimately, saliva-based assays from Tecan have the potential to replace invasive diagnostic testing and significantly improve patient outcomes.

More information.

To find out more or to see our full portfolio please visit:

www.ibl-international.com/complementary-medicine/saliva-diagnostics
www.tecan.com/the-power-of-saliva-diagnostics

* Product availability and regulatory status may vary across regions outside the EU depending on local country-specific registration. Consult with your Tecan associate for further information.

References
  1. Bellagambi, F.G. et al. Saliva sampling: Methods and devices. An overview. TrAC Trends in Analytical Chemistry, 2020, 124, 115781. doi: 10.1016/j.trac.2019.115781.
  2. Lewis J. G. Steroid analysis in saliva: an overview. The Clinical Biochemist. 2006, 27(3), 139-146. PubMed ID: https://pubmed.ncbi.nlm.nih.gov/17268582.
  3. Gonshor, A. and Yeska, N. Salivary hormone testing – the way of the future?. Accessed 7th July 2023. Available at: https://www.biocompare.com/Editorial-Articles/570053-Salivary-Hormone-Testing-The-Way-of-the-Future/.
  4. Gonshor, A. and Yeska, N. Salivary hormone testing – The blood of the 21st century?. Labcompare. Accessed 7th July 2023. Available at: https://www.labcompare.com/10-Featured-Articles/569602-Salivary-Hormone-Testing-The-Blood-of-the-21st-Century/.
  5. Landman, A.D. et al. Testosterone in human saliva. Experientia, 1976, 32(7), 940-941. doi: 10.1007/bf02003781.
  6. Chojnowska, S. et al. Salivary biomarkers of stress, anxiety and depression. Journal of Clinical Medicine, 2021, 10(3), 517. doi: 10.3390/jcm10030517.
  7. Rahman, S.A. et al. Clinical efficacy of dim light melatonin onset testing in diagnosing delayed sleep phase syndrome. Sleep Medicine, 2009, 10(5), 549-555. doi: 10.1016/j.sleep.2008.03.020.
  8. Sufi, S.B. et al. Multicenter evaluation of assays for estradiol and progesterone in saliva. Clinical chemistry, 1985, 31(1), 101-103. doi: 10.1093/clinchem/31.1.101
  9. Lewis J. G. Steroid analysis in saliva: an overview. The Clinical biochemist, 2006, 27(3), 139-146. PubMed ID: https://pubmed.ncbi.nlm.nih.gov/17268582/.
  10. Budde, H. et al. The cortisol response to exercise in young adults. Frontiers in behavioral neuroscience, 2015, 9, 13. doi: 10.3389/fnbeh.2015.0001.