Intended Purpose
Enzyme immunoassay for the quantitative determination of Melatonin Sulfate in human urine. Quantification of melatonin sulfate indicates physiological functions or states of the pineal gland that regulates sleep-wake cycles. Patient population includes healthy adults and adults suspected to be affected by sleep disorders. The assay should not be performed with patient samples that might be affected by interference from exogenous melatonin or samples that might be affected by drugs that interact with melatonin metabolism. The Melatonin-Sulfate Urine ELISA is a solid phase enzymelinked immunosorbent assay (ELISA), based on the principle of competitive binding and measured on an absorbance reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as absorbance microplate reader/washer, vortexer and pipettes to execute the test. Test results may be calculated manually from a standard curve and compared to laboratory established reference ranges from healthy adults (i.e., normal ranges). The test kit is intended for professional laboratory use only. The test kit is not for self-testing. The Melatonin-Sulfate Urine ELISA is NOT intended for near-patient testing.
Clinical significance
Melatonin is an intermediate product of tryptophan metabolism and is released into the bloodstream originating from the pineal gland. Melatonin production is regulated by the circadian timing system. In healthy individuals, it is produced in synchrony to the light/dark cycle, being tightly restricted to the night, provided it is dark. Light stimulus (mainly in the blue range) inhibits melatonin synthesis. The role as a physiological marker has been documented in review articles [1-7] and textbooks.[8-10] Most of the circulating melatonin is metabolized in the liver to 6-hydroxymelatonin and subsequently to 6-sulfatoxymelatonin which is excreted into the urine. The concentration of 6-hydroxymelatonin sulfate in urine correlates well with the total level of melatonin in plasma during the collection period.[7] Melatonin concentrations play an important role in the regulation of sleep patterns. The start of melatonin production in the human body can we assessed via the timing of the acrophase and/or the dim light melatonin onset (DLMO). Disruption to healthy sleep patterns (exposure to bright light at nighttime or the participation in night shift work) can alter the DLMO and lead to a phase advance or phase delay of the melatonin concentration in the sample. Urinary melatonin sulfate is a useful biomarker in circadian dysregulation through shift work or exposure to bright light at night. Furthermore, time-resolved quantification of melatonin levels can provide information about diurnal type (morning versus evening).[11] Melatonin and melatonin sulfate concentrations in circulation are highly variable. During the day, melatonin sulfate levels are very low. At night, melatonin sulfate concentrations rise.[12, 13, 14] A large variety of methods to assess the onset of melatonin production has led to a formation of an expert group to establish recommendations for the calculation beginning of melatonin secretion. Laboratories should follow consensus guidelines on the generation of data for circadian pace making. Measurements of Melatonin-sulfate in urine show the accumulated amount of 6-sulfatoxymelatonin during an interval of time; overnight Melatonin sulfate levels can be calculated from the first morning void and compared to daytime collected urine fraction.[14] Clinicians should consider the effects of non-modifiable factors (e.g. age), modifiable factors (lighting, seasonal change, physical activity), comorbidities (ophthalmic diseases, spinal cord injuries, liver diseases and disorders, kidney diseases and disorders) and drugs or nutrition supplements that either increase (melatonin, antidepressants, MAO inhibitors) or decrease (1-adrenergic blockers alpha-2 adrenergic agonist, benzodiazepines) on the measurement of melatonin and its metabolite melatonin sulfate.[11]
*Product availability and regulatory status may vary across regions outside the EU depending on local country-specific registration. CE IVD under IVDR to be launched soon. Consult with your Tecan associate for further information.
For concrete data please consult the Instruction for Use in the download box on the top right side.
For concrete data please consult the Instruction for Use in the download box on the top right side.
(1) Delagrange, P.; Guardiola-Lemaitre, B. Melatonin, Its Receptors, and Relationships with Biological Rhythm Disorders. Clin. Neuropharmacol. 1997, 20 (6), 482–510. https://doi.org/10.1097/00002826-199712000-00002.
(2) Macchi, M. M.; Bruce, J. N. Human Pineal Physiology and Functional Significance of Melatonin. Front. Neuroendocrinol. 2004, 25 (3–4), 177–195. https://doi.org/10.1016/j.yfrne.2004.08.001.
(3) Benloucif, S.; Burgess, H. J.; Klerman, E. B.; Lewy, A. J.; Middleton, B.; Murphy, P. J.; Parry, B. L.; Revell, V. L. Measuring Melatonin in Humans. J. Clin. sleep Med. JCSM Off. Publ. 2008, 4 (1), 66–69.
(4) Zawilska, J. B.; Skene, D. J.; Arendt, J. Physiology and Pharmacology of Melatonin in Relation to Biological Rhythms. Pharmacol. Reports 2009, 61 (3), 383–410. https://doi.org/10.1016/S1734-1140(09)70081-7.
(5) Xie, Z.; Chen, F.; Li, W. A.; Geng, X.; Li, C.; Meng, X.; Feng, Y.; Liu, W.; Yu, F. A Review of Sleep Disorders and Melatonin. Neurol. Res. 2017, 39 (6), 559–565. https://doi.org/10.1080/01616412.2017.1315864.
(6) Cipolla-Neto, J.; Amaral, F. G. do. Melatonin as a Hormone: New Physiological and Clinical Insights. Endocr. Rev. 2018, 39 (6), 990–1028. https://doi.org/10.1210/er.2018-00084.
(7) Amaral, F. G. do; Cipolla-Neto, J. A Brief Review about Melatonin, a Pineal Hormone. Arch. Endocrinol. Metab. 2018, 62 (4), 472–479. https://doi.org/10.20945/2359-3997000000066.
(8) Pandi-Perumal, S. R. Melatonin: Biological Basis of Its Function in Health and Disease; CRC Press, 2005. https://doi.org/10.1201/9781498713511.
(9) Korf, H.-W.; Schomerus, C.; Stehle, J. H. The Pineal Organ, Its Hormone Melatonin, and the Photoneuroendocrine System; Advances in Anatomy, Embryology and Cell Biology; Springer Berlin Heidelberg: Berlin, Heidelberg, 1998; Vol. 146. https://doi.org/10.1007/978-3-642-58932-4.
(10) Rodenbeck, A.; Huether, G.; Rüther, E.; Hajak, G. Nocturnal Melatonin Secretion and Its Modification by Treatment in Patients with Sleep Disorders. Adv. Exp. Med. Biol. 2000, 467, 89–93. https://doi.org/10.1007/978-1-4615-4709-9_12.
(11) Rzepka-Migut, B.; Paprocka, J. Melatonin-Measurement Methods and the Factors Modifying the Results. A Systematic Review of the Literature. Int. J. Environ. Res. Public Health 2020, 17 (6), 1916. https://doi.org/10.3390/ijerph17061916.
(12) Ba-Ali, S.; Brøndsted, A. E.; Andersen, H. U.; Sander, B.; Jennum, P. J.; Lund-Andersen, H. Assessment of Diurnal Melatonin, Cortisol, Activity, and Sleep−wake Cycle in Patients with and without Diabetic Retinopathy. Sleep Med. 2019, 54, 35–42. https://doi.org/10.1016/j.sleep.2018.10.018.
(13) Wiesner, C. D.; Davoli, V.; Schürger, D.; Prehn-Kristensen, A.; Baving, L. Melatonin Secretion during a Short Nap Fosters Subsequent Feedback Learning. Front. Hum. Neurosci. 2018, 11. https://doi.org/10.3389/fnhum.2017.00648.
(14) Mahlberg, R.; Tilmann, A.; Salewski, L.; Kunz, D. Normative Data on the Daily Profile of Urinary 6-Sulfatoxymelatonin in Healthy Subjects between the Ages of 20 and 84. Psychoneuroendocrinology 2006, 31 (5), 634–641. https://doi.org/10.1016/j.psyneuen.2006.01.009.
Our comprehensive immunoassay portfolio includes a number of specialty diagnostic immunoassays for endocrinology, immunology and autoimmunity, as well as for diagnosis of multiple infectious diseases. We are pioneers and market leaders in saliva diagnostics, with over 40 years of experience supplying a broad portfolio of luminescence- and ELISA-based tests, including our highly acclaimed HMGB1 and MuSK-Ab ELISAs.
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