Melatonin direct Saliva ELISA

Available as an IVDR compliant product!

Enzyme immunoassay for the direct, quantitative determination of melatonin in human saliva.

Intended purpose

Enzyme immunoassay for the direct quantitative determination of Melatonin in human saliva. Quantification of melatonin indicates physiological functions or states of the pineal gland that regulates sleep-wake cycles. This test is applied as an aid for the diagnosis of sleep disorders. Patient population includes healthy individuals and individuals 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 test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or layperson use. The test kit is intended for manual use or can be adapted to different open platform ELISA processors and can be applied to open automated platforms.

Summary and explanation

Melatonin is an intermediate product of tryptophan metabolism and is released into the blood-stream 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] . 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 dim light melatonin onset (DLMO). The DLMO allows characterization of the circadian rhythm secretion in multiple matrices (such as saliva). In apparently healthy individuals, DLMO occurs 2 - 3 hours before bedtime. Disruption to healthy sleep patterns (exposure to bright light at night time 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. Salivary melatonin 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 concentrations in circulation are highly variable. During the day, melatonin levels are very low. At night, melatonin concentrations rise. Illustrative examples for melatonin concentrations can be found in the scientific literature for example in the publications by Ba-Ali et al.[12] and Wiesner et al.[13]. 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 pacemaking. Benloucif et al. have published a consensus statement for measuring melatonin in humans in different matrices (such as saliva).[3] Several methods to obtain the DLMO in a consensus statement by Benloucif et al.[3] For example, DLMO can be defined with a threshold calculated at 2 standard deviations above the average baseline of three or more pre-rise samples. Clinicians should consider the effects of non-modifiable factors (e.g. age) and modifiable factors (lighting, seasonal change, physical activity) on the measurement of melatonin concentration produced in humans that are discussed in detail in peer-reviewed literature.[11] Recommendations for sampling conditions are given in a consensus statement by Benloucif et al.[3] Clinicians should consider the effects of comorbidities (ophthalmic diseases, spinal cord injuries, liver diseases and disorders, kidney diseases and disorders) on the measurement of melatonin concentration produced in humans that are discussed in detail in peerreviewed literature. [11] Clinicians should consider the effects of 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 concentration produced in humans that are discussed in detail in peer-reviewed literature. [11] Laboratories should consider the effect of crossreactivity on the daytime melatonin concentrations that set the baseline for the quantification of melatonin onset.

*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.