In-vitro diagnostic medical devices for determining saliva volume

Abstract

The invention relates to a method of collecting saliva from the oral cavity for detecting a test substance, comprising the steps of (a) cleaning the oral cavity, (b) stimulating saliva secretion with a saliva-collecting solution, (c) removing the saliva-saliva collecting solution mixture from the oral cavity and collecting it in a container (1), (d) transferring the saliva-saliva collecting solution mixture into a sealable collection vessel.

Description

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to a method of collecting saliva from the oral cavity for detecting a test substance, a saliva-collecting solution for obtaining saliva, containers for biological fluids comprising a base part and a cover part, each with an external face and an internal face, the cover part having a cut-out in the form of a recess in which a transfer mechanism is disposed and incorporates a mechanism for penetrating a collection vessel provided on the external face of the cover part and a projection with two ends provided on the internal face of the cover part, a sealable collection vessel for accommodating biological fluids such as blood, for example, with an internal face directed towards a biological sample, a saliva simulation solution for imitating the composition of physiological saliva, a calibrator solution for quantifying the volume of saliva, a test kit for obtaining saliva and applications th...

AI Technical Summary

Benefits of technology

[0023] The objective of the present invention is to propose individual components and a method for taking and quantifying reproducible samples of saliva for further analysis purposes.

[0024] This objective is achieved by the invention independently in each case by a method of collecting saliva from the oral cavity with a view to detecting substances to be analysed, comprising the steps of (a) cleaning the oral cavity, (b) stimulating saliva secretion with a saliva-collecting solution, (c) removing the saliva-saliva collecting solution mixture from the oral cavity and collecting it in a container, (d) transferring the saliva-saliva collecting solution mixture to a sealable collection vessel, and is also achieved by means of a saliva-collecting solution containing a substance with taste-stimulating properties, an indicator substance and/or reagent and water, and by means of a container such that when the container is in the assembled state, the end of the projection of the transfer mechanism disposed closer to the base part is at a distance of 3 mm maximum from the base part, and by means of a sealable collection vessel whereby a solution containing a stabilising reagent or preservative and a reagent for dissolving the biological fluid and its contents, by means of a saliva imitating solution containing sodium, potassium or potassium compounds, human serum albumin, urea and water, by means of a calibrator solution of saliva-collecting solution and/or saliva imitation solution and sodium azide, potassium benzoate and/or Thimerosal®, and by means of a test kit consisting of a saliva-collecting solution and a container and the use thereof. The advantage of this approach is that adopting a standardised method and stan

Problems solved by technology

The disadvantages of blood as an analysis material are its complex matrix, a limited availability, the need for qualified personnel to take samples and the time involved in this process, as well as the discomfort of the patient, accompanied by pain and stress.

Although saliva is produced constantly in the waking state, a total of approximately 1000 ml in 24 hours, and can be readily taken from the oral cavity, problems can also arise when collecting saliva samples, especially in the case of older patients.

Under certain conditions, however, this stimulation is not enough, for example in the case of dialysis patients and older patients, particularly in the morning after waking.

However, the disadvantage which all of the above methods have in common is the fact that only a very small quantity of saliva can be collected from patients or, in the case of persons who have a low saliva flow, the taking of samples is not reproducible, the volume is barely quantifiable and thus gives rise to problems when it comes to using it for diagnostic purposes.

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