In-vitro diagnostic medical devices for determining saliva volume

a medical device and saliva volume technology, applied in the field of collecting saliva, can solve the problems of pain and stress, limited availability, and inability to meet the needs of qualified personnel, and achieve the effects of increasing the reproducibility and reliability of tests, reducing variability from subject to subject, and increasing saliva secretion

Inactive Publication Date: 2006-04-06
GREINER BIO ONE GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 con

Method used

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  • In-vitro diagnostic medical devices for determining saliva volume

Examples

Experimental program
Comparison scheme
Effect test

embodiment 1

[0159] Before gargling 2 ml of saliva-collecting solution corresponding to the composition listed in the table, the patient rinses the mouth with distilled water in order to remove any food remains or other components which might lead to distortion from the oral cavity.

[0160] Saliva-Collecting Solution:

Pilocarpin 6 mgYellow orange S200 mgCholesterine100 mgStrawberry flavouring 10 mgTop up with distilled water to a volume of 1000 mlAdjust to a pH value of 4.5

[0161] After gargling four times a minute, each time with 2 ml of saliva-collecting solution, all of the saliva-saliva collecting solution mixture in the container 1 is collected, the distance of the tubular projection 9 from the base of the base part 2 of the container 1 being 2 mm. A filtration unit 13 of glass wool is also disposed in the container 1, in the region of the tubular projection 9. The pore size of the filtration unit 13 is 50 μm.

[0162] The saliva-saliva collecting solution mixture is transferred to an evacuate...

embodiment 2

[0170] The patient gargles 6 ml of saliva-collecting solution based on the composition specified in the table.

[0171] Saliva-Collecting Solution:

Ascorbic acid4 gCurcumin2 gTop up with distilled water to a volume of 1000 mlAdjust to a pH value of 5

[0172] After gargling the saliva-collecting solution for 5 minutes, the saliva-saliva collecting solution mixture is collected in the container 1, the distance of the tubular projection 9 from the base of the base part 2 of the container 1 being 0.9 mm. Also disposed in the container 1 in the region of the tubular projection 9 is a filtration unit 13 in the form of a nitrocellulose membrane between the penetration device 8 and the tubular projection 9. The pore size of the filtration unit 13 is 10 μm.

[0173] The saliva-saliva collecting solution mixture is transferred to an evacuated collection vessel, which is coated with the solution specified in the table.

[0174] Solution with Reagents:

Potassium benzoate 8 g / lSodium chloride15 g / l

[01...

embodiment 3

[0181] Before gargling 5 ml saliva-collecting solution based on the composition specified in the table, the patient rinses the mouth with distilled water in order to remove any food remains or other components which might cause distortion from the oral cavity.

[0182] Saliva-Collecting Solution:

Sodium dihydrogen citrate20 g Sodium citrate tribasic monocitrate8 gGlucose5 gTop up with distilled water to a volume of 1000 mlAdjust pH value to 4.0

[0183] After gargling with the saliva-collecting solution for three minutes, the saliva-saliva collecting solution mixture is collected in the container 1, the distance of the tubular projection 9 from the base of the base part 2 of the container 1 being 3 millimetres.

[0184] The saliva-saliva collecting solution mixture is transferred to an evacuated collection vessel, which is coated with the solution specified in the table.

[0185] Solution with Reagents:

Potassium benzoate  1 g / lPotassium chloride0.05 g / l

[0186] The collection vessel with th...

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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...

Claims

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Application Information

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IPC IPC(8): C12Q1/00C12Q1/34
CPCA61B10/0051A61B10/0096
Inventor KONRAD, FRANZ
Owner GREINER BIO ONE GMBH
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