MXPA00005213A - Method and apparatus for preserving human saliva for testing - Google Patents

Abstract

A method and apparatus for the preservation of a saliva sample for use in subsequent quantitative chemical assays. The method involves collecting a saliva sample at a location, directly into a specimen cup. The specimen cup contains a predetermined volume of aqueous solution of pH buffered saline and enzymatic inhibitor and is optionally adapted with a constituent compound specific, qualitative test unit.

Description

METHOD AND APPARATUS FOR PRESERVING HUMAN SALIVA FOR ANALYSIS FIELD OF THE INVENTION This invention relates to a method for the preservation of human fluid samples. More particularly, this invention relates to a method for the preservation and storage of human saliva samples for use in subsequent analyzes to determine the presence of drugs.

BACKGROUND The abuse of drugs and alcohol are common problems in today's society, which destroy the individuals that suffer from it and that adversely affect those close to these individuals. While the abuse of drugs and alcohol are problems for society as a whole, employers are particularly susceptible to its harmful effects.

In the modern workplace, focused and efficient employees are essential for employers, who want to maintain high quality and productivity while minimizing costs and absenteeism. In order for employees to achieve and sustain high productivity, it is crucial that every employee stays healthy and alert. An employee in poor health or who is not attentively reduces efficiency and may increase the risk of harming himself or herself and other employees. Reduced productivity and quality, the increase in health care costs and the potential for long-term abuse are just three problems that an employer may encounter when an employee abuses drugs or alcohol. In an effort to combat drug and alcohol abuse in the workplace, many employers require their employees to undergo compulsory drug testing. These exams, which are usually ordered spontaneously, generally require the employee to leave his or her place of occupation and move to an examination facility close to it. Alternatively, the examination could take place at the workplace but many of these tests require a urine sample that, of course, includes providing the employee with at least a minimum of privacy. The current way of examining results, therefore, in at least two problems: 1) the employee is required to leave his job to undergo the examination when he might otherwise be working; and 2) the privacy required by urine tests provides the employee with the opportunity to deliver a fraudulent sample (for example, the employee could obtain a sample from another person and deliver that sample without drugs for examination). In this way, it would be desirable for an employer to have a method to examine an employee in the place of his occupation with only a minimum level of personal inconvenience for the employee. Alternatively, a similar method is useful in helping a law enforcement officer keep a suspicious saliva sample for later forensic analysis, for example, to determine the level of alcohol or other drug in an individual's blood. As a method to avoid the inconvenience and expense associated with laboratory drug testing, it would also be desirable that a qualitative analysis be made at the time of saliva collection to determine if a quantitative analysis is warranted. The present invention provides a method for preserving saliva in a liquid solution for subsequent chemical tests. This method would allow the employee to remain at his workplace, would require only minor inconvenience during the analysis and would provide the necessary assurances against the delivery of fraudulent evidence and at the same time would ensure that a precise and accurate drug test could be conducted at a time later. The present invention is also useful to provide an instantaneous, qualitative test for a drug after the saliva sample has been sealed inviolably.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of a sample container of the present invention; and Figure 2 is a cross-sectional view of a capillarity of the sample container shown in Figure 1.

SUMMARY OF THE INVENTION The present invention is a method and composition for the preservation of a saliva sample for use in subsequent quantitative chemical assays. The method includes collecting a saliva sample at a location, directly in a sample container. The sample container contains a predetermined volume of aqueous solution of saline solution stabilized in pH and enzyme inhibitor. The sample bottle is optionally fitted with a qualitative test unit, specific for a constituent compound contained within a capillarity extending from the bottle. The qualitative test unit contains a vacuum-packed vial containing dry enzyme, a plug that swells on contact with the solution and a colorimetric reagent. When the vial is broken, a predetermined volume of solution is withdrawn towards capillarity, thereby activating the qualitative test unit. The plug that swells on contact with solution is then swollen briefly to separate the qualitative test volume from the contents of the sample container. After an inviolable seal has been practiced, the sample container is then transported to a second off-site location, where the saliva sample solution is quantitatively analyzed by a saliva constituent compound by common conventional means for urine analysis or blood.

DESCRIPTION OF THE PREFERRED MODALITY (S) (S) Many hydrophilic compounds in general, and alcohol in particular, once absorbed from the intestinal tract, and into the blood stream are mixed uniformly in the total body water of the body. body. For the purpose of the present invention, a hydrophilic compound is defined as a substance that is found in the body plasma, either in administered form or as a metabolite thereof. While the description details a method and composition for the preservation of a saliva sample for the determination of ethanol content, it is appreciated that the present invention is operative for the measurement of various other hydrophilic compounds absorbed and excreted by the parenchyma. These other compounds include, illustratively: protein, mucin; marijuana, opiates, cocaine, cannabinoles, metabolites thereof; catecholamine and catecholamine derivatives. Fatty tissues include tissues or tissue fractions joined by lipid membranes such as erythrocytes. Hydrophilic compounds enter a tissue like this, but do not dissolve in the fat, but preferably in the water contained within that tissue. Thus, it is completely found that alcohol, for example, after several times of circulation is in a volume of approximately 0.60-0.68 liter / kg in a male person and approximately 0.52-0.54 liter / kg in a person of the female sex Once in the water of the body, the alcohol is distributed throughout this volume of water and is subject to limits of metabolism, excretion, separation and excretion. Some parts of blood, especially the water component of the blood, are essential for the perfusion of glandular tissues such as, for example, the exocrine glands of the alimentary tract, those glands of the mouth and the oral cavity, the pancreas and other lower organs in this route. In particular, the perfusion of the salivary glands of the buccal and pharyngeal cavities, which include: the parotid glands, the submaxillary glands and the sublingual glands, which are of importance for this method. During the process of the blood that perfuses these glands, nutrients (amino acids, carbohydrates and fats) and water that represents the largest volume are taken from the capillarity bed (s) of these glands, and exposed to the individual cells of the gland. The cells are usually referred to as the "parenchymal" cells of the gland, for example, the cells that "secrete" water, protein or other substances (mucin, etc.). It is the fraction of "water that represents the greatest volume", for example, the water present in the parenchyma, which makes up the fluid portion of any secretion coming from a gland. Finally, a substance dissolved in the "water that represents the greatest volume" of the gland is often excreted when the gland is called to excrete. In the case of any of the salivary glands, the water, and some protein material are excreted in the saliva. In this way, the excretions of the salivary glands are composed of an isotonic or slightly hypertonic aqueous salt solution, generated from the blood plasma. These excretions may also contain several enzymes since they are characteristic of the gland, the various enzymes have proteolytic activity to disintegrate or metabolize proteins to peptides and / or amino acids; dissociation properties of complex carbohydrate; and to a lesser degree, lipid metabolizing properties. Ethyl alcohol ("alcohol"), when present in plasma (or blood) derived from the consumption of ethanol, is a component of the blood that perfuses the salivary glands. It is known that alcohol is extracted into saliva and that it is concentrated from the plasma during this process, so that, in humans, there is a concentration of 8 to 15% of the present concentration in an equivalent blood sample. The ethanol content in saliva has been measured to be approximately 9% higher than that found in capillary blood, C. Lenter, Geigy Sci in ti fi c Tabl es, Vol. 1, Uni ts ofMeasurement, Body Fl uids, Compositions of the Body, Nu tri ti on, Basle: Ciba-Geigy, 1981; which is incorporated here as a reference. In a saliva sample, the measurement of the level of alcohol in the blood is determined by quantifying the concentration of alcohol in a saliva sample. Studies indicate a high correlation between ethanol concentrations in samples of saliva, breath and blood taken simultaneously. A correlation coefficient of r = 0.97 between blood and saliva was measured. A difference in mean saliva-blood concentration of 9.4 percent concentration was observed. Statistically, at a 95% confidence level, the concentration of alcohol in the saliva varies from 88 to 136 percent concentration of the blood alcohol level (BAL). TO. . Jones, Clin. Chem. (1993), Vol. 39 (9): 1837-1843, which is incorporated herein by reference. Studies conducted by the inventor have determined that the volume of any saliva "spittoin" randomly from the mouth will be an average of approximately 2.0 milliliters, normally averaging 1.85 to approximately 2.35 milliliters. A sample of saliva like this can be used to estimate the concentration of alcohol present in the blood that perfuses the salivary glands that produce the saliva sample. If a person can not spit, for example, because they are fearful or scared or in any way become unable to generate a saliva sample, they are optionally put in contact with the oral cavity substances to generate a reflex stimulation of saliva through the glands above mentioned. These substances include, illustratively, citric acid (e.g., a trickle of lemon) or milk. The saliva sample, when obtained and preserved in a suitable solution, is subsequently used to estimate a concentration of alcohol in the blood in the person from whom it was taken. The solution in which the saliva is placed includes an agent to decrease the degradation of saliva by inhibiting the enzymatic metabolism of the alcohol or the test substance present in the sample by bacteria, fungi, leukocytes, macrophages or other organisms that they can reside in the environment of the mouth or respiratory cavities of the donor of the sample. The solution contains a solute present at a concentration in the range of osmolalities associated with normal physiological body fluids. Body fluids include: body plasma, urine and saliva. In a preferred embodiment of the present invention, a sample solution is prepared containing a solution of diluted aqueous protein matrix and salt that mimics body plasma or urine, and an enzyme inhibiting agent. Commercially available diluted protein and salt matrices are operative in the present invention. A protein and salt matrix mimics the osmolality, composition, pH and general properties of body plasma or urine. The known parameters associated with the body plasma serve as a baseline calibration for the quantitative analysis of the sample within the matrix solution. The constituent substances of a salt and protein matrix like this include illustratively: bicarbonate, calcium, chloride, phosphate, potassium, sodium, sulfate, sulfite, albumins, amino acids, nucleotides, nucleosides, urea, creatine, citrate, format and lactate . The salt and protein matrix is optionally replaced with a conventionally used solution for the storage of bodily fluids, among which are included, illustratively: a solution of isotonic saline buffer solution (0.085 g / L NaCl); and 50 m buffer solution. The pH of this solution is preferably between 7 and 8. An enzyme inhibiting agent of the present invention is present at a concentration of 0.01 to 10 mole percent, regarding the water of sample solution. The agent serves to stop the action of enzymes that degrade substances such as drugs or alcohol inside the living cells contained in the sample or in the solution of the sample container. In the embodiments of the present invention, the operation in the determination of the alcohol concentration, the inhibition of alcohol dehydrogenase is of particular concern. More preferably, the enzyme inhibiting agent is present from 0.05 to 1 mole percent relative to the sample solution. Enzyme inhibiting agents of the present invention include: aminoglycosides, cephalosporins, tetracyclines, sulfa drugs, penicillins and similar antibiotics. It is appreciated that the optimum concentration of enzyme inhibiting agent is dictated by the effectiveness of the specific compound in altering the enzymatic activity. The agents of the present invention may also have secondary biocidal effects on the organisms present in the sample container. Preferably, the enzyme inhibitor functions to interfere with the reactions of the glycolysis pathway. Optionally, a fungicide (or mycocide) is added to the sample solution. Preferably, the fungicide (or mycocide) is present in a concentration of about 0.01 to 10 mole percent, relative to the water of the sample solution. More preferably, the fungicide (or mycocide) is present in a concentration of about 0.05 to 1 mole percent, relative to the water of the sample solution. Fungicides or functional mycocides in the present invention include, illustratively: polymyxins, polinoxilins, nystatin, hedaquinium chlorides, tetrachloroisophthalonitrile, and ketoconazole. Optionally, a bactericide is added to the sample solution. Preferably, the bactericide is present in a concentration of about 0.01 to 10 mole percent, relative to the water of the sample solution. More preferably, the bactericide is present at a concentration of about 0.05 mole percent, relative to the sample solution water. The bactericides operative in the present invention include, by way of illustration: aminoglycosides, cephalosporins, tetracyclines, sulfa drugs, penicillins and similar antibiotics. The order by which these reaction agents are prepared or mixed is not essential and has no impact on the ultimate utility of the solution in the present invention. The above reaction agents should be mixed well and, preferably, shipped to sterile containers, with a volume of between 10 and 40 milliliters and preferably of at least 15 and less than about 18 ml. This volume of material and reaction agent is suitable for analysis by a laboratory to determine the concentration of alcohol present in the sample container by conventional techniques such as an analysis of alcohol dehydrogenase. Optionally, a different volume of the solution is used in the sample container for the collection of a sample, according to the established analysis techniques. It is appreciated that dilution of the sample with large volumes of solution in the sample container may require a primary amplification of the sample to produce accurate results of the analysis. The sample container preferably has sealing means to prevent violation or opening prior to the examination. The sample container has, more preferably, a port for the extraction of a test aliquot. In the operation of the present invention, a test participant spits in the sample container containing matrix solution. Once a sample has been taken, the container is sealed and transported to an off-site laboratory for further analysis. Preferably, the container containing the sample is stored at a temperature between about 4 ° C and 25 ° C. An aliquot of the sample of 100 microliters (0.1 ml), then analyzed, the values thus obtained are multiplied by a factor of 44.8 to estimate a concentration of alcohol in the blood in milligrams per deciliter (mg / dl) in the original blood sample. The studies carried out by the inventor found an error of 6 to 8 percent concentration when comparisons were made between saliva samples of the present invention and levels in venous blood withdrawn simultaneously and containing ethyl alcohol. Comparative analyzes were carried out by gas chromatography. A second embodiment of the present invention, which can be applied to the determination of alcohol in the blood, incorporates a means to quantify the amount of alcohol present in the sample, at the location of the sample collection, or having an agent system of reaction that performs the required chemical reactions, and a coupled detector system that allows the analysis and / or visualization of the sample. To add such a component to the collection system, in addition to the above reaction agents in the sample solution to collect, contain and maintain the sample, an analysis solution in itself also contains reagents to perform alcohol analysis, using an enzymatic analysis which incorporates the formation of NADPH from NADP which acts as a cofactor in conjunction with the conversion of alcohol dehydrogenase enzyme, from ethanol to acetaldehyde. It is appreciated that the use of alcohol oxidase, alone or in combination with a peroxidase enzyme, can also provide a colorimetric product by redox reaction. Under the conditions of the test, the alcohol in the saliva sample reacts with the enzyme and the excess NADP to form a product, acetaldehyde, and the reduced cofactor, NADPH in quantitative yield. In addition, for the detection of a salivary constituent compound other than alcohol, a different enzyme system is required, these enzymes are known in the art, as is the use of catalytic antibodies to effect redox chemistry in the constituent compounds. An additional reagent required to determine the concentration of alcohol in a saliva sample results in an interaction of NADPH with nitro blue tetrazolium (NBT - nitro blue tetrazolium). The NBT will interact with NADPH in a quantitative way to form a reduced formazan. These components are of intense color, usually dark blue and in this way can be easily quantified by spectrophotometric means. The following examples are provided for purposes of illustrating various embodiments of the invention and do not mean that they limit the present invention in any way. Figure 1 shows, in general with the number 10, a sample container designed to perform, on site, the qualitative detection of a compound constituent of saliva and the subsequent quantitative analyzes. A threaded cap 12 is adapted to selectively seal the mouth 14 of a bottle 16. An inviolable adhesive tape is optionally deployed in contact with the lid 12 and the bottle 16 after collection of a sample of saliva (not shown). The bottle 16 has at least one hollow capillarity 18 extending from the wall 20 of the bottle. The capillarity 18 extends from the wall 20 of the bottle in a position so as to ensure that the sample solution within the bottle 16 covers the capillarity opening when the sample container 10 is placed in an upright position. Preferably, the capillarity 18 is an integral part of the bottle 16. The bottle 16 is injection molded of a suitable thermoplastic material. The bottle 16 is transparent or translucent in appearance. A sample container designed for the qualitative, on-site detection of a compound constituting the saliva is designed to remove a predetermined volume of solution for detection and then isolate that volume from the total sample solution. Isolation of the volume for detection ensures that the reagents of the qualitative detection do not interfere with the subsequent qualitative analyzes. Figure 2 shows a cross-sectional view of the capillarity 18. The thickness 22 of the capillarity wall 18 is, optionally, less than the thickness of the wall 20 of the bottle. A thin capillary wall is flexible and allows the capillarity to bend. A thin-walled ampule 24 is adapted to be inserted within the inner diameter of the capillary 18. The ampoule 24 fills most of the volume of the inner diameter of the capillarity. The vial 24 contains the reagents for the colorimetric detection if shown collectively at 26, as well as a plug material 28 which swells upon contact with the solution. Preferably, the contents of the ampule 24 are stored under vacuum. The reagents 26 include a frozen dry enzyme specific for the constituent of interest of the saliva and a suitable colorimetric indicator activated by redox reaction. Optionally, the enzyme and the indicator are mixed with an inert substrate, such as, for example, glass fiber. The plug 28 that swells on contact with the solution is preferably an inert hydrophilic polymer that is susceptible to rapid hydration upon contact with the sample solution. The plug 28 that swells on contact with the solution is, illustratively, cellulose, carboxymethyl cellulose, gelatin, alginates and mixtures thereof. An ampoule containing specific reagents for the constituent compound and an inflatable plug material is inserted into the flexible capillarity. A quantity of measured solution is sealed in the bottle. A sample of saliva is collected from the user, removing the lid and causing it to spit inside the bottle, subsequently, the bottle is resealed and, optionally, sealed inviolably with an adhesive tape. When the saliva solution becomes cloudy, the capillarity is bent to break the ampule contained in it. While the vial ruptures, the solution fills the capillarity to balance the pressure between the capillarity and the upper space within the sample container vial. The amount of solution withdrawn towards capillary action is controlled by the pressure and volume of the vial. Once the solution has filled the capillarity, the detection reagents are activated and the inflatable plug is hydrated to separate the detection volume from the rest of the solution. Based on the amount of detection reagents used, a colorimetric change is used to indicate a minimum amount of constituent compound that is present in the saliva sample. Therefore, multiple capillaries integrated into the sample container bottle are used to repeat the examination, for the incremental detection of a single substance, or the detection of baseline of multiple substances. The colorimetric change in the test reagents associated with the detection of the compound can be observed through the transparent or translucent wall of the capillarity.

An ampoule of the present invention is constructed of a glass tube, for example from a Pasteur pipette or a tube at melting temperature. One end of the glass tube is sealed by flame and then the material of the inflatable plug and the reagents for detection are added sequentially to the tube. The open end of the vial is then coupled to a vacuum line to reduce the pressure inside the bottle. While the vacuum line is evacuating the tube, a region of the tube above the reactants is softened by means of a heat source until the tube is sealed and removed free of the vacuum line. The vacuum line is maintained by a conventional means, such as a vacuum cleaner or a mechanical rotary pump. The vacuum-sealed ampule, optionally, is marked or otherwise thinned at a specific point to facilitate controlled fracture.

Example 1; The following compounds are individually operable as enzymatic inhibitor components of a sample solution of the present invention. The approximate effective concentrations for the individual enzyme inhibitor components are also provided.

Compound Concentration-10 mM deoxyglucose otenone 1-5 mM reduced luteinase (GSH) 1 mM 0.5 mM tatamate 0.5 mM ß-NADH 1.0 mM hydrogen peroxide H202 and Fe +++ 1.0 mM 1.0 mM odoacetate 1.0 mM odoacetamide 1 mM 1 mM soluble cyanides 1 mM aluminum chloride chlorhexidine 5 mM soluble sugars 0.5 mM 5 mM butyl parabens 5 mM cyclohexyladenosine 5 mM alpha-cyano-4-hydroxycinnamate 1 mM alpha-cyano-beta (1-phenylindol-3 -1 mM) glycerol acrylate 1 mM paraquat 1 mM manoheptulose 1 mM 3 -bromopyruvate 0.5 mM glucose 1, 6-bisphosphate 1 mM zul Cibacron 3G-A 1 mM 3-deoxyglucosone (3-DG) 1 mM actinomycin D 1 mM cycloheximide 1 mM magnesium citrate 1 mM 27. oxalates 1 mM 28. glutamates 1 mM 29 soluble fluorides and nitroprussides 4 mM Example 2; To 1 liter of sterile deionized water, the following compounds are added to give a suitable solution concentration for storage of a body fluid: 2.0 mM NaCl; KCl 0.35 mM; CaCl2 0.07 m; CaS04 0.1 mM; Na2P04 0.12 mM; creatine 23 mg, urea 300 mg, lactic acid 3 mg and bovine serum albumin 0.5 mg. The solution is stabilized at a pH of 7.1 using disodium EDTA. The enzyme inhibitor iodoacetate of Example 1 is added to give a concentration of 1.3 mM.

Example 3; 15.0 ml of the sample solution of the Example 2 is placed in a 2 oz. Graduated sample container having a sealable lid. A subject for expectoration test in the sample container. The total volume of the sample solution and saliva is measured to be 17 mi. Then 1 microliter (0.1 ml) is analyzed, the values obtained thus multiply by a factor of 44.8 to estimate the concentration of alcohol in the blood in mg / dl in the original blood sample. This multiplication factor incorporates the fact that the concentration of ethyl alcohol in saliva is 1.13-1.15 times that of the simultaneous BAL of the object under test. The aliquot is analyzed quantitatively by conventional gas chromatography techniques, while a venous blood sample is extracted simultaneously. There is a 7.1 percent concentration error between the BAL based on the saliva sample versus the blood sample. The urea present in the sample solution serves as a standard for quantitative analysis.

Example 4; The method as described in Example 3 is repeated with an aliquot which is analyzed by conventional gas chromatography techniques for methylamphetamine. An error of between 5 and 11 percent in concentration is observed for the levels of methylamphetamine based on the saliva test obtained from the present invention, when compared to the blood under examination.

Example 5; The method as described in Example 3 is repeated with an aliquot which is analyzed by conventional gas chromatography techniques for catecholamine. An error of between 5 and 9 percent in concentration is observed for the catecholamine levels based on the saliva test obtained from the present invention, when compared to the blood under examination.

Example 6; The method as described in Example 3 is repeated with an aliquot which is analyzed by conventional gas chromatography techniques for an opiate. An error of between 6 and 12 percent in concentration is observed for the levels of an opioid or opiate metabolite based on the saliva test obtained from the present invention, when compared to the blood under examination. The invention can also be incorporated into other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore considered, in all respects, as illustrative and not restrictive, the scope of the invention is indicated by the appended claims rather than by the foregoing description and all changes that come within the meaning and range equivalence of the claims are, therefore, intended to be included in it.

Claims (25)

1. NOVELTY OF THE INVENTION Having described the present invention, it is considered as a novelty and, therefore, the content of the following CLAIMS is claimed as property; 1. A case for the collection of a sample for analysis by direct collection and for the conservation of a saliva sample for subsequent analysis of a hydrophilic compound; the kit comprises: a) an ionic solute that upon dilution of a preselected volume in water, yields a solution with an osmolality of a normal physiological body fluid; and b) an enzyme inhibitor of an enzyme capable of using the hydrophilic compound as a substrate, the enzyme is present in the saliva sample. The kit according to claim 1, wherein the ionic solute is a salt and protein matrix having at least one constituent concentration of a normal body fluid. The kit according to claim 2, further comprising a buffer to maintain the solution at a predetermined pH between 7 and 8 after the introduction of the saliva sample. 4. The kit according to claim 2, wherein the hydrophilic compound is ethanol and the enzyme is alcohol dehydrogenase. 5. The kit according to claim 2, wherein the body fluid is plasma or urine. The kit according to claim 1, wherein the hydrophilic compound is selected from the group consisting of: ethanol, protein, marijuana, marijuana metabolites, opiates, opiate metabolites, cannabinoles, cannabinoid metabolites, cocaine, cocaine metabolites, catecholamine derivatives and metabolites thereof. The kit according to claim 2, wherein the salt and protein matrix contains substances selected from the groups consisting of: bicarbonate, calcium, chloride, phosphate, potassium, sodium, sulfate, sulfite, amino acid albumins, bilirubin, nucleotides, nucleosides, urea, creatine, citrate, format and lactate. The kit according to claim 1, wherein the enzyme inhibitor is selected from the group consisting of: 2-deoxyglucose, rotenone, reduced glutathione (GSH), octaoate, β-NADH, hydrogen peroxide H202 and Fe +++, iodoacetate, iodoacetamide , soluble cyanides, aluminum metal, chlorhexidine, soluble azides, butylparabenos, cyclohexyldenosine, alpha-cyano-4-hydroxycinnamate, alpha-cyano-beta (1-phenylindol-3-yl) acrylate, glycerol, paraquat, manoheptulose, 3-bromopyruvate , glucose 1, 6-bisphosphate, Cibacron Blue 3G-A, 3-deoxyglucosone (3-DG), actinomycin D, cycloheximide, Mg2 citrate, oxalates, glutamates, soluble fluorides and nitroprussides. The kit according to claim 6, wherein the enzyme inhibitor functions to interfere with the reactions of the glycolysis pathway. The kit according to claim 1, further comprising: a bactericide present in a concentration of about 0.1 to 10 mole percent. The kit according to claim 1, further comprising: a fungicide present in a concentration of about 0.1 to 10 mole percent. 12. A method for determining the presence of a compound in body plasma comprising the steps of: a) collecting a saliva sample at a first location directly into a sample container, the sample container containing a measured aqueous solution consisting essentially: saline solution stabilized in pH and an enzyme inhibitor; b) inviolably seal the sample container; c) transporting the sample container to a second location; and d) analyzing the sample for the compound at the second location. The method according to claim 12, wherein the compound is selected from a group consisting of: ethanol, protein, marijuana, marijuana metabolites, opiates, opiate metabolites, cannabinoles, cannabinoid metabolites, cocaine, cocaine metabolites, derivatives of catecholamine and metabolites thereof. 14. The method according to claim 12, wherein the compound is ethanol. 15. The method according to claim 12, wherein the measurement of the aqueous solution has a volume ranging from 10 to 40 milliliters. 16. The method according to claim 12, wherein the measured solution further consists essentially of: a salt and protein matrix that simulates a body fluid composition. 17. The method according to claim 12, wherein the matrix is a standard of quantitative analysis. 18. The method according to claim 12, wherein the measured solution further consists essentially of a fungicide. 19. The method according to claim 12, wherein the measured solution further consists essentially of a bactericide. 20. A kit for the collection of a sample for analysis for the qualitative detection and quantitative analysis of a hydrophilic compound within saliva, comprising: a) an ionic solute which, during dilution of a pre-selected volume in water, yields a solution with an osmolality of a normal physiological body fluid; and b) an enzyme inhibitor of an enzyme capable of using the hydrophilic compound as a substrate, the enzyme is present in the saliva sample; c) a sample bottle containing the solution and the inhibitor, the bottle has a light transmissive capillarity, which can be compressed and extending from the bottle, the capillarity has an opening covered by the solution and a distant portion fused; d) an ampoule adapted to fit inside the capillarity, the ampoule has an internal pressure lower than that of the atmosphere; e) an enzyme adapted to provide a product from the hydrophilic compound as a substrate, wherein the enzyme is contained within the ampule; and f) a colorimetric indicator system adjacent to the enzyme for coupling the product with redox, wherein the indicator system is contained within the vial. 21. The kit according to claim 20, wherein the sample bottle is composed of a thermoplastic. 22. The kit according to claim 20, further comprising a stopper that swells upon contact with the solution, wherein the stopper is contained within the ampule. 23. The kit according to claim 20, wherein the ionic solute is a salt and protein matrix having at least one constituent concentration of a normal body fluid. The kit according to claim 20, wherein the hydrophilic compound is ethanol and the enzyme is selected from the group consisting of alcohol dehydrogenase; and alcohol oxidase / peroxidase. 25. The kit according to claim 24, wherein the indicator system is NADP which reacts in a reduced form with nitro blue tetrazolium.