Method of urine specimen identification

The invention includes a method of, and substances for use in the method of, identifying the source of a urine sample to be collected for biochemical analysis including administering to a person or animal whose urine is to be tested a formulation containing predetermined portions of one or more identifying substances that are vitamins, maintaining an identification of the formulations so that the person or animal to which it was administered and a urine collecting means can be identified, obtaining a urine sample from the person or animal in the urine collecting means, and analyzing the urine sample for the presence of the identifying substances or their metabolites.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The invention described and claimed herein relates to urinalysis and 
particularly to a method of identifying urine samples. More particularly, 
it relates to identifying the source of urine samples collected for 
biochemical analysis where there is potential for laboratory error or 
deceptive substitution of one urine specimen for another. 
2. Description of Related Art 
Known analysis techniques can give quantitative and qualitative indications 
of the concentration of a drug or other biological or chemical substance 
in a biological specimen. There are, however, possibilities for error at 
various steps in these testing processes. For example, because the 
validity of the biochemical analysis depends upon whether the specimen 
submitted is indeed that of the individual in question, the collection and 
custody of the sample itself must be closely monitored. Until now, no 
analytic technique has been described that can positively identify or 
confirm the source of the specimen. 
The patent literature includes a labelling system for clinical laboratory 
specimens as described in U.S. Pat. No. 3,733,178 to Eriksen, entitled 
"Chemical Coding Method". According to the disclosed method, known amounts 
of inert chemicals are added to specimens after collection, so that at the 
time, the specimens are analyzed, the chemical identifiers disclose 
concentrations uniquely associated with the sample. Another method of 
chemical labeling is disclosed in U.S. Pat. No. 3,451,778 to Fearson, 
entitled "Method of Labeling." According to this method, substances are 
labeled by the addition of a chemical compound of a noble gas. Thereafter, 
these noble gases may be detected to identify the substance to which they 
have been added. 
U.S. Pat. No. 4,223,004 to Hsia et al., filed May 23, 1977, entitled "Drug 
Compositions", describes a method for detecting whether a drug addict 
patient in a maintenance therapy program has supplemented his prescribed 
dosage of a drug with drugs obtained from another source. The patient 
consumes drug compositions containing known proportions of a drug and its 
isotopic analogue. If the patient is in compliance with the maintenance 
program, analysis of the patient's urine or blood should reveal ratios 
that are the same as those in the drug prescribed. 
The labeling methods in the art described above, relate either to labeling 
of specimens after collection to insure against subsequent mishandling or 
to detecting whether an individual supplemented his drug dosage from 
another source. None, however, will indicate whether there has been a 
deceptive or mistaken substitution of one urine for another. We have 
invented and describe herein a method for urine specimen identification 
utilized before collection for the purpose of positively identifying its 
source. 
SUMMARY OF THE INVENTION 
In a method of urine specimen identification described and claimed herein 
the individual whose urine is to be tested is asked to consume in the 
presence of one or more trusted witnesses, or is given by injection or 
otherwise, one or more formulations, including tablets, capsules, powders 
or liquids, containing one or more harmless identifying substances that 
can be rapidly absorbed by the body and will quickly appear in the urine. 
With knowledge of which substances were consumed by or introduced into the 
individual, the collected urine may later be analyzed for the presence of 
these substances or the metabolic products of these substances. Thus, 
through analysis of the urine, it is possible to determine the source of 
the specimen and detect any deliberate or accidental substitution by the 
laboratory or by the individual. There are numerous applications of the 
present method, which will be described more fully in the detailed 
description which follows.

DETAILED DESCRIPTION OF THE INVENTION 
The invention comprises a method for identifying the source of urine 
samples collected for biochemical analysis. Identification is accomplished 
by introducing into the individual whose urine is to be analyzed, or 
having the individual consume, in the presence of one or more trusted 
witnesses, one or more formulations such as tablets, capsules or liquids 
containing harmless identifying substances in predetermined proportions. 
After administration, these substances are rapidly absorbed by the body 
and will appear very quickly in the urine. The amount and character of 
each substance detected in the collected urine sample will reflect the 
amount and character of substances contained in the formulation, e.g., 
tablet, capsule, etc. Since the laboratory knows which formulation was 
given to a particular individual, detection of the corresponding 
proportions of substances in the urine will assure that the biochemical 
findings derived from the specimen are applicable to the individual in 
question, and not to another individual. If the specimen collected fails 
to show the expected profile, there would be reason for suspicion and 
retesting. 
This method has particular utility for reducing error where there is 
potential for mishandling of specimens by the laboratory as well as for 
detecting deliberate substitution of one urine specimen for another in 
drug detection programs, drug treatment programs, athletic events, horse 
races or medical examinations for life or health insurance purposes. In 
the case of humans, this procedure eliminates the inconvenience, 
embarrassment and cost of having a witness accompany each person being 
tested to the restroom to insure that the urine specimen was produced by 
the individual being tested. 
More particularly, the method of this invention incorporates into a tablet, 
capsule, or fluid, for example, one or more identifying substances that 
will induce a specific profile or ratio in the urine. The number of 
different formulations required to drastically reduce or eliminate the 
danger of substitution among a number of individuals would depend on the 
size of the population screened. The incorporated substances should have 
certain characteristics. Preferably, they should be harmless, easily 
absorbed by the body, quickly excreted in the urine, and identifiable in 
the urine. Ideally, the substances should not be normally present in the 
urine in amounts capable of compromising the identification process. 
The particular identifying substances that may be used must be harmless and 
are preferably included on the FDA's "Generally Recognized As Safe" list 
(GRAS), which is incorporated herein by reference. The substances used in 
the method of this invention are certain vitamins and their metabolites. 
They are used in amounts ranging from 25 to 100 mgs. or in greater amounts 
sufficient to be detected by methods such as NMR spectroscopy and gas 
chromatography/mass spectometry (GC/MS). 
Detection and determination of the amounts of the identifying substances in 
the urine may be accomplished by standard laboratory instruments. Of 
course, the method of analysis depends on the type of substance utilized. 
It also might be necessary to have two types of urine identification, one 
that is rapid and less costly to perform and a secondary analysis which is 
more accurate, but more expensive and difficult to perform. The initial 
test of, for example, combinations of certain vitamins, could be detected 
by their fluorescence, while a second test could be GC/MS detection of the 
same vitamins specially synthesized to contain a rare or unusual isotope 
of an atom in the molecule. The thiamine, riboflavin, niacinamide, and 
pyridoxine vitamins or their metabolites, for example, will normally be 
present in urine. However, by using ratios of different vitamins, by 
marked dilution of the urine due to ingestion of fluids, by collecting the 
urine within two hours, it will be possible to clearly identify the urine 
specimen. The subjects can also be questioned as to whether they are 
presently taking vitamins and allowance for such vitamin supplementation 
can be taken into account. 
The following illustrates the manner in which our urine identification 
method may operate. As an athlete enters the locker room he is approached 
by the manager of the team who is well acquainted with each of the team 
members and a testing officer who has a list of the names of each team 
member and a collection of sealed and serial-numbered envelopes containing 
tablets with identifying vitamins or their metabolites. The testing 
officer randomly picks out an envelope, copies down the serial number 
after the player's name and requests him to open the envelope and swallow 
the tablet in the presence of the testing officer and team manager. The 
player is then requested to collect a urine sample after about 30-120 
minutes in a bottle (or other fluid retaining vessel or fluid collection 
apparatus) labeled with the same serial number. When the sample is 
subjected to biochemical analysis, the sample is tested to make sure it 
contains the exact combination of known vitamin(s) that had been in the 
consumed tablet. If the sample does in fact belong to the player, the 
pattern of substances detected in the urine should match the expected 
pattern for that tablet. If, for example, the tablet that the player 
consumed contained a large amount of harmless substance A, a moderate 
amount of harmless substance B, and zero quantities of harmless substances 
C and D, analysis of the collected urine sample would disclose this 
specific pattern of identifying substances, indicating that the urine 
specimen submitted by the player was in fact his own. 
If traces of cocaine and/or marijuana are found in the urine sample with 
the serial number assigned to the player, the player may protest that the 
lab or someone must have mixed up the urine samples. Because the manager 
and testing officer both witnessed his consumption of the tablet 
containing the predetermined amounts of vitamins or their metabolites and 
those amounts were found in the urine sample attributed to the player, an 
excuse that the urine samples were mixed up is insupportable. 
If the urine sample is evaluated and found to contain no traces of cocaine, 
marijuana or any other drug, but the pattern of substances in the tablet 
that the player consumed does not match that found in the urine, this 
would indicate that the specimen bottle did not contain the player's urine 
but the urine of someone else. Further, by checking the records, it can be 
established whether another person on the team had injested the tablet 
with the pattern found. 
The following are examples of useful vitamin markers and particular amounts 
thereof: 
(1) Thiamine, 25 mg 
(2) Riboflavin, 25 mg 
(3) Niacinamide, 50 mg 
(4) Pyridoxine, 50 mg 
(5) Thiamine, 25 mg+Riboflavin, 25 mg 
(6) Thiamine, 25 mg+Niacinamide, 50 mg 
(7) Thiamine, 25 mg+Pyridoxine, 50 mg 
(8) Riboflavin, 25 mg+Niacinamide, 50 mg 
(9) Riboflavin, 25 mg+Pyridoxine, 50 mg 
(10) Niacinamide, 50 mg+Pyridoxine, 50 mg 
(11) Thiamine, 25 mg; Riboflavin, 25 mg; Niacinamide, 50 mg; Pyridoxine, 50 
mg 
(12) Riboflavin 25 mg; Niacinamide, 50 mg; Pyridoxine, 50 mg 
(13) Thiamine, 25 mg; Niacinamide, 50 mg; Pyridoxine, 50 mg 
(14) Thiamine, 25 mg; Riboflavin, 25 mg; Pyridoxine, 50 mg 
(15) Thiamine, 25 mg; Riboflavin, 25 mg; Niacinamide, 50 mg 
The use of the four vitamins (thiamine, riboflavin, niacinamide and 
pyridoxine) is based on the fact that they are excreted in the urine 
either unchanged or as a metabolic derivative(s), each of which can be 
detected either qualitatively or quantitatively by an established 
fluorometric method. These compounds appear in urine rapidly (1-2 hours), 
and in sufficient amounts so that the urine could be diluted considerably 
(1:50 or 1:100) without influencing the results of the assay. Their 
detection in urine either individually or as a ratio, if one or more 
vitamins are contained in the formulation, would serve as a signature or 
identification of that particular urine specimen. It should be noted that 
the number of the above formulations could be increased simply by altering 
the amount of vitamin present in the tablet; these vitamins are nontoxic, 
and much larger amounts than in the example cited above are present in 
various vitamin products. The advantage of using vitamins for this purpose 
is that they would be acceptable in terms of safety and extremely 
sensitive methods, e.g., fluorometric methods, are available for their 
detection in urine. 
Of course, the invention described and claimed herein is useful for animals 
other than humans, including for example, horses and dogs. The vitamin 
metabolites are thiochrome, N'-methylnicotinamide and 4-pyridoxic acid.