Assaying device and container for in field analysis of a specimen and later shipment of the unadulterated specimen

An assaying device is provided for both collecting and analyzing a sample which includes a container and an opening for collecting the sample in a chamber for storing the sample. A cap is provided for sealing the container opening and at least one assay system is attached to the container for chemically analyzing the sample. A channel is provided for enabling a portion of the sample to enter the assay system upon a change of orientation of the container. A tamper-proof device is provided through the use of a releasable seal which permits the sample to enter the assay system only when desired.

The present invention generally relates to assaying devices and is 
particularly suitable for field devices for determining the presence of 
chemical constituents in a great number of areas. In today's present earth 
conscious society it has become very important to detect the presence of 
unwanted or undesirable compounds which may exist in the environment or in 
animals. 
As an example, it is important to be able to assay on a field basis the 
presence of water pollutants which may include any number of industrial 
chemicals, as well as pesticides. In addition, body fluids of animals are 
often tested to determine pollutants which may range from pesticides to 
drugs. 
Regarding the latter, the increased availability and use of drugs by the 
general population has caused employers, government agencies, sports 
groups, and other organizations to utilize drug screenings as both 
conditions of employment and maintenance of safety in the work place. 
Because of the large numbers involved, the collection and testing of body 
fluid samples, such as urine, must be simple and cost-effective. 
In addition to this, it is also a requirement that the samples taken be 
guaranteed as to their integrity; i.e., adulteration of the samples must 
be prevented in order to guarantee accurate test results. This requirement 
for integrity, of course, may raise the question of invasion of privacy if 
a visual observation of the collection step is required. 
Most importantly, the onset of AIDS (Acquired Immune Deficiency Syndrome) 
has significantly increased the health risks associated with the handling 
of body fluids. Heretofore utilized devices for the collection and taking 
of body fluids, such as urine, for example, have involved separate steps. 
The first step was the collection of the sample and thereafter a number of 
steps which require transfer of the urine sample to an analysis system or 
device was needed. Naturally, this multiple step procedure has 
necessitated the manual handling of the sample through the use of 
pipettes, syringes or other devices. The use of these transfer devices 
inevitably causes a few spills which may result in contamination to the 
analyst or his/her surroundings. 
In addition, another major drawback to conventional collection and testing 
systems is the fact that the sample tested must be removed from the 
collection device, and as a result, there is the possibility for a mix-up 
or misidentification of the sample drawn from the collection cup. This 
mix-up of samples can prove embarrassing and often results in detrimental 
results in regard to the employment and clinical record of the person 
being tested. 
Inasmuch as typical drug screening tests are performed only for the purpose 
of quickly identifying on a qualitative basis the presence of drugs in a 
body fluid, such as urine, with a complete analysis of the sample being 
performed only if the screening results are positive, it is of utmost 
importance that the results of drug screening performed on the body fluid 
sample being positively identified with the sample in order to ensure 
proper one-to-one correlation of the sample with the person being tested. 
This, of course, is placed in jeopardy once a sample is transferred from a 
collection cup to another separate analysis device or system. 
The present invention is directed to an assaying device, suitable for 
in-field testing for chemical constituents in fluids for any number of 
applications as hereinabove set forth, that requires no specimen handling 
after the collection step. Hence, not only is the risk of contamination 
virtually eliminated, but since the collection and analysis are performed 
by a single device, no misidentification of the sample is possible. 
In the case of assaying body fluids for drugs, a measured specimen volume, 
specimen storage and tamper-evident access to the specimen after a test 
are provided by the present invention. Further, a multiplicity of drug 
analyses may be performed simultaneously with the device hereinbelow 
described. 
SUMMARY OF THE INVENTION 
An assaying device, in accordance with the present invention, for both 
collecting and analyzing samples, generally includes a container having an 
opening for collection of a sample and a chamber for storing the collected 
sample. A cap provides a means for sealing the container opening and assay 
means, attached to the container, is provided for chemically analyzing the 
sample. 
Importantly, means are provided for introducing a portion of the sample 
within the chamber into the assay means when the cap is in the position 
sealing the container opening. In this manner, there is no requirement for 
removing the sample from the assaying device in order to conduct a 
chemical analysis. 
In this regard, the apparatus of the present invention totally eliminates 
the transfer of a sample from the device in order to conduct chemical 
analysis as is the case with all prior art devices. As hereinabove noted, 
this has a significant advantage in terms of both laboratory safety and 
time savings. 
Of particular importance, one embodiment of the present invention 
particularly suitable for drug screening of body fluids includes means for 
preventing premature or inadvertent entry of the sample into the assay 
means. In addition, since the body fluid sample never leaves the device, 
if a positive test for a drug is indicated, the entire device may be 
removed or shipped to another area or laboratory in order to complete a 
quantitative and confirmatory analysis of the body fluid. 
More particularly, in accordance with the present invention, the assay 
means may include chromatograph means positioned on the container for 
enabling direct visual observation thereof. Thus, no additional step is 
necessary for effecting a drug screening analysis of body fluid. 
As hereinabove noted, the drug screening device, in accordance with the 
present invention, may further include means for preventing body fluid to 
enter the chromatograph means during collection of the body fluid. This is 
important in order to prevent a premature or inadvertent activation of the 
drug screening analysis; and further, the possibility of adulteration of 
the body fluid by the person being tested is substantially, if not 
totally, eliminated. 
Channel means may be provided for enabling a portion of the body fluid to 
enter the chromatograph means on a change of orientation in the container. 
Particularly, the means for preventing body fluid from entering the 
channel means during collection of the body fluid may be configured for 
enabling body fluid to enter the channel means only when the container is 
inverted. 
Preferably, in accordance with the present invention, means are provided 
for releasably sealing the channel means in order to prevent body fluid 
from prematurely or inadvertently entering the channel means. 
The chromatograph means may be permanently attached to the exterior of the 
container side wall, and the channel means includes a plenum and means 
defining at least one bore in the container side wall for conveying body 
fluid to the chromatograph means. 
The chromatograph means may comprise a plurality of separated thin layer 
chromatograph strips with each strip comprising means for chemically 
analyzing the body fluid for a different specific analyte. 
More particularly, the chromatograph means may include wick means for 
evenly distributing the body fluid to each of the plurality of separated 
chromatograph strips and the chromatograph strips may be disposed in a 
generally parallel relationship with one another and a longitudinal axis 
of the container. The wick means may be disposed at one end of each 
chromatograph strip and the chromatograph means may further include a pad 
in order to receive fluid passing through the strips.

DETAILED DESCRIPTION 
Turning now to FIGS. 1 and 2, there is shown an assaying device 10, in 
accordance with the present invention, for both collecting and analyzing a 
sample such as, for example, a body fluid (not shown). The device 
generally includes a container 12 having an opening 14 which provides a 
means for collecting the body fluid and a chamber 18 which provides a 
means for storing the collected body fluid. 
The container 12 may be formed, or molded, from any suitable material, such 
as plastic, and may include a circumferential rib 22 for providing 
rigidity to the container 12 and screw threads 24 formed into the 
container proximate the opening 14 are sized for accepting a cap 28. As 
hereinafter described, the cap 28, when screwed onto the threads 24, 
provides a means for sealing the opening 14. For drug screening, a typical 
container 12 may have a capacity of between about 100 to about 120 ml; 
however the present invention is not intended to be limited to this size 
or capacity. 
On an inside wall 30 of the container 12, there is formed a plenum, or 
reservoir, 34 and a plurality of bores 36 through the container wall, as 
shown in FIGS. 2 and 3. As hereinafter described in greater detail, the 
plenum 34 and bores 36 provide a means for conveying body fluid to assay 
means 40 which provides for chemically analyzing the sample. In the case 
of drug testing, the sample may be a body fluid, such as urine, and the 
assay means may be a chromatograph system as hereinafter described. It 
should be apparent that the assay system 40 utilized must have activity 
for testing one or more related components of the sample. 
While only one reservoir 34 is shown, it should be appreciated that a 
plurality of reservoirs may be utilized, each communicating with a bore 
36. 
Generally, the chromatograph means 40 includes a housing 42 molded into a 
flat side 44 of the container 12. A plurality of latex/antibody strips 46 
and a cover 48 for the latex/antibody strips 46 may be of any conventional 
thin layer chromatograph strips. 
Each of the strips may be specific to a different analyte, thereby enabling 
up to five analyte specific tests to be run concurrently on the body 
fluid. For example, the test may be for THC--COOH, Benzoylecgonine, 
Morphine, Amphetamine/Methamphetamine, and Phencyclidine. 
It should be appreciated that any number of concurrent analyte specific 
tests may be performed with the device 10 of the present invention. While 
five strips are shown, a greater or smaller number of individual strips 
may be utilized, depending upon the desired number of tests to be run upon 
the body fluid. When assembled, as shown in FIG. 3, a wick material 52, 
disposed on one end 54 of each strip 46, provides a means for distributing 
the body fluid to each of the plurality of thin layer chromatograph strips 
46 from the bores 36 when the container 12 is inverted as will be 
hereinafter discussed in greater detail. 
When introduced into the end 54 of each strip 46 by the wick material 52, 
the body fluid advances through capillary action along the strip 46 to 
another end 56 of each strip 46 (see arrow 58 in FIG. 3), at which point 
it is absorbed by a pad 60. Seals 62, 64 on the top 66 and bottom 68 of a 
cover 48 prevent the escape of any body fluid from the chromatograph means 
40. The bottom seal 64 may not be necessary depending on the absorbency of 
the pad 60. 
The cover 48 may be permanently fixed to the container, thereby ensuring 
that the results of chemical analysis remain with the container 12, and if 
the cap 28 and threads 24 are made in a conventional manner preventing an 
easy removal of the cap, the remaining body fluid within the chamber 18 is 
permanently attached to the chemical analysis record provided by the 
chromatograph means 40. In this regard, the cover 48 may have a 
transparent portion 70 to enable visual observation of the chromatograph 
strips 46 therethrough. 
As shown in FIGS. 1 and 5, the plurality of strips 46 may be separated from 
one another by affixing the end 54 to the wick in a spaced apart 
relationship, and the ends 56 to the pad 60 in a spaced apart 
relationship. Thereafter, sealing of the cover 48 to the container 12 
maintains sufficient tension in the strips 46 to prevent contact with one 
another. 
Alternatively, as shown in FIG. 4, a plurality of spaced apart longitudinal 
ribs 78 may be disposed on the bars before positioning of the strips 46 
and maintaining separation therebetween. 
It should be appreciated that there should be minimum contact between the 
strips 46 and any surface, in order to prevent microhydrolic problems, 
such as channeling along an interface between the ribs 78 and the strips 
46, which may otherwise compete with the capillary action of the fluid 
passing from one end 54 to another end 56 of each strip 46, thereby 
interfering with the chemical tests occurring during the movement of the 
body fluid along the strips 46. It has been found that with a minimum or 
no support of the strips 46, except by their ends 54, 56, the strips 46 
may be disposed generally along the longitudinal axis 80 of the cup 12. 
As shown in FIG. 1, an inner cap 84 may be affixed within the chamber 18 
over the plenum 34 by gluing or the like which provides a means for 
preventing body fluid from entering the chromatograph means 40 during 
collection of the body fluid. 
As best shown in FIGS. 6 and 8, the inner cap 84 includes a downwardly 
depending flap 88 which establishes a flow path indicated by an arrow 90 
(FIG. 8) for body fluid and therefore provides a means for introducing a 
portion of the body fluid within the chamber 18 into the chromatograph 
means 40 via the plenum 34 and bore 36 when the cap 28 is in the position 
of sealing container 12 and the container is tipped, or inverted. 
The inner cap 84 provides an important function in substantially reducing 
or eliminating the possibility of adulteration of the body fluid by a 
person being tested. The inner cap 84 provides a visual block of the 
plenum and prevents downwardly projected body fluid, collected by the 
chamber 18, from directly entering the plenum 34. It is only when the 
container 12 is inverted that body fluid is able to flow along the flow 
path 90 under the inner cap 84 and into the plenum 34. 
Once inverted, the plenum is filled by the body fluid and the amount of 
fluid in the plenum is sufficient to wet the strips 46 as it is 
distributed by the wick 52. Thus, the plenum and the wick provide a means 
for eliminating the flooding of the strips 46. 
The cap 84 may be formed of any suitable plastic material or the like with 
an unsupported shape, as shown in FIG. 8, having a planar portion 92 
covering the reservoir with the flap 88 molded thereto and pivotable about 
an arcuate joining portion 94. 
As hereinbefore discussed, the cap 28 is sealably attached to the container 
12 by means of threads 24 which are configured for enabling the cap to 
sealably engage the container 12 at both a first angular position shown in 
solid line in FIG. 7, in which a depending member 96 forces the depending 
flap 88 into a closed and sealed position against the inside wall, as 
shown in FIG. 6, to a second position, as shown in broken line in FIG. 7, 
which displaces the depending member 96 away from the depending flap 88, 
thus allowing the initial resiliency of the inner cap 84 to assume the 
free position shown in FIG. 8, which establishes the flow plan 90, as 
hereinabove mentioned. 
Thus by rotation of the cap 28 with respect to the container, access to the 
reservoir by the sample in the container is controlled without breaking 
the integrity of the seal between the cap 28 and the container 12. 
Although there has been hereinabove described an assaying device in 
accordance with the present invention, for the purpose of illustrating the 
manner in which the invention may be used to advantage, it should be 
appreciated that the invention is not limited thereto. Accordingly, any 
and all modifications, variations, or equivalent arrangements which may 
occur to those skilled in the art, should be considered to be within the 
scope of the present invention as defined in the appended claims.