U.S. patent application number 11/063408 was filed with the patent office on 2005-09-29 for changeable machine readable assaying indicia.
Invention is credited to Lappe, Murray.
Application Number | 20050214865 11/063408 |
Document ID | / |
Family ID | 26937042 |
Filed Date | 2005-09-29 |
United States Patent
Application |
20050214865 |
Kind Code |
A1 |
Lappe, Murray |
September 29, 2005 |
Changeable machine readable assaying indicia
Abstract
A machine readable assaying system comprising a test card having
machine readable assaying means. A plurality of individual analysis
strips, each strip comprising antibodies and/or reagents capable of
indicating the positive presence of distinct illicit substances
form a pattern of elements including one or more fixed strips and
one or more blank regions. The detection of the presence of a
particular substance or drug will result in one or more of the
analysis strips changing from a first (light reflective) color to a
second darker (light absorbent) color. The pattern of analysis
strips, fixed strips and blank regions may be provided to encode
one or more characters/digits of information. By the inclusion of
the analysis strips with the plurality of fixed strips and blank
regions, the detection of one or more illicit substances may alter
the overall pattern of fixed and test strips and blank regions, and
hence cause the encoded information represented thereby to be
altered. Accordingly, the particular pattern of bars and spaces
that result from an exposure the physiological fluids of a donor is
contemplated to produce a distinct machine readable indicia. The
transformation which occurs on the test card will be
uninterpretable by the administrator of the test, thus preserving
the anonymity and privacy of the tested individual.
Inventors: |
Lappe, Murray; (Beverly
Hills, CA) |
Correspondence
Address: |
HOVEY WILLIAMS LLP
2405 GRAND BLVD., SUITE 400
KANSAS CITY
MO
64108
US
|
Family ID: |
26937042 |
Appl. No.: |
11/063408 |
Filed: |
February 23, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11063408 |
Feb 23, 2005 |
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10954823 |
Sep 30, 2004 |
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10954823 |
Sep 30, 2004 |
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10779014 |
Feb 13, 2004 |
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10779014 |
Feb 13, 2004 |
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10072154 |
Feb 6, 2002 |
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6716393 |
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10072154 |
Feb 6, 2002 |
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09444926 |
Nov 24, 1999 |
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6514461 |
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09444926 |
Nov 24, 1999 |
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09245175 |
Feb 5, 1999 |
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6342183 |
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09444926 |
Nov 24, 1999 |
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09025559 |
Feb 18, 1998 |
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5902982 |
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09444926 |
Nov 24, 1999 |
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09018487 |
Feb 4, 1998 |
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6036092 |
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09444926 |
Nov 24, 1999 |
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08832957 |
Apr 4, 1997 |
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5929422 |
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09444926 |
Nov 24, 1999 |
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08801041 |
Feb 14, 1997 |
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5916815 |
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Current U.S.
Class: |
435/7.1 ;
702/19 |
Current CPC
Class: |
G01N 33/54366 20130101;
G06K 2019/06253 20130101; G06Q 30/018 20130101; B01L 2400/0683
20130101; G16H 10/60 20180101; G01N 35/00871 20130101; B01L
2300/046 20130101; G06K 19/10 20130101; B01L 2300/042 20130101;
B01L 2400/0406 20130101; G16H 10/40 20180101; B01L 3/502715
20130101; B01L 2300/0663 20130101; B01L 2300/069 20130101; Y10T
436/12 20150115; B01L 2300/0832 20130101; G16H 40/63 20180101; B01L
2300/021 20130101; G01N 33/94 20130101; G06K 9/00154 20130101; G16H
40/67 20180101; B01L 2300/0825 20130101; Y10T 436/25 20150115; B01L
2200/0605 20130101; B01L 3/502 20130101; B01L 3/545 20130101; Y10T
436/13 20150115; B01L 2400/0478 20130101; B01L 2200/141 20130101;
B01L 2300/025 20130101; B01L 2300/047 20130101; G01N 33/528
20130101 |
Class at
Publication: |
435/007.1 ;
702/019 |
International
Class: |
G01N 033/53; G06F
019/00; G01N 033/48; G01N 033/50 |
Claims
I claim:
1. A method of carrying out a test to detect for the presence or
absence of a target substance in a human donor-derived
physiological sample, said method comprising the steps of:
providing: (1) a test surface adapted to contact said sample and
having at least one machine-readable indicium thereon, said
indicium having an initial state and being capable of changing to
an altered state in response to contact with said sample; and (2) a
scanning unit capable of scanning said machine-readable indicium on
said surface, said scanning unit including a programmed processor
and a memory unit; contacting said test surface with said sample;
and after said contacting step, using said scanning unit to scan
said at least one indicium, and operating said processor to
generate test data as a result of said scan, said indicium being
machine-readable only and not human interpretable in the absence of
said machine reading.
2. The method of claim 1, including the step of transmitting said
test data to data storage separate from said scanning unit.
3. The method of claim 2, said transmitting step comprising the
step of transmitting the test data over a communications link.
4. The method of claim 1, wherein said sample is a fluid
sample.
5. The method of claim 1, said surface having a plurality of
machine-readable indicia thereon.
6. The method of claim 1, said sample being a urine sample.
7. Apparatus for carrying out a test to detect for the presence or
absence of a target substance in a human donor-derived
physiological sample, said apparatus comprising: a test surface
adapted to contact said sample and having at least one
machine-readable indicium thereon, said indicium having an initial
state and being capable of changing to an altered state in response
to contact with said sample; and a scanning unit capable of
scanning said machine-readable indicium on said surface, said
scanning unit including a programmed processor and a memory unit,
said scanning unit, operable, upon scanning of said test surface
previously contacted with said sample, to generate said test data
through operation of said processor.
8. The apparatus of claim 7, including structure for transmitting
said test data to data storage separate from said scanning
unit.
9. The apparatus of claim 8, said structure comprising a
communications link.
10. The apparatus of claim 7, said surface adapted for contacting a
fluid sample.
11. The apparatus of claim 7, said surface having a plurality of
machine-readable indicia thereon.
Description
RELATED APPLICATION DATA
[0001] This application is a continuation of U.S. application Ser.
No. 10/954,823 filed Sep. 30,2004, which is a division of U.S.
application Ser. No. 10/779,014 filed Feb. 13, 2004, which is
division of U.S. application Ser. No. 10/072,154 filed Feb. 6,2002
(now U.S. Pat. No. 6,716,393), which is a division of U.S.
application Ser. No. 09/444,926 (now U.S. Pat. No. 6,514,461) filed
Nov. 24, 1999, which is a Continuation-In-Part of U.S. application
Ser. No. 09/245,175 (now U.S. Pat. No. 6,342,183) filed Feb. 5,
1999, and a continuation-in-part of U.S. application Ser. No.
09/025,559 (now U.S. Pat. No. 5,902,982) filed on Feb. 18, 1998,
and a continuation-in-part of U.S. application Ser. No. 09/018,487
(now U.S. Pat. No. 6,036,092) filed Feb. 4, 1998, and a
continuation in part of U.S. application Ser. No. 08/832,957
(issued as U.S. Pat. No. 5,929,422 and reissued as U.S. Pat. No.
RE38,509) filed Apr. 4, 1997, and a continuation in part of U.S.
application Ser. No. 08/801,041 (now U.S. Pat. No. 5,916,815) filed
Feb. 14, 1997. The disclosures of the aforementioned applications
are, by reference, incorporated herein.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to an assaying system. More
particularly, the invention relates to a machine readable assaying
system for analyzing a specimen of physiological fluid to detect
the presence or absence of particular substances therein. In a
preferred embodiment, the machine readable assaying system
contemplates the utilization of machine readable bar-code patterns
imprinted upon a test card which change form in response to a
physical, chemical or biological reaction. The test result which is
encoded within the bar-code indicia imprinted upon the test card is
read by an appropriate decoding apparatus (i.e. a bar-code
reader/scanner), and the decoded results are stored in a memory
unit and transmitted, if desired, to a distinct location. A test
administrator merely scans the bar-code. Because the bar-code
patterns change form in such a subtle yet varied manner, the
administrator or another observer of the test card is unable to
discern the results. Accordingly, the privacy interests of the
donor are preserved, as well as human interpretation errors,
transcription and translation errors.
[0004] The increase in drug use over the past several decades has
created a sharp need for more effective, expeditious methods of
analyzing whether a particular individual is a user of certain
illegal substances. Both private industry employers as well as
governmental employers often need to determine whether an
individual has drug residue present in his or her biological
system, and hence determine whether such an individual is a drug
user or drug abuser and thus an unqualified employee.
[0005] Typically, the status of an individual as a drug user or
abuser is determined by analysis of the individual's physiological
fluids, namely urine. A specimen of urine is collected, and a
highly sensitive screening test is first performed, usually at a
centralized laboratory. If specimen samples screen positive at the
central laboratory, then a more sensitive and controlled
confirmation analysis must be performed.
[0006] In addition to being an extremely costly process, the above
mentioned procedure also involves great time delays to employers
desirous of obtaining new qualified employees. Upon collection of
the urine sample, the employer must wait to receive test results
from the central laboratory before hiring any potential employees.
Furthermore, the massive amount of handling and transfer of the
sample of urine from the initial collection site to the central
laboratory.
[0007] To combat the above mentioned timeliness problem which faces
many employers in awaiting results from the central laboratory,
various "on-site" or "hand-held" assaying devices have been
developed. A major problem inherent in these "on-site" testing
devices is that the privacy concerns of the potential employee
being tested are not adequately addressed. Since all of the on-site
testing devices available heretofore attempt merely to identify
drugs present (i.e. simply to indicate which specimens do indeed
possess the prohibited substance/drug), the anonymity of a
presumptive positive donor is impossible to conceal. Due to such
lack of anonymity, many employers (governmental in particular) will
not employ such an assaying system as it does not comply with
federally mandated regulations regarding privacy and civil
liberties during drug-employment testing. A more anonymous,
reliable and expeditious assaying system is needed, wherein
negative results can be obtained quickly without compromising the
privacy concerns of the tested individual. The results are not
"human readable" and thus are not subject to interpretation.
SUMMARY OF THE INVENTION
[0008] It is an object of the invention to produce an assaying
system for analyzing a specimen of body fluid to detect the absence
of particular substances therein.
[0009] It is another object of the invention to provide an assaying
system which provides more anonymous, reliable and expeditious
results than those assaying systems presently found in the art,
wherein said results can be obtained quickly without compromising
the privacy concerns of the tested donor individual.
[0010] It is a further object of the invention to provide an
on-site, portable assaying system which allows the results of said
assay to be determined and utilized almost immediately by an
employer, without jeopardizing the privacy rights of the individual
being tested.
[0011] It is a still further object of the invention to provide an
assaying system which allows the results of said assay to be
encoded in a machine readable format (such as bar-coding) such that
said encoded results are visually undetectable and must be de-coded
by appropriate apparatus. Accordingly, the administrator of the
assay lacks access to the test results.
[0012] It is yet another object of the invention to provide an
assaying system which possesses a memory unit to store resultant
decoded assay data, and communication means for transmitting said
decoded data to a distinct location (such as a central
laboratory/processing office). Upon receiving the assay data, the
central laboratory/processing office could then electronically,
telephonically or manually (via a delivered hard copy) communicate
a responsive "negative test certificate" to the employer for those
individuals testing negative (indicating that these individuals are
candidates for immediate employment). A sample specimen of
physiological fluid from only those individuals who tested positive
would then be requested by the central laboratory for standard
"confirmation" testing.
[0013] It is yet another object of the invention to provide an
assaying system such as that discussed above which possesses means
capable of detecting adulteration of the specimen.
[0014] To the accomplishment of the above and related objects the
invention may be embodied in the form illustrated in the
accompanying drawings. Attention is called to the fact, however,
that the drawings are illustrative only. Variations are
contemplated as being part of the invention, limited only by the
scope of the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1A illustrates a diagrammatic perspective view of a
test card of an on-site machine reable assaying system.
[0016] FIG. 1B illustrates an enlarged portion of the embodiment of
the test card of FIG. 1A.
[0017] FIG. 2 is a high level functional diagram of an embodiment
of an assaying system apparatus to read/interpret the test card of
FIG. 1A in accordance with the invention.
[0018] FIG. 3 provides a more detailed block diagram of an
embodiment of if the apparatus of FIG. 2.
[0019] FIG. 4 provides another embodiment of an apparatus to
read/interpret test cards of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0020] FIG. 1 depicts a test card 22 of an on-site machine readable
assaying system, having various indicia inscribed thereupon. More
specifically, the test card 22 possesses machine readable assaying
means 32 (also to be referred to hereafter as an encoded machine
readable data source). The machine readable assaying means 32
preferably comprise in part a plurality of individual analysis
strips 34, each consisting of antibodies and/or reagents capable of
chemically analyzing a sample volume of urine to detect a positive
presence of a particular substance (such as marijuana, opiates,
amphetamines, cocaine, PCP, etc.). Traditionally, assaying means in
this particular field were configured merely to visually indicate
the positive presence of particular substances. If a "positive"
indication was given, it was automatically inferred that the donor
individual who provided the urine was a drug user/abuser (although
secondary testing is always conducted to confirm these results).
This system posed great threats to individual privacy and civil
liberty concerns, and hence proved unsatisfactory. The employment
of the assaying means by the instant invention, however, addresses
these deficiencies.
[0021] As seen in detail in FIG. 1B, the plurality of individual
analysis strips 34 are illustrated as an essential component of the
machine readable assaying means 32 (also referred to as bar code
indicia). As mentioned earlier, each of said analysis strips 34
consists of the antibodies and/or reagents which are capable of
visually indicating the positive presence of distinct illicit
substances. In particular, the machine readable assaying means 32
may be formed, as shown in FIG. 1B, of a pattern of elements
including one or more fixed strips 33a, one or more blank regions
33b, and the analysis strips 34, to produce the encoded machine
readable data source. In a preferred embodiment, the detection of
the presence of a particular substance or drug will result in one
or more of the analysis strips 34 changing from a first (light
reflective) color to a second darker (light absorbent) color--or
visa versa.
[0022] As seen in the arrangement depicted in FIG. 1B, the pattern
of analysis strips 34, fixed strips 33A, and blank regions 33B
(which may also be termed "bars" and "spaces" by those skilled in
the art), when configured to comprise the encoded machine readable
data source may be provided to encode one or more characters/digits
of information or other data. Accordingly, by the inclusion of the
analysis strips 34 along with the plurality of fixed strips 33a and
blank regions 33b, the detection of one or more illicit substances
may cause the overall pattern of fixed 33A and test 34 strips
(bars) and blank regions 33B (spaces) to vary, and hence the
encoded information represented thereby to be altered. For example,
machine readable assaying means 32 comprising the encoded machine
readable data source may be comprised of one or more bar code
indicia whose pattern of bars and spaces (and associated coded
digits) is altered in accordance to the particular substances
detected via the inclusion and appearance of one or more analysis
strips 34 within the bar code indicia. Accordingly, the particular
pattern of bars and spaces that result from an exposure the
physiological fluids of a donor, as provided by the machine
readable assaying means 32, is contemplated to produce a distinct
machine readable indicia.
[0023] It is contemplated in the preferred embodiment that one or
more of the individual analysis strips 34 which comprise the bar
code indicia of the machine readable assaying means 32 contain
reagents or antibodies whose visual appearance is altered in
response to physiological fluid, regardless of whether any illicit
drugs are present within said fluid. It is further contemplated
that these "control" analysis strips 34C be situated such that
their detection amongst the pattern of strips 33A and 34 and blank
regions 33B (bars and spaces) comprising the bar code indicia does
not vary the character of the information encoded therewithin. For
instance, the bar code indicia of the machine readable assaying
means 32 would indicate, if decoded by an appropriate device prior
to contact with physiological fluid, a negative presence of illicit
drugs. Upon contact with a volume of physiological fluid which
lacks the presence of illicit drugs, the "control" analysis strips
34C will appear. However, their placement amongst the standard test
strips 34, fixed test strips 33A and blank regions 33B will not
effect the initial encoded character of the bar code indicia.
Accordingly, a negative assay will be determined.
[0024] The function of the "control" analysis strips 34 is to
prevent an administrator of the test from learning the outcome of
the assay. If, subsequent to the administration of each assay, some
type of change occurs to the visual appearance of the machine
readable assaying means 32, then the test administrator will be
unable to discern positive test results from negative results. Only
the device used to decode the encoded bar code indicia will be able
to determine whether the donor's specimen of physiological fluid
tests positive for illicit drugs, and if so, which particular
substances were present.
[0025] The test card 22 of FIG. 1A also possesses adulteration
detection means 36. Said adulteration detection means 36 are
capable of determining whether a particular specimen of urine or
other physiological fluid has been tampered with by administering
either chemical analysis (to ensure that the chemical composition
of said specimen is consistent with that of standard,
non-adulterated human urine) and/or temperature analysis (to ensure
that the specimen has been recently excreted from the donor and has
not been brought to the test site by the donor from an earlier
excretion). Furthermore, quality control indication means 38 are
also present upon said test cards 22 to ensure that the reagents of
the analysis strips 34 are functioning properly. Said quality
control indication means 38 are configured to generate a signal
upon contact with urine or other physiological fluids, regardless
of the presence of illicit substances, to indicate that the
analysis strips 34 have not been degraded due to improper storage,
etc. If the quality control indication means 38 fail to generate a
signal upon contact with the urine, the test card 22 should be
discarded.
[0026] Further included upon the test card 22 of FIG. 1A is an
identification code 42, which may be provided as a pattern encoding
items such as production batch numbers of the test card, a date of
manufacture, etc. It is important to note that the identification
code 42 pattern represents a machine readable (and decodeable)
pattern, and as such may easily be "read" by a suitable device and
received by a computer or controller means for processing,
dissemination, or other appropriated actions.
[0027] Also seen in FIG. 1A are alignment aids 46 that may be
provided to aid in the alignment of the test card 22 for reading or
scanning by a properly arranged device. It is important to note
that other arrangements of the identification code 42, the quality
control indication means 38, the adulteration means 36, and the
assaying means 32 are possible and contemplated. For example,
skilled persons will appreciate modifications such as including the
quality control indication means 38 and the adulteration means 36
within the elements composing the assaying means 32, as seen in
FIG. 1B. Accordingly, quality control indication means 38 and the
adulteration means 36 may determine the overall "coding" provided
by said assaying means 32. In one embodiment of the instant
invention, it is contemplated that the quality control indication
means 38 be incorporated with the "control" test strips 34 and
situated such that their detection amongst the pattern of strips
33A and 34 and blanks 33B (bars and spaces) comprising the bar code
indicia does not vary the character of the information encoded
therewithin. Still other modifications are possible and
contemplated.
[0028] Turning now to FIG. 2, there is provided a high level
functional diagram of a test card reading apparatus 60. As shown, a
test card reading unit 54 is included, which is operatively coupled
to a control and communication means 56. The test card reading
means 54 is provided to "read" and determine the particular
patterns present on the test card 22. As such, the reading of the
patterns of the test card 22 may result in a plurality of digits or
characters being determined (or generated) by the test card reading
units 54, which may be communicated to a control and communication
means 56. Subsequently, the received characters may be transmitted,
via a communication link 66, to a central laboratory 58 for
checking, decoding, and or general evaluation. Therefore, the
pattern of the assaying means 32, the condition of the adulteration
detection means 36 and the quality control indication means 38, and
the identification code may be provided as "machine readable" and
may be transmitted in an anonymous and confidential manner to the
central laboratory 58, in accordance with the privacy features of
present invention. Those skilled in the art will appreciate the
available means to embody the test card 22 of FIG. 1A, and further
may provide modifications and alterations to the embodiments of the
test card reading apparatus 60 of FIGS. 2 and 3.
[0029] One possible embodiment of the test card reading apparatus
60 is seen in FIG. 3. Included is a scanner 54a and decoder 54b
configured to read the test card 22 and decode the plurality of
patterns contained thereon. The patterns may include the assaying
means 32, the identification code 42, the adulteration detection
means 36, and the quality control indication means 38. A controller
module 62 is provided to establish the functional characteristics
of the test card reading apparatus 60. The controller module 62 may
be embodied as shown by providing a processor 62a, a memory unit
62b (providing a suitable application program), and any required
interface circuitry 62c. The controller module may be arranged to
receive from the decoder information including one or more
(decoded) digits or characters. The information may then be
transmitted by a communication module 63 via the communication link
66 to the central laboratory 58. The information processed and or
transmitted to the central laboratory 58 for analysis. Also shown
is a user interface module 64 to enable an individual to enter
information into the test card reading apparatus 60 and provide
information to said individual. The user interface may include
known items such as a display 64a, a keyboard 64b, an audio unit
64c, and printer 64d. For example, an identification code such as
the donor's social security number may be keyed into the keyboard
64B of the user interface module 64 and transmitted via the
communication link 66 to the central laboratory 58. Other user
interface items may also be provided (which are not shown in FIG.
3) including pointing devices, a fax transmission module, touch
screen displays, etc.
[0030] It should be noted that the controller module 62 may be
provided by known programmable single chip microcomputers and any
additional analog/digital circuitry required. Further, it is
contemplated that the controller module 62 may be provided (in an
alternate embodiment to that shown in FIG. 3) by one or more
programmable logic devices (PLDs), or by discrete components
including digital MSI and LSI logic functions. Those skilled in the
art will appreciate the plethora of commercially available
(off-the-shelf) devices and components that may be utilized to
embody the controller module 62 and the communication module 63.
Also, although the scanner 54b may in a preferred embodiment be
realized by a laser scanning device, other suitable devices, such
as a CCD imaging device may be employed. It is also contemplated
that the test card reading apparatus 60 may be realized by a
properly configured personal or workstation computer. For example,
an IBM..RTM.. compatible personal computer (PC) may be arranged
with a scanner 54a, a fax modem or networking card, etc. In such an
embodiment, the functionality of the test card reading apparatus 60
may be provided by the execution of an (custom) application
program. Therefore, it should be understood that the embodiments of
the FIGS. 3 and 4 are illustrative of a number of possible
embodiments, which may be provided by skilled persons.
[0031] Another embodiment of the test card reading unit 54 of FIG.
2 is provided in FIG. 4. An important feature of this invention is
the use of an "interpretation means", such as interpreter 72, which
will "read" the test card 22, along with an encoder 76 that may be
employed to generate (e.g. print) a result summary 82. The result
summary 82 is contemplated to include one or more printed bar code
indicia. In a preferred embodiment of the present invention, the
result summary 82 may be provided (printed) using standard bar code
symbologies (such as Code 39, Interleaved 2 of 5, PDF417, etc.),
and accordingly could be read using "off-the-shelf" scanning
devices and decoders to provide scanner 54a and decoder 54b of FIG.
3. An advantage of the arrangement of FIG. 4, is that the assaying
means 32 need not be configured initially in a "standard" bar code
indicia. For instance, rather than configuring the machine readable
assaying means 32 in standard bar code language format, a
customized configuration can be employed (by using, for instance,
optical scan sheets). It is the function of the interpreter 72 and
the encoder 76 to then decipher this customized configuration and
provide a standard bar code indicia (that is scannable by low cost
and known devices and apparatus).
[0032] The aforementioned configuration of the machine readable
assaying system of the instant invention render said system capable
of being employed on-site at an employer's individual location. A
donor individual is given a collection container and provided a
private environment where said donor individual is to excrete a
specimen volume of urine into the collection container for
analysis. A volume of urine is then brought into contact with the
test card 22 (by bathing the test card 22 with a small amount of
urine, inserting the test card 22 into the urine, etc.) The quality
control indication means 38 and/or the control test strips 34 are
then checked to assure the integrity of the assaying means 32.
Assuming that the assay is functioning properly, the adulteration
detection means 36 are then checked to determined whether the donor
individual tampered with the specimen. If the adulteration
detection means 36 indicate that the specimen is unadulterated,
then the machine readable assaying means 32 are then read by the
test card reading unit 54 (such as the scanner 54a and decoder
54b). The results of the assay are then stored in the memory unit
62B of the controller module 62 for transmission to a desired
location such as the centralized laboratory 58.
[0033] Upon the central laboratory 58 receiving the assay data, the
names or identification codes of those donor individuals who
provided negative results may be immediately communicated to
prospective employers, so that those particular donors may be
offered employment. All positive assay urine specimens will be
requested from the test site by the central laboratory 58 for
further confirmation analysis. Accordingly, the employer is
immediately provided with a number of qualified potential employees
to choose from, and the privacy concerns of the donor individual
are safeguarded.
* * * * *