Immunochemical-based test device with lift and twist specimen full tab

A chromatographic assay test device for use with immunoassays. The test device has a sample collection member pivotally coupled to a test strip receiving member. The sample collection member has a window for applying a test sample to a pad accessible through the window and the pad is repositionable to an inverted position to contact a chromatographic member inserted into the test device. The chromatographic member is then brought into opposition to the sample collection member thus improving test performance by reducing the manipulation of samples. The test device is constructed from five interconnected panels which are die cut from SBS cardboard. The first panel has a window for inserting a test strip and the second panel has a window for viewing the test strip during the test procedure. The third panel has the repositionable pad section. The fourth panel has a window for applying the test sample and the fifth panel covers the test sample window. The first and second panels are coupled to form a first planar member and the third and fourth panels are coupled to form the sample collection member. The fifth panel includes a reusable adhesive for securing the fifth panel over the sample window in the fourth panel.

CROSS-REFERENCE TO RELATED APPLICATIONS 
This application is related to application Ser. No. 08/119,466, entitled 
"Bevel Closure and Device", filed on Sep. 10, 1993 by Joyce Norell now 
U.S. Pat. No. 5,441,698, and to application Ser. No. 08/194,793, entitled 
"Assay Device", filed on Feb. 10, 1994 by H. M. Chandler, now pending, 
which is a continuation of application Ser. No. 07/888,831, entitled 
"Assay Device", filed on May 27, 1992 by H. M. Chandler, now abandoned, 
all of which are assigned to the assignee of this application, and are 
hereby incorporated by reference. 
BACKGROUND OF THE INVENTION 
This invention relates in general to an immunochemical-based test method 
and apparatus, and more specifically, to an integrated housing and sample 
collection method and apparatus having a lift and twist specimen pull tab. 
Among the many analytical systems used for detection and/or determination 
of analytes, particularly analytes of biological interest, are 
chromatographic assay systems. Such chromatographic systems are frequently 
used by physicians and medical technicians for rapid in-office diagnosis 
and therapeutic monitoring of a variety of conditions and disorders. They 
are also increasingly used by patients themselves for at-home monitoring 
of such conditions and disorders. Among the most important of such systems 
are the "thin layer" systems in which a solvent moves across a thin, flat 
absorbent medium. 
Although useful, currently available chromatographic techniques using test 
strips have a number of drawbacks. Many samples, such as fecal samples, 
contain particulate matter that can clog the pores of the chromatographic 
medium, greatly hindering the immunochromatographic process. Other 
samples, such as blood, contain cells and colored components that make it 
difficult to read the test. Even if the sample does not create 
interference, it is frequently difficult with existing chromatographic 
test devices to apply the sample to the chromatographic medium so that the 
sample front moves uniformly through the chromatographic medium to insure 
that the sample reaches the area where binding is to occur in a uniform, 
straight-line manner. 
Sample preparation and waste generation are responsible for other problems 
with currently available devices and techniques for immunochromatography. 
The increased prevalence of diseases spread by infected blood and blood 
fractions, such as AIDS and hepatitis, has exacerbated these problems. It 
is rarely possible to apply a sample (such as feces) or a sampling device 
(such as a throat swab) directly to the chromatographic medium. Several 
extraction and pretreatment reactions are usually required before the 
sample can be applied to the chromatographic medium. These reactions have 
typically been carried out by the physician or technician performing the 
test in several small vessels, such as test tubes or microfuge tubes, 
requiring the use of transfer devices such as pipettes. Each of these 
devices is then contaminated and must be disposed of using special 
precautions so that workers or people who may inadvertently come into 
contact with the waste do not become contaminated. 
Improved chromatographic devices for the performance of 
immunochromatographic assays or other analogous assays have been 
developed. Such devices are capable of receiving a possibly contaminated 
sample or a sample preparation device directly so as to eliminate the need 
for extraction vessels and transfer devices. Such devices include a test 
strip and are able to deliver the sample to the chromatographic medium 
uniformly and evenly to improve accuracy and precision of the tests. This 
aspect of assay devices is particularly important in avoiding false 
negatives and false positives. 
However, several steps are required in performing the test. Samples must 
first be collected and applied to a collection device. After the required 
number of samples are collected, the collection container is closed and 
forwarded to a doctor or a laboratory for testing. Before the lab can test 
the samples, a specimen has to be taken from the collection container and 
placed in an assay device. 
These assay devices include a conductive barrier attached to an opposable 
component of a device containing at least two opposable components. The 
assay devices make use of pressure to transfer fluid from one opposable 
component to another opposable component, and also to drive fluid through 
the chromatographic medium. The pressure not only speeds up the operation 
of the device, but allows the performance of additional steps such as 
extraction steps to remove interfering particulate components within a 
single device. The pressure is generated by holding the opposable 
components together with engagers such as interlocking elements on each of 
the opposable components. Preferably, a predetermined pressure is applied 
to ensure the optimum performance of each step of the assay procedure. 
It can be seen then that there is a need for a test method and device which 
improves test performance by reducing manipulation of samples. 
It can also be seen that there is a need for a simplified method and 
apparatus for carrying out the test procedure. 
It can also be seen that there is a need to reduce cost by minimizing the 
number of parts required and by reducing the operational steps. 
It can also be seen that there is a need to improve manufacturability and 
quality of test devices by reducing the number of components and the 
number of manufacturing steps. 
It can also be seen that there is a need to encourage testing by reducing 
the complexity of the test. 
SUMMARY OF THE INVENTION 
To overcome the limitations in the prior art described above, and to 
overcome other limitations that will become apparent upon reading and 
understanding the present specification, the present invention discloses a 
immunochemical-based test device having a sample collection member 
pivotally coupled to a test strip member. The sample collection member has 
a window for applying a test sample to a pad accessible through the window 
and the pad is rotatable to an inverted position to contact a 
chromatographic member as it is brought into opposition to the sample 
collection member. 
The present invention solves the above-described problems by providing a 
test method and device which improves test performance by reducing 
manipulation of samples. 
A system in accordance with the principles of the present invention 
comprises a test strip receiving member for receiving a chromatographic 
test strip and having an external viewing window, a sample collection 
member coupled to the test strip member, the sample collection member 
having a port for applying a test sample to an accessible pad. The pad is 
repositionable to an inverted position for contacting the chromatographic 
test strip as the test strip receiving member is brought into opposition 
to the sample collection member. 
The test strip receiving member and the sample collection member are 
constructed from five interconnected panels. The first panel has a window 
for insertion of a test strip. The second panel has a window for viewing 
the test strip during the test procedure. The third panel has a perforated 
section having a specimen pad coupled to one side, the perforated section 
being repositionable to expose a collected sample deposited onto the 
specimen pad to the test strip. The fourth panel has a window for applying 
the test sample and the fifth panel forms a covering for the test sample 
window. 
The fourth panel also includes a notch for facilitating the repositioning 
of the repositionable section of the third panel. The first and second 
panels are coupled to form a first planar member and the third and fourth 
panels are coupled to form a second planar member. The fifth panel 
includes a repositionable adhesive for securing the fifth panel over the 
sample window in the fourth panel. 
The bodies of the panels or opposable components are preferably made of 
laminated cardboard that is sufficiently impervious to moisture to contain 
the liquids involved in the performance of the assay carried out by the 
device. Other cellulose-based materials, such as paperboard or solid 
bleached sulfite (SBS) can also be used. Alternatively, the bodies of the 
opposable components can be made of plastic that is impervious to 
moisture. A suitable plastic is a polycarbonate plastic such as Lexan.TM.. 
In the preferred embodiment, the panels are die cut from SBS cardboard 
having a thickness of about 0.024 inches. 
One aspect of the present invention is that the test device simplifies the 
method for carrying out the test procedure. 
Another aspect of the present invention is that cost is reduced by 
minimizing the number of parts required and by reducing the operational 
steps. 
Another aspect of the present invention is that manufacturability and 
quality of test devices are improved by reducing the number of components 
and the number of manufacturing steps. 
Yet another aspect of the present invention is that testing is encouraged 
by reducing the complexity of the test. 
These and various other advantages and features of novelty which 
characterize the invention are pointed out with particularity in the 
claims annexed hereto and form a part hereof. However, for a better 
understanding of the invention, its advantages, and the objects obtained 
by its use, reference should be made to the drawings which form a further 
part hereof, and to accompanying descriptive matter, in which there is 
illustrated and described specific examples of an apparatus in accordance 
with the invention.

DETAILED DESCRIPTION OF THE INVENTION 
In the following description, reference is made to the accompanying 
drawings which form a part hereof, and in which is shown by way of 
illustration the specific embodiment in which the invention may be 
practiced. It is to be understood that other embodiments may be utilized 
as structural changes may be made without departing from the scope of the 
present invention. 
One aspect of the present invention comprises chromatographic assay devices 
particularly useful for the assay of analytes in biological samples. These 
devices are suitable for the direct application of biological samples, 
without preliminary extraction steps, and are constructed so as to reduce 
manipulation of test samples and simplify the test procedure. 
FIG. 1 illustrates an integrated housing 10 of the invention as it is die 
cut. The integrated housing is preferably die cut from 0.024" thick SBS 
cardboard. However, it is to be understood that other materials could be 
used in manufacturing the invention. For example, the integrated housing 
could be formed from vinyl or may be produced using injection molding. 
Initially, the integrated housing comprises five panels. The first panel 12 
includes a window 14 for insertion of a test strip (not shown in FIG. 1, 
see FIG. 6). The second panel 20 includes a viewing window 22 for reading 
the test strip during the test procedure. The third panel 30 preferably 
comprises a perforated section 32 which may be lifted and twisted as 
explained more fully with reference to FIG. 7. The fourth panel 40 has a 
window or port 42 exposed centrally therein for applying the test sample. 
It is to be understood that the port 42 is not meant to be limited to any 
particular shape. The fourth panel also has a notch 44 cut along one of 
its sides which allows the lift and twist tab 32 of the third panel 30 to 
be more easily accessed. Finally, the fifth panel 50 functions as a cover 
for the test sample window 42. 
FIG. 2(a) illustrates a sample panel 60 applied to the fourth panel 40 in 
alignment with the sample window 42. Glue is applied to an area 62 of the 
first panel 12 as illustrated so that when the first panel 12 is folded 
over, the first panel 12 and second panel 20 form a first single planar 
member or planar test strip receiving member 70 as illustrated in FIG. 
2(b). In addition, a specimen pad 80 is attached to the perforated 
repositionable tab 32 in the third panel 30. A reusable adhesive is 
applied to a section 82 at the end of the fifth panel 50 such that the 
fifth panel 50 may be temporarily affixed to the fourth panel 40 thereby 
covering the sample window 42. However, the nature of the reusable 
adhesive allows a patient/user to easily peel back the fifth panel 50 
exposing the sample window 42. FIG. 2(b) illustrates the first 12 and 
fifth 50 panels in their folded positions over the second 20 and fourth 40 
panels, respectively. 
FIG. 3(a) illustrates the application of glue across the width 102 of the 
third panel 30 at each end. Thereafter, the fourth panel 40 and fifth 50 
panel are folded over the third panel 30 as illustrated in FIG. 3(b). The 
third 30 and fourth 40 panels are thus combined to form a second planar 
member or sample collection member. Note that FIG. 3(b) illustrates the 
opposite side on the test device 10 as compared to FIG. 3(a). Also, FIG. 
3(b) illustrates the lift and twist tab 32 protruding beyond the notch 44 
cut in the fourth panel 40. 
Finally, FIG. 4 illustrates the compact test device wherein the first 
planar member formed by the first 12 and second 20 panels has been brought 
toward the second planar member formed by the third 30 and fourth 40 
panels. 
FIG. 5 illustrates the first step 200 in the sample collection procedure. 
The fifth panel 50 is pulled away from the integrated housing 10 thereby 
exposing the sample well 42 and the sample metering panel 60 superimposed 
over the sample pad 80. After the patient/user opens the fifth panel 50, a 
sample is deposited to the sample well 42 using an applicator 202. The 
patient/user then closes the fifth panel 50 thereby allowing the 
integrated housing 10 to be forwarded to a physician or to a laboratory 
for carrying out the test procedure. 
FIG. 6 illustrates the planar test strip receiving member, formed by the 
first 12 and second panels 20, being pulled away from the integrated 
housing structure 10 thereby exposing the test strip cut out 14 in the 
first panel 12. The physician or laboratory technician may install a test 
strip 300 into the invention at the cut out 14 of the first panel 12. The 
test strip 300 may be elongated having a first end 301 for engaging the 
specimen pad and a second end 302 distal from the first end 301. 
The first and second planar member combinations may be held together by a 
tab-insert combination which is well known in the art, or preferably, by a 
latching mechanism formed by a beveled edge 303, formed at an edge of the 
planar combination of the first 12 and second panels 20, and an undercut 
edge 304 formed on a closure portion or planar fixed member 306 that is 
fixed to the third panel 30, as is disclosed in U.S. patent application 
Ser. No. 08/119,466, now U.S. Pat. No. 5,441,698 entitled "Bevel Closure 
and Device," referenced above. 
FIG. 7 illustrates the use of the preferred embodiment of the 
repositionable tab 32. Alternatively, as discussed with reference to FIGS. 
10 and 11, the specimen pad 80 may be fixedly secured to the planar 
combination formed by the third 30 and fourth 40 panels in the window (not 
shown in FIG. 7), and in alignment with test strip 300. However, certain 
disadvantages are inherent to a stationary pad. These disadvantages are 
discussed with reference to FIG. 8 below. 
Referring to the preferred embodiment illustrated in FIG. 7, the physician 
or laboratory technician lifts the perforated specimen pull tab 32 away 
from the third panel 30 and twists the specimen pull tab 32 180.degree. to 
an inverted position so that the specimen pad pull tab 32 may be refitted 
into a recessed area originally vacated by the specimen pad pull tab 32. 
The specimen pad pull tab 32 may or may not remain coupled to the third 
panel 30. Accordingly, the specimen pad 80 in the inverted position faces 
the test strip 300 and engages with the test strip 300 upon closure of the 
housing 10. However, it is to be understood that this embodiment is 
presented for illustration only and is not meant to limit the invention. 
Those skilled in the art will recognize that other embodiments 
incorporating the teaching of the present invention are possible without 
departing from the invention. For example, the outside edge 308 of the 
specimen pad pull tab 32 may be flipped over to the opposite side of the 
third panel 30 to an inverted position thereby exposing the specimen pad 
80. In this embodiment, the position of the test strip window 14 may have 
to be offset so that the specimen pad 80 aligns with the test strip 300 in 
the flipped position. 
Referring now to FIG. 8, a buffer 402 is added to the specimen pad 80 to 
facilitate the interaction between the specimen pad 80 and the test strip 
300 before the housing 10 is closed. The buffer when applied to the pad 80 
permeates down into the pad 80 itself and thus does not negatively affect 
the test strip as the test strip is brought into opposition with the 
specimen pad 80. As is now readily apparent, the invention embodying a 
stationary specimen pad 80 will lead to the buffer, as it is applied to 
the sample side of the pad 80, permeating through the pad 80 and into the 
test strip 300 thereby negatively affecting the test by causing the sample 
front to move non-uniformly through the chromatographic test strip 300. 
Thus, the lift embodiment for positioning the pad 80 for engagement with 
the test strip 300 is preferred. 
FIG. 9 illustrates the integrated test device after the unit 10 is closed 
thereby allowing the specimen pad 80 to engage the test strip 300. The 
physician or lab technician may read the results of the test through the 
observation window 22 in the second panel 20. 
FIG. 10 illustrates the alternative embodiment of the integrated housing 
500 of the invention. The integrated housing 500 is die cut from 0.024" 
thick SBS cardboard to form five panels. However, in this embodiment, the 
third panel 30 has the stationary specimen pad 80 fixedly disposed therein 
in alignment with test strip 300. 
FIG. 11 illustrates a side view of the alternative embodiment 500 wherein 
the stationary specimen pad 80 extends beyond the surface of the third 
panel 30. Thus, the stationary specimen pad 80 is accessible through the 
window 42 in the fourth panel 40. However, since the pad 80 is stationary, 
the test sample applied to the specimen pad 80 must permeate to the side 
of the third panel 30 which engages the test strip member 300. 
The foregoing description of the preferred embodiment of the invention has 
been presented for the purposes of illustration and description. It is not 
intended to be exhaustive or to limit the invention to the precise form 
disclosed. Many modifications and variations are possible in light of the 
above teaching. It is intended that the scope of the invention be limited 
not with this detailed description, but rather by the claims appended 
hereto.