U.S. patent number 3,819,505 [Application Number 05/233,079] was granted by the patent office on 1974-06-25 for testing apparatus.
This patent grant is currently assigned to Becton, Dickinson and Company. Invention is credited to John H. P. Andrews, Jr., Ronald A. Parent.
United States Patent |
3,819,505 |
Parent , et al. |
June 25, 1974 |
TESTING APPARATUS
Abstract
A unit for retaining a disposable electrophoresis test kit
adapted for detecting the presence of hepatitis associated antigen
and the like includes a base, means for illuminating said test kit
spaced within said base, a work platform for supporting the test
kit, wherein the platform has at least one pair of electrodes
oppositely disposed thereon and connected to said base for
generating an electric potential across said test kit; a removable
cover connected to said base for enclosing said unit, said cover
having a transparent viewing port spaced therein for observing said
test kit and an electrical circuit in said unit for supplying power
to said illuminating means and said electrodes.
Inventors: |
Parent; Ronald A. (Columbia,
MD), Andrews, Jr.; John H. P. (Baltimore, MD) |
Assignee: |
Becton, Dickinson and Company
(East Rutherford, NJ)
|
Family
ID: |
22875807 |
Appl.
No.: |
05/233,079 |
Filed: |
March 9, 1972 |
Current U.S.
Class: |
422/430; 436/516;
D24/223 |
Current CPC
Class: |
G01N
27/44756 (20130101) |
Current International
Class: |
G01N
27/447 (20060101); B01k 005/00 () |
Field of
Search: |
;204/18G,299 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Shandon Instruments, Tombs et al., " Acrylamide Gel
Electrophoresis," Jan. 1967, pp. 9 and 10..
|
Primary Examiner: Mack; John H.
Assistant Examiner: Prescott; A. C.
Attorney, Agent or Firm: Kane, Dalsimer, Kane, Sullivan and
Kurucz
Claims
Wherefor we claim:
1. Unit for retaining a disposable electrophoresis test kit adapted
to detect the presence of hepatitis associated antigen or the like
comprising:
a. a base;
b. means for illuminating said test kit spaced within said
base;
c. a work platform for supporting said test kit, said platform
having at least one pair of electrodes oppositely disposed thereon
and connected to said base for generating an electrical potential
across said test kit;
d. a removable cover connected to said base for enclosing said
unit, said cover having a transparent viewing port for observing
said test kit;
e. an electrical circuit in said unit for supplying power to said
illuminating means and said electrodes;
f. said work platform having a spaced apart elongated troughs in
parallel relation and said cover has a hip roof portion
substantially enclosing said troughs; and
g. said means for illuminating said test kit including a pair of
opposed lights mounted beneath said work platform and means for
intercepting predetermined portions of light emitted from said
lights such that the space between said troughs is highlighted to
facilitate visual reception thereof.
2. The invention in accordance with claim 1 including at least one
safety interlock switch for opening and closing said electrical
circuit and one magnet for each said interlock switch mounted in
said cover for actuating said switch and closing said electrical
circuit, said interlock switch being normally opened.
3. The invention in accordance with claim 1 in combination with a
disposable test kit, said kit including a buffer tray having a pair
of spaced apart reservoirs, each reservoir adapted to seat in one
of said opposed troughs, a recessed platform spaced between said
reservoirs and an agarose gel coated test plate having a plurality
of pairs of spaced apart test wells and, at opposite ends of said
plate, an unfoldable wick having one end thereof embedded in said
gel wherein said test plate is received in said recessed platform
on said buffer tray.
4. A unit for retaining a disposable electrophoresis test kit
adapted to detect the presence of hepatitis associated antigen or
the like comprising:
a. a rectilinear bin having air vents therein;
b. a chassis mounted within said bin, said chassis having mounted
thereon a pair of parallelly opposed fluorescent lamps;
c. means for intercepting the light emitted from each said lamp to
provide an illuminating arc of at least about 80.degree. from the
vertical directed upwardly toward the central portion of said
bin;
d. a work platform mounted on said bin above said chassis, said
work platform having a pair of elongated rectangular troughs, each
trough spaced above one of said fluorescent lamps;
e. at least one pair of electrodes removably mounted on said
platform, one of said electrodes associated with each trough and
extending substantially to the bottom of said trough;
f. at least one magnetically actuated interlock switch mounted on
said platform;
g. a removable cover for said work platform, said cover having a
transparent hip roof portion spaced above said troughs and one
magnet connected to said cover for each said interlock switch
adapted to close said interlock switch upon engagement;
h. an electrical circuit in said unit for supplying power to said
illuminating means and electrodes, wherein each said interlock
switch electrically connected to said circuit and is adapted to
open said circuit when in the normally open position and to close
said circuit when actuated by said magnet; and
i. a circuit electrically connected to each of said electrodes for
monitoring the current passing through said electrodes and for
signaling when said current falls below a predetermined level
necessary for electrophoresis.
5. Unit for retaining a disposable electrophoresis test kit adapted
to detect the presence of hepatitis associated antigen or the like
comprising:
a. a base;
b. means for illuminating said test kit spaced within said
base;
c. a work platform for supporting said test kit, said platform
having at least one pair of electrodes oppositely disposed thereon
and connected to said base for generating an electrical potential
across said test kit;
d. a removable cover connected to said base for enclosing said
unit, said cover having a transparent viewing port for observing
said test kit;
e. an electrical circuit in said unit for supplying power to said
illuminating means and said electrodes; and
f. a circuit electrically connected to each of said electrodes for
monitoring the current passing through said electrodes and for
signaling when said current falls below a predetermined level
necessary for electrophoresis.
Description
BACKGROUND OF THE INVENTION
The invention relates to a system for detecting the presence of
hepatitis associated antigen and other immunological procedures
and, in particular, it relates to a compact power supply and
viewing test unit employed with a disposable test kit for screening
multiple blood or serum samples for hepatitis associated
antigen.
Electrophoresis has now become a well-established biochemical
method for analyzing complex biological substances and has acquired
scientific approval for use in clinical laboratory analyses in the
study of normal and abnormal soluble and/or insoluble, animal and
plant fluid constituents, particularly as they relate to the
diagnosis and treatment of disease. In spite of the acceptance of
this method as a biochemical method of analysis and protection its
use has been restricted by the complexities of interpreting the
electrophoretic patterns and by the limitations arising from the
apparatus available in accomplishing this method. Conventional
electrophoretic separation units and test systems are illustrated
in U.S. Pat. Nos. 3,407,133; 3,432,414; 3,479,265 and application
Ser. No. 300,341, now U.S. Pat. No. 3,788,210, referred to in the
U.S. Pat. No. 3,479,265.
Consequently, effective use of the electrophoretic method has
primarily been restricted to experts trained in interpreting and
overcoming the complexities referred to hereinabove. The use of
involved and intricate apparatus has resulted in many deficiencies.
Such deficiencies include: inaccuracies arising from the
application of dyes, such as fluorescent labels to render the
separated portions visible and the necessity for intricate optical
scanning means or radio isotopic scanning means and the like. The
problem is particularly acute in the case of blood banks which are
faced with a problem of screening hundreds of donors for viral or
bacterial diseases employing relatively untrained personnel and
sometimes under difficult field conditions. No practical system for
screening potential blood donors has been developed up to now which
is adapted to be used with relatively untrained personnel. With the
prevalance of hepatitis in modern society, the need to develop such
a mass detection system has become acute.
It is, therefore, a primary object of the present invention to
provide a system for rapidly testing and detecting multiple samples
of blood for the presence of a particular bacteria or virus
antigen.
It is another object of the present invention to provide a unit for
generating an electrical potential across a disposable
electrophoresis test kit and for illuminating the kit within the
unit to observe test results.
It is yet another object to provide a screening apparatus for
detecting hepatitis-associated antigen in blood plasma or serum
adapted for repeated use with high reproducibility and
accuracy.
Other objects and advantages will become apparent from the
following discussion:
SUMMARY OF THE INVENTION
These and other objects are met in a unit for retaining a
disposable electrophoresis test kit adapted to detect the presence
of hepatitis associated antigen or the like which includes a base;
means for illuminating said test kit spaced within said base; a
work platform for supporting said test kit, said platform having at
least one pair of electrodes oppositely disposed thereon and
connected to said base for generating an electrical potential
across said test kit; a removable cover connected to said base for
enclosing said unit, said cover having a transparent viewing port
for observing said test kit and an electrical circuit in said unit
for supplying power to said illuminating means and said
electrodes.
A disposable test kit adapted for use with the aforesaid unit
includes a buffer tray hving a pair of spaced apart reservoirs for
retaining an electrophoresis buffer solution and a recessed
platform spaced between the reservoirs for retaining a gel coated
test plate. The test plate has a plurality of pairs of spaced apart
test wells, and at opposite ends thereof, an unfoldable wick having
one end thereof embedded in said gel for electrically connecting
the test plate with the buffer solution in said tray reservoir.
It has been found that when a blood specimen containing hepatitis
associated antigen is placed in one test well on the test plate and
second well of the test pair is filled with hepatitis associated
antibody, then upon electrophoresis of the test plate in the unit
of the invention, a visible precipitin line forms between the well
pairs, thereby indicating the presence of hepatitis associated
antigen. The line may be visible to the naked eye on close
examination, but is rendered completely visible by the use of
illuminating means, such as fluorescent lights and the like. The
unit is adapted to readily test over 50 individual blood specimens
for bacteria or virus associated antigen and, particularly,
hepatitis associated antigen, also known as Australia antigen. No
dyes are employed, no intricate optical scanning means are employed
and relatively unsophisticated technicians can easily employ the
test unit of the invention in blood banks with highly reproducible
results.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings illustrate an embodiment of the invention
in which:
FIG. 1 is a fragmentary enlarged top plan view showing the
formation of a precipitin line on a disposable test plate of the
invention;
FIG. 2 is a fragmentary, enlarged vertical sectional view of the
test plate taken along line 2--2 of FIG. 1;
FIG. 3 is a top plan view of the test plate with a pair of wicks
extending therefrom;
FIG. 4 is a perspective view of an alternate test plate;
FIG. 5 is a perspective view of a disposable test kit which may be
employed with the power and illumination unit of the invention;
FIG. 6 is an exploded view of the power and illumination unit;
FIG. 7 is a top plan view of the power and illumination unit
containing a pair of test plates;
FIG. 8 is a top plan view of the unit in FIG. 7 with the cover
removed;
FIG. 9 is a vertical cross-sectional view of the power and
illumination unit containing an electrophoresis test kit taken
along line 9--9 of FIG. 8;
FIG. 10 is a vertical cross-sectional view taken along line 10--10
of FIG. 8;
FIG. 11 is a horizontal cross-sectional view taken along line
11--11 of FIG. 9;
FIG. 12 is a functional block diagram of the electrical circuitry
of the power and illumination unit; and
FIG. 13 is a wiring diagram of the various circuits for the power
and illumination unit.
DESCRIPTION OF PREFERRED EMBODIMENTS
Turning now to FIGS. 6 and 10 there is illustrated a power and
illumination unit for housing a disposable electrophoresis test
kit. The unit 11 includes base 10. Base 10 is preferably a
rectilinear bin with an inlet orifice 12 for receiving power cord
14. A second orifice 13 is spaced above power cord orifice 12 and
is adapted to receive a line fuse 16. A first and second pair of
threaded studs 18 project upwardly from top flange 20 of base
10.
Base 10 has a plurality of slots 22 in its floor 24 in order to
permit circulation of air through the base to prevent overheating
of the unit during operation of the electrical components and
lamps. To support the base of supporting leg 19 is located adjacent
each corner of the base underside.
As seen in FIGS. 6, 9, 10 and 11, chassis 26 is mounted to the
floor 24 of base 10 by means of floor mounting screws 28 extending
through the floor 30 of chassis 26. As shown in FIG. 10, the screws
also extend through shoulders 32 of base floor 24 and are removably
mounted thereto by means of nuts 33.
Chassis 26 contains the illuminating and power elements for unit 11
housing the disposable test kit. For this purpose chassis 26 has a
pair of integral, upstanding walls 34 connected to opposite sides
of the chassis floor 30 and terminating in a pair of opposed
flanges 36 extending toward each other in parallel relationship
with chassis floor 30.
As seen in FIGS. 9 and 10 a fluorescent lamp 38 is mounted along
the respective side edges of the chassis co-extensive with each of
said flanges 36. At either end of each fluorescent lamp is a lamp
socket 39. Each socket is mounted to the floor of said chassis
30.
In order to control the direction and intensity of light emitted by
each of the fluorescent lamps 38, a light diffuser 40 is mounted
adjacent each fluorescent lamp. As seen in FIGS. 9 and 11, each
diffuser has a vertical wall portion 42 which is co-extensive in
length with the spaced adjacent to each fluorescent lamp. The
height of wall 42 is less than the diameter of the fluorescent
lamp. The wall serves to block the passage of light emanating from
the lamp in a horizontal direction across the unit and upwardly to
about a 20.degree. arc. An angular flange 43 extends downwardly
from lamp diffuser wall 42 and serves to reflect any diffused light
to a central upper portion of the unit. Flanges 36 prevent rear
light passage.
Turning now to FIGS. 6 and 9 there are illustrated a pair of high
voltage warning lights 46 which cooperate with a cover actuated
safety interlock system to remind the operator that electric
circuits are active immediately below the cover when the unit is in
operation. The electrical connections between the high voltage
lamps 46 and the safety interlock system is described hereinafter.
High voltage warning lamps 46 are set in sockets 44. Each socket is
connected by mounting bracket 50 to chassis wall 34.
As illustrated in FIGS. 6 and 8-10 working platform 52 is
co-extensive with the base of the unit and covers chassis 26. The
working platform serves to support the disposable test plate
apparatus and electrodes and also houses the electrical components
for initiating and monitoring the electrophoresis testing. Platform
52 is preferably formed from a single piece of transparent acrylic
plastic, suitably vacuum formed. The working platform includes a
peripheral mounting shoulder portion 54 co-extensive with top
flange 20 of base 10. The rear portion 56 of shoulder 54 contains
the controls which operate the viewing and testing apparatus.
Adjacent the side shoulders 58 of the working platform are a pair
of spaced apart banana jacks 60 for receiving electrode pairs 62 of
the electrophoresis test kit.
As shown in FIG. 9 the central stage 64 of the work platform is
stepped below the side and front shoulders 54, 58. The central
stage of the unitary work platform contains a pair of opposed
rectangular elongated troughs 66 extending from the front to the
back of the central stage. A generally rectangular central plateau
68 extends between the opposed troughs.
As illustrated in FIGS. 8 and 10, a pair of conventional reed
safety interlocks 70 are connected, respectively, immediately
beneath the front and rear shoulders of the work platform. The
safety interlocks are adapted to cooperate with a pair of magnets
located in the unit cover to insure that the unit is in the off
position when the cover is removed from the unit.
At least one pair of removable electrodes 62 are provided for the
unit. Each electrode has a banana plug 72 at one end adapted to fit
into a banana jack 60 in the work platform. The body 73 of the
electrode is in the shape of an inverted U terminating at the other
end in an elongated metallic probe 74 adapted to penetrate trough
66 near its bottom.
It is preferred that central stage 64 be transparent in order to
permit light from the fluorescent lamps to pass through the stage
and illuminate an electrophoresis testing apparatus mounted on the
stage. The cones of light emitted from the fluorescent lamps 38 are
directed by the diffuser 40 to intersect immediately below work
platform central plateau 68 and form a reinforced beam extending
upwardly and outwardly therefrom in a cone shaped configuration so
as to provide maximum illumination to the central plateau.
Turning now to FIG. 7, removable unit cover 76 is formed from a
unitary piece of chemically resistant acrylic plastic. The portion
that covers the central stage 64 is shaped in such a manner that
condensate which forms from the underside of the cover during a
test will not drip onto the counterelectrophoresis plates. Four
holes 78 penetrate the cover to permit the guide studs 18
protruding from base 10 to capture the cover. Four cap nuts lock
the cover to the work platform and base to form a completely
aligned unit.
A pair of magnets 80 are embedded in the cover and are adapted to
interact with the high voltage interlock switches 70 to complete
the power circuit for the unit. As illustrated in the functional
block diagram in FIG. 12 and the circuit diagram in FIG. 13 the
reed interlock switches form a part of the power control circuit
and, if not properly closed by the magnets in the unit cover 76,
the unit is not energized. This prevents an operator from suffering
accidental electric shocks should he insert his fingers into the
unit during testing with the cover removed.
As seen in FIGS. 6, 7, 9 and 10 cover 76 has a mounting rim portion
82 which is generally co-extensive with the front, side and rear
shoulder portion of working platform 52. Along each side edge 84 of
the cover is a lifting wing 86 to permit an operator to remove the
cover. Central stage 54 of work platform 52 is enclosed by a
generally rectangular raised portion 88 of cover 76. The vertical
walls 90 of raised portion 88 extend above work platform 52
sufficiently to clear electrodes 62.
To provide a surface which will direct condensate from the central
portion of the cover to the trough section 66 of the work areas a
peaked roof or hip roof 92 is provided on the cover generally
co-extensive with the work area central plateau 68 and extending,
on each side, above the trough 66 of the work platform. In order to
permit an operator to view central plateau 68, which carries an
electrophoresis test plate during operation, it is necessary that
the peaked roof 92 be transparent. As shown in FIG. 7 it is also
preferable that a pair of opposed squares 94 on the raised portion
88 of the cover be transparent. The squares are aligned above
warning lamps 46.
While adapted for various testing purposes the aforedescribed
apparatus is preferably employed in combination with a disposable
electrophoresis test kit. While such kits have been proposed
heretofore, as in U.S. Pat. No. 3,407,133, the following kit is
preferred. The test kit includes a rigid, preferably plastic buffer
tray 96 as illustrated in FIGS. 5 and 9. Buffer tray 96 includes a
pair of opposed elongated buffer reservoirs 98 spaced apart by a
central recessed depression 100. Tray reservoirs 98 are adapted to
be received within work platform troughs 66. Depression 100 rests
on platform central plateau 68.
As shown in FIGS. 3-5, the power unit and viewer 11 is adapted to
receive and test one or two buffer trays. A disposable test plate
102 of complimentary configuration with depression 100 of tray 96
is preferably provided with a precast layer of conventional agarose
gel adapted for electrophoresis work. The bottom of the plate is
covered with a thin layer of agarose gel and a plurality of opposed
pairs of test wells 104 are precut into the gel. Alternatively, the
opposed pairs of test wells 104 can be precut into the test plate
which is then covered with a thin layer of agarose gel. Each row
105 of opposed test wells is in parallel alignment, in use with
buffer tray reservoirs 98.
Each test plate is equipped with an opposed pair of electrophoresis
test wicks 106. A side edge 108 of each wick is embedded within the
agarose gel. Prior to use each wick is tightly rolled for storage
purposes. Each wick is sufficiently long to extend, when unfolded,
substantially to the bottom of each tray reservoir 98, as shown in
FIG. 9.
Included with the electrophoresis test kit are premeasured
quantities of hepatitis associated antibody 110 and hepatitis
associated antigen 112. A supply of premeasured solid buffer 111 is
provided. The preferred buffer is a mixture of sodium barbital,
diethylbarbituric acid and thimerosal (1:25,000). In order to
deposit the antigen and antibody into a pair of opposed test wells
of the test plate an automatic pipette 113 with a disposable tip is
provided. The preferred automatic pipette in the HEPASCREEN
Automatic Pipette distributed by SPECTRA BIOLOGICALS, a division of
Becton, Dickinson and Company.
Turning now to FIGS. 12 and 13 the counterelectrophoresis power
unit and viewer 11 includes a power control circuit A. The power
control circuit protects the power and viewer unit against line
surges on the input power and internal circuit overloads, controls
the application of power to the viewing lamps and power supply
circuits, provides for interruption of the power to the power
supply circuit B when the top cover 76 is removed from the unit and
indicates when power is being applied to the power supply circuit.
The viewing lamps circuit C provides illumination for viewing the
counterelectrophoresis test plates 102 and interpreting the test
results. The viewing lamps circuit consists of two parallel
connected conventional fluorescent lamp circuits electrically
connected to lamp switch 126.
The power supply circuit B converts the AC input power to filtered,
regulated 180 volts DC power for electrophoresis testing using
suitable rectifiers. It also isolates this input power from the
output to lessen the danger of electrical shock. The power supply
positive output is connected to the positive electrode 61. The
negative output is connected through the low current alarm circuits
to the negative electrodes 63.
Each position on the work platform adapted to engage a disposable
buffer tray has a separate low current alarm circuit D. The circuit
monitors the current from the power supply B through the test plate
102. If the current is low (below about 16 micro amps) the low
current alarm lamp 114 (as illustrated in FIG. 8) associated with
the tray position being monitored, will flash.
As shown in FIG. 12 the electrodes, both positive and negative,
provide the electrical conduit for conducting current from the
supply output through the buffer solution, wicks, and
counterelectrophoresis test plate 102.
FIG. 13 shows the circuit diagram for the electrical components of
the unit and the general location for the electrical components.
The power control circuit includes line fuse 16 to protect against
input power overloads and circuit overloads. Test power switch 120
controls power application to caution lamps 46 and power supply
circuits. Reed switches 70 interrupt power to circuit B when cover
76 is removed. Power control circuit A also includes lamps 46 to
indicate power is being supplied to circuit B.
In order to operate the unit the solid buffer 111 is solubilized in
water and the resulting solution is dispensed to the opposed
reservoirs 98 of the buffer tray. Next, the cover is removed from
the power and viewing unit by disengaging the cap nuts 79. The
positive and negative electrodes 61, 63 are removed from the unit
by pulling straight up on the electrode body 62.
Next, the disposable buffer tray 96 is installed in the troughs 66
of the work platform. The positive and negative electrodes are then
inserted into their respective jacks in the unit.
Wicks 106 for the positive and negative electrode, as seen in FIG.
3, are unfolded from test plate 102. About 0.02 milliliters of
hepatitis associated antibody is pipetted using the automatic
pipette into the left hand well 116 of each pair of test wells as
shown in FIG. 1. Next about 0.02 milliliters of control hepatitis
associated antigen is pipetted into the right hand well 118 of the
control pair. Finally about 0.02 milliliter of test samples are
pipetted into the right wells 118 of each test pair. A separate
pipette tip is employed for dispensing each test sample.
Next, test plate 102 is placed in the central depression 100 of
buffer tray 96. The keyed wick labeled "positive electrode" is
immersed in the buffer tray adjacent the positive electrode 61. For
test purposes it is necessary that the hepatitis associated
antibody be placed in the test well of the pair closest to the
positive electrode. The test sample is placed in the well closest
to the negative electrode 63.
The other wick labeled "negative electrode" is then immersed in the
tray adjacent the negative electrode 63. The cover is replaced on
the power and viewing unit and the unit is now ready for testing.
The unit is energized by closing the test power switch 120. Closing
the switch energizes the power control circuit and the warning
lamps 46.
In order to confirm that sufficient current is passing through the
circuit formed by the positive and negative electrodes the
respective buffer solutions in the buffer troughs, the wicks and
test plate, indicator lamp 114 is provided for each testing
portion. For testing the tray switch 124 is moved to the closed
position thereby completing the testing circuit. During testing the
unit is preferably at room temperature to achieve optimum reaction
conditions. The unit is operated for about 2 hours of continuous
testing.
In order to read the unit and determine whether the specified
sample contained hepatitis associated antigen, lamp switch 126 is
closed completing the circuit through the fluorescent lamps 38.
Strongly positive test samples will form distinctive illuminated
precipitin lines within 30 minutes. The full 2 hour test period is
employed to insure the detection of extremely low titered hepatitis
associated antigen positives.
Prior to illuminating the test plate after the testing period is
completed, all switches are turned to the off or opened position.
The cover is removed from the power and testing unit 11. The viewer
power switch 126 is then closed thereby actuating the fluorescent
lamps. The test plate is examined for precipitin lines. A typical
precipitin line is illustrated in FIG. 1. For comparision purposes
a precipitin line should appear between the control antigen and
antibody, indicating that the system has functioned properly.
Upon completion of test plate evaluation the viewing switch 126 is
opened and the buffer tray and test plate are removed from the unit
and preferably autoclaved.
Generally, impact resistant rigid materials are employed for the
unit. The cover, base and work area are preferably formed from
chemically resistant, high impact KYDEX brand acrylic plastic. The
disposable buffer tray is preferably formed from clear polyvinyl
chloride. In order to provide a bench mark on the buffer trays to
indicate that the proper amount of buffer solution is present in
each, a molded step (not shown) may be formed at the inner top edge
of each buffer tray reservoir at the appropriate level.
As indicated in FIG. 11 baffle 37 is employed to separate heat
sensitive electrical components mounted on the chassis from the
fluorescent lamps. Chassis 26 is preferably formed from aluminum.
Electrodes 62 are preferably formed from LEXAN brand polycarbonate
plastic.
The unit has been licensed by the Division of Biologics Standards
for hepatitis associated antibody. The following theory of
operation has been postulated. The agarose gel formation causes the
antigen molecule in the test wells to become negatively charged and
the antibody molecules to be nearly neutral. An electric field is
established across the plate between the wicks when the plate is
placed in the test unit and the test power activated. The resulting
electrophoretic force accelerates the movement of the negatively
charged antigen molecules and they converge with the antibody
molecules in less time then if acted upon by only a diffusive
force. The nearly neutral antibody molecule is moved toward the
antigen by electro-osmosis.
Additionally, the electrophoretic force causes migration of
hydrogen ions. The buffer solution acts as a reservoir of hydrogen
ions to maintain the pH in the agarose gel so that the antigen
remains charged throughout the test. The charge on the antigen, a
macromolecule, is influenced by the concentration of hydrogen
ions.
During testing the electrical resistance inherent in the agarose
gel causes the gel to heat and limits the voltage difference that
can be applied across the test plate. In the illustrated unit the
voltage difference across the plate is about 25 volts. The test
plate is about 7.5 centimeters wide. Monitoring the current across
the test plate provides verification that the correct voltage
difference is being applied across the plate. The low current
indicator lights signal when the current drops below that needed to
provide satisfactory test results.
Among the advantages provided by the counterelectrophoresis power
and viewer unit are the peaked cover or hip rooftype cover which
provides a controlled environment for optimum reaction conditions
and prevents condensed liquid (heated by the fluorescent lamps or
the like) from dripping onto the test plates. The cover actuated
safety interlock switches interrupt the voltage when the cover is
removed thus protecting the user from accidental contact with high
voltage. The built-in viewing lamps provide light at proper angle
and intensity for interpreting test results. The infection risk to
laboratory personnel is minimized by eliminating the need for
handling the test plates to view the test results. Further, a
second test plate can be added even while a first test is being run
without effecting results. The disposable test kit including the
buffer tray and test plate with prefolded wicks eliminates
contamination problems.
A workable electrophoresis unit is 14 1/4 inches wide by 17 inches
long by 5 3/4 inches high. It will be obvious to those skilled in
the art that various modifications may be made the specific
embodiments described herein. While particular embodiments have
been discussed it will be understood that the invention is not
limited thereto and that it is contemplated to cover any such
modifications in the appended claims as fall within the true spirit
and scope of the invention.
* * * * *