Immunity testing device

Details Immunity testing device Immunity testing device

1999-03-03

2001-12-04

Nguyen, Bao-Thuy L. (Department: 1641)

Chemistry: analytical and immunological testing

Involving an insoluble carrier for immobilizing immunochemicals

C422S051000, C422S051000, C422S051000, C422S067000, C422S067000, C435S007100, C435S007930, C435S007940, C435S287700, C435S287800, C435S287900, C435S805000, C435S810000, C435S969000, C435S970000, C435S975000, C436S518000, C436S530000, C436S541000, C436S810000, C436S823000, C436S066000

Reexamination Certificate

active

06326214

ABSTRACT:

BACKGROUND OF THE INVENTION
The invention is an improved Immunity Testing Device which consists of a thin sheet of material folded to three portions, and the two end portions (named “front cover” and “back cover” hereinafter) fold back to different sides of the center part (named base seat hereinafter) which supplies a complete protection for the base seat. The testing device easily achieves both immunological method and chemical method without polluting the environment. The invention also greatly reduces the production cost in comparison with the conventional device production. In all, it takes less storage space, provides more versatility, it is more economic in terms of manufacturing cost and bench labor. It is also more environmental friendly.
FIG. 1
shows a conventional immunity testing device which includes an outer case
10
, an internal storage pad
11
, a first filter element
12
, a second filter element
13
and a wicking membrane
14
. The outer case
10
is drilled with a hole
15
above the storage pad
11
and a window
18
directly positioned above a test index section
16
and a test index comparison section
17
.
In use, a liquid test sample is added through the drilled hole
15
to be absorbed by the storage pad
11
. Then the test sample moves and passes through the first and second filter elements
12
,
13
containing a certain amount of labeled test agent. Most of the unwanted substance are filtered by the two filter elements. The remaining components continuously pass into the wicking membrane
14
.
In the case that a labeled tested component exists in the test sample, the test sample will bond with the test index section
16
. The remaining labeled test agent will combine with the test index comparison section
17
. Through the window
18
, the result of the index sections
16
,
17
can be observed.
Some shortcomings exist in the above conventional immunity testing device are as follows:
1. Prior to use, the drilled hole
15
and the window
18
of the immunity testing device are not shielded and are likely to be imbued with external contaminant. This will reduce the accuracy of the test or even destroy the test result. to high cost and fails to meet the requirement of environmental protection.
2. After use, the storage pad
11
and the wicking membrane
14
of the conventional immunity testing device will contain biohazard waste carrying bacteria or viruses. Without shielding, they tend to contaminate the environment. In addition, the outer casw
10
is generally made of plastic and can be hardly destroyed. Also, the outer case
10
contains therein pollutants and thus cannot be recycled. This leads to high cost and fails to meet the requirement of enviromental protection.
3. The relatively complicated manufacturing procedure of the conventional test device contributes to its high cost, which greatly decreases the accessibility of the test.
4. The complicated design of the outer case of the conventional testing device requires much room and is rigid without the possibility of bending. Therefore, it is inconvenient to carry, store or to use the testing device.
5. With respect to overcoming the problem of false positive result in the test of human Hb, the single monoclonal immunity testing method can achieve remarkable effect. However, with respect to the test of human Heme from the disease of upper digestive organ, such method is not efficient and thus is not applicable. Therefore, a general test must be performed in cooperation with another chemical test
80
as to accomplish a boarder medical evaluation. However, there is no testing device on the market that combines both of chemical method and immunity method in one single device. As a result, the above two kinds of tests must be performed separately. This incurs a higher cost of the test as well as complication the bench work and makes the test time-consuming.
SUMMARY OF THE INVENTION
The primary object of the present invention is to provide a simple immunity testing device formed of a thin sheet instead of the conventional plastic-made case. The thin sheet of material is folded to three equal portions, the “front cover” and “back cover” fold back to different sides of the base seat to provide protection shields to both faces of the base seat from contaminants prior to use, as well as to prevent biohazardous pollution after use. Moreover, the complete device can be burnt down to ash as its nature. In general, it provides greater safety before, during, and after use.
A second object of the present invention is to use a thin, light and flexible material to provide convenience in use, carrying, and storage.
It is still a further object of the present invention to improve the conventional immunity testing procedure by providing additional chemical methodology on the same test strip, This “two in one” test device greatly increases the practicality, convenience, and economic efficacy of the test.
The present invention can be best understood through the following description and accompanying drawings, wherein:


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