A blister packaging and protecting system developed for test sensors

Abstract

The invention relates to a blister packaging and protecting system developed to protect sensors, test kits and especially immunological test sensors from moisture and to prevent their degradation, to which a catalyst may be added in order to increase the sensitivity of said sensors.

Description

[0001] A BLISTER PACKAGING AND PROTECTING SYSTEM DEVELOPED FOR TEST SENSORS

[0002] Technical Field

[0003] The invention relates to a blister packaging and protecting system developed to protect sensors, test kits and especially immunological test sensors from moisture and to prevent their degradation, to which a catalyst may be added in order to increase the sensitivity of said sensors.

[0004] State of the Art

[0005] Lateral Flow Immunoassay test sensors (LFI) are highly sensitive, selective, and easy- to-use sensors. They are frequently used in many areas of daily life to detect antigens of drugs, viruses and cancer cells, including Covid tests and pregnancy tests.

[0006] The LFI sensors used in the state of the art are highly sensitive and degrade quickly when exposed to moisture. This shortens the shelf life of the test kits and causes inaccurate results.

[0007] The LFI sensors in the state of the art are placed in aluminum-reinforced plastic bags containing silica gel and packaged under an inert gas, after they are produced. Before the measurement, these sensors are removed from their packages and placed inside the test kits. As these kits contain washing liquids, the sensors are exposed to an excessive humid environment, and their life span and performance decrease over time to 1-2 weeks depending on the moisture. In addition, due to the amount of moisture in said environment, inaccurate results occur at the end of certain periods of time during the measurements.

[0008] The document no. US2022178943A1 in the state of the art relates to kits and methods used based on lateral flow testers for the presence or amount of one or more test analytes in a test sample taken from the skin of a mammal. The invention in said document is not suitable for all types of sampling. For example, in cases where samples cannot be taken as a swab, it does not work on porous surfaces as the samples are taken only from a part of a surface with a swab in the invention. In addition, the sampling and analysis steps in said invention require a separate processing. This can lead to unnecessary loss of time and risks in measurement sensitivity.

[0009] In the state of the art and in order to eliminate the above-mentioned disadvantages, new systems need to be developed.

[0010] Summary of the Invention

[0011] The present invention relates to a blister packaging and protection system developed to protect sensors, test kits and especially immunological test sensors from moisture and prevent their degradation in order to eliminate the above mentioned disadvantages and provide the related technical field with new advantages.

[0012] The different types of moisture traps in the system of the invention eliminates the problems of protecting the LFI (Lateral Flow Immunoassay) sensors from moisture and preventing their degradation in the test kits containing liquid. Thus, a 2-week shelf life of the test kits in the state of the art is increased to 1 year thanks to the invention.

[0013] The blister packaging system of the invention is very easy and functional to use and integrate into the test kits. In addition, the invention provides a low-cost system which is very cheap and suitable for an industrial-scale production, in particular to prevent degradation caused by moisture. Thus, the invention offers a safe and reproducible operating performance.

[0014] The invention protects the LFI sensors placed in the test kits from the moisture caused by the washing liquid in the kit and the environmental factors. In addition, the notches in the packaging system of the invention keep the sensors immobile and fixed in the pack.

[0015] By leaving a gap in the area where the LFI sensor draws liquid, a catalyst other than the liquid form (in powder form or in sponge impregnated form) may be added. Thus, the invention prevents the degradation of both the LFI sensor and the catalysts.

[0016] Embodiments of the present invention which are briefly summarized above and discussed in more detail below, may be understood by referring to the exemplary embodiments of the invention illustrated in the accompanying drawings. It should be noted, however, that the accompanying drawings only depict typical embodiments of this invention and are not to be construed as limiting the scope thereof.

[0017] Fig. 1 is a representative front view of the blister packaging system of the invention.

[0018] Fig. 2 is a perspective side view of the blister packaging system of the invention.

[0019] Fig. 3 is a representative view of the blister packaging system of the invention in a disassembled form.

[0020] In order to provide a better understanding of the invention, the numerals in the figures are provided below:

[0021] 1. First Layer

[0022] 1.1 Notch

[0023] 2. Test Sensor

[0024] 3. Moisture Trap

[0025] 4. Catalyst

[0026] 5. Second Layer

[0027] Detailed Description of the Invention

[0028] Exemplary embodiments are described in more detail below with reference to the accompanying descriptions. However, embodiments may be constructed in different forms and should not be construed as limited to the embodiments set forth herein. Instead, these exemplary embodiments are provided for the completeness of this disclosure and to fully convey its scope to those skilled in the art.

[0029] The terminology used in this specification is intended to be used only to describe a specific exemplary embodiment and is not intended to be restrictive. As used herein, the context of the forms "one", "at least", "preferably" and "and / or" also includes plural forms unless expressly stated otherwise.

[0030] The invention relates to a blister packaging and protecting system developed to protect sensors, test kits and especially immunological test sensors from moisture and to prevent their degradation, to which a catalyst may be added in order to increase the sensitivity of said sensors characterized in that it comprises:

[0031] - at least one first layer (1 ) made of a moisture-proof transparent plastic, which has a raised form taking the shape of the test sensor (2) and the moisture trap (3), on a front side thereof, and in which the test sensors (2) are placed,

[0032] - at least one notch (1 .1 ) positioned on the first layer (1 ) to keep the test sensor (2) fixed in the system,

[0033] - at least one moisture trap (3) which traps moisture when it is present and prevents moisture from permeating into the system,

[0034] - at least one water-absorbing catalyst (4) which increases the performance of the test sensors (2),

[0035] - at least one second layer (5) made of moisture-proof aluminum, which allows a movable blade mechanism included in the test kits to easily pierce and the washing liquid to permeate to the sensor.

[0036] In an embodiment of the invention, the catalyst (4) in the system of the invention is, but not limited to, an impregnated sponge, a paper, or cotton. In an embodiment of the invention, the catalyst (4) is, but not limited to, a melamine sponge, a polyethylene sponge, a polyimide sponge, or a polyurethane sponge. In an embodiment of the invention, the catalyst (4) is, but not limited to, a polyester paper, or a polypropylene paper. In an embodiment of the invention, the catalyst (4) is, but not limited to, a glass wool.

[0037] Any liquid in the test kit is desorbed by the water-absorbing catalyst (4) before entering the test sensor (2), and the washing liquid is fed in this way. This increases the performance of the test sensors (2). Briefly, when the washing liquid enters the blister, it first permeates through the impregnated sponge, which is the catalyst (4), and then to the test sensor (2) after taking the catalyst (4) into the washing liquid. The first layer (1) is transparent so that the positive-negative results obtained from the test sensors (2) may be easily read by a user, but the embodiment is not limited thereto.

[0038] In one embodiment of the invention, the types of moisture traps (3) included in the system are, but not limited to, a silica card, a silica gel, a bentonite clay, a molecular sieve, calcium chloride, calcium sulfate, or activated alumina, which are in the form of powder or a pellet.

[0039] The notches (1.1 ) in the system of the invention also keep the test strip in an upright position, thereby ensuring the test to be performed accurately and maintaining the same fixed in the blister pack. In addition, the moisture trap (3) and the catalyst (4) impregnated sponge contained in the invention prevent each other from touching and thus prevent the moisture trap (3) from absorbing the washing liquid.

[0040] The movable blade mechanism in the sensor test kits makes a small slit in the second layer (5) contained in the invention. In this way, the washing liquids containing the target molecules may reach the LFI or test sensors (2) in the blister pack. Once the washing liquid containing the target molecules has reached the LFI or test sensors (2), the result may be read from the first layer (1).

[0041] Any features described in this specification (including attached claims, abstract, drawings) may be replaced by other alternative features that may have equivalent or similar purposes, unless expressly stated otherwise. That is, unless explicitly stated otherwise, each feature is only one instance of a set of equivalent or similar features.

[0042] The above embodiments are intended only to describe the technical concept and characteristics of the present invention, and the object of the present invention is to enable the skilled one in the art to understand the content of the present invention and implement the present invention, and the scope of the present invention is not limited thereto. Equivalent alterations or modifications made in accordance with the spirit of the invention are intended to be included in the scope of the invention.

[0043] Industrial Applicability of the Invention The invention relates to a blister packaging and protecting system developed to protect sensors, test kits, and in particular immunological test sensors (2) from moisture and prevent their degradation, and has an industrial applicability. The invention is not limited to the above exemplary embodiments, and a person skilled in the art may easily present other different embodiments of the invention. These should be considered within the scope of protection of the invention claimed in the claims.

Claims

CLAIMS1 . A packaging system, characterized in that in order to protect sensors, test kits and especially immunological test sensors from moisture and to prevent their degradation, it comprises:- at least one first layer (1 ) made of a moisture-proof transparent plastic, which has a raised form taking the shape of the test sensor (2) and the moisture trap (3), on a front side thereof, and in which the test sensors (2) are placed,- at least one notch (1.1) positioned on the first layer (1 ) to keep the test sensor (2) fixed in the system,- at least one moisture trap (3) which traps moisture when it is present and prevents moisture from permeating into the system,- at least one water-absorbing catalyst (4) which increases the performance of the test sensors (2),- at least one second layer (5) made of moisture-proof aluminum, which allows a movable blade mechanism included in the test kits to easily pierce and the washing liquid to permeate to the sensor.

2. A packaging system according to Claim 1 , characterized in that it comprises at least one catalyst (4) which is an impregnated sponge, a paper, or cotton.

3. A packaging system according to Claim 2, characterized in that it comprises at least one catalyst (4) which is a melamine sponge, a polyethylene sponge, a polyimide sponge, or a polyurethane sponge.

4. A packaging system according to Claim 2, characterized in that it comprises at least one catalyst (4) which is a polyester paper, or a polypropylene paper.

5. A packaging system according to Claim 2, characterized in that it comprises at least one catalyst (4) which is a glass wool.

6. A packaging system according to Claim 1 , characterized in that it comprises at least one moisture trap (3) which is a silica card, a silica gel, a bentonite clay, a molecular sieve, calcium chloride, calcium sulfate, or activated alumina, in the form of powder or a pellet.

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