Blistered rapid diagnostic test with incorporated moisture absorbent material

Abstract

A package which incorporates, integrated in the composition of one of the components of the test's package, a plastic base (1), a moisture absorbing agent, so that this does not affect them, in combination with one or more polymers, which may be packaged in a blister produced by a base sheet (7) with structures which give rise to cavities (9), in each one whereof a rapid diagnostic test (5) is placed, whose base sheet (7) is complemented with a cover sheet (8) which seals the previous by heat fusion, achieving the hermeticity of each cavity.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a §365 (c) continuation application of PCT / ES2005 / 000235 filed Apr. 29, 2005, which in turn claims priority to ES Application P200401045 filed Apr. 30, 2004 and ES Application P 200401085 filed May 6, 2004, each of the foregoing applications is incorporated herein by reference.FIELD OF THE INVENTION [0002] The present invention relates to a rapid diagnostic test with incorporated moisture absorbent material, which avoids that said moisture may affect the test or even invalidate it, giving erroneous results for the test being performed. Likewise, the invention relates to its form of blister packaging which may be formed in unit form or comprising several units which can be separated from one another. [0003] The object of the invention is, therefore, to provide a new rapid diagnostic test system which incorporates the moisture absorbent material in its own structure, which permits the use of smaller packaging with the ...

AI Technical Summary

Benefits of technology

[0014] Thus, the rapid diagnostic test claimed is characterized in that it incorporates a moisture absorbing agent within the test in one of its constituent parts, or in one of the general structural components of said test, which eliminates said moisture during the time in which it remains packaged, so that it does not affect or invalidate it, giving erroneous results when performing the test.

[0020] The blister, either as independent unit or as units which are separable or detachable, by a tear line between two consecutive cavities or structures, will have the surface upon which the sealing or fixing of the cover sheet will be performed, provided with embossing by way of knurling, with the object of permitting better sealing of the cover sheet to the base sheet.

[0021] We should highlight the fact that the blister has an external punch-hole adjacent to one of the ends of each separable unit, wherefrom the cover sheet will be separated from the base sheet, which will facilitate the grip and, therefore, the pulling to separate or open the blister of that specific unit.

[0026] The blister packaging system for rapid diagnostic test also has several advantages compared to traditional packaging, and among said advantages we can cite the possibility of forming several detachable units in a single body, each with its hermetic test, drastically reducing the dimensions of each unit, as well as the manufacturing costs, given the possibility of making multiple blisters, minimal or practically null moisture transfer, reduction in transport costs and commercialization and permanent maintenance of the test's shelf-life as they are independently sealed.

Problems solved by technology

The great problem with all these types of rapid diagnostic tests is that moisture considerably affects them, changing their characteristics and properties, and may even possibly invalidate them.

On some occasions, instead of this, packaging manufacturers exist that incorporate the absorbent material in the stopper, which logically increases their price.

These types of multiple test packaging have, among others, the great drawback that once the packaging has been opened, it is difficult to guarantee the subsequent shelf-life of the product contained therein.

This type of single-test packaging has some different types of drawbacks, e.g. a considerably larger bag than the test is necessary so that the sachet or pellet of moisture absorbent material can easily be inserted therein in the filling process, with the consequent increase in packaging costs.

Furthermore, two different operations are required in the filling process, one to insert the test in the packaging and the other to insert the moisture absorbent material, which hinders said packaging process.

Another drawback they have is that in many cases the use of these tests is geared towards personal use and not towards qualified personnel, so that there may be confusion in the use of the pellet or sachet of absorbent material instead of the test, with subsequent possible implications, and they may even be ingested.

On the other hand, as the size of the packaging bag is considerably larger than the test, its transport, very important in this area, is considerably affected and its costs are greatly increased.

The blister packaging system as means of packaging and commercialization of products and / or items is very common in different fields and sectors of the art, especially in the pharmaceutical sector, nevertheless, in the diagnostics sector, conventional blister packaging presents serious problems and drawbacks since the tests are seriously affected by moisture, as previously mentioned.

In any case, the blister packaging system can be considered as totally rejected in the industrial diagnostic sector, and probably due to the deficiency of traditional aluminums, wherein micropores exist, as well as the necessary thickness for decent insulation, which involves a large quantity of aluminum necessary to form the blister, also due to the considerable dimensions necessary to blister package the rapid diagnostic test, together with the moisture absorbent material and the high cost of the machinery to manufacture the blister, as well as for the blister packaging process.

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