FI108357B - Means intended to be used in the diagnosis of diseases and their use therefor - Google Patents

Abstract

The invention relates to a device intended for sample collection in the diagnostics of diseases, the device comprising a stick (1) and on the outer surface of its tip a porous part (2) which absorbs, preserves and yields fluid and any cells, microbes and the like possibly present therein, which part is according to the invention a cellulose sponge, preferably a pressure molded cellulose sponge. The invention also relates to the use of the above-mentioned sample collection device for collecting a sample from an infected area containing <i>Streptococcus pneumoniae</i> and <i>Neisseria gonorrhoeae</i> bacteria.

Description

108357

FIELD OF THE INVENTION The present invention relates to a device for use in the diagnosis of diseases 5, and in particular to a device comprising a stick and a fluid and liquid on the outer surface of its head. cells, microbes, and the like, which absorb, store, and donate a porous portion. The invention also relates to the use of the above-mentioned device.

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Correct diagnosis is the cornerstone of the treatment of diseases such as infectious diseases. A correct diagnosis, on the other hand, requires obtaining a sample that is as representative as possible from the test site, such as an infected area, and therefore obtaining a sufficiently large sample for examination is essential for diagnosis. It is also important that the instrument used for sampling is inexpensive and simple to use, as these factors lower the sampling threshold and reduce the cost of diagnostics. For diagnostic purposes: it is not sufficient to obtain a representative sample of the test item but to retain this sample in the sampler up to the time of examination 20 and to transfer the sample in the sampler for further examination, eg in a test tube or petri dish.

Sampling sticks for this purpose are known in the art and have a swab at the end of the stick, for example a wooden stick, which may be cotton, cotton-based material or synthetic fiber. However, these materials are not particularly absorbent, they do not absorb cells and microbes in the liquid very well, it is difficult to determine whether the swab has absorbed any sample at all, since the swab does not particularly swell when exposed to the swab, 5 keep cells and microbes that may have been transported with the fluid alive, and sample delivery to the site may be deficient. Thus, such prior art sampling sticks do not best meet the basic diagnostic requirements for the most representative sample collection, the good preservation of sensitive cells and bacteria, and the best possible delivery of the recovered sample for diagnosis. In contrast, these prior art sampling sticks are cheap, but due to the above reasons, their performance is not optimal and it is difficult to determine whether there have even been any sampling. This problem occurs in particular when a sample is taken from openings in the body that do not show sufficient sampling material at the point of sampling.

It is an object of the present invention to eliminate the above drawbacks and to provide a sampling device for use in the diagnosis of diseases comprising a stick and a porous portion of fluid and any cells, microbes, and the like contained therein, microbes and the like. According to the invention, said porous portion is a cellulosic fungus.

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The use of cellulose sponge in sampling is well known in the art. Then ·· · - · · i '. ·. ; however, a cellulose sponge is inserted into a sampling device, wherein 3 108357 test fluid is aspirated or impregnated into a sampling device, which may be, for example, a micropipette or a syringe (Copeland et al., Invest Ophthalmol Vis Sci, 1982 Jan 22: 1,103-10 and U.S. Patent 3,704,206). ) or a flexible capillary tube 5 inserted into a surgical wound (U.S. Patent No. 77,569). However, such sampling equipment is not suitable for sampling from sites for which the sampling sticks are designed.

Preferably, the cellulosic sponge 10 on the outer surface of the sampler stick according to the invention contains micro- and macro-pores communicating with each other, the micro-pores being as large as possible, the micropore distribution center being preferably 5-15 µm and the macropores as large as their distribution center. 4-0.9 mm. Such a cellulose-15 fungus is highly absorbent of the fluid and its accompanying cells, microbes and the like, maintaining these for long periods of time for sample diagnosis.

::: The preparation of cellulose sponge is well known in the art and is described, for example, in U.S. Patent No. 77,569.

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The cellulose sponge on the outside of the head of the sampler stick according to the invention is particularly preferably a molded cellulose sponge, which has the advantage that it, when subjected to strong swelling, swells efficiently. the fluid and the cells along with the fluid as well as the microbes. Because the cellulose sponge is on the outer surface of the 25 sampler sticks, the sampler is also easily able to visually assess the success of <· · · - «· · * · · sampling and even the smallest amount of fluid by swelling the cellulose sponge.

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The molded cellulose sponge at the end of the sampler stick according to the invention has, for example, an outer diameter of about 1-10 mm when dry and fully swollen up to about 2-30 mm. Due to its small outer diameter 5, the sampling stick can be inserted and swollen even in narrow openings, and its large diameter change, i.e. swelling, makes it easy to determine the success of the sampling.

The sticky portion of the sampler according to the invention is preferably 10 times the length of the cellulosic sponge at its end, and the sticky portion is preferably of a resilient material such as wood, plastic or metal. The advantage of a long wooden stick is that it is easily cut off, for example, by pressing against the inner wall of the sample receiving tube, leaving the cellulose sponge in the test tube and only that part of the wooden stick which has not been touched by hand. In other respects, the elastic properties of the stick are selected so that the cellulosic sponge at its end can be pressed with sufficient force against the sampling surface.

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The present invention is further directed to the use of the above-mentioned sampling stick 20 for sampling an infected area with highly deadly microbes such as Streptococcus pneumoniae and Neisseria gonorrhoeae. It has been found that such susceptible bacteria remain capable of dispersing for extended periods in the cellulose sponge at the end of the sampling stick of the present invention, which is essential for correct diagnosis.

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Thus, in a preferred embodiment, the invention is directed to a sampling stick having a defined cellular sponge with a defined pore structure on the outer surface of the head and used for sampling in the diagnosis of diseases. The good absorption of the sample into the cellulose sponge stick is reflected by an increase in the volume of the cellulose sponge. The cellulose sponge absorbs and delivers sample material significantly more than previously used sampling sticks. In addition, its ability to retain, for example, susceptible bacteria is superior to previous sampling sticks of other materials.

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The cornerstone of the treatment of infectious diseases is therefore the correct diagnosis, as stated above. To ensure a correct diagnosis, a sample is taken from the subject to identify the pathogen. Although methods of varying sensitivity are used for identification, the amount of pathogen in the test sample is essential. Therefore, it is important to get as much sample as possible for further research. When using current sampling equipment, the sampler does not always know whether the sample is sufficiently representative because the amount of sample absorbed, in particular the small amount, cannot be ophthalmic. · Degree to evaluate ..

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As the costs of microbiological examination and sampling of the sample are significantly higher (> 100 times) than the cost of the sampling stick, improving the quality of the sampling increases the cost-effectiveness of the whole process.

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The invention will now be described in more detail with reference to the accompanying drawings, * · '! · 1. . Figure 1a shows the sampling stick of the invention before, 108357 o the sampling stick and Figure Ib the sample stick according to the invention after immersion in water, Figures 2 and 3 again show bar charts of sucking and dispensing of the amounts.

Figures 1a and Ib show an elongated stick of plastic, metal or wood according to the invention with reference numeral 1 and a cellulose sponge portion 10 in its shape adhered around its head. Referring to Figures 1a and Ib, 2 is significantly larger than in Fig. 1a, which indicates that the sampling has been successful. Even when completely swollen, the diameter of the cellulosic sponge portion 2 is not substantially larger than that of the prior art 15 sampling sticks, which is important for the success of sampling, for example, in a narrow nasopharynx or ear canal.

4. . . Figures 2 and 3 show the ability of the sampler according to the invention to absorb and> deliver various fluids in grams compared to known and widely used samplers: Dacron®, Sterilin® and

Transpocult®. The swabs of these known sampling sticks do not swell when wetted, and the swab of the latter is made of cotton, ·· «synthetic fibers of both (Dacron®).

When comparing the inventive molded cellulose sponge sampler according to the invention to the above known sampler sticks, it was found that it absorbs 1.3-1.9 times more weight and delivers 3.5-4.6 times more sample material t) as weight units (g). verrokkitikut. Measurements were made prior to dipping the sticks into the sample material, after absorption of the sample material, and after 5 sample sticks were rotated on the surface of the agar dish without breaking the agar surface. The study used BHI (brain heart infusion broth) as sample material in the diagram in Figure 2 and human blood in the diagram in Figure 3.

The survival of the very dying bacteria, Streptococcus pneumoniae and Neisseria gonorrhoeae, in the cellulose sponge stick according to the invention and in the above-mentioned control sticks after sampling was investigated at different temperatures and media.

Example 1

Conditions: Streptococcus pneumoniae bacterium, BHI medium (brain / heart infusion broth), room temperature, initial concentration of 4 different bacterial suspensions • t from 7.75x10E5 CFU / ml to 12x 10E6 CFU / ml, streak 20 stored in sterile sealed glass tube after aspiration : The bacterial colony counts cultured on a blood agar plate remained unchanged for 96 hours in the cellulose sponge. In Dacron® • · and Sterilin®, colony counts were reduced by 6 hours and bacteria <96 dead at all concentrations.

At 25 hours with Transpocult®, growth was observed at only two concentrations.

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Example 2 l.

Conditions: Streptococcus pneumoniae bacterium, BHI medium, temperature 5 + 4 ° C, 3 different initial concentrations of bacterial suspension between 12x10E6 CFU / ml and 29x 10E6 CFU / ml, the stick was stored after aspiration in a sterile sealed glass tube:

The bacterial colony counts maintained under blood agar remained

in a cellulose sponge for 96 hours unchanged. With reference sticks I

The colony counts were already reduced after 24 hours (Dacron® and Sterilin®) and the colony counts had decreased 5-10 times after 96 hours with the two bacterial concentrations used, compared to the cellulose sponge.

Example 3 15

Conditions: Neisseria gonorrhoeae, BHI medium, room temperature, 5 different bacterial suspension initial concentrations between 1.7x10E4. CFU / ml - 6.2x 10E5 CFU / ml, the stick was stored after aspiration of the specimen in a sterile sealed glass tube: The results of the Sterilin® stick were similar to those of a cellulose sponge. In contrast, colonies in Dacron® and Transpocult® 25 were dramatically reduced after 4 hours, and bacteria were dead at 24 hours at all concentrations.

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Example 4

Conditions: Neisseria gonorrhoeae bacterium, BHI medium, temperature +4 5 ° C, 2 different initial concentrations of bacterial suspension between 1.7χ10Ε4 CFU / ml and 6.2χ10Ε5 CFU / ml, the specimen was stored after aspiration in a sterile sealed glass tube:

The bacterium was cultured on a gonococcal plate in a cellulose sponge flask at both bacterial concentrations after 24 hours and the other at a further concentration of 48 hours. Control sticks were cultured at both concentrations after 24 hours.

Example 5 Conditions: Neisseria gonorrhoeae, two media, modified Stuart and Amies carbon, temperature +4 ° C, 4 different initial concentrations of bacterial suspension between 4.2x10E4 CFU / ml and 5.0x 10E4 CFU / ml.

The bacterium was cultured at two bacterial concentrations of «1 ♦ after 48 hours in a cellulose fungal strain in Amies carbon medium and 20 Stuart medium at all bacterial concentrations after 48 hours. Steril® sticks in Amies carbon medium were no longer cultured after 24 hours, Transpocult® sticks in Stuart medium gave positive results at three bacterial concentrations after 24 hours but cultures were negative after 48 hours.

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Claims (6)

An agent intended for use in the diagnosis of diseases, comprising a spike (1) and a porous portion (2) on the outer surface, of its end, which cellulose sponge portion absorbs, retains, and delivers fluid and any existing cells, microbes and / or the like, characterized in that the porous portion (2) is a cellulose sponge in which micro and macropores are present which are in contact with each other. An agent according to claim 1, characterized in that the distribution center of the micropores is 5 - 15 μm and the macropores 0.4 - 0.9 mm. 3. A composition according to claim 1 or 2, characterized in that the cellulose sponge portion (2) consists of a cellulose sponge, which is molded into the mold (1), which swells strongly when it becomes moist. 4. A composition according to claim 3, characterized in that the outer diameter of the molded cellulose sponge part (2) present in the mold (1), which is dry, is about 1-10 mm, and which is completely swollen about 2-30 mm. 20 I · Agent according to any of the preceding claims, characterized in that the stick (1) is multiply longer than the porous cellulose sponge portion (2) at its end, which cellulose sponge portion absorbs, preserves and emits liquid and any existing cells, microbes and any existing cells, microbes and that the stick (1) consists of elastic material, preferably of wood, plastic or metal. 1 Use of an agent intended for use in sampling in the diagnosis of diseases, which comprises a stick (1) and a ·; A porous cellulose sponge portion (2) on the outer surface of its end, which cellulose sponge portion is micro and macropores staring in contact with each other, and which cellulose sponge portion absorbs, preserves, and emits a liquid sample, characterized in that it is used to sample it. from the infected area, which contains lightly dying microbes, such as the bacteria Streptococcus pneumoniae and Neisseria gonorrhoeae. t I · • · ·