Applying reagent onto matrix material

FIELD: chemistry.

SUBSTANCE: test device has two surface impermeable layers, a layer of absorbing matrix material on which the reagent is applied and which is placed between the impermeable layers. One of the impermeable layers has multiple openings superimposed with the matrix material and capable of absorbing the sample into the matrix material from the surface. The device is laminated and is fitted with apparatus for separating the sample from the surface when rubbed. Disclosed is an alternative version of the test device, versions of the method of extracting the sample from the surface of test devices and a method of making the test device. The invention increases adhesion strength between layers of the test devices and ensures separation of the sample from the surface of the devices when rubbed.

EFFECT: high-speed and large-scale manufacturing of test devices.

58 cl, 6 dwg

 

The present invention relates, generally, to a matrix material with reagents, put on them to use as indicators (prototypes). According to one feature of the invention it relates to the application of reagents to a matrix material, according to another particularly to the indicators, which include matrix materials, which are the carriers of reagents. It is, in particular, is used for reagents and matrix materials used in the tests, especially for Autonomous pilot devices containing the sampler, which includes a matrix material and reagents, as well as, optionally, the indicator test result.

For local testing of the analyte, which is expected in the sample, it is important to minimize the number of stages, the number of test components and the number of used reagent. Many commercially available samples consist of samplers and some types of transport units for transporting Sviatoslavich samples to the laboratory for rapid analysis. However, this practice has many disadvantages because it sets very high requirements to the sampler, transport, environment and transport unit. Therefore, it is extremely important assumption of the existence of a bound the second delay in obtaining test results from the lab.

To overcome these shortcomings have been developed various kinds of local tests. There are several well-known, independent of the experimental device, which caused reagent that detects an analyte as a result of entering into the reaction with him. A positive result may occur, for example, in the form of visible changes observed usually in this type of prototypes, where the reagent on the matrix material, to which you then add sample for testing.

Widely known examples of this type of prototypes tests for the presence of pregnancy and tests for the determination of protein, proteolytic enzymes and leukocytes in urine. Then, more specific examples.

Such tests, compositions and reagents are disclosed for example in U.S. Patent US-4278763, US-4299917 and US-4657855. In these inventions, it is necessary to use filter paper, successively impregnated with reagents, and then dried to implement the test, the device for collecting urine. After collecting her urine is placed in a receiver for prototype or lead indicator strip in contact with urine.

In the Patent US-5049358 disclosed device and method of determining the presence and concentration of protein, such as albumin or protein Bence-Jones in the prototype.

Patent US-2004/0214339 refers to the JV is to sobs and devices for determination of proteins in aqueous solution of the test fluid, in which the buffer additive maintains the pH level corresponding to the sample.

Patents US-6397690 and US-6378386 relate to the technology and devices to determine the magnitude of the surface and purity. Using technology to measure the specific surface contamination by determining the loss of reflectance before and after wiping.

Patent US-6770485 relates to a method of identifying a biological material, in particular, tests, methods and equipment for detection of hazardous biological agents such as microorganisms, biological toxins, etc. In the above-mentioned patent disclosed a method in which the specimen is collected with a swab or pad, etc. In contact with one or more reagents, protein produces an audible signal (such as paint), in addition to the test strips impregnated with an indicator protein, the indicator strip may also include sugar and pH detectors. They can be provided by a separate test strips.

US-5981287 relates to a method for detection of house dust and house dust is treated with a detector protein. When applying reagent detector protein on the filter dust substance is painted.

In General, the matrix material may take various forms in a wide range, but usually it is an absorbing m is a material predetermined, one of the examples which the paper web. Standard products made of paper paintings, have some important properties. Usually they are used for cleaning or wiping, and therefore they must be a very strong absorbent and have good performance. For example, in Patent US-6649025 described product for cleaning made of individual layers, which have different surface characteristics on each side of the product. The first and the second outer layer may be laminated to each other. They can be embossed and nested into each other. The product disclosed in this patent is approved and is suitable mainly for cleaning and polishing any surface or object.

In General, the efficiency of the sample can be achieved using compact prototype, which has all the necessary reagents and possesses the functions required for the sample, in many samples, you can use two or more reagents, which are combined with each other during, after and even before the selection of the sample (sample). To meet these requirements, you can enter other technical solutions, such as patterns, divided into compartments, with separate reagent reservoirs. Some prototypes have been developed for various types of analysis, to the which are intended to facilitate sampling, both in laboratory and in delaboratory conditions. For delaboratory conditions also handy to have narodnosti reagents, which allow easy transportation and disposal of waste.

As a rule, in these experimental models, the reagents are applied to a matrix material, usually a matrix material impregnated in the absorbent. As a result, the test is ready to use. We know a number of technologies for the application of the reagent. However, many such known techniques are time-consuming and costly. Generally known technology is error-prone. Here are some examples of well-known technologies.

Technology type disclosed in US-4046513 and GB-1601283, both of which dated back to the late 1970s, consists of applying reagents to the matrix material using a stamping technology of printing, for example, screen printing or offset printing, in which a contact element having applied thereto a reagent, is imprinted on the matrix material.

Newly developed technologies are as follows.

Patents EP-0342771 (and patents US-5763262, US-2001/0023075 and US-2002/0187561) provide a method of supplying aerosol, in which the reagent is applied on the matrix material in the form of a thin liquid jet through a small hole nozzle with the use of industrial printing device. In spacebefore used sound vibration and electrostatic field to control the deposition of the reagent.

In the Patent US-5958790 disclosed a method of impregnating reagents to nitrocellulose paper by keeping the paper in the solution containing the reagent. This method is very long.

In the Patent US-5252496 used the method of linear sputtering for the deposition of antibodies on the membrane. In addition, US-5149622 disclosed as Pocatello adding reagent on the filter, or, alternatively, the use of different areas of pictures intended for either spraying or deposition on them matrix material.

In EP-1107004 disclosed reagent distribution for hydrophilic target surface non-absorbent substrates using the technology unstressed printing, in which a stream of microdroplets is directed to the substrate.

In US-5658 disclosed a technology for applying reagents to the solid substrate with the formation of the diagnostic grid in which the grid of drops of reagent is placed on the drawing using the technology of inkjet printing.

In US-2002/0064887 disclosed printing device comprising a reservoir, a capillary tube or nozzle for deposition of liquids on a solid substrate.

In the review of the technologies used for applying reagents to the matrix material, become more and more sophisticated and technically complex. Obviously, this creates a demand for a methodical approach. The first feature of the invention consists in the improvement of technology for applying reagents to the matrix material.

According to the first features of the present invention is provided a method of applying a reagent or particles, which are the carriers put on them reagent, matrix material, and the method includes the imprinting of the reagent or particles on the matrix material due to the bringing into contact of the roller on which the deposited reagent or particles, which is a carrier reagent matrix material when the contact roller is rotated or when the contact roller and the matrix material move relative to each other. In addition, according to the first features of the invention, is provided with a matrix material with the reagent or particles caused by this method.

It was considered that the use of such technology contact printing is achieved by cheap, quick and favorable for the production of the way of manufacturing products in large quantities and for a short period of time. For example, the following described variant embodiment, in which the used printing technology "roller to roller, and a device that is usually the standard in the field of printing. Such a standard technology of printing "roller to roller" is able to provide high-speed, large-scale production with consistent quality.

- Implemented method clearly differs from technologies by hand or ispolzuya is complicated spraying or inkjet printing. The method used in the present invention is more reliable in operation than the known technology, and therefore it is applicable for large-scale continuous production. Similarly, the method is not as susceptible to qualitative changes, as known techniques.

Matrix material coated with a reagent is particularly useful in the Autonomous pilot devices suitable for local clinical or hygienic research when it is ready to use due to the presence of the necessary reagents for sample. For example, the experimental device may contain a sampler and an indicator of the tests. Absopositively usefulness is also very high, as for reading the test result does not require any devices.

The use of such printing technology also has the advantage of facilitating the application of the reagent or particles to matrix material in a predetermined pattern. For example, you can select a specific figure to increase the concentration of the sample in the location of agents or particles, or may be one or more alphanumeric characters, which can help the user. This can be achieved by the original location of the reagent or particles on the contact element in the picture.

The method is applicable on the I agents for printing, used in liquid form, for example, in the form of a solution, and is applicable to chemicals for printing, which is applied to the particles. A useful application is in the chromatographic test. Moreover, the method is similarly applicable for particles used for printing, which are not carrying any reagent.

The reagent may be of any type, including single compound or a mixture. The invention is particularly applicable to a reagent capable of acting as a sample, at least one chemical or biological analyzed material in the sample, or suitable for determination of pH of the sample. One preferred reagent is a ligand or inteligent. Some additional specific examples of useful reagents listed below.

The matrix material may be of any type suitable for transfer reagent or particles, including, but not limited to, matrix solution, paper, membrane or impregnated with a caliper. Often the matrix material is absorbent, so that the reagent or particles impregnated with a matrix material, which facilitates the retention of the reagent or particles. Similarly, the absorbing material may facilitate the addition of sample to the reaction with the reagent or particles. Thus, the invention is particularly applicable for trichloro material, intended for use in the experimental device, especially in the experimental device, suitable for local testing. In this device, the matrix material may also be placed in an Assembly fixture, forming the casing of the sample or the cartridge.

Absorbent capacity of the matrix material can be selected by selection of the matrix material. The matrix material may constitute, as an example, but without limitation, tissue or netchenawoe cellulose, viscose, polypropylene, polyester, polyamide or a mixture thereof. The matrix material can have a surface structure or it can be keperawanan to increase capillary surface properties of the absorbing material. The thickness of the matrix material can also be adjusted to achieve the desired absorptive capacity.

Mainly, there may be at least one additional layer of material laminated together with a matrix material. Laminating material can have many different purposes, some examples of which are the following. Various lamination technology can also be used to increase as the exfoliation of the sample and its concentration in the matrix. Additional material can be an impermeable layer on one or both sides of the matrix material. Updat the additional material may make the device more rigidity. Additional material can be a layer of semi-permeable material, for example, to reduce or prevent leaching reagents or flow of the matrix material during sampling.

The way in which the testing device is used for clinical or hygienic tests.

The second feature of the present invention concerns improvements in the functioning of the test device, comprising a matrix material, which is a carrier reagent.

According to other features of the invention, first, provided a testing device containing:

two impermeable layer; and

the layer of matrix material, installed between impermeable layers,

matrix material, which is a carrier reagent, and

one or more impermeable layers containing a few holes, combined with a matrix material, and through which matrix material can be applied to the sample (the sample).

To perform testing or analysis of the sample can be applied through the holes in the matrix material, and, therefore, the reagent deposited on the matrix material. Particular advantages are achieved by providing multiple holes, in comparison with the mentioned one large hole, as follows.

While providing several them of holes in the observed increase in the intensity of reaction with the reagent, and therefore, the improvement of test results, for example, consisting in the fact that the change in color becomes more visible. The reason achieve these results is not clear, but it is assumed that they are achieved due to capillary action within the matrix material, as described hereinafter. Holes can be seen as providing the performance of the individual responses under each hole, consisting in the fact that the sample under each hole comes in contact with the matrix material. This leads to local saturation of the matrix material species in each location under the hole, and breed diffuses outward relative to the periphery of each hole. It is believed that this causes the concentration of the barrier, which locally leads to a more intense reaction.

Multiple holes may also contribute to obtaining a sample from the surface due to the edges of each of the holes formed in the impermeable layer, when it is scraping away from the surface.

According to other features of the invention, secondly, provided a testing device containing:

two impermeable layer;

the layer of matrix material, installed between impermeable layers, and one of the impermeable layers has at least one hole,combined with a matrix material, and through which the sample can be applied to the matrix material; and

semi-permeable layer extending at least through one hole, and a semi-permeable layer made of semi-permeable material, which allows the sample to pass through it, at the same time, limiting the leakage of the reagent.

Semi-permeable layer has the advantage that the reduction in leaching or leaking components from a matrix material during sampling. Moreover, it reduces leaching and permeation of moisture back to the surface.

The testing device is used for clinical or hygienic tests.

To provide a better understanding of the embodiment of the present invention will be further described using non-limiting example with reference to the accompanying drawings.

In the drawings:

Figure 1 is an illustration of a device for pre-treatment process;

Figure 2 is an illustration of apparatus for carrying out the printing process of the reagent;

Figure 3 is an illustration of a device for laminating process;

Figure 4 is a perspective image with a spatial separation of the parts of the test device formed by the laminated matrix material;

Figure 5 pre who is a top view with the spatially separated parts of a variant embodiment of the test device; and

6 is a top view with the spatially separated parts of another variant embodiment of the test device.

There is first described a device that is used to implement technology contact printing, suitable for application of reagents to the matrix material by printing. More precisely, using the device's reagent impregnated matrix, designed for technology high-speed, multi-pass standard print type roller to roller, usually intended for printing documents, and not the implementation of diagnostic tests. Technology roller to roller in itself known, but will be described to the extent necessary for the application of the invention.

The device is designed for application to the matrix material of bromocresol green (BKZ) reagent containing bromcresol green, acetic acid, methyl acetate and alcohol. Despite this, it should be noted that the technology is not limited BKZ, but, in General, the matrix can be applied any of the reagents, using similar technology. The technology is equally applicable for the deposition of particles, which are a carrier for the reagent. Reagent distribution on the particles, which is a carrier, is a particular case of application of the reagent, which is the ligand or inteligenta. Frequent the hospitals can be of any type, material or size, for example, can be latex particles, colloidal gold particles or magnetic particles. Particles can be painted or unpainted.

In this variant embodiment the matrix material 1 is a paper web, but it should be noted that the matrix material can take any form, preferably, to be absorbent material to facilitate its use in a test device.

Implementation to test the reaction to a protein on the basis of bromocresol green chemical reagent held by type roller to roller, can be divided into three distinct phases, namely: 1) pre-processing matrix material, 2) the printing of a solution of the reagent on the test matrix, and (3) laminating a test matrix containing the printed solution, with one or more auxiliary layers for the formation of a test object with one or more layers, having a compact form. A device for implementing these three steps will be described hereinafter, but it should be noted that these steps cannot be performed in this order.

Pre-processing matrix material 1 can be done either by washing the matrix material 1 in an acid bath or by printing the desired acid solution directly on m is tricom material. The acid may be any type of acid (e.g. citric acid, acetic acid, ascorbic acid, tartaric acid), and its function is to buffer the test matrix of relatively small changes in pH. Consequently, this increases the reliability and stability testing. Pre-treatment by washing process includes immersing the matrix material 1 in an acid bath containing acid with a specified pH, until complete wetting of the matrix material 1, followed by subsequent drying period.

Pre-processing by printing can be either a process roller to roller, or the type of process stops.

Figure 1 is an illustration of a device 20 for pre-treatment, where as the technology for pre-treatment involved intaglio-type roller to roller, and as a reagent for pre-treatment used citric acid. Figure 1 and subsequent drawings, the arrows indicate the direction of flow of the matrix material 1. The device 20 for pre-treatment are arranged as follows.

Outdoor pallet 21 contains acid 22 for pre-treatment. The contact roller 23 are partially submerged in the acid 22, whereupon the acid 22 osajda is conducted on the contact roller 23 as it rotates. The contact roller 23 is in contact with the matrix material 1 under the action of the roller 24 located on the opposite side of the matrix material 1, and also in contact with the matrix material 1. Prater 25 is installed close to the contact roller 23 to remove excess acid 22 before bringing the contact roller 23 in contact with the matrix material 1 during rotation.

In the process, the contact roller 23 and the pressure roller 24 rotate at the same speed, while the matrix material 1 is fed between them so that he progressively moved relative to the contact roller 23 and the roller 24. The contact roller 23 moves the acid 22 of the tray 21 to the matrix material 1 and due to the contact with the matrix material 1 under the action of pressure caused by the pressure roller 24, imprints acid 22 on the matrix material 1.

The application of the reagent 32, which in this example is a concert hall, carried out using the standard technology of printing, as described above for pre-processing step. In particular, Figure 2 represents the device 30 for performing the printing process of the reagent in which the technology of printing for applying reagent 32 used technology of gravure printing is about the principle of "roller to roller". The device 30 for performing the printing process of the reagent is arranged as follows.

Outdoor pallet 31 contains a reagent 32. The viscosity of the reagent 32 may be in the range of 5-5000 JV, but preferably the viscosity is 100-1000 SP. The contact roller 33 is partially immersed in the reagent 32, whereupon the reagent 32 is deposited on the contact roller 33 as it rotates. The contact roller 33 is in contact with the matrix material 1 under the action of the roller 34 located on the opposite side of the matrix material 1, and also in contact with the matrix material 1. Prater 35 is installed close to the contact roller 33 to remove excess acid 32 before bringing the contact roller 33 in contact with the matrix material 1 during rotation.

During the process of operation of the contact roller 33 and pressure roller 34 rotate at the same speed, while the matrix material 1 is fed between them so that he progressively moved relative to the contact roller 33 and the pressure roller 34. The contact roller 33 moves the acid 32 from tray 31 to the matrix material 1 and due to the contact with the matrix material 1 under the action of pressure caused by the pressure roller 34, imprints acid 32 on the matrix material 1.

In the case of a device 30 for the implementation of the process of printing the reagent, and unlike device 20 for the pre-treatment process, the gravure printing process carried out using the contact roller 33 having a recess in a predetermined pattern, so that the reagent 32 is deposited on the contact roller 33 in the recess and is applied to the matrix material 1 in the recess of the given figure. Any given pattern can be used as appropriate for the application of the reagent. One type of the given figure represents one or more alphanumeric characters, for example, one or more letters or symbols, or combinations thereof. They may, for example, to display the test result, for example, in the form of such terms as "clean", "dirty", "positive", "+" ("++", "+++", etc.), "negative" or "-".

The matrix material 1 may be laminated with an additional layer 48. Generally speaking, such lamination can be accomplished either by use of the process roller to roller, or the process stops, but the latter is preferable. A suitable device 40 for the lamination process is shown in figure 3 and is arranged as follows.

On the first 4A is a schematic depiction of a device 40 for performing the lamination process, the adhesive 42 is applied on the matrix material 1 using the standard printing technology that described above for the Tapa pre-treatment and application stage reagent. In particular, on the first 4A schematic image as printing technology for applying adhesive 42 using gravure printing on the principle of "roller to roller, which is as follows.

Outdoor pallet 41 contains adhesive 42. Contact roller 43 is partially immersed in the adhesive 42, whereupon the adhesive 42 is deposited on the contact roller 43 when it is rotating. Contact roller 43 comes into contact with the matrix material 1 under the action of the roller 44 located on the opposite side of the matrix material 1, and also in contact with the matrix material 1. Prater 35 is installed close to the contact roller 43 to remove excess adhesive 42 before bringing the contact roller 43 into contact with the matrix material 1 during rotation.

During the process of operation of the contact roller 43 and the pinch roller 44 rotate at the same speed, while the matrix material 1 is fed between them so that he progressively moved relative to the contact roller 43 and roller 44. The contact roller 44 moves the adhesive 42 from the tray 41 to the matrix material 1 and due to the contact with the matrix material 1, under the action of pressure caused by the pressure roller 44, imprints adhesive 42 on the matrix material 1.

On the second 4b schematic picture of the device 40 to about what westline the lamination process, adhesive 42 applied on the matrix material 1, and dried. On the second 4b schematic representation of a matrix material with multiple valve roller 46 is passed through the dryer 47, in which the adhesive 42 applied on the matrix material 1, apply hot air.

On the third 4 schematic representation of the device 40 for carrying out the process of laminating an additional layer 48 is laminated with a matrix material 1 by sticking to it using glue 42. The matrix material 1 and the additional layer 48 serves using valve rollers 49 in the area of contact with each other between the two pinch rollers 50. Rollers 50 are putting pressure on the matrix material 1 and the additional layer 48, causing adhesion of the adhesive 42 to both of them. Rollers 50 are applied at room temperature for the application of pressure, for example, from 0.5 to 10 bar up to, preferably, 2-4 bar.

The adhesive 42 may be a hot glue or cold glue. If the adhesive 42 is a cold glue can be applied on the surface of the matrix material in liquid form and dried, as shown in the second 4b schematic representation before laminating an additional layer 48. Another useful type of cold glue, which can be used is an ultraviolet (UV) curing adhesive. In atomlike instead of the process for drying the adhesive 42, depicted on the second 4b is a schematic image, you can use the process in which use ultraviolet radiation to cure the adhesive 42.

If the adhesive 42 is hot glue, it is a thermoplastic material, and it is applied to the surface of the matrix material 1 at a temperature above its transition into the glassy state. In this case, the drying in the process, presented at the second 4b schematic image is optional, but for bonding with each other matrix material 1 and an additional layer 48 is then ispolzuyutsa pressure and temperature.

In the device 40 to the lamination process, the adhesive 42 is applied on the matrix material 1, but, alternatively, it is possible to put on an extra layer 48.

The device 40 for the lamination process can be used for lamination of several additional layers, if necessary. An extra layer 42 can take many different forms. Examples of possible additional layers (which can be used in any combination) include:

a) plastic materials used as an element of rigidity and/or as a protective layer;

b) impermeable materials, used as a drawing and/or as a protective layer;

c) polypropyleneimine, used as a protective layer,

(d) capillary membrane used as an additional absorbing layer.

The thickness of the matrix material 1 and an additional layer 48 that is used in the above devices 20, 30 and 40, is typically in the range of 1-500 μm, and preferably in the range of 1-100 microns.

In the device described above, the matrix material 1 is served with a speed equal to the peripheral speed of rollers, for example, the contact roller 43 and roller 44. Also, each of the pair of opposing rollers, for example the contact roller 43 and the pinch roller 44, have the same dimensions. However, these characteristics can be varied for different applications, for example, by using rollers with different diameters and launching into operation at speeds different from each other and/or from the speed of the matrix material 1.

Next will be described the testing device 60 shown in Figure 4. The testing device 60 can be created using the above devices 2, 3 and 4, and the testing device 60 creates simply by cutting part of the solid matrix material 1 produced in the device 40 to the lamination process.

The testing device 60 contains a layer of matrix material 1 having applied thereto a reagent, laminated with three of the optional layers, namely, the semi-permeable layer 61, adjacent to the matrix material 1; impervious surface layer 62 located on the outer side relative to the semi-permeable layer 61; and an impermeable base layer 63, adjacent to the matrix material 1 on the side opposite the semi-permeable layer 61.

Semi-permeable layer 61 is optional, and in some embodiments the embodiment of the test device 60 may be omitted.

The testing device 60 may further comprise (optional) capillary layer 64 between the matrix material 1 and impermeable base layer 63 to increase the absorption of the sample matrix material 1.

Impervious surface layer 62 and an impermeable base layer 63 create a seal around the edge of the matrix material 1. Seal essentially you can create during the lamination process or a separate element.

Impervious surface layer 62 and an impermeable base layer 63 prevent contact of the liquid with a matrix material, except when it is controlled, as will be described later. To allow the sample to come into contact with the matrix material 1, impermeable surface layer 62 can be made removable, or it may contain holes, in consequence of which he ceases to be continuous, for example, due to the physical modification by removing part of it.

Two examples of the test device 60, in which the surface layer 62 includes the holes shown in Figure 5 and 6.

In the example according to Figure 5 the surface layer 62 has a single hole 65 that is created at one end of the test device 60, exposing region 66 semi-permeable membrane 61, which acts as the sampling surface for receiving the sample (sample). Used the sample can be applied to the area 66, wiping the testing device on the surface, Pocatello causing the liquid sample to the test device 60 or bringing into contact the edge 70 of the test device adjacent to the hole 65, with a solid sample, or immersing it in a liquid sample. The surface layer of the source 62 can be provided with a hole 65 formed by removing part of the surface layer 62, for example, by providing perforations in the surface layer around the edge of the hole 66.

In addition, the testing device 60 is equipped with two (or, in General, any number) slots 67, created in the hole 65 and extending through the entire thickness of the test device 60, allowing you to collect a sample with a sharp object such as a knife, which slides through the slot 67 under the action of the user.

The size and shape of the slots 67 and holes 65 can be changed in accordance with the requirements of the applications to the deposits. The hole 65 may be, as indicated above, any size or shape, for example, the shape of the flat edge 70, and extend a short cut or a part thereof, the projection of a short cut, and the projection may be of any size or shape. Naturally, the above mentioned signs may also refer to the long edge of the test device 60 instead of 70 short edge.

In the example according to Fig.6 surface layer 62 has a lot of holes 71. In this case, there are sixteen holes 71, but this number can be changed. The holes 71 are circular, but they may have other shapes. The holes 71 are arranged in a regular manner, which, however, has no special advantage, allowing only the positioning holes 71 compact. Providing numerous holes 71 in the example according to Fig.6 observed to provide a more distinct test result, compared with the single hole 65 in the example according to Figure 5. It is believed that this is due to the capillary effect, which creates a local concentration at the border of the matrix material 1 under each hole 71, as described above. The presence of several holes 71 also promotes the separation of the sample from the surface, because the edges of each hole 71 can scrape the surface.

In both examples, according to Figure 5 and 6 the remainder of the surface so outside holes 65 or holes 71 forms a grip 68 for the user. The grip 68 may be separated from the holes 65 or holes 71 bend 69. Degree bending angle 69, as well as the size and shape of the grip 68 can be changed in accordance with the requirements of the application.

Alternatively, the capillary channel may also be arranged in the form of a projection plane with holes or small slits, exposing the matrix material 1 the cross section of the test device 60.

There is a danger that the reagents are deposited on the matrix material 1 will be coming out during use, causing the leakage of the reagent matrix material 1 on the surface or on the subject of the study. This leakage may become noticeable when the wetting of the surface for sampling, with the assistance of the separation of the sample from the surface with subsequent movement of the sample in the matrix material 1 sampler for the implementation of the interaction of the reagent with the analyzed substance in the sample. Hydrated matrix material 1 may be suitable to prevent leakage of the reagent due to the high level of moisture introduced during sampling.

Therefore, the desired one-sided leakage can be detected by various means.

One option is that the semi-permeable material layer 61, you can choose to reduce or protect the reagent from leaching from the matrix Mat is the real 1. For example, semi-permeable layer 61 can be obtained from the hydrophobic layer. Suitable hydrophobic material is a nonwoven polypropylene material. The material may be either permanently or non-permanent hydrophobic, depending on the application. The materials used to slow the swelling reagent matrix material 1 after its moisture through the surface. Similarly, they slow down the flow of the sample on said surface. From a hygiene point of view, this is a very important property because it reduces or prevents the sample, which may contain microorganisms, from re-soiling them to the surface. Moreover, the surface remains dry after sampling and not turn into a platform for the emergence of new problems associated with pollution.

This effect is achieved through a semi-permeable layer 61, which extends through the opening 65 or openings 71. This follows from the construction shown in Figure 4, in which a semi-permeable layer 61 covers the entire surface of the matrix material 1 between the matrix material 61 and the surface layer 62. However, there are other constructions in which a semi-permeable layer 61 extends through the opening 65 or openings 71, for example, with a semi-permeable layer 61, covering only the area of the hole 65 is whether the holes 71, or is opposite of the surface layer 62.

Another example of a means to prevent material from washing out with the test device 60 is in use, for example, as shown in Figure 5, impermeable surface layer 62 with a hole 65, providing a capillary surface, channel, or any surface, allowing the humidified sample to penetrate into the matrix material 61. The design of the holes 65 may be a simple slice or projection, designed to achieve direct contact.

One or both of two layers (optional) - an impervious surface 62 and an impermeable base 63 are transparent in the region adjacent to the hole 65 or holes 71. This allows the examination of the matrix material 1 to determine where there has been a visible change of the test result.

The testing device 60 can be designed to increase the concentration of the sample in the place where the reagent is applied on the matrix material 1. One option is to give relief matrix material 1, for example, using the technology of printing, which is obtained this relief. Another option is to apply, for example, by printing, ink impermeable to the figure, which thus increases the concentration. Pattern and is impervious ink can represent any suitable pattern, and the technology of its application is known in other areas and is known wiper products used for cleaning. For example, the pattern or impervious ink may be a convex figure with depression, grids or circles to reduce spreading of the liquid and/or to improve fluid flow and concentration in a small area of the surface.

To improve the separation of the sample from the sample surface, the testing device 60 may include a corresponding laminated layer, for example, impervious surface material is selected so that it had the structure favorable for separation of the sample. The drawings used to separate the sample, can be a relief groove, growths or similar drawings, and may be part of a pattern of material or can be engraved on said material during the process of preparation for the test. The surface structure can also be used for concentrating the separated sample to the matrix material 1. Impervious laminated material can be perforated for the formation of surface images, similar to those described for the imprinted pattern on the layer of absorbing material.

Another option is that the layer of impervious material used in the t to stiffen the desired level and the formation of the test device 60. This material may also form a shell of matrix material 1. Consequently, the matrix material 1 can be placed in an Assembly fixture (casing or cartridge), which is the carrier for the matrix material 1 and creates the conditions that allow you to extend the storage time of the test device. The shell may contain perforations to application of the sample and a display for displaying the analyzed material. All the testing device 60 may have a desired shape and size, depending on the model and user requirements.

Another option is to use a blister pack having a liquid compartment containing a liquid or gel-like surface-wetting agent. Bay can be a separate element attached to the test device 60 during a single build process. Moisturizing substance is released, for example, compression and rupture of the blister package from one end.

On the matrix material 1 can also be applied conductive material, for example, by printing using printing technologies used for reagents. Such conductive material may facilitate connection of the test device 60 with an external power source, for example, to facilitate heating or preheating the test device 60. This nahrewali heating of the test device 60 can be performed in the presence of ICA - reagents (BCC, ICA - bicinchoninic acid) to increase the sensitivity of detection of the protein. The sensitivity of the method ICA depends on time and temperature. Therefore, the test duration can also be used to increase the sensitivity. Heating or preheating of the test device 60 to +40-100°C., preferably 55°C, facilitates the detection of reducing sugar level that cannot be detected at room temperature. Moreover, the use of electric current provides electrophoretic separation of compounds with different charge. In addition, it provides amplification of the signal detected by electricity. In the case of electrophoretic separation, the matrix material 1 can be applied the gel, for example, using the technology of printing used for reagents.

Similarly, it is possible to apply, for example, using the technology of printing used for reagents, the power source in the form of a thin-film battery (sometimes called a paper battery) for low power applications, such as battery type made Enfucell Ltd and Voltaflex Corporation.

In more complex applications can be obtained by selective or non-selective microbial growth due to the additional coating of the substrate or the cultural environment in matrix mater what al 1 or another component of the test device 60, for example, using printing technology used for reagents. Cultural environment can be selective or non-selective and may be in dry form or in a condition suitable for use. The culture medium can be used in combination with a conductive material or a thin-film battery is installed to provide heating or heating of the sample to a suitable temperature, typically in the range from 30°C to 45°C, preferably up to 37°C. This can be done, for example, passing a current through a wire of high electrical resistance or passing a current between two electrodes in a matrix material 1.

For more precise analysis, the reagent is deposited on the matrix material 1, may be any ligand or inteligent, which can be impregnated with a matrix material (or its surface) to ensure detection of a selected biological markers.

In many test devices reagent gives reaction, which leads to a noticeable change. In this case, the outer surface of the test device 60 can be printed using standardized reference panel indicating the values of various changes in the matrix material. For example, standardized reference panel can correlate different colors with the corresponding intensities of the reaction is, thus, to a certain extent to calibrate the test material.

The above characteristics of the test device 60 can be applied individually or in any combination. Indeed, they can also be applied to the test device, in which the reagent is applied on the matrix material with the help of some technology, non-contact printing.

As already mentioned, the reagent may take any form. Just, then, by bringing examples and without limitation of the scope of the invention will be described some specific control procedures with the participation of the respective reagents. If not stated otherwise, the methods used are standard chemical, biochemical and physical technology.

Similarly, the pattern may take any form. The sample may be a liquid. In other cases, the sample may be a substance other than the liquid, for example a biological sample, such as a protein. In this case, the sample can be dampened or moistened with liquid, e.g. water or buffer solution, to facilitate the movement of the matrix material 1. In this case, a semi-permeable membrane 61 allows the sample to pass through it in a suspension or solution.

The process of testing for the presence of protein can be applied in the following way. In this process, use sovan the composition of the reagent, having the ability to react with protein concentration was low. For a given composition of the reagent of any of the known methods of detecting a protein, including, but without limitation, bromcresol green (BKZ), pyragollole red, Kumasi blue, complex bisengimana acid (BCC, ICA) - copper. The interaction between the component and the protein yields a visually or instrumentally detectable and/or measurable results. According to a process wetted surface wipe test device 60. Hydration can be obtained by using a separate device for added moisturizing substances to the sample surface or through a compartment containing a given amount of moisturizing substances attached to the test device 60 in the open form and from which the wetting agent is available to hydrate the surface of the sample surface. The pressure exerted on the surface during sampling, presses moisture, wetting the sample, through a semi-permeable layer 61. Excess moisture left on the sample surface can be absorbed by the matrix material 1 through the opening 65, exposing the capillary channel, as described above. The same capillary channel can also be used to obtain a sample of fluid. If the sample contains protein, it will interact with the reagent, available in a matrix material 1. This will cause a change in color of the reagent with yellow-orange to green, which, consequently, will be visually detectable through the transparent semi-permeable layer 61 both qualitatively and quantitatively.

Process pH testing can be applied in the following way. BKZ-reagent, as described above, can also be used as a pH indicator simply by applying pre-treated acid 22 deposited on the matrix material 1, in the neutral pH-range or by selecting a reagent matrix material with a neutral pH. Property pH indicator BKZ-reagent can be used as an independent pH-test or as a simultaneous measurement of the level of protein, and pH, by dividing the contact surface of the sample to a measurement of the pH level and the area level measurement of the protein.

The testing device 60 can be supplied as part of a diagnostic kit. This kit is suitable for use in the present methods and, in General, is suitable for the diagnosis and evaluation of the amount of protein in samples from surfaces, for monitoring hygiene. The kit must be suitable for the format of the sample for which is set. Typically, the kit contains a test device 60 in the form of opican the th above or non-laminated matrix material 1, contains reagents for detecting, for example, proteins, carbohydrates, sugars, pH, ligands or intelligendo, which manifests in the form of painting or sludge. Typically, the kit may contain other reagents or components intended for use in a particular test, such as buffer solutions, precipitating agents, agents for labeling and/or detection. In one variant embodiment, the kit can include instructions, such as leaflet invested in packaging, instructs users set with respect to the contents of the kit and the format of the test.

1. Testing device for wiping the surface to obtain a sample that contains:
two impermeable surface layer,
the layer of absorbent matrix material, which caused a reagent and which is located between impermeable layers, with
one of the impermeable layers has many holes, combined with a matrix material and made with the possibility of absorption of the sample in the matrix material from the surface through them, and the device is laminated and provided with means for separating the sample from the surface when wiping.

2. The testing device according to claim 1, additionally containing a semi-permeable layer that extends through the many hole is, moreover, the semi-permeable layer made of semi-permeable material, ensure the passage of the sample through it, and at the same time limiting the leakage of the reagent.

3. The testing device according to claim 2, in which a semi-permeable material is hydrophobic.

4. The testing device according to claim 2, in which a semi-permeable material is a nonwoven polypropylene.

5. The testing device according to claim 2, in which a semi-permeable layer is installed between the layer of matrix material and an impermeable layer with holes.

6. The testing device according to any one of claims 1 to 5, in which the reagent is able to function as a probe, at least one chemical or biological analyte in the sample.

7. The testing device according to claim 6, in which an analyte is a protein, carbohydrate, sugar, ligand or inteligent.

8. The testing device according to claim 6, in which the reagent is a ligand or inteligent.

9. The testing device according to any one of claims 1 to 5, in which the reagent is suitable for determination of pH of the sample.

10. The testing device according to any one of claims 1 to 5, in which the matrix material is additionally applied to any one or more substances: culture medium, gel, conductive material or a thin-film battery.

p> 11. The testing device according to any one of claims 1 to 5, in which the matrix material is further caused to the cultural environment and either a conductive material or a thin-film battery for heating or preheating of the cultural environment.

12. The testing device according to any one of claims 1 to 5, in which the matrix material deposited reagent, which the carrier particles are.

13. The testing device according to claim 1, in which the matrix material caused the terrain to increase the concentration of the sample.

14. The testing device according to claim 1, containing means for increasing the intensity of the reaction color change.

15. The test device according to item 13, in which the relief caused by the technology of printing.

16. The test device according to item 13, in which relief is a convex figure with depression, grids or circles.

17. Testing device for wiping the surface to obtain a sample that contains:
two impermeable surface layer;
the layer of absorbent matrix material, which caused a reagent and which is located between impermeable layers, and
semi-permeable layer made of semi-permeable material and having the ability to pass the sample through it and limit the leakage of the reagent matrix material, with one of the impermeable layers has, IU the greater extent, one hole, combined with a matrix material and made with the possibility of absorption of the sample in the matrix material from the surface through him,
and the device is made laminated and provided with means for separating the sample from the surface when wiping.

18. The test device according to 17, in which a semi-permeable material is hydrophobic.

19. The test device according to 17, in which a semi-permeable material is a nonwoven polypropylene.

20. The test device according to 17, in which a semi-permeable layer is installed between the layer of matrix material and one of the impermeable layers having at least one hole.

21. The test device according to 17, in which one of the impermeable layers has a lot of holes.

22. The testing device according to any one of p-21, in which the reagent is able to function as a probe, at least one chemical or biological analyte in the sample.

23. The test device according to item 22, in which an analyte is a protein, carbohydrate, sugar, ligand or inteligent.

24. The test device according to item 22, in which the reagent is a ligand or inteligent.

25. The testing device according to any one of p-21, in which the reagent is suitable for the op is adelene pH of the sample.

26. The testing device according to any one of p-21, in which the matrix material is additionally applied to any one or more substances: culture medium, gel, conductive material or a thin-film battery.

27. The testing device according to any one of p-21, in which the matrix material is further caused to the cultural environment and either a conductive material or a thin-film battery for heating or preheating of the cultural environment.

28. The testing device according to any one of p-21, in which the matrix material deposited reagent, which the carrier particles are.

29. The test device according to 17, in which the matrix material caused the terrain to increase the concentration of the sample.

30. The test device according to 17, containing means for increasing the intensity of the reaction color change.

31. The test device according to clause 29, in which the relief caused by the technology of printing.

32. The test device according to clause 29, in which relief is a convex figure with depression, grids or circles.

33. The method of extraction of the sample with the surface at which: provide a testing device containing:
two impermeable surface layer,
the layer of absorbent matrix material, which caused a reagent and which is located between the impermeable when oami,
one of the impermeable layers has many holes, combined with a matrix material and made with the possibility of absorption of the sample in the matrix material from the surface through them, when this device is manufactured of laminated and provided with means for separating the sample from the surface when wiping, and
wipe the surface of the test device to absorb the sample in the matrix material from the surface through the holes.

34. The method according to p, wherein the testing device further comprises a semi-permeable layer extending through at least one hole, and a semi-permeable layer made of semi-permeable material, which allows the sample to pass through it, and at the same time limiting the leakage of the reagent.

35. The method according to clause 34, wherein the semi-permeable material is hydrophobic.

36. The method according to clause 34, wherein the semi-permeable material is a nonwoven polypropylene.

37. The method according to any of PP-36, in which a semi-permeable layer is installed between the layer of matrix material and an impermeable layer with holes.

38. The method according to any of PP-36, which additionally add a wetting agent to the surface or to the test device to the specified wiping.

39. The method of extraction of the sample with which poverhnosti in which: provide a testing device, contains:
two impermeable surface layer;
the layer of absorbent matrix material, which caused a reagent and which is located between impermeable layers, and a semi-permeable layer made of semi-permeable material and having the ability to pass the sample through it and limit the leakage of the reagent matrix material, with one of the impermeable layers has at least one hole, combined with a matrix material and made with the possibility of absorption of the sample in the matrix material from the surface through him, and the device is laminated and provided with means for separating the sample from the surface when wiping; and
wipe the surface of the test device to absorb the sample in the matrix material from the surface through the holes.

40. The method according to § 39, in which a semi-permeable material is hydrophobic.

41. The method according to § 39, in which a semi-permeable material is a nonwoven polypropylene.

42. The method according to § 39, wherein the semi-permeable layer is installed between the layer of matrix material and one of the impermeable layers having at least one hole.

43. The method according to any of PP-41, in which the mentioned at least one hole includes a number of holes.

44. The method according to l is the Boma from PP-42, in which optionally add a wetting agent to the surface or to the test device to the specified wiping.

45. The method of manufacturing the test device for wiping the surface to obtain a sample, including:
application of a reagent or particles carrying reagent in absorbent matrix material, which is performed by the printing reagent or particles in the matrix material by bringing the contact roller having deposited thereon a reagent or particles carrying the reagent in contact with the matrix material during the rotation of the contact roller and moving relative to it a matrix material;
the lamination of the matrix material between two impermeable layers, with one of the impermeable layers has at least one hole, combined with a matrix material and made with the possibility of absorption of the sample in the matrix material from the surface and through him, and
supply device, means for separating the sample from the surface when wiping.

46. The method according to item 45, wherein one of the impermeable layers has a lot of holes.

47. The method according to item 45, wherein optionally laminated matrix material and two impermeable layers of semi-permeable layer extending over at least one of the opening, moreover, the semi-permeable layer made of semi-permeable material, which allows the sample to pass through it, and at the same time limiting the leakage of the reagent or particles carrying reagent.

48. The method according to p, in which a semi-permeable material is hydrophobic.

49. The method according to p, in which a semi-permeable material is a nonwoven polypropylene.

50. The method according to any of PP-49, in which the said step of bringing into contact of the contact element with a matrix material is carried out with the pinch roller located on the side of the matrix material, the opposite contact element, and in contact with the matrix material and rotating.

51. The method according to any of PP-49, further comprising the deposition of the reagent or particles, which are the carriers of the reagent to contact the roller due to the rotation of the contact roller through the pallet with the reagent or particles carrying reagent.

52. The method according to any of PP-49, in which the reagent has a viscosity in the range of 5-5000 SP.

53. The method according to any of PP-49, in which the reagent is capable of acting as a probe, at least one chemical or biological analyzed material in the sample.

54. The method according to item 53, wherein the analyzed material is predstavljaet a protein carbohydrate, sugar, ligand or inteligent.

55. The method according to item 53, wherein the reagent is a ligand or inteligent.

56. The method according to any of PP-49, which is a method of applying a reagent which is suitable for detecting the pH of the sample.

57. The method according to any of PP-49, further comprising applying a conductive material in a matrix material.

58. The method according to any of PP-49, further comprising applying cultural environments in the matrix material.



 

Same patents:

FIELD: medicine.

SUBSTANCE: reagent for testing total α-amylase activity in serum, blood plasma and urine contains as a substratum 2-chlorine-4-nitrophenl-4-O -β-D-galactopyranosylmaltoside (GalG2CNP), sodium chloride, potassium sulphocyanate, sodium azide, EDTA, calcium acetate, Triton X-100, 2-morpholinoethanesulfonic acid (MES) and water. The pH value of said reagent is 5.5-6.5.

EFFECT: use of the reagent enables high precision and results reproducibility α-amylase test.

1 tbl, 4 ex

FIELD: medicine.

SUBSTANCE: invention concerns a kit of reagents for pancreatic α-amylase activity test including a reagent 1 containing sodium chloride, potassium sulphocyanate, sodium azide, water-soluble calcium salt, monoclonal salivary α-amylase antibodies (MAB), 2-morpholinoethanesulfonic acid (MES) and water, and a reagent 2 containing 2-chloring-4-nitrophenyl-4-O-β-D-galactopyranosylmaltoside (GalG2CNP), MES and water, differing by the fact that the reagent 1 in addition contains EDTA and bovine serum albumin (BSA), and as calcium salt, it contains calcium acetate, and the reagent 2 in addition contains EDTA and sodium azide in the proportions specified in the patent claim.

EFFECT: enhanced stability of the set of reagents with maintaining high accuracy and result reproducibility of the analysis.

1 tbl, 4 ex

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine, namely to methods of predicting post-operational complications, namely to methods of predicting development of scars after previous acne. In order to predict scar development content of receptor antagonist of interleukin-1 (RAIL) is determined during 15 days after resolution of inflammatory process. Scarless development of process is diagnosed at level RAIL in peripheral blood serum after disease being within physiological norm (300-800 pg/ml). If level of RAIL is lower than said norm prediction of acne complication in form of skin scars is diagnosed. Possibility of development of hypertrophic scars is predicted if RAIL concentration is lower than 200 pg/ml.

EFFECT: method makes it possible to predict type of complications after previous acne, therefore correcting therapy carried out in due time can prevent risk of skin scar formation and improve patient's life quality.

2 cl, 1 tbl, 4 ex

FIELD: medicine.

SUBSTANCE: developing hypoxia in a pregnant woman of the third trimester of gestation is predicted by evaluating peripheral blood oxyhemoglobin (HbO2) and 2,3 diphosphoglycerate phosphatase (2,3DPG) concentrations. A discriminator (D) is calculated by formula D=+17.072·2.3DPG + (-0.041·HbO2), 2,3DPG - concentration, mol/l, HbO2 - amount, %. The D value within 97.09-112.37 enables to predict threatened hypoxia in a pregnant woman had an acute condition of herpes virus infection.

EFFECT: use of the method allows well-timed detection of a risk group and correct prediction of developing hypoxia.

2 ex

FIELD: medicine.

SUBSTANCE: threatened reduced erythrocyte oxygenation in a pregnant woman suffering an acute attack of bronchial asthma in the first trimester of gestation is predicted by evaluating oxyhemoglobin (HbO2) and 2,3 DPG (2,3 diphosphoglycerate phosphatase). This is followed by calculating a D discriminator value by formula D=18.05·2,3DPG + (-0.075·HbO2), and observing the D value within 88.66 to 102.42, threatened reduced erythrocyte oxygenation that leads to hypoxia is predicted.

EFFECT: use of the method enables predicting threatened reduced erythrocyte oxygenation in a pregnant woman with the acute attack of bronchial asthma.

1 ex

FIELD: medicine.

SUBSTANCE: differentiated detection large and small circulating immune complexes in blood serum is ensured by a follow-on examination of blood serum clarified by short centrifugation with a method of circulating immune complexes precipitation PEG -6000 of the end concentration 4 % and 6 %. Thereafter, the results are recorded by a turbidimetric method with using a microplate spectrophotometer in a two-wave mode: basic - 340 nm, reference filter - 620 nm. Duration of an incubation step at temperature +18-25°C is 15 minutes. Using the method enables higher effectiveness and reliability of determining the level of large circulating immune complexes, results reproducibility, as well as differential measurement of the level of small CIC which are a diagnostically significant indicator of human body immune responsiveness in many types of a pathology, decreased volume of analysed serums to 0.06 ml, and incubation duration to 15 minutes.

EFFECT: method is suitable for clinical screenings.

1 dwg, 1 tbl, 1 ex

FIELD: measurement equipment.

SUBSTANCE: invention refers to biophysics. In order to determine calcium concentration on the basis of discharged photoproteins, bioluminescent reaction of photoproteins and calcium ions is performed, intensity of the solution fluorescence is measured, calibration dependence of fluorescence intensity on calcium concentration in double logarithmic coordinates is built and logarithm value of calcium concentration is determined as per the logarithm of the measured fluorescence intensity. Fluorescence is initiated with the light source after bioluminescent reaction is completed. Fluorescence intensity is measured at the specified length of excitation and recording wave.

EFFECT: method allows determining calcium concentration in various media as per fluorescence intensity of discharged photoproteins, which allows performing continuous measurements of calcium concentration in "in vivo" system.

2 dwg, 6 ex

FIELD: medicine.

SUBSTANCE: when admitted, an acuity patient is analysed for total protein concentration and creatine phosphokinase activity in blood serum. If the analysed values are within normal limits, the absence of skeletal muscles injures is diagnosed; total protein concentration being within normal limits and creatine phosphokinase hyperactivity indicate the presence of an accompanying injury of the skeletal muscles, while lowered total protein concentration with underlying creatine phosphokinase hyperactivity shows progressing hypoproteinemia.

EFFECT: method provides pre-clinical detection of the presence of the accompanying injures of the muscles and progressing hypoproteinemia.

3 ex

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine, in particular toxicology and resuscitation science and can be used for early prediction of pneumonia development in patients. On the first day of staying in hospital functional state of albumin in blood serum is analysed in patients by fluorescent method. Intensity of K-35 probe fluorescence in blood serum albumin in medium with high ionic power is determined. If value of K-35 probe fluorescence intensity in albumin is lower than or equals 36 conv.units, development of pneumonia in patient is predicted.

EFFECT: method allows to increase efficiency of performed treatment in said category of patients.

2 tbl, 4 ex

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to internal diseases, diagnostics. Method is based on determination of general oxidant activity (GOA) and general antioxidant activity (GAA) with further determination of oxidant index (OI), which equals ratio of GOA to GAA. In accordance with the invention oxidant activity is determined by degree of echinochrome A oxidation by components of oxidant system of blood serum or plasma, and general antioxidant activity is determined by degree of echinochrome A oxidation with chloramine B, added to blood serum or plasma. OI index of healthy donor is taken as a unit. OI value higher than a unit testifies to disbalance of general oxidant status of organism. Method ensures up to 20 fold reduction of amount of analysed serum or plasma in comparison with standard methodology, reduction for carrying out analysis from 72 hours to 2 hours. When ranging it is possible to perform analysis of more than 500 samples during one day, using microboards and microplate spectrophotometers.

EFFECT: method is simple in implementation, economical and does not require large volume of thermostatically controlled chambers.

1 tbl, 2 ex

FIELD: medicine, analytical biochemistry.

SUBSTANCE: invention relates to laboratory methods of investigations. Method involves sampling specimen from patient to be inspected, extraction of serotonin and histamine from a specimen, chromatography of extract and determination of concentration of serotonin and histamine by the fluorescence intensity value. Saliva is used as biological fluid. Saliva by volume 1 ml is extracted with 4 ml of 1 N hydrochloric acid solution, 2 g of anhydrous potassium carbonate and 5 ml of mixture of butanol and chloroform in the ratio 3:2 are added, extract is shaken up and centrifuged. Organic phase (4 ml) is sucked off from extract and passed through chromatography column (diameter is 3 mm, height is 16 mm) filled with ion-exchange resin KB-4 or KB-4P-2 or Bio Rex-70 in H+-form, size of granules is 0.1 ± 0.02 mm. Histamine is eluted with 4 ml of 0.1 N hydrochloric acid at the rate of eluting solution 0.4 ml/min. Histamine concentration is determined by reaction with ortho-phthalic aldehyde dissolved in ethanol. Serotonin concentration is determined by reaction with ninhydrin in organic passed through column. Method provides assaying the saliva concentration of serotonin and histamine with high precision.

EFFECT: improved assay method.

FIELD: medicine.

SUBSTANCE: method involves studying blood samples with venous blood mixed with vital stain like methylene blue. Degree of vital stain absorption by erythrocytes is determined by applying photocolorimetry. The value drop being more than 25%, extracorporal detoxication is to be predicted as ineffective.

EFFECT: simplified method.

6 tbl

FIELD: medicine, infectology.

SUBSTANCE: one should detect the level of terminal stable metabolites of nitrogen oxide (NOx) in whole blood. At its value ranged 39.6-86.0 mcM/l one should evaluate hemorrhagic fever accompanied with renal syndrome (HFRS) of average severity, at NOx value ranged 86.7-141.5 mcM/l - severe form of HFRS and at its values ranged 88.2-128.6 mcM/l at the background of pronounced clinical picture - as complicated disease flow. The method enables to shorten the terms for carrying out the assays.

EFFECT: higher accuracy of evaluation.

3 ex, 1 tbl

FIELD: medicine, biochemistry.

SUBSTANCE: in blood serum one should detect the level of lactoferrin and biliary acids. At their ratio being equal to 5-17 it is necessary to detect chronic hepatitis of high activity.

EFFECT: higher accuracy of detection.

3 ex

FIELD: medicine, dermatology, clinical laboratory diagnostics.

SUBSTANCE: the present method deals with detecting the focus of neutrophilic phagocytic activity lesion in capillary blood. At the values of cells' capacity to phagocytosis in percentage and phagocytic number on the 10th d of therapy being below 20% and 3.3, correspondingly one should evaluate therapeutic efficiency to be low, if it is above 40% and 4.0, correspondingly - as high.

EFFECT: higher accuracy of evaluation.

2 ex, 3 tbl

FIELD: medicine.

SUBSTANCE: method involves studying blood serum, processing obtained data and setting disease diagnosis. The study is carried out by preparing dried blood serum sample as suspension in Vaseline oil and doing the infrared spectroscopy analysis in the bandwidth of 120-1000 cm-1 and determining absorption strip peak heights having maximum at 1180; 1165; 1160; 1150; 1130; 1070; 1025 cm-1 and then calculating the following two ratio groups, the first of which is ratio of peak height with maximum at 1165 cm-1 to 1150 cm-1; 1160 cm-1 to 1130 cm-1; 1070 cm-1; 1025 cm-1. The second group has ratio peak having maximum at 1165 cm-1 to 1160 cm-1; 1180 cm-1 to 1130 cm-1; 1065 cm-1; 1070 cm-1. The obtained three-dimensional distribution of the first group is projected to frontal plane for calculating two-dimensional coordinates and comparing to flat reference diagnostic images of hepatic pathologies and to a normal reference diagnostic image represented as flat polygons which boundaries are given by the following values. The norm is represented by X(-2.3;2.0;4.0;4.0) and Y(1.6;0.8;0.8;1.6), respectively. Oncology is represented by X(1.7;1.7;0.0;0.0) and Y(1.9;1.25; 1.25;1.9). Hepatites are represented by X(1.9;2.2;1.8;1.4 and 1.9;1.8;4.0) and Y(1.9;1.9; 0.5;0.5 and 08;0.5;0.8). Cirrhosis is represented by X(1.9;2.6;1.4) and Y(1.6;0.8;0.4). Diseases are differentiated by interpreting point position within particular area. Three-dimensional distribution of the second group is projected to frontal plane and compared to diagnosis images of pathology and norm. Coordinate values of the second group are as follows: norm - X(1.8;2.9;2.5;1.5), Y(2.7;2.0;1.2;1.6); oncological cases - X(0.27;0.67;0.63), Y(0.27;0.67;0.3); hepatitis - X(1.5;2.5;2.4;1.2), Y(1.6;1.2;0.2;0.9); cirrhosis - X(1.1;0.9;0.9). Final diagnosis of pathology is set when particular data values belong to the corresponding pathology zone in both cases.

EFFECT: high accuracy of diagnosis.

FIELD: medicine.

SUBSTANCE: method involves studying biological material by applying infrared spectroscopy techniques. The obtained data are processed and diagnosis is set. Blood serum is used as the biological material. The study is carried out by preparing dried blood serum sample as suspension in Vaseline oil and doing the infrared spectroscopy analysis in the bandwidth of 120-1000 cm-1 and determining absorption strip peak heights having maximum at 1170; 1165; 1160; 1150; 1140; 1060; 1050; 1040; 1025 and then calculating the following ratio values like peak height with maximum at 1160 cm-1 to 1140 cm-1; 1165 cm-1 to 1150 cm-1; 1040 cm-1 to 1025 cm-1. The obtained distribution of this group is projected to frontal plane for calculating two-dimensional coordinates and comparing to flat reference diagnostic images of prostate pathologies and to a normal reference diagnostic image represented as flat polygons which boundaries are given by the following values. The norm is represented by X(-1.15;-0.9;0.45;0.0;-0.65) and Y(0.99;4.2;0.9;0.46), respectively. Pathology by X(-1.15;-1.15;0.35;0.0;0.65) and Y(0.99;-0.03; 0.48;0.09;0.46). The norm and pathology are differentiated. Additional mathematical processing is carried out on infrared spectra of blood serum samples of patients belonging to pathology image according to parameter values. First of all, three-dimensional distribution is calculated as peak having maximum at 1160 cm-1 to one having maximum at 1150 cm-1; 1170; 1160 cm-1; 1160 cm-1 to 1025 cm-1. It is projected then to frontal plane and compared to diagnosis images of prostate adenoma and images of prostate carcinoma. The second group relationships the following values are used: oncological cases - X(0.28;0.77;1.24;0.96), Y(0.75;0.46;-0.13;-0.02); adenoma - X(0.28;1.24;2.21;1.24;0.77), Y(0.75;1.24;-0.12;-0.13;0.46). Differential diagnosis of pathologies is set by interpreting point position within particular pathology image.

EFFECT: high accuracy of differential diagnosis.

FIELD: medicine.

SUBSTANCE: method involves determining mean cytochemical coefficient of lipid accumulation in peripheral blood leukocytes in conditional units before beginning therapy application (MCC1) and in 2-3 or 5-6, or 10-12, or 20-24 months of therapy application (MCC2). Therapy effectiveness coefficient is calculated in conditional units from formula K= MCC2/MCC1. The value being equal to or greater than 1, leprosy therapy is predicted to be effective.

EFFECT: simplified prognosis method.

1 dwg, 1 tbl

FIELD: medicine.

SUBSTANCE: method involves determining infrared radiation absorption coefficient in blood plasma in bandwidth of 1543-1396 cm-1. The infrared radiation absorption coefficient is determined in %. The value being equal to 29.7±1.1%, catarrhal cholecystitis is diagnosed. The value being 26.4±1.4%, phlegmonous cholecystitis is diagnosed. The value being 21.2±1.8%, gangrenous cholecystitis is diagnosed. The value being equal to 18.6±0.5%, gangrenous perforated cholecystitis case is diagnosed. The value in norm is equal to 32.4±0.8%.

EFFECT: high accuracy and specificity of diagnosis.

FIELD: medicine.

SUBSTANCE: method involves pouring venous blood treated with heparin into five conic test-tubes in the amount of 0.1 ml. The first three of them contain 0.1 ml of non-colored latex suspension with particle size of 1.5 mcm, the fourth one contains 0.1 ml of medium 199 and 0.1 ml of 0.1% aqueous solution of tetrazole nitro blue, the fifth one contains .1 ml of latex suspension and 0.1 ml of 0.1% aqueous solution of tetrazole nitro blue. The first test-tube is incubated in thermostat for 5 min at37°C, the second one for 30 min, the third one for 1 h, the fourth and the fifth one for 40 min. Smears are prepared from 0.2 ml of incubation mixture on glasses and dried at 37°C, fixed in burner flame, stained with 0.1% aqueous solution of tetrazole nitro blue, repeatedly dried and studied with microscope under immersion with magnification of 90x10. Test results are evaluated from absorption activity in phagocytosis reactions in determining the number of phagocytes, phagocytic number, phagocytic integral index and phagocytosis rate values. Tetrazole nitro blue test response is determined by counting formazan-positive cell number, calculating cytochemical activity index and tetrazole nitro blue test stimulation index.

EFFECT: accelerated test; high accuracy and low cost of examination.

1 dwg, 3 tbl

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