CN111603182A - A Skin Test Reactor for Assisted Screening of Common Mental Illnesses - Google Patents

Abstract

The invention relates to a skin test reactor for auxiliary screening of common mental diseases. Specifically, the present invention relates to a kit and method for auxiliary diagnosis of mental diseases based on niacin skin test. The reagent combination or kit of the present invention can be used to assist in detecting or diagnosing mental illness (including schizophrenia and affective disorder) for a specific population, especially male subjects, and the detection specificity is nearly 100%, The accuracy is very high. At the same time, the skin test reactor of the present invention can also conveniently and quickly complete the above-mentioned diagnosis process.

Description

A Skin Test Reactor for Assisted Screening of Common Mental Illnesses

technical field

The present invention relates to the technical field of medical detection, in particular, the present invention provides a stick-type skin test reactor.

Background technique

Schizophrenia is a long-term, debilitating and extremely complex psychotic mental disorder. Clinically, it is often manifested as a syndrome with different symptoms, involving various disorders such as perception, thinking, emotion and behavior, as well as the incoordination of mental activities. The patients are generally conscious and their intelligence is basically normal, but some patients may experience cognitive impairment in the course of the disease.

Mood disorders (MD), also known as affective disorders (AD), are a class of diseases that are caused by various reasons and are characterized by significant and lasting changes in emotion and mood. Clinically, it is mainly manifested as emotional high or low, accompanied by corresponding cognitive and behavioral changes and psychotic symptoms such as hallucinations and delusions. According to the phase characteristics of emotions, it can be divided into three categories: unipolar mania, unipolar depression and bipolar disorder.

Mood disorders and schizophrenia are two different types of mental diseases, but due to their close relationship, similar symptoms, and high clinical misdiagnosis rate, resulting in poor response to drug treatment and unsatisfactory prognosis, special attention should be paid to these two types in clinical diagnosis. Identification and differentiation of diseases. There is currently no objective clinical diagnostic marker to accurately diagnose common psychiatric disorders such as schizophrenia and affective disorders, which also increases the difficulty of targeted treatment of the disease.

Therefore, there is an urgent need in the art to develop a rapid detection and screening of common mental diseases, as well as a test method and corresponding device for distinguishing schizophrenia and affective disorders.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a rapid detection and screening of common mental diseases, as well as a test method and corresponding device for distinguishing schizophrenia and affective disorders.

A first aspect of the present invention provides a skin test reactor, comprising:

A test panel, the test panel has one or more test areas (901), and the test panel includes:

sample coating;

A flexible coating surface wrapped around the outer periphery of the sample coating layer; wherein, the flexible coating surface has one or more openings, and the openings are combined with the sample coating layer to thereby The described test area is formed.

In another preferred example, the test area is a circular hole with a diameter of 5-15 mm.

In another preferred embodiment, the reactor further has a skin adhesive layer, and the skin adhesive layer is attached to the test panel and has a first adhesive surface.

In another preferred embodiment, the test panel includes:

a first adhesive tape layer (1), the first adhesive tape layer has one or more test holes (101), and the first adhesive tape layer is adhered to the first surface of the sample coating layer; and

a second adhesive tape layer (3) adhered to the second surface of the sample coating layer, the second adhesive tape layer having one or more test hole regions (301);

And the test hole overlaps with the test hole area.

In another preferred example, the second adhesive tape layer is a double-sided medical adhesive tape.

In another preferred embodiment, the sample coating layer is medical filter paper (2).

In another preferred embodiment, the reactor further includes a first release paper (6), and the first release paper is adhered to the first adhesive surface of the skin adhesive layer.

In another preferred embodiment, the reactor further comprises a positioning layer (5) that can be separated from the test panel, and the positioning layer has a second adhesive surface.

In another preferred embodiment, the positioning layer is a single-sided thin medical tape.

In another preferred embodiment, the positioning layer is located at the top of the test panel, and the second adhesive surface is adhered to the first release paper.

In another preferred embodiment, the reactor further includes a second release paper (4), and the second release paper is adhered between the first adhesive surface and the positioning layer, so that the The positioning layer and the first adhesive surface are separated from each other.

In another preferred example, the first tape layer is a medical foam tape.

In a second aspect of the present invention, there is provided a kit for screening mental disorders, the kit contains the skin test reactor according to the first aspect of the present invention.

In another preferred embodiment, the kit also contains:

(a) a first container, and a first solution in the first container, the first solution is a 0.08-0.12M solution of nicotinic acid compound;

a second container, and a second solution in the second container, the second solution is a 0.008-0.012M solution of nicotinic acid compound;

a third container, and a third solution located in the third container, the third solution is a 0.0008-0.0012M solution of nicotinic acid compound;

An optional fourth container, and a fourth solution within the fourth container, the fourth solution being a 0.00008-0.00012M solution of a nicotinic acid compound.

In another preferred embodiment, the kit further includes instructions, and the instructions record the following judgment criteria:

(1) When the 5min score is 0 under the concentration of 0.1M methyl nicotinate solution, it indicates that the subject suffers from mental illness or the probability of mental illness is higher than that of the normal population;

(2) When the subject is male, and the total score is less than 19 or the 15min score at 0.1M methyl nicotinate solution concentration is less than 3, it indicates that the subject suffers from mental illness or the probability of mental illness is higher than normal crowd; and/or

(3) When the subject is female, and the total score is less than 13 or the 15min score at 0.1M methyl nicotinate solution concentration is less than 2.5, it indicates that the subject suffers from mental illness or the probability of mental illness is higher than normal crowd.

In another preferred example, the kit also includes the following description of the judgment criteria:

(4) When the subject is suspected of SZ and MD, if the score of 0.1M methyl nicotinate solution in 15 minutes is less than 2.5 and the sum of all scores is less than 20, it indicates that the subject suffers from schizophrenia; and/or

(5) When the subject is suspected of SZ and MD, if the 15min concentration of 0.1M methyl nicotinate solution scores ≥ 2.5 and/or the sum of all scores ≥ 20, it indicates that the subject has an affective disorder.

In another preferred embodiment, the kit (a) is used to detect whether the subject suffers from mental illness; and/or (b) is used to distinguish whether the subject suffers from schizophrenia (SZ) and emotion Disability (MD), the subject is human.

In another preferred embodiment, the kit includes the description of the following judgment criteria:

(a) When the male subject has a score of 0 under the concentration of 0.1M methyl nicotinate solution for 5 minutes, it is suggested (or auxiliary diagnosis) that the subject has a mental illness or a high probability of developing mental illness in the normal population; and/or

(b) When the female subject has a score of 0 under the concentration of 0.1M methyl nicotinate solution for 5 minutes, it is suggested (or auxiliary diagnosis) that the subject suffers from mental illness or has a high probability of developing mental illness. in the normal population.

In another preferred embodiment, the kit further includes a timer for setting the timing time.

In another preferred embodiment, the timer can be set to be selected from the following group: 5 minutes, 10 minutes, 15 minutes, 20 minutes, or a combination thereof.

In another preferred embodiment, the nicotinic acid compound is selected from the group consisting of nicotinic acid, methyl nicotinate (AMN), ethyl nicotinate, or a combination thereof.

In another preferred embodiment, the reagent combination includes:

(1) a first solution, the first solution is a 0.1M methyl nicotinate solution;

(2) a second solution, the second solution is a 0.01M methyl nicotinate solution;

(3) a third solution, which is a 0.001M methyl nicotinate solution; and

(4) A fourth solution, the fourth solution is a 0.0001M methyl nicotinate solution.

In another preferred embodiment, the mental illness is selected from the group consisting of schizophrenia, affective disorder, or a combination thereof.

In another preferred example, the total score is the total sum of 16 scoring values (4 concentrations×4 time points), of which 4 concentrations are 0.0001M, 0.001M, 0.01M and 0.1M, 4 time points Points are 5 minutes, 10 minutes, 15 minutes and 20 minutes.

In another preferred embodiment, the scoring value (or "score" or "scoring") is carried out according to the following standard: the subject's skin is in contact with the first, second, third and fourth solutions for 0.5- Stop contact after 2 minutes (eg 1 minute), and then score the redness and swelling of the skin at 5 minutes, 10 minutes, 15 minutes and 20 minutes after the contact is stopped: no redness and swelling reaction is 0 point, partial redness and swelling reaction is 1 point, contact Complete redness within the area was scored as 2 points, and redness and swelling beyond the contact area was scored as 3 points.

It should be understood that within the scope of the present invention, the above-mentioned technical features of the present invention and the technical features specifically described in the following (eg, the embodiments) can be combined with each other to form new or preferred technical solutions. Due to space limitations, it is not repeated here.

Description of drawings

Fig. 1 shows a broken line graph of the mean distribution of nicotinic acid skin test scores for schizophrenia, affective disorder and healthy control groups obtained in Example 1 of the present invention.

Figure 2 shows the scatter diagram of the score distribution of the three groups of schizophrenia, affective disorder and healthy controls under two score nodes: the two score nodes are "15min score at 0.1M AMN concentration <2.5" and "sum of all scores" <20"; where A is male; B is female.

FIG. 3 shows a schematic diagram of the niacin skin test reactor in Example 5. FIG.

FIG. 4 shows the design of the niacin skin test reactor in Example 5. FIG.

Among them, 1 is the first tape layer, 2 is the sample coating layer, 3 is the second tape layer, 4 is the second release paper, 5 is the positioning layer, and 6 is the first release paper; 101, 102, 103 and 104 are test wells, 301, 302, 303 and 304 are test well areas; 9 is the skin test reactor, 901 is the test area.

Detailed ways

After extensive and in-depth research, the present inventor found for the first time that the use of the reagent combination or kit of the present invention can assist in detecting or diagnosing mental illness (including schizophrenia) for a specific population, especially male subjects. and affective disorders), the specificity of the detection is nearly 100%, and the accuracy is very high. At the same time, the reagent combination of the present invention can further provide validity information for distinguishing schizophrenia and affective disorder, with high accuracy. On this basis, the present inventors have completed the present invention.

the term

As used herein, the terms "schizophrenia" and "SZ" are used interchangeably and refer to a type of mental illness. Common symptoms include delusions, hallucinations, confusion, auditory hallucinations, reduced levels of social engagement and emotional expression, and lack of motivation. Clinical diagnosis is usually judged by clinicians based on the diagnostic criteria of DSM-5 or ICD-11 combined with clinical experience.

As used herein, the terms "affective disorder" and "MD" are used interchangeably and refer to a class of psychiatric disorders characterized by marked and persistent changes in affect and mood from a variety of causes. Clinically, it is mainly manifested as emotional high or low, accompanied by corresponding cognitive and behavioral changes and psychotic symptoms such as hallucinations and delusions. According to the phase characteristics of emotions, it can be divided into three categories: unipolar mania, unipolar depression and bipolar disorder.

As used herein, the term "nicotinic acid compound" includes the following compounds: nicotinic acid, methyl nicotinate, ethyl nicotinate, or combinations thereof.

Niacin redness

Niacin redness is a response to epidermal vasodilation and skin flushing mediated by Hydroxy-carboxylic acid receptor 2 (HCA2). Studies in Caucasians have found that this response tends to be significantly attenuated in people with schizophrenia compared to people with affective disorders and healthy people.

The present invention adopts the method of semi-quantitative water-soluble methyl nicotinate (Aqueous methyl nicotinate, AMN) patch and scoring to study the effect of niacin redness and swelling reaction in two common mental diseases (schizophrenia and affective disorder) and normal Different manifestations in the population, aiming to find an effective method that can screen out the niacin-insensitive subgroup of patients with common mental illnesses from the normal population, and distinguish patients with schizophrenia and affective disorders, thereby reducing the misdiagnosis rate.

Detection method

As used herein, the auxiliary detection method of the present invention comprises: contacting the subject's skin with the first, second, third and fourth solutions described in the first aspect of the present invention for 0.5-2 minutes (eg 1 minute, respectively). ) and then stop the contact, and then score the redness and swelling of the skin at 5 minutes, 10 minutes, 15 minutes and 20 minutes after the contact is stopped: no redness and swelling reaction is 0 point, partial redness and swelling reaction is 1 point, and complete redness and swelling reaction in the contact area is 2 points, redness and swelling reaction exceeding the contact area is 3 points; auxiliary detection is performed according to the scoring situation and the judgment standard of the present invention.

In another preferred embodiment, the method for auxiliary detection of mental illness includes the steps of:

(i) providing a methyl nicotinate solution, wherein the methyl nicotinate solution has a concentration of 0.08-0.12 M; and (ii) combining the subject's skin with a solution of the nicotinic acid compound (eg, methyl nicotinate) Solution) after 0.5-2 minutes of contact, stop contact, and then detect the redness and swelling of the skin after 5 minutes after the contact is stopped, if there is no redness and swelling, it indicates (or auxiliary diagnosis) that the subject suffers from mental illness or mental illness. The probability is higher than the normal population.

Judgment standard

(1) When the 5min score is 0 under the concentration of 0.1M methyl nicotinate solution, it indicates that the subject suffers from mental illness or the probability of mental illness is higher than that of the normal population;

(2) When the subject is male, and the total score is less than 19 or the 15min score at 0.1M methyl nicotinate solution concentration is less than 3, it indicates that the subject suffers from mental illness or the probability of mental illness is higher than normal crowd;

(3) When the subject is female, and the total score is less than 13 or the 15min score at 0.1M methyl nicotinate solution concentration is less than 2.5, it indicates that the subject suffers from mental illness or the probability of mental illness is higher than normal crowd;

(4) When the subject is suspected of SZ and MD, if the score of 15 minutes under 0.1M AMN concentration is less than 2.5 and the sum of all scores is less than 20, it indicates that the subject has schizophrenia or a high probability of onset of schizophrenia in the normal population;

(5) When the subject is suspected of SZ and MD, if the score of 0.1M AMN in 15 minutes is ≥2.5 and/or the sum of all scores is ≥20, it indicates that the subject has an affective disorder or a high probability of developing affective disorder in the normal population.

skin test reactor

The present invention also provides a skin test reactor designed for the above method, the reactor includes the following components:

A test panel, the test panel has one or more test areas 901, and the test panel includes a sample coating layer 2 located in the inner layer of the test panel; and a flexible coating layer wrapped around the outer periphery of the sample coating layer Covering surface; wherein, the flexible covering surface has one or more openings, and the openings are combined with the sample coating layer to form the test area. The flexible covering surface can be bent or folded to conform to the skin of the test subject.

The test area is not covered by the flexible coating surface, so that the sample coating layer of the inner layer is exposed. The test area can be in any shape, preferably a plurality of circular holes with a diameter of 5-15mm. The respective test areas are preferably of the same size in order to control test errors.

The reactor may have a skin-adhesive layer, and the skin-adhesive layer adheres to the test panel and has a first adhesive surface. In use, the first adhesive surface can be adhered to the skin for sensitivity testing.

The test panel can be a layered structure, and in a preferred embodiment, the layered structure includes:

A first adhesive tape layer 1, the first adhesive tape layer has a plurality of test holes 101, 102, 103 and 104, and the first adhesive tape layer is adhered to the first surface of the sample coating layer; and The second adhesive tape layer 3 on the second surface of the sample coating layer has one or more test hole regions 301 . The first adhesive tape layer and the second adhesive tape layer together form the flexible casing, and the test hole overlaps with the test hole area to form a test area.

The sample coating layer can be any semi-permeable medium, such as medical filter paper, non-woven fabric, medical gauze and the like.

In a preferred embodiment, the first tape layer is a medical foam tape.

For the convenience of use, the reactor further includes a first release paper 6, and the first release paper is adhered to the first adhesive surface of the skin adhesive layer. In the case of use, the first release paper can be uncovered to expose the skin adhesive layer and stick to the subject's skin surface.

The first release paper can be any available material, and in a preferred embodiment, it is a transparent release paper. In other embodiments, for example, a plastic sheet, a silicone sheet, a metal film, etc. may be used instead of the release paper.

In order to enhance the observation accuracy, the reactor further includes a positioning layer 5 which can be separated from the main body of the test panel and has a second adhesive surface. In a preferred embodiment, the second adhesive surface has a different adhesive coefficient than the first adhesive surface, so that when the main body of the test panel is peeled off, the positioning layer can remain on the skin surface of the test subject. The positioning layer can be any material, and in a preferred embodiment, the positioning layer is a single-sided thin medical tape.

In another embodiment of the present invention, the positioning layer is located at the end of the test panel, and the second adhesive surface is adhered to the first release paper 6 . At the same time, the reactor also includes a second release paper 4, and the second release paper is adhered between the first adhesive surface and the positioning layer, so that the positioning layer It is separated from the first adhesive surface (that is, separated by a second release paper, so that the positioning layer and the main body part are not adhered to each other, in this case, the second adhesive surface and the first adhesive surface together form the skin adhesive layer). Through the above structure, the positioning layer can be separated from the test panel without using materials with different adhesion coefficients.

The main advantages of the present invention include:

1. The reagent combination of the present invention can provide effective information for distinguishing schizophrenia and affective disorders, and has strong specificity and high accuracy.

2. For specific groups, especially male subjects, it can accurately diagnose whether they suffer from mental diseases (including schizophrenia and affective disorders), with a specificity of nearly 100% and a very high accuracy.

3. The present invention adopts the methyl nicotinate solution patch attached in vitro to diagnose common mental diseases such as schizophrenia through skin redness and swelling reaction, and has the advantages of convenient operation, non-invasiveness and the like.

4. The niacin skin test reactor realizes the integration of four concentration patches, the patch position and size are more standardized, and one person can easily complete the entire operation process.

5. The reactor of the present invention can effectively avoid the redness of the skin caused by tearing, reduces the influence on the observation and scoring of the skin redness reaction, and because the positioning layer is set, it is convenient for subsequent photography and observation, and it is convenient for use in connection with map recognition software. .

The present invention will be further described below in conjunction with specific embodiments. It should be understood that these examples are only used to illustrate the present invention and not to limit the scope of the present invention. In the following examples, the experimental methods without specific conditions are usually in accordance with conventional conditions, or in accordance with the conditions suggested by the manufacturer. Percentages and parts are by weight unless otherwise indicated.

Unless otherwise specified, the materials and reagents used in the examples of the present invention are all commercially available products.

Example 1 The redness and swelling reaction of niacin is different in schizophrenia, affective disorder and normal control group

1. Sample Collection

A total of 163 patients with schizophrenia, 63 patients with affective disorders and 63 normal controls diagnosed by ICD-10 were collected. All the enrolled individuals had no physical diseases such as diabetes, malignant tumor, fever, inflammation, etc., and all female individuals were not pregnant. This study has been reviewed by the Ethics Committee of the Fourth People's Hospital of Wuhu City, and the experimental protocol is in line with ethical principles, and all participants have been formally informed in writing.

2. Reagent preparation and skin test scoring

1) Four concentrations (0.1, 0.01, 0.001 and 0.0001 M) of methyl hydrochloride solution (AMN, C7H7NO2, 99%, Sigma-Aldrich, St. Louis, MO, US) were freshly prepared.

2) A circular filter paper sheet with a diameter of 1.29 cm was used as a patch and was immersed in four concentrations of AMN solutions.

3) Affix the transparent ruler to the inside of the subject's forearm to locate the patch.

4) Four patches soaked with different concentrations of AMN were attached to the inner skin of the subject's forearm in turn, and the patches were removed after one minute.

5) After 5 minutes, 10 minutes, 15 minutes and 20 minutes, respectively, take pictures perpendicular to the patch position on the medial forearm.

6) Scoring according to the skin redness and swelling of the testee at the patch site in the photo, using a 4-point scoring method: 0-no redness and swelling, 1-partial redness and swelling, 2-complete redness and swelling within the scope of the patch, 3-redness and swelling The reaction is beyond the patch. Two trained researchers scored independently.

3. Data Analysis

The scores of the two researchers were averaged as the final score. Each subject has 16 scores (4 concentrations x 4 time points), the sum of the 4 concentrations, the sum of the 4 time points, and the total sum of all 16 scores. BMI, education, and nicotine dependence (FTND) were used as covariates to compare across disease groups and across genders.

As can be seen from Figure 1, the niacin redness and swelling response was different in schizophrenia, affective disorders and normal controls. The scores of the schizophrenia group were generally lower than those of the normal control group, which meant that schizophrenia patients were insensitive to methyl nicotinate, had a slow reaction speed, and had a low degree of reaction (Figure 1). The affective disorder group showed similar performance to the schizophrenia group at the lowest concentration of methyl nicotinate (0.0001M) or the shortest time (5min), but with the increase of methyl nicotinate concentration and the prolongation of time, the redness and swelling reaction was similar to that of the normal control group Close to, even at 0.1M methyl nicotinate for 20min, the redness and swelling reaction exceeded that of normal people. This suggests that methyl nicotinate-induced skin redness was delayed, but not attenuated, in patients with affective disorders.

Example 2 Screening of common mental disorders

The experimental results showed that at high methyl nicotinate concentrations, skin redness and swelling occurred rapidly in the normal control group, while the skin response in the schizophrenia group and the affective disorder group was delayed. Therefore, nicotinic acid skin redness response is used to assist in the screening of patients with common psychiatric disorders.

1. Taking "0.1M AMN concentration of 5 minutes to score 0" as the standard (also known as an index or node), those who meet the conditions are judged to be insensitive to niacin (that is, suffering from common mental diseases or high possibility of mental diseases)

Using this index as a clinical auxiliary screening marker for common psychiatric disorders (including schizophrenia and affective disorders), the sensitivity was 26.22% and the specificity was 96.83% (Table 1). As can be seen from Table 1, in men, the specificity of this indicator as a clinical auxiliary screening marker can reach 100%, and the sensitivity is 26.98%; in women, the specificity and sensitivity are 96.23% and 25.25%, respectively.

Table 1 The specificity and sensitivity of auxiliary screening of common mental disorders with "0.1M AMN concentration 5min score = 0" as the node

male Female sum Sensitivity 26.98% 25.25% 26.22% specificity 100.00% 96.23% 96.83%

2. Screen common mental diseases with two conditions: 15min scoring value and all scoring sum (total score) under 0.1M AMN concentration. The total score sum (total score) refers to the total sum of the 16 score values (4 concentrations x 4 time points). Gender is one of the influencing factors affecting the skin redness and swelling reaction of niacin. According to different genders, the present invention adopts different thresholds as screening criteria for males and females respectively.

In the male population, the "total score <19 or 0.1M 15min<3" is used as the standard, and those who meet the conditions are judged to be insensitive to niacin (that is, suffering from common mental illness or a high possibility of developing mental illness). The specificity for screening common psychiatric disorders was 90.00%, and the sensitivity was 62.20% (Table 2).

In the female population, the "total score <13 or 0.1M 15min<2.5" is used as the standard, and those who meet the conditions are judged to be insensitive to niacin (ie, suffering from common mental illnesses or a high possibility of developing mental illnesses), and this standard The specificity of screening common mental disorders was 79.25%, and the sensitivity was 49.49% (Table 2).

In Table 2, the two conditions of "15min scoring value at 0.1M AMN concentration and the sum of all scoring" are commonly used to screen mental disorders

Example 3 Screening for schizophrenia and affective disorders

In univariate analysis, partial η2 is often used to assess the effect of independent variables on disease grouping. The 0.1M AMN15min score had the largest deviation of η ² between the schizophrenia group and the affective disorder group (0.045), and the sum of all scores had the largest deviation of η ² between the schizophrenia group and the normal control group (0.115), representing the two Indicators can better differentiate between different disease groups. The present invention takes "0.1M AMN 15min<2.5 and the sum of all scores<20" as the standard, and those who meet the conditions are considered to be insensitive to niacin (that is, suffering from common schizophrenia or high possibility of schizophrenia)

The results showed that under this criterion, 73% of niacin-insensitive individuals were accurately diagnosed with schizophrenia. Using this index can better screen schizophrenia patients, and distinguish between schizophrenia and affective disorders (Table 3). Taking "score of <2.5 in 15 minutes at a concentration of 0.1 MAMN and the sum of all scores <20" as the node, niacin-insensitive patients with schizophrenia and affective disorder niacin-insensitive patients can be distinguished.

Table 3 uses "0.1M AMN 15min score < 2.5 and the sum of all scores < 20" as the node to assist in screening schizophrenia patients, and distinguish schizophrenia and affective disorders

SZ and HC SZ and MD SZ and HC+MD Sensitivity 31.45% 31.45% 31.45% specificity 83.33% 87.30% 85.37%

Taking into account the effect of gender on the skin reaction of niacin, after subgrouping the subjects according to gender, the scoring situation is shown in Figure 2. As can be seen in Figure 2, in men, this indicator showed good specificity. In women, the sensitivity was 42.03%.

Example 4. Niacin skin test kit for screening common mental illness niacin-insensitive population

The product is a prefabricated methyl nicotinate patch. The viscous carrier is divided into two parts: a scale and a test area. The test area has 4 circular filter paper sheets with a diameter of 1.29cm, which are immersed in 0.1M, 0.01M, 0.001M, and 0.0001M methyl nicotinate solutions in sequence. The adhesive carrier is covered with a plastic film, and the plastic film is removed, and the entire adhesive carrier is flatly attached to the inner side of the upper arm, and the low-concentration (0.0001M) methyl nicotinate patch is close to the wrist. After attaching for 1 minute, tear off the test area along the dotted line, and take pictures and upload them to the remote end such as a mobile phone at 5min, 10min, 15min, and 20min respectively. Ask the subjects to take pictures as perpendicular to the arm as possible, and take the ruler part together. The red and swollen part of the subject's arm was scored (Table 4).

Table 4 Score Table

Note: AMN is methyl nicotinate solution.

Example 5 Portable Skin Test Screening Kit

The niacin skin test reactor is shown in Figures 3 and 4. In this embodiment, the first tape layer is a medical foam tape, the sample coating layer is a medical filter paper, and the second tape layer is a skin-friendly double layer. The surface medical tape and the second release paper are transparent release paper, the positioning layer is a single-sided thin medical tape, and the above-mentioned layers are pasted on the surface of the first release paper. The first tape layer and the second tape layer respectively have four fully overlapping small holes with a diameter of 10 mm. The 6-layer unit fits snugly together.

The first release paper was peeled off before use to expose the second tape layer and positioning layer; the reactor was attached to the inner side of the subject's forearm with the adhesive tape. The aqueous solutions of nicotinic acid compounds with four concentrations were dropped into four circular holes on the reactor in turn, and the aqueous solutions wetted the medical filter paper and contacted the skin. After 1 minute, the main body of the test reactor (the first tape layer, the sample coating layer, the second tape layer, and the second release paper) was peeled off at the same time, and the single-sided thin medical tape was left on the skin of the forearm, which is convenient for Then position observation. The skin redness and swelling of the subjects were observed by taking pictures at 5min, 10min, 15min, and 20min respectively.

All documents mentioned herein are incorporated by reference in this application as if each document were individually incorporated by reference. In addition, it should be understood that after reading the above teaching content of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.

Claims (10)

1. A skin test reactor, comprising:

a test panel having one or more test areas (901), the test panel comprising:

a sample coating layer;

the flexible coating surface is wrapped on the periphery of the sample coating layer; wherein the flexible coating surface has one or more openings, and the openings combine with the sample coating layer to form the test area.

2. The skin test reactor of claim 1, further comprising a skin adhesive layer attached to said test panel and having a first adhesive surface.

3. The skin test reactor of claim 1, wherein said test panel comprises:

the first adhesive tape layer (1) is provided with one or more test holes (101) and is adhered to the first surface of the sample coating layer; and

a second tape layer (3) adhered to a second surface of said sample application layer, said second tape layer having one or more test aperture regions (301);

and the test hole is overlapped with the test hole area.

4. The skin test reactor as set forth in claim 1, wherein the sample coating layer is medical filter paper (2).

5. The skin test reactor as set forth in claim 2, further comprising a first release paper (6) adhered to the first adhesive surface of the skin adhesive layer.

6. The skin test reactor as set forth in claim 1, further comprising a positioning layer (5) separable from the test panel, the positioning layer having a second adhesive surface.

7. The skin test reactor as set forth in claim 6, further comprising a second release paper (4) adhered between the first adhesive surface and the positioning layer, thereby separating the positioning layer and the first adhesive surface from each other.

8. The skin test reactor of claim 3, wherein the first tape layer is medical foam tape.

9. A kit for screening for psychiatric disorders comprising the skin test reactor of claim 1.

10. The kit of claim 9, further comprising:

(a) a first container, and a first solution in the first container, wherein the first solution is a 0.08-0.12M solution of a nicotinic acid compound;

a second container, and a second solution in the second container, wherein the second solution is 0.008-0.012M nicotinic acid compound solution;

a third container, and a third solution in said third container, said third solution being a 0.0008-0.0012M solution of a nicotinic acid compound;

optionally, a fourth container, and a fourth solution in said fourth container, said fourth solution being a 0.00008 to 0.00012M solution of a niacin compound.

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