What does diaskintest contain. Diaskintest instructions for use in adults and children

One of the methods for detecting such a dangerous disease as tuberculosis is Diaskintest, the instructions for use of which will be discussed later. This is a modern diagnostic method that many consider an alternative to the well-known Mantoux test, which has been used for over 100 years. However, there are also quite a few opponents of a complete transition to Diaskintest. To understand why this situation has developed, it is necessary to consider the properties of this drug in more detail.

Like the Mantoux test, Diaskintest is not a vaccine. It is a test sample. With its help, you can determine the presence or absence of the body's response to tuberculosis, both in active and inactive form.

The country of origin of the drug is the Russian Federation. The international name is diaskintest. According to the international non-proprietary name (INN), the drug is referred to as a tuberculosis recombinant bacterial allergen.

Diaskintest has only one release form. It is produced as a solution for intradermal use. The drug is packaged in glass bottles of 3 ml, which is 30 doses per 1 bottle. It can also be produced in containers of 12 doses (1.2 ml).

The composition of Diaskintest includes two antigens that are artificially linked to each other using genetic engineering. Both of these antigens are present in mycobacterium tuberculosis, but are absent in the BCG vaccine. They are contained in the CFP10-ESAT6 protein, which is the main component of the drug.

In addition, it includes additional components:

• sodium chloride;
• phenol;
• polysorbate;
• phosphate sodium and potassium;
• water for injections.

The mechanism of action of Diaskintest is based on the detection of the response of the immune system to the antigens contained in it. It is determined by the presence of a specific reaction on the skin at the injection site.

When a sample is taken

In Diaskintest, the indications for use are similar to the Mantoux test.

It is used for:

• identifying tuberculosis and determining how actively the process of its development is taking place;
• separate diagnosis of tuberculosis with other diseases;
• separate diagnosis of an allergic reaction that arose as a result of vaccination and a reaction that arose as a result of infection;
• to monitor the effect of the applied treatment (together with other methods).

Individuals who are at risk for the incidence of tuberculosis, as well as those who need an additional examination, can be sent for Diaskintest.

The test with diaskin can be administered to both adults and children, starting from the age of one. It can be done in children's institutions as part of measures to prevent tuberculosis, as well as in polyclinics or specialized anti-tuberculosis medical institutions.

Only in a specialized institution, a sample is placed if necessary, separate diagnosis of tuberculosis and other diseases.

Carrying out Diaskintest provides for compliance with certain rules.

They are quite simple:

1. You can do a test strictly according to the doctor's prescription.
2. Manipulation should only be carried out by highly qualified medical personnel who are well aware of the technique of subcutaneous injections.
3. The injection must be done only with a special tuberculin syringe. The needle of the syringe should be short and thin and have an oblique cut.
4. Before using Diaskintest, it is mandatory to check the expiration date of both the medicine itself and the syringes.

If it is necessary to make a test for a child, the date of its conduct should be consistent with the calendar of preventive vaccinations. Usually the test is done before vaccinations. In the event that they have already been done, the procedure must be postponed for at least a month after their completion.

The sampling procedure is the same as for the Mantoux test. It is done in a sitting position, and the injection is made into the inner region of the forearm in its middle third. The injection site is pre-treated with 70% medical alcohol. 0.2 ml of the drug is drawn into the syringe, then half is released into a cotton swab. The swab must be sterile. The drug is injected into the upper layers of the skin, which is stretched before that. Dosage - 0.1 ml. After the procedure is completed, a papule 7 to 10 mm in diameter appears at the injection site. It has a whitish color and the appearance of a lemon peel.

If the subject has a tendency to allergies, Diaskintest can only be done simultaneously with taking drugs that reduce the sensitization of the body. It is necessary to start taking them 5 days before the test and continue for another 2 days after it.

Result interpretation

From the time of the test to the evaluation of its result, at least 72 hours must pass. Only a qualified doctor or nurse can interpret it.

To evaluate the result, measure the transverse diameter of the papule and the area of ​​concomitant hyperemia. Hyperemia is considered only if the patient does not have a papule (infiltrate).

Interpret the results obtained as follows:

• the patient has only a trace from an injection up to 2 mm in diameter, and there are no papule and hyperemia - a negative result;
• only hyperemia is present - a dubious result;
• there is a papule of any diameter - a positive result.

A negative reaction to Diaskintest can be interpreted as follows:

• in the patient's body there are no Mycobacterium tuberculosis;
• mycobacteria are present but in an inactive form;
• the patient who had previously been ill was completely cured of tuberculosis.

It should also be noted that a negative reaction can also be observed in patients with tuberculosis, whose immunity is in an extremely depressed state.

A positive reaction to Diaskintest, in turn, is divided into 4 more types depending on the size of the papule:

1. Weakly expressed. This is considered a reaction in the presence of a papule up to 5 mm in size.
2. Moderately pronounced - size from 5 to 9 mm.
3. Expressed - 10-14 mm.
4. Hyperergic reaction - over 15 mm.

Patients whose sample gave a doubtful or positive result should be referred for additional examination.

The effectiveness of Diaskintest is usually emphasized by comparing it with the Mantoux test. Compared with it, this drug has a number of advantages.

These include:

1. The antigens contained in the diaskin test are not present in the BCG vaccine. This means that it does not affect its results in any way. A positive reaction to Diaskintest can only be observed with true infection with mycobacteria.
2. Compared to the Mantoux test, Diaskintest is much more accurate. It is 90%.
3. Higher drug sensitivity. It allows you to detect mycobacteria even at their low concentration.
4. The ability to more accurately assess the effectiveness of the therapy, since the recovered people will have a negative test result.

But still, despite a number of obvious advantages, there are many opponents in the medical environment of the complete replacement of the Mantoux test with Diaskintest. They argue their position with data that indicate that in the case of active tuberculosis in children, the sensitivity of the Mantoux test is higher. In addition, with the help of Diaskintest, mycobacteria are well detected, the habitat of which is the human body. This test does not detect other types of pathogens. At the same time, it is a proven fact that the causative agents of bovine tuberculosis can provoke the development of extrapulmonary forms of the disease, and the Mantoux test gives a positive reaction to them.

It should also be noted that despite the fact that Diaskintest is considered a remedy that is well tolerated by adults and children, it can still cause certain side effects.

These include:

• headache;
• temperature rise;
• general weakness.

In addition, there are a number of contraindications for the use of this drug. You can not do the test if the patient has infectious diseases during the period of exacerbation. An exception is made only when there is a direct suspicion of tuberculosis. In the same way, people with exacerbated somatic diseases, epilepsy, dermatological problems and allergic diseases should not be tested. Diaskintest is canceled for children during the announcement of quarantine for childhood infectious diseases in schools and preschool institutions.

During pregnancy, the use of the test is allowed. However, before making a decision on its implementation, the doctor must seriously assess the possible risks.

Thus, Diaskintest is undoubtedly an effective and innovative tool for diagnosing tuberculosis. However, at present, there is no need to talk about replacing the Mantoux test with it. Therefore, in medical practice, both of these tools will be used in parallel for a long time.

Instructionfor medical use

medicinal product

DIASKINTEST

Tradename

Diaskintest

International non-proprietary name

Dosage form

Solution for intradermal administration

Compound:

One dose of the drug contains

active substance- recombinant protein CFP10-ESAT6 0.2 µg (calculated value),

Excipients: sodium hydrogen phosphate dihydrate, sodium chloride, potassium dihydrogen phosphate, polysorbate - 80 (Tween ® 80), phenol, water for injection.

Description

Colorless transparent liquid

Pharmacotherapeutic group

Tuberculosis test

ATX code VO4CF

Pharmacological properties

Diaskintest allergen tuberculosis recombinant in standard dilution is a recombinant protein produced by a genetically modified culture of Escherichia coli BL21(DE3)/pCFP-ESAT, diluted in a sterile isotonic phosphate buffer solution, with a preservative (phenol). Contains two antigens present in virulent

strains of Mycobacterium tuberculosis and absent in the BCG vaccine strain.

Immunological properties

The action of Diaskintest is based on the detection of a cellular immune response to specific Mycobacterium tuberculosis antigens. When administered intradermally, Diaskintest causes a specific skin reaction, which is a manifestation of delayed-type hypersensitivity (DTH), in persons with tuberculosis infection and does not cause a DTH reaction associated with BCG vaccination in persons not infected with tuberculosis infection.

Indications for use

Diagnosis of tuberculosis, assessment of the activity of the process and identification of persons at high risk of developing active tuberculosis

Differential diagnosis of tuberculosis

Differential diagnosis of post-vaccination and infectious allergies (delayed-type hypersensitivity)

Evaluation of the effectiveness of anti-tuberculosis treatment in combination with other methods

For individual and screening diagnostics

Used as prescribed by a phthisiatrician or with his methodological support

For identification (diagnosis) of tuberculosis infection, a sample with the drugDiaskintest is carried out:

Persons referred to an anti-tuberculosis institution for additional examination for the presence of a tuberculosis process

Persons belonging to high-risk groups for TB disease, taking into account epidemiological, medical and social risk factors

Persons referred to a phthisiatrician based on the results of mass tuberculin diagnostics

For differential diagnosis of tuberculosis and other diseases

In combination with clinical, laboratory and X-ray examination in the conditions of an anti-tuberculosis institution

To monitor patients registered with a phthisiatrician with various manifestations of tuberculosis infection in the conditions of an anti-tuberculosis institution, they are carried out during a control examination in all groups of dispensary registration with an interval of 3-6 months.

Dosage and administration

The test is carried out on the prescription of a doctor for children, adolescents and adults by a specially trained nurse who has access to intradermal tests. The drug is administered strictly intradermally. For the test, tuberculin syringes and thin short needles with an oblique cut are used. Before use, check the date of issue and expiration date.

After opening, the bottle with the drug can be stored for no more than 2 hours. 0.2 ml (two doses) of Diaskintest is drawn up with a syringe and the solution is released to the 0.1 ml mark into a sterile cotton swab.

The test is carried out by the subject in a sitting position. After treating the skin area on the inner surface of the middle third of the forearm with 70% ethyl alcohol, 0.1 ml of Diaskintest is injected into the upper layers of the stretched skin parallel to its surface.

When a test is performed, as a rule, a papule is formed in the skin in the form of a "lemon crust" 7-10 mm in size, whitish in diameter.

For persons who have a history of non-specific allergy manifestations, the test is recommended to be carried out while taking desensitizing drugs for 7 days (5 days before the test and 2 days after it).

Side effects

Some individuals may experience short-term signs of a general reaction: malaise, headache, fever.

Contraindications

Acute and chronic (in the period of exacerbation) infectious diseases, with the exception of cases of suspected tuberculosis

Somatic and other diseases in the period of exacerbation

Common skin diseases

Allergic conditions

Epilepsy

In children's groups where there is a quarantine for childhood infections, the test is carried out only after the quarantine is lifted.

Drug Interactions

For healthy persons with a negative test result, preventive vaccinations (except for BCG) can be carried out immediately after evaluating and recording the result of the test.

Testing with Diaskintest should be planned before preventive vaccinations. If preventive vaccinations have been carried out, then a test with the Diaskintest preparation is carried out no earlier than 1 month after vaccination.

special instructions

Due to the fact that the drug does not cause a post-vaccination HRT reaction associated with BCG vaccination, tk. does not contain a vaccine strain, a sample with Diaskintest cannot be used instead of a tuberculin test to select individuals for primary vaccination and BCG revaccination. The interval between the introduction of Diaskintest and preventive vaccinations (including BCG) should be at least 1 month.

Accounting for results

The result of the test is evaluated by a doctor or a trained nurse after 72 hours from the moment it was carried out by measuring the transverse (in relation to the axis of the forearm) size of hyperemia and infiltration (papules) in millimeters with a transparent ruler. Hyperemia is taken into account only in the absence of infiltration.

The response to the sample is considered:

- negative- in the complete absence of infiltrate and hyperemia or in the presence of a "prick reaction" up to 2 mm;

- dubious- in the presence of hyperemia without infiltrate;

- positive- in the presence of infiltrate (papules) of any size.

Positive reactions to Diaskintest conditionally differ in severity:

• a mild reaction - in the presence of an infiltrate up to 5 mm in size;
• a moderately pronounced reaction - with an infiltrate size of 5-9 mm;
• a pronounced reaction - with an infiltrate size of 10-14 mm;
• hyperergic reaction - with an infiltrate size of 15 mm or more, with vesicle-necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

Persons with a doubtful and positive reaction to Diaskintest are examined for tuberculosis.

In contrast to the delayed-type hypersensitivity reaction, skin manifestations of nonspecific allergy (mainly hyperemia) to the drug, as a rule, are observed immediately after the test is placed and usually disappear after 48-72 hours.

There is usually no reaction to Diaskintest:

In individuals who are not infected Mycobacterium tuberculosis;

In individuals previously infected Mycobacterium tuberculosis with inactive tuberculosis infection;

In patients with tuberculosis during the period of completion of the involution of tuberculous changes in the absence of clinical, X-ray tomographic, instrumental and laboratory signs of process activity;

In people who have recovered from tuberculosis.

At the same time, a test with Diaskintest may be negative in tuberculosis patients with severe immunopathological disorders due to the severe course of the tuberculosis process, in individuals in the early stages of infection Mycobacterium tuberculosis, in the early stages of the tuberculous process in persons with concomitant diseases, accompanied by an immunodeficiency state.

The accounting documents say:

a) the name of the drug;

b) manufacturer, series number, expiration date;

c) the date of the test;

d) injection of the drug into the left or right forearm;

e) test result.

Pregnancy and lactation

The effect of the drug on women during pregnancy and lactation has not been studied,

the effect on the fetus when administered to pregnant women is unknown.

Skin test Diaskintest in the complex diagnosis of tuberculosis in pregnant women can be used only in case of emergency.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms.

There are no data on the negative effect of the drug on the ability to drive a car or work with mechanisms.

Overdose

Not found.

Release form and packaging

3 ml (30 doses) in glass vials, sealed with rubber stoppers with aluminum-plastic caps with a control of the first opening.

1 bottle in a blister pack made of polyvinyl chloride film.

1 blister pack, together with instructions for medical use in the state and Russian languages, is put into a pack of cardboard.

Storage conditions

The drug is transported and stored in accordance with SP 3.3.2.1248-03 in the "cold chain" system at a temperature of 2 0 C to 8 0 C. Do not freeze.

Store between 2 0 C and 8 0 C. Do not freeze.

Keep out of the reach of children!

Shelf life

Do not use after the expiry date stated on the packaging!

Terms of dispensing from pharmacies

For treatment-and-prophylactic and sanitary-prophylactic institutions.

Manufacturer

ZAO LEKKO, Russia

601125, Vladimir region, Petushinsky district, pos. Volginsky,

Tel/Fax: +7 (49-243)-71-5-52

Name and country of the marketing authorization holder

CJSC "LEKKO", Russian Federation

Address of the organization accepting claims from consumers on the quality of products in the territory of the Republic of Kazakhstan:

Instructions for use:

Diaskintest is a tool used to diagnose tuberculosis.

Release form and composition

Diaskintest is produced in the form of a clear, colorless solution for intradermal administration [3 ml (30 doses) in glass vials, 1 or 5 vials in a blister pack, in a carton pack 1 package with 1 vial, 1 or 2 packages with 5 vials].

Active ingredient: recombinant protein CFP10-ESAT6 *, in 1 dose (0.1 ml) - 0.2 μg.

* The protein is produced by a genetically modified culture of Escherichia coli BL21 (DE3)/pCFP-ESAT, diluted in a sterile isotonic phosphate buffer solution using phenol as a preservative, contains 2 antigens - CFP10 and ESAT6.

Auxiliary components: polysorbate 80, water for injection, phenol, sodium chloride, sodium phosphate disubstituted 2-water, potassium phosphate monosubstituted.

Indications for use

Diaskintest is intended for staging an intradermal test in people of all ages. Indications for use are:

• diagnosis of tuberculosis, assessment of the activity of the process and identification of persons at high risk of developing active tuberculosis;
• differential diagnosis of an infectious and post-vaccination allergic reaction (delayed-type hypersensitivity);
• evaluation of the effectiveness of anti-tuberculosis therapy (in combination with other diagnostic methods).

For the diagnosis of tuberculosis infection (screening and individual), a test with Diaskintest is placed as prescribed by a phthisiatrician or with his methodological support.

For the diagnosis (identification) of tuberculosis infection, the test is carried out for the following categories of persons:

• referred to a phthisiatrician based on the results of mass tuberculin diagnostics;
• belonging to high-risk groups for developing tuberculosis, taking into account social, medical and epidemiological risk factors;
• sent to an anti-tuberculosis institution for additional examination on suspicion of the presence of a tuberculosis process.

For the differential diagnosis of tuberculosis and other diseases, the test is carried out in the conditions of an anti-tuberculosis institution in combination with X-ray and clinical and laboratory examinations.

In order to monitor patients who are registered with a phthisiatrician, have various manifestations of tuberculosis infection and are in the conditions of a specialized anti-tuberculosis institution, a test with Diaskintest is carried out in all groups of dispensary registration during a control examination at intervals of 3–6 months.

The recombinant CFP10-ESAT6 protein does not cause delayed-type hypersensitivity reactions associated with BCG vaccination, therefore, Diaskintest cannot be used to select individuals for primary vaccination and BCG revaccination instead of the tuberculin test.

Contraindications

• allergic conditions;
• common skin diseases;
• any diseases (including somatic) during the period of exacerbation;
• acute infectious diseases and exacerbation of chronic diseases, except for cases of suspected tuberculosis.

In children's groups (kindergartens, preschool institutions and schools), where there is a quarantine in connection with childhood infections, the test is carried out only after the end of the quarantine.

Method of application and dosage

The Diaskintest test is carried out for children, adolescents and adults as directed by a doctor. Injection is allowed only by a specially trained nurse who is authorized to conduct intradermal tests.

The solution is intended for intradermal administration only. For this, tuberculin syringes and thin short needles with an oblique cut are used. Immediately before the introduction, it is necessary to check the date of their release and expiration date.

0.2 ml of the solution (2 doses) is drawn into the syringe, after which part of the solution is released into a sterile cotton swab up to the 0.1 ml mark on the syringe.

The drug is administered with the patient in a sitting position. The injection site is the inner surface of the middle third of the right or left forearm. Before the introduction of the skin in this area is treated with 70% ethyl alcohol. Diaskintest is injected into the upper layers of the stretched skin parallel to its surface.

When a skin test is performed, a whitish papule resembling a “lemon peel” is usually formed in the skin, 7–10 ml in diameter.

For patients with a history of indications of manifestations of nonspecific allergies, it is recommended to test with the drug under the cover of desensitizing agents - they should be taken 5 days before the test and continue for another 2 days after it (prophylactic course - 7 days).

Accounting for results

The result of the Diaskintest test is evaluated by a trained nurse or doctor 72 hours after it is carried out. To do this, measure the transverse (with respect to the axis of the forearm) size of hyperemia and papule (infiltration) in millimeters using a transparent ruler. Hyperemia is taken into account only in the absence of papule.

Reaction results:

• negative: the absolute absence of infiltration and hyperemia, or the presence of an injection mark (the so-called "prick reaction") up to 2 mm in size;
• doubtful: the presence of only hyperemia without infiltration;
• positive: the presence of papule regardless of its size.

In turn, positive reactions are conditionally divided into 4 groups depending on the severity:

• mild: infiltrate size up to 5 ml;
• moderately pronounced: the size of the infiltrate is from 5 to 9 mm;
• pronounced: the size of the infiltrate is from 10 to 14 mm;
• hyperergic: the size of the infiltrate from 15 mm, the presence of vesicle-necrotic changes and / or lymphangitis, the presence of lymphadenitis, regardless of the size of the infiltrate.

Persons with a doubtful and positive reaction are sent for examination in connection with suspected tuberculosis.

Skin manifestations of nonspecific allergy (mainly hyperemia) to Diaskintest are observed, as a rule, immediately after the test is performed and usually disappear after 48–72 hours.

There is no reaction to Diaskintest, as a rule, in the following categories of patients:

• not infected with Mycobacterium tuberculosis;
• previously infected with Mycobacterium tuberculosis, but with inactive tuberculosis infection;
• cured of tuberculosis;
• tuberculosis patients during the completion of the involution of tuberculous changes in the absence of laboratory, X-ray tomographic, instrumental and clinical signs of process activity.

In addition, the test may be negative:

• in patients with tuberculosis with severe immunopathological disorders due to the severe course of the tuberculosis process;
• in the early stages of infection with Mycobacterium tuberculosis;
• in the early stages of the tuberculous process in persons with concomitant diseases accompanied by an immunodeficiency state.

In the records, the doctor or nurse who conducted the test notes:

• the name of the drug;
• manufacturer, batch number and expiration date of the drug;
• the date of the test;
• injection site (right or left forearm);
• the result of the test, evaluated 72 hours after the administration of the drug.

Side effects

Diaskintest is generally well tolerated. Some patients experience short-term reactions in the form of malaise, headache, fever.

special instructions

For healthy people with a negative test result, preventive vaccinations (with the exception of BCG) can be carried out immediately after evaluating and recording the result of the test.

There is no information on the safety of using Diaskintest during pregnancy and lactation.

drug interaction

Diaskintest should not be used during preventive vaccinations. It is necessary to plan the test before the introduction of the vaccine or at least 1 month after the vaccination.

Analogues

There is no information about analogues of Diaskintest.

Terms and conditions of storage

Store and transport at 2-8°C. Avoid freezing. Keep away from children.

Shelf life - 2 years, after opening the bottle - no more than 2 hours.

Terms of dispensing from pharmacies

It is released for treatment-and-prophylactic and sanitary-prophylactic institutions.

Diaskintest (Diaskintest)

Compound

0.1 ml (1 dose) of Diaskintest contains:
Recombinant CFP10-ESAT6 protein - 0.2 µg;
Sodium chloride - 0.46 mg;
Sodium phosphate disubstituted 2-water - 0.3876 mg;
Potassium phosphate monosubstituted - 0.063 mg;
Phenol - 0.25 mg;
Polysorbate 80 - 0.005 mg;
Water for injection - up to 0.1 ml.

pharmachologic effect

Diaskintest is a recombinant tuberculosis allergen in a standard dilution. Diaskintest solution for intradermal administration is a recombinant protein that is produced by genetically modified cultures of Escherichia coli BL21(DE3)/pCFP-ESAT, diluted in isotonic sterile phosphate buffer solution using a preservative (phenol).
Diaskintest contains two antigens that are present in virulent strains of Mycobacterium tuberculosis and absent in the BCG vaccine strain.

The mechanism of action of Diaskintest is based on the detection of a cellular immune response to specific antigens for Mycobacterium tuberculosis. In patients with tuberculosis infection, the administration of Diaskintest leads to the development of a specific skin reaction, which is a manifestation of delayed-type hypersensitivity.

Indications for use

Diaskintest is used to conduct an intradermal test in patients of all age groups in order to diagnose tuberculosis, assess the activity of the process and identify patients with a high risk of developing an active tuberculosis process.
Diaskintest is used for the differential diagnosis of tuberculosis, infectious and post-vaccination allergies (delayed-type hypersensitivity reactions), as well as for evaluating the effectiveness of anti-tuberculosis therapy in combination with other methods.
It should be borne in mind that Diaskintest does not cause the development of a delayed-type hypersensitivity reaction, which is associated with BCG vaccination, and therefore cannot be used instead of a tuberculin test in order to select patients for revaccination and primary BCG vaccination.

For individual and screening diagnosis of tuberculosis, an intradermal test using Diaskintest is used as prescribed by a phthisiatrician or with his methodological support.
To diagnose tuberculosis infection, a test using Diaskintest is recommended for patients referred to a tuberculosis facility for additional examination, patients who are at high risk for tuberculosis (taking into account medical, social and epidemiological factors), as well as patients referred to a TB specialist for results of mass tuberculin diagnostics.

For the differential diagnosis of tuberculosis, a test using the Diaskintest preparation should be carried out in combination with X-ray and clinical and laboratory studies in the conditions of an anti-tuberculosis institution.
In order to monitor patients registered with a phthisiatrician with manifestations of tuberculosis infection, a test using the Diaskintest preparation should be carried out in the conditions of an anti-tuberculosis institution during a control examination of all dispensary registration groups at intervals of 3-6 months.

Mode of application

Testing:
Diaskintest is intended for intradermal testing. The introduction of the drug should be carried out by specially trained medical personnel who know the technique of intradermal injection. A test using the drug Diaskintest is carried out for adolescents, adults and children as prescribed by a doctor. The solution can only be administered intradermally. For the test, it is recommended to use tuberculin syringes and short thin needles with an oblique cut. Before using Diaskintest, check the release date and expiration date of the drug and syringes.

To carry out the test, two doses of Diaskintest (0.2 ml of solution) are drawn into the syringe and the solution is released into a sterile cotton swab to the 0.1 ml mark. The patient during the test should be in a sitting position. The test is carried out on the inner surface of the middle third of the forearm, having previously treated the area of ​​the skin with 70% ethyl alcohol. To set the test, 0.1 ml of Diaskintest solution is injected into the upper layers of the stretched skin. The introduction should be carried out parallel to the surface of the skin. Immediately after the test, patients usually develop a whitish papule in the form of a "lemon peel", the size of which is 7-10 mm in diameter.
Patients with a history of manifestations of nonspecific allergies are recommended to conduct a test while taking desensitizing drugs (desensitizing drugs are selected by a doctor and, as a rule, are taken within 5 days before the test using Diaskintest and within 2 days after).

Accounting for results:
Evaluation of the result of the test using the drug Diaskintest is carried out by a doctor or nurse 72 hours after the test. The assessment is carried out by measuring the size of hyperemia and papule (infiltrate) transverse relative to the axis of the forearm. The size is calculated in millimeters using a transparent ruler, while it must be borne in mind that hyperemia is considered only if there is no infiltration.
The reaction to the sample is considered negative in the case of the complete absence of infiltration and hyperemia, or if their size does not exceed 2 mm.
The reaction to the sample is considered doubtful if the patient has hyperemia without infiltration.

The reaction to the sample is considered positive if there is a papule (infiltrate) of any size (in this case, such reactions should be divided according to severity). In the presence of an infiltrate less than 5 mm in size, the reaction is considered mild, with a papule size of 5 to 9 mm, the reaction is considered moderately pronounced, with a papule size of 10 to 14 mm, a pronounced reaction. A hyperergic reaction is considered to be the presence of an infiltrate larger than 15 mm, as well as the development of vesicle-necrotic changes, lymphangitis or lymphadenitis, regardless of the size of the papule.
Patients with a doubtful and positive reaction to a test using Diaskintest should be examined for tuberculosis. It should be borne in mind that skin manifestations of nonspecific allergies (including hyperemia), in contrast to delayed-type hypersensitivity reactions, develop immediately after the injection and, as a rule, disappear within 48-72 hours.
Diaskintest does not cause delayed-type hypersensitivity reactions that are associated with BCG vaccination.

Cases of no response to the drug Diaskintest:
Negative test results using the drug Diaskintest can be observed in patients who are not infected with Mycobacterium tuberculosis, in people who have recovered from tuberculosis, as well as in patients previously infected with Mycobacterium tuberculosis with an inactive tuberculosis infection. In addition, negative test results may be in patients with tuberculosis during the period of completion of the involution of tuberculous changes with the absence of X-ray tomographic, clinical, laboratory and instrumental signs of process activity.
It should be noted that the test with the drug Diaskintest may be negative in patients with tuberculosis who have severe immunopathological disorders, which are caused by the severe course of the tuberculosis process. Identification of a negative test is possible in patients with early stages of infection with Mycobacterium tuberculosis or patients with early stages of the tuberculosis process with concomitant diseases that are accompanied by immunodeficiency states.

Registration of accounting documents during the test with the drug Diaskintest:
It is necessary to note in the documents the name of the drug and the manufacturer, the expiration date and the batch number of the drug, as well as the date of the test, the injection site (right or left forearm) and the result of the test.

Side effects

The drug Diaskintest, as a rule, is well tolerated by patients of any age. Individual cases of systemic adverse reactions have been reported, in particular, after the test, weakness, hyperthermia and headache may develop.

Contraindications

Diaskintest is not used for testing in patients with acute and chronic (during relapse) diseases of infectious etiology, except when there is a suspicion of tuberculosis.
A test with Diaskintest should not be performed in patients with somatic and other diseases during an exacerbation, as well as in patients suffering from epilepsy, allergic diseases and common skin diseases.
In children's groups during quarantine for childhood infections, it is forbidden to test using the Diaskintest preparation (testing is carried out only after quarantine is lifted).

Pregnancy

During pregnancy, the decision to conduct a Diaskintest test is made by the doctor.

drug interaction

It is recommended to conduct a test with Diaskintest before preventive vaccinations. In this case, in the case of a negative test result, vaccinations (excluding BCG) can be carried out immediately after evaluating and recording the results of the test.
After prophylactic vaccinations, a test with Diaskintest is allowed no earlier than 1 month after prophylactic vaccination.

Overdose

There are no data on an overdose of the drug Diaskintest.

Release form

Solution for intradermal administration of Diaskintest, 30 doses (3 ml) in glass bottles with a rubber stopper and an aluminum cap with first opening control, in a carton pack of 1, 5 or 10 glass bottles enclosed in a contour package made of polymeric materials.

Storage conditions

Diaskintest is suitable for use within 2 years after release, provided that it is stored and transported at a temperature of 2 to 8 degrees Celsius. It is forbidden to freeze Diaskintest solution.
After opening the vial, the solution can be used within 2 hours.
After the expiration date, Diaskintest should be disposed of. Information about the drug is provided for informational purposes only and should not be used as a guide to self-treatment. Only a doctor can decide on the appointment of the drug, as well as determine the dose and methods of its use.

Diaskintest is a diagnostic solution designed to determine if a test subject has tuberculosis. It is administered intradermally.

Diagnosis of tuberculosis is a rather complex multi-stage process. The incidence of this infection is quite high and the number of patients with tuberculosis is increasing every year. In order to speed up the process of identifying possible patients, there are screening methods. One of them is diaskintest.

You can ask a question, but what? Yes, this diagnostic option with a long history of use is also used. However, the Mantoux test has one important drawback - an “unfriendly” attitude towards the BCG vaccine, which is expressed in possible unreliable results.

But Diaskintest, registered on August 11, 2008 (certificate No. LSR-006435/08), is free from this drawback.

For reference. Diaskintest is the trade name for a diagnostic method that allows you to determine the presence of an immune response to antigens entering the body.

Diagnosticums for diaskintest are obtained in the laboratory. To do this, Escherichia coli are trained to produce two mycobacterium protein antigens, by which the immune system recognizes tuberculosis infection.

E. coli are the normal microflora of the human body and do not pose any threat to health. They are trained by introducing genes responsible for the synthesis of the necessary two proteins.

For reference. Modified E. coli begin to produce mycobacterium antigens, which are used to prepare diaskintest.

An extract of the necessary proteins is prepared, diluted with saline in the required dilution. Standard diaskintest kits already have the required dosage, where 0.1 ml is equal to one dose of antigen.

Specificity and sensitivity of the method

For reference. Specificity is an indicator that reflects the number of false positive responses.

According to statistics, a false answer is received by up to 2 people out of 100 healthy people who have passed the test. This indicator is considered high in comparison with other research methods.

False positive responses occur because there are acid-fast bacteria that are similar in antigenic composition to.

For reference. These infectious agents do not cause a specific disease, but stimulate the formation of immunity against Koch's bacillus antigens. The human immune system recognizes them as mycobacterium tuberculosis, and therefore subsequently reacts to diaskintest.

Sensitivity is the inverse of specificity. It determines how many false negative responses researchers receive per 100 tests performed.

For diaskintest, the indicator ranges from 4-12 false responses per 100 tuberculosis patients who have passed the study. This means that up to 12 TB patients out of 100 will receive a negative result after undergoing a diaskintest. This figure is considered high.

Thus, despite the presence of false positive and false negative responses, diaskintest is considered to be a fairly specific and sensitive technique.

The purpose of diaskintest

For reference. Diaskintest is necessary to assess the immune response to the introduction of Koch's bacillus antigens.

The fact is that upon contact with any infectious agent, the human immune system produces specific cells and macromolecules. These include T-lymphocytes and antibodies produced by B-lymphocytes.

At the first contact with an infection, in response to its antigens, the body begins to produce antibodies and train T-lymphocytes. The immune system has a memory for antigens, therefore, upon repeated contact with the same infection, the immune response is already ready. The action of diaskintest is based on this principle.

The test contains specific recombinant proteins of Mycobacterium tuberculosis. These proteins are antigens by which the immune system recognizes Koch's sticks. In the event that the body has already met with mycobacterium, there are specific T-lymphocytes against these antigens.

For reference. Diaskintest is carried out using intradermal injection of mycobacterium proteins. In the presence of immunity, T-lymphocytes rush to the injection site and cause a local allergic reaction. Objectively, this is manifested by local inflammation.

Immunity in tuberculosis is formed in two cases: after suffering primary tuberculosis in the past and with active tuberculosis in the present.

These two options must be able to differentiate, since diaskintest in both cases will show a positive result. If there is no immune response to the introduction of the antigen, then the result of the diaskintest will be negative, which can also indicate several conditions associated with both the lack of contact with the mycobacterium and the deep suppression of the immune system.

Indications

There are few indications for the appointment of diaskintest. Most often it is carried out for children with a preventive purpose. In many countries, including the Russian Federation, diaskintest is used instead of the Mantoux test in children attending preschool and school institutions.

Regardless of the presence or absence of TB symptoms, all children are tested at school.

For children, an indication for an emergency test is the presence of symptoms of tuberculosis, for example, a persistent persistent cough or antibiotic-resistant pneumonia.

Attention! If the child had a Mantoux test, and it turned out to be positive, he should also do a diaskintest.

The informativeness of the test in this case is explained by the fact that individuals who have never been in contact with wild strains of mycobacteria do not have immunity to the two diagnostic antigens used in the test.

If the reaction turned out to be positive, then the child has already become infected with tuberculosis. Either he is ill with it at the moment, or he has had a primary form of tuberculosis and is now healthy.

In adults, with a preventive purpose, this technique is meaningless. Almost every person after 18 years of age has immunity to Mycobacterium tuberculosis.

Important. An indication for diaskintest in adults is the suspicion of an open form of tuberculosis.

An appointment for a test may be issued with the following symptoms:

• the presence of an infiltrate or pathological focus in the lungs, which is not treated with conventional antibiotics,
• persistent cough for more than two weeks,
• causeless increase in body temperature to subfebrile figures or emaciation.

Attention. Diaskintest acquires diagnostic value only if it is used in combination with other methods for diagnosing tuberculosis.

After treatment for tuberculosis, a test is also used to evaluate the effectiveness of the therapy.

Contraindications

Contraindications to the technique are:

• Infections, excluding suspected tuberculosis;
• Any chronic pathology in the stage of decompensation;
• Skin diseases that prevent the test on both hands;
• Allergic reactions tolerated at the time of the technique;
• The introduction of preventive vaccination less than a month before the test;
• Any form of epilepsy.

For reference. It should be noted that impaired renal and hepatic function do not affect the sample. In addition, diaskintest is not contraindicated for pregnant and lactating women, but only if an active form of tuberculosis is suspected.

Sample frequency

For the purpose of early diagnosis of primary tuberculosis, diaskintest is used annually for children. If the child has not been vaccinated with the BCG vaccine, more frequent monitoring is necessary. Such children are tested at least once every six months.

For adults, there is no such periodicity. As a method of early diagnosis of active tuberculosis, diaskintest is uninformative. Adults annually undergo a fluorographic examination, and a test with a diagnosticum is carried out only if indicated.

For reference. You can re-test after any period of time, if necessary.

Adverse reactions

Adverse reactions are extremely rare and are due to individual sensitivity to the drug. These reactions include:

• Headache;
• An increase in body temperature, as a rule, to subfebrile numbers;
• Weakness, fatigue;
• Nonspecific allergic reaction at the injection site.

The few side effects and a small percentage of occurrence are due to intradermal administration of drugs. Diagnosticum does not enter the systemic circulation, therefore it rarely causes generalized reactions.

For reference. More often, side effects are associated with a violation of the diaskintest technique. In this case, extensive hematomas can form at the injection site, generalized allergic reactions develop, and in the elderly, an increase in blood pressure is possible.

The danger of diaskintest

This diagnostic method is considered relatively safe. The opinion that tuberculosis can be infected during diaskin is erroneous.

Diagnosticum does not contain mycobacteria or their tissues. Enter only two proteins that carry the antigenic load.

Important. These proteins cannot cause any disease other than an immune reaction. In addition, the preparation does not even contain Escherichia coli, on which the necessary proteins were grown. Only sterile extract is injected.

The only possible danger is the risk of developing a non-specific allergic reaction. A hypersensitivity reaction is possible for any foreign protein.

In the case of diaskintest, allergy is more often local and in rare cases generalized forms are observed with symptoms typical of hypersensitivity.

Diaskintest and Mantoux

Several methods can be used to detect the presence of immunity to Mycobacterium tuberculosis antigens. The most common of them at the moment are diaskintest and the Mantoux test. Both methods have the same mechanism of action and even the method of administration.

In both cases, 0.1 ml of a diagnosticum containing antigens of Koch's sticks is injected intradermally.

For reference. The difference is that Diaskintest is a genetically engineered product. Proteins are grown artificially on other bacteria and then removed. The preparation includes only two antigens, which are present only in virulent (dangerous) strains of mycobacteria.

Tuberculin for the Mantoux test is prepared by extracting proteins from weakened mycobacteria. The antigenic structure of tuberculin is greater than that of diaskintest.

The Mantoux test gives a positive reaction not only to virulent strains, but also to the immunity left by the BCG vaccine. In addition, tuberculin gives more cross-reactions with other types of bacteria.

Important. The sensitivity of both methods is the same. However, diaskin is more specific, it gives fewer false positive reactions than the Mantoux test.

The advantage of tuberculin diagnostics is that it recognizes earlier immunity than diaskintest. The reaction to diaskintest antigens occurs later than to other proteins of mycobacteria.

Sometimes it is allowed to perform both tests on different hands.

Preparation for the introduction of Diaskin

This technique does not require specific preparation, but there are a number of conditions that must be observed. First of all, they concern children who have reached the age of the next prophylactic revaccination.

Attention. After any vaccination, diaskintest can be done no earlier than a month later. Therefore, it is more expedient to first carry out diagnostics, and then revaccination.

BCG vaccine should not be administered a month before the test and immediately after it. This should be taken into account when revaccinating BCG children at the age of seven.

In addition, non-specific allergic reactions in susceptible individuals should be excluded. To do this, allergy sufferers are prescribed antihistamines in standard doses a week before the test, which lasts until the result is registered.

Adults should not drink alcohol for three days before the test and three days after the test. There are no data on the effect of smoking on the result of diaskintest. In addition, after setting the sample, you can drive a car and take any previously prescribed drugs.

Where is testing done

Diaskintest is an invasive diagnostic technique that can only be performed by medical personnel. For children, the test is carried out in educational institutions according to the preventive examination schedule. Adults can contact the local therapist, in which case the diaskintest will be carried out in the manipulation room of the clinic.

In addition, there are institutions involved in the prevention, diagnosis and treatment of tuberculosis. These include specialized dispensaries, sanatoriums, research institutes. They also conduct outpatient appointments and have TB prevention rooms. You can contact one of these institutions and have a diaskintest done by specialists.

Test methodology

The test can only be performed by a specially trained nurse who knows the technique of intradermal drug administration. The fact is that the introduction of a diagnosticum subcutaneously, intramuscularly or intravenously is a gross mistake. In this case, the test will be uninformative and can lead to complications.

The nurse checks the vial for leaks, evaluates the expiration date and the appearance of the contents. After that, 0.2 ml of the contents of the vial is drawn into the tuberculin syringe. This volume is equal to two diagnostic doses.

For reference. The middle third of the inner surface of the forearm is disinfected with alcohol, after which 0.1 ml of diagnosticum is injected intradermally, which is equal to one diagnostic dose. With proper administration, a "lemon peel" is formed at the injection site.

Contact of the injection site with water

Diaskintest, like the Mantoux test, can be wetted. Water does not react with the diagnosticum in any way and does not change the test result. But before registering the result, it is not recommended to take a bath.

This is due to the fact that an infection can get into the wound left by the needle from the water. As a result, non-specific inflammation will develop, which will blur the whole picture. For the same reason, you should not rub the injection site with a washcloth, soap or towel.

You should also avoid visiting saunas, baths, swimming pools and open water. Shower can be taken without restriction.

results

The result is evaluated exactly after three days, measuring the remaining morphological elements at the injection site with a ruler perpendicular to the axis of the forearm. What matters is the size and appearance of the morphological element.

Possible results

There are three types of reactions to the introduction of the drug:

• Negative. There is a trace from the injection and there are no other morphological elements.
• Doubtful. There is no subcutaneous compaction at the injection site, but there is redness of various sizes.
• Positive. Under the skin, a seal of various diameters is groped. As a rule, it protrudes above the surface of the skin in the form of a nodule (papules).

A positive result is divided into varieties as follows:

• Weak - the seal does not exceed 0.5 cm in diameter;
• Moderate - compaction from 0.6 to 0.9 cm in diameter;
• Pronounced - the diameter of the papule is from 1 to 1.5 cm;
• Hypersensitive - compaction of more than 1.5 cm or the presence of other morphological elements (pustules, crusts, inflammation of the lymphatic vessels).

Result interpretation

A negative result is observed if the body has never encountered Mycobacterium tuberculosis. In countries with a poor epidemic situation, a negative result is most often found in children.

Attention. In adulthood, a negative result means immunosuppression.

For example, it occurs in HIV-infected people in the AIDS stage even if they have active tuberculosis.

A doubtful result does not give an unambiguous answer about the intensity of immunity and requires a second test in 2-3 months.

For reference. A positive result means either the presence of immunity due to the fact that tuberculosis was previously transferred, or active disease at the moment.

As a rule, the severity of the reaction correlates with the activity of the pathological process. Persons with a positive reaction are subject to further examination in order to make a final diagnosis.

Reaction by day

For reference. Immunity to mycobacteria is formed in the form of delayed-type hypersensitivity. This means that the immune response to the administration of the drug will begin no earlier than a day later. However, due to the low dose of the drug, the response develops slowly.

A day after the test, hyperemia or a small seal may appear, which gradually increases in size.

It reaches its maximum only on the third day.

The appearance of a reaction a few hours after the administration of the drug speaks in favor of a non-specific reaction.

Allergy to Diaskintest

Allergy to diaskin develops in less than a third of the subjects, which is associated with the protein origin of the drug. A non-specific allergic reaction develops along the path of immediate hypersensitivity and occurs several minutes or hours after the injection.

At the same time, there are:

• local itching,
• hyperemia of the injection site,
• possible formation of urticaria.

Less commonly, a generalized reaction occurs with lacrimation, runny nose, swelling of the eyelids. Quincke's edema appears even less often or bronchial asthma worsens. If an allergic reaction occurs, you should take an antihistamine and consult a doctor who directed you to diaskintest.

Bruising at the injection site

Hemorrhage or a small bruise is not a reaction. It occurs if the vessel has been damaged. Even if the insertion technique is observed, it is possible to injure superficial vessels with a needle.

For reference. When evaluating the results, the bruise is not taken into account.

positive test

In adults and children, a positive diaskintest result can be interpreted in different ways. In children, the first positive result is called the test turn. It means that the child first encountered Mycobacterium tuberculosis.

In this case, a primary infection develops, which, as a rule, is asymptomatic, leaving behind stable immunity. In order to identify the danger of the disease for a particular child, a consultation with a phthisiatrician is necessary.

In adults, a positive result means that immunity to mycobacteria has already been developed. As a rule, people living in the CIS countries carry primary tuberculosis even before adulthood, because adults have immunity.

If diaskintest gave a positive result in an adult, this can be considered the norm. However, a pronounced reaction may also indicate active tuberculosis.

For reference. The more pronounced the immune response to the administration of the drug, the greater the chance that the patient has an active form of tuberculosis. The final conclusion can only be given by a TB doctor after an additional examination.