Diaskintest: instructions for use. Instructions for use of diaskintest for adults and children Diaskintest technique

Diaskintest is a drug (solution) that belongs to the pharmacological group of allergens. Important features of the drug from the instructions for use:

Sold by prescription

Package

Dosage form

Solution for intradermal administration

Compound

One dose (0.1 ml) of the drug contains: recombinant protein CFP 10-ESAT 6 - 0.2 μg, sodium phosphate disubstituted 2-water, sodium chloride, potassium phosphate monosubstituted, polysorbate 80, phenol, water for injection - up to 0, 1 ml

Description of the dosage form

Colorless transparent liquid.

Characteristic

Diaskintest ® Tuberculosis allergen recombinant in standard dilution is a recombinant protein produced by a genetically modified culture of Escherichia coli BL 21 (DE 3) / p CFP - 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.

Pharmacological group

MIBP is an allergen.

Pharmacological (immunobiological) properties

The action of the drug Diaskintest ® is based on the detection of a cellular immune response to Mycobacterium tuberculosis-specific antigens. When administered intradermally, Diaskintest ® causes a specific skin reaction in persons with tuberculosis infection, which is a manifestation of delayed-type hypersensitivity.

Indications

Diaskintest ® is intended for intradermal testing in all age groups for the purpose of individual and mass diagnosis of tuberculosis infection, including:

diagnosis of tuberculosis in persons belonging to high-risk groups for tuberculosis, in combination with other methods;
identification of individuals at high risk of developing active TB (latent TB infection) * ;
differential diagnosis of post-vaccination (BCG) and infectious allergies (delayed-type hypersensitivity);
evaluation of the effectiveness of anti-tuberculosis treatment in combination with other methods.

Due to the fact that the drug does not cause a delayed-type hypersensitivity reaction associated with BCG vaccination, a sample with Diaskintest ® cannot be used to select individuals for BCG vaccination and revaccination (BCG-M), however, its results must be taken into account when making a decision on immunization against tuberculosis.

For differential diagnosis of tuberculosis, a test with Diaskintest ® is carried out in combination with clinical, laboratory and X-ray examinations. To monitor patients registered with a phthisiatrician with various manifestations of tuberculosis infection, in the conditions of an anti-tuberculosis institution, an intradermal test with Diaskintest ® is carried out during a control examination in all groups of dispensary registration with an interval of 3-6 months.

*) Latent tuberculosis infection is a state of persistent immune response to Mycobacterium tuberculosis antigens, in the absence of clinical manifestations of active tuberculosis.

Contraindications

acute and chronic (in the period of exacerbation) infectious diseases, with the exception of cases suspected of tuberculosis;
somatic and other diseases during 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.

Use during pregnancy and lactation

The effect of the drug on women during pregnancy and lactation has not been studied, and the effect on the fetus and reproductive function is also unknown. Skin test Diaskintest ® in the complex diagnosis of tuberculosis in pregnant women can only be used if the intended benefit to the mother outweighs the potential risk to the fetus. There are no data on the ingestion of the drug into the milk of women during lactation.

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 taken with a syringe and the solution is released up 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).

Accounting for results:

The result of the test is evaluated by a doctor or a trained nurse after 72 hours from its setting, by measuring the transverse (with respect to the axis of the forearm) size of hyperemia and infiltration (papules), in mm, with a transparent ruler. Hyperemia is taken into account only in the absence of infiltration.

The criteria for evaluating the response to the Diaskintest ® sample are presented below:

Reaction Category	Criteria for evaluation
negative	The complete absence of infiltration and hyperemia or the presence of a “prick reaction” up to 2 mm.
Doubtful	The presence of hyperemia without infiltration.
Positive	The presence of an infiltrate (papules) of any size.
Weakly expressed	The size of the infiltrate is up to 5 mm.
Moderately pronounced	The size of the infiltrate is from 5 to 9 mm.
Expressed	The size of the infiltrate is from 10 to 14 mm.
hyperergic	The size of the infiltrate is 15 mm or more; vesiculonecrotic changes; and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

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. Diaskintest ® does not cause a delayed-type hypersensitivity reaction associated with BCG vaccination.

Persons with a doubtful and positive reaction to Diaskintest ® are subject to a comprehensive examination for tuberculosis.

Not all infected persons may develop delayed-type hypersensitivity to the Diaskintest ® test. There are factors that reduce this reaction, such as: HIV, active tuberculosis with severe immunopathological disorders caused by the severe course of the process; concomitant diseases accompanied by an immunodeficiency state.

In accounting documents for registration of test results indicate: a) the name of the drug; b) manufacturer, series number, expiration date; c) date of sampling; d) injection site (left or right forearm); e) test result.

Side effects

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

Interaction

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 prophylactic vaccinations. If prophylactic vaccinations have been carried out, then a test with Diaskintest ® is carried out no earlier than 1 month after vaccination.

special instructions

The drug is used intradermally in a minimal dose and practically does not penetrate into the systemic circulation. Therefore, there are no features of use in patients with impaired liver and kidney function.

There are no age restrictions on the use of Diaskintest ®.

Influence on the ability to drive vehicles and work with mechanisms:

There are no data on the adverse effect of the drug on the ability to drive vehicles and work with mechanisms.

Release form

1.2 ml (12 doses) or 3 ml (30 doses) in glass vials, sealed with rubber stoppers with aluminum-plastic caps with a control of the first opening.

1 or 5 bottles in a blister pack made of polyvinyl chloride or polyethylene terephthalate film.

1 blister pack with 1 bottle or 1 or 2 blister packs with 5 bottles together with instructions for use - in a carton pack.

Storage conditions

In the conditions of the "cold chain" in accordance with the requirements of SP 3.3.2.1248-03 at a temperature of 2 to 8 °C. Do not freeze. Transportation is allowed at a temperature not exceeding 15 ° C - no more than 7 days.

One-time storage is allowed at a temperature not exceeding 15 °С - not more than 15 days or not higher than 25 °С - not more than 7 days.

Keep out of the reach of children.

Best before date

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

Terms of dispensing from pharmacies

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

Active substance

Recombinant protein CFP10-ESAT6*

Release form, composition and packaging

Solution for intradermal administration colorless, transparent.

Excipients: sodium phosphate disubstituted 2-water - 387.6 mcg, - 460 mcg, potassium phosphate monosubstituted - 63 mcg, polysorbate 80 - 5 mcg, phenol - 250 mcg, water for injection - up to 0.1 ml.

3 ml (30 doses) - glass bottles (1) - blister packs (1) - cardboard packs.
3 ml (30 doses) - glass bottles (5) - blister packs (1) - cardboard packs.
3 ml (30 doses) - glass bottles (5) - blister packs (2) - cardboard packs.

* produced by a genetically modified culture of Escherichia coli BL21 (DE3)/pCFP-ESAT, diluted in sterile isotonic phosphate buffer solution, with a preservative (phenol), containing two antigens CFP10 and ESAT6.

pharmachologic effect

Tuberculous recombinant in standard dilution. It is a recombinant protein produced by a genetically modified culture of Escherichia coli BL21(DE3)/pCFP-ESAT. Contains 2 antigens present in virulent strains of Mycobacterium tuberculosis and absent in the BCG vaccine strain.

The action of Diaskintest is based on the detection of a cellular immune response to Mycobacterium tuberculosis-specific antigens. When administered intradermally, Diaskintest causes a specific skin reaction in persons with tuberculosis infection, which is a manifestation of delayed-type hypersensitivity.

Indications

It is intended for setting up an intradermal test in all age groups in order to:

— diagnosing tuberculosis, assessing the activity of the process and identifying individuals at high risk of developing active tuberculosis;

- differential diagnosis of tuberculosis;

- differential diagnosis of post-vaccination and infectious (delayed-type hypersensitivity);

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

For individual and screening diagnosis of tuberculosis infection, an intradermal test with Diaskintest is used as prescribed by a phthisiatrician or with his methodological support.

To identify (diagnose) tuberculosis infection, a test with Diaskintest 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 the differential diagnosis of tuberculosis and other diseases, a test with the Diaskintest preparation is carried out in combination with a clinical, laboratory and X-ray examination in 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, an intradermal test with Diaskintest is carried out during a control examination in all groups of dispensary registration with an interval of 3-6 months.

Due to the fact that the drug does not cause a delayed-type hypersensitivity reaction associated with BCG vaccination, a test with Diaskintest cannot be used instead of a tuberculin test to select individuals for primary vaccination and BCG revaccination.

Contraindications

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

- somatic and other diseases during the period of exacerbation;

- common skin diseases;

- allergic conditions.

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

Dosage

The test is carried out as prescribed by the doctor children, teenagers and adults by a specially trained nurse qualified to perform 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. 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 treatment of the skin area on the inner surface of the middle third of the forearm with 70%, 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" measuring 7-10 mm in diameter, whitish in color.

Accounting for results

The result of the test is evaluated by a doctor or a trained nurse 72 hours after it was carried out by measuring the transverse (with respect 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 infiltration;

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

Positive reactions to Diaskintest conditionally differ in severity:

mild reaction- in the presence of an infiltrate up to 5 mm in size;

moderate reaction- with an infiltrate size of 5-9 mm;

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.

Diaskintest does not cause a delayed-type hypersensitivity reaction associated with BCG vaccination.

There is usually no reaction to Diaskintest:

- in persons not infected with Mycobacterium tuberculosis;

- in persons previously infected with 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 the activity of the process;

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 people in the early stages of Mycobacterium tuberculosis infection, in the early stages of the tuberculosis process in people with concomitant diseases accompanied by an immunodeficiency state.

Collapse

Doctors are constantly looking for new diagnostic and preventive measures to prevent serious diseases. Tuberculosis is one of them. Despite the enormous work of scientists and doctors, the number of patients and carriers of mycobacteria does not decrease.

The insidiousness of the pathology lies in the fact that in the early stages it is asymptomatic, which makes it difficult to diagnose. It is important to recognize such patients in a timely manner; for this, the Mantoux test has been used for decades. But now it is increasingly being replaced, the instructions for use claim that the drug is more sensitive.

About the drug

Most of the adult population in their bodies have such a resident as Koch's wand. This is an inactive form of tuberculosis that does not pose a threat to human health.

But this may not always continue, and under the influence of certain factors, the pathology can become active. Diaskintest just allows you to detect the presence of tuberculosis bacteria in the body, when outwardly there are still no manifestations of the disease.

Diaskintest is not a vaccination, but just a test for tuberculosis, which allows you to recognize the disease at the very first stages of development. Concerns that the drug may be harmful to health or cause infection with mycobacteria are unfounded and unfounded.

Annotation to the drug states that the active substance reacts only to microorganisms that can cause an open form of tuberculosis. There is no reaction to BCG vaccination or other factors.

Carrying out Diaskintest is relevant when Mantoux showed a positive response of the immune system, and it is necessary to find out the reason for this.

Indications for use

You can use the test for tuberculosis at almost any age. The indications are as follows:

Identification of an active form of tuberculosis.
Finding people at high risk of developing an open form of the disease.
Differential diagnosis.
Recognition of an allergic reaction after vaccination or against the background of an infectious disease.
Setting Diaskintest allows you to evaluate the effectiveness of the treatment of tuberculosis infection.
On the recommendation of a specialist for individual diagnostics.

It is also done to persons referred to a tuberculosis dispensary for additional examination if they fall into a high-risk group for this disease.

To recognize tuberculosis among other infectious pathologies of the respiratory system, Diaskintest is done along with laboratory tests and fluorography.

Test instructions

The instructions for use contain all the detailed information about the indications for the use of the drug, the technique of setting and possible adverse reactions.

The use of Diaskintest implies not only the frequency of the test, but also the preparation for the procedure, the technique of execution and the rules of behavior after it.

Frequency in children and adults

How often can Diaskintest be done for a child or an adult patient? The requirements are fixed in the recommendations signed by the Ministry of Health:

Children from 8 to 17 years of age are tested once a year.
For patients registered in a specialized medical institution, the frequency changes up to 2 times a year.

Not vaccinated with BCG.
Diagnosed with diabetes.
With nonspecific pathologies of the chronic form of the organs of the respiratory system.
Small patients treated with corticosteroids undergoing radiation therapy.
HIV-infected.

The consent of the parents or the patient himself, if he is over 15 years old, is required for the test.

From what age and until what age?

At what age can Diaskintest be done? If the result of the body on the Mantoux test is positive, then Diaskintest is allowed to be done by babies from the age of one.

The question may arise, but until what age do the test? Such diagnostics is practiced until the age of 17-18, and then a fluorographic examination can be performed once a year.

If we are talking about a re-test, then here are the recommendations:

You can make Diaskintest after any infectious disease no earlier than a month from the moment of complete recovery.
After BCG vaccination or any other vaccination, the test can be done only after a month, otherwise there is a high risk of obtaining distorted results.
To clarify the diagnosis, after receiving a dubious reaction of the body to Diaskintest, it can be repeated only after a couple of months.

Consent to the test must be given by the parents, but the decision on its expediency is made by the specialist. Mommy is better to rely on the experience of a specialist and not refuse the test.

Preparation

Special preparation before Diaskintest is not required. If the child has a tendency to allergic reactions, then the doctor may recommend starting antihistamines 4-5 days in advance. But before visiting the treatment room, you must definitely visit a pediatrician, any infectious pathologies in the acute stage must be excluded, the time intervals between vaccination and the test must be observed.

Insertion technique

Testing is only allowed for medical personnel with access to intradermal testing. How is Diaskintest performed? The algorithm is the following:

Does Diaskintest hurt? Given the shallow penetration of the needle with a thin tip, the procedure does not cause pain.

Actions after injection

After Diaskintest, in order to obtain a more reliable result, it is important to follow some rules:

It is not recommended to wet the injection site, although experts believe that if Diaskintest is exposed to moisture, then the result should not be distorted.
Do not rub or scratch the injection site.
Do not stick with a plaster, the sweat that is released irritates the skin and can cause redness and irritation.
After the introduction of the drug, it is better not to swim in open water to prevent dirt from entering the wound.
Cannot be treated with antiseptics.

Side effects

The drug is usually well tolerated by patients of any age. But the reaction of each organism is unpredictable, so you can expect the following short-term side effects that will pass in a couple of days:

General weakness.
Increased fatigue.
development of hyperemia.
Slight rise in temperature.
Hyperergic reaction with the tendency of the body to allergic manifestations.

But these manifestations cannot be considered specific for Diaskintest, they can be observed after any vaccination or test. Most often, an allergy to the drug can be observed in babies. This is explained by the presence of pure protein in the composition, which is a powerful allergen. Older children tolerate the drug perfectly.

How long does it take to evaluate results?

The final interpretation of the body's response to the introduction of Diaskintest is carried out only after 72 hours after drug administration. It does not make sense to do this before, skin reactions during this time may change, but later it will not be possible to obtain a reliable result.

Consequences of misplacement

The setting of Diaskintest should be carried out in compliance with special rules, if the sample technique is violated, then the following consequences can be expected:

Conclusion

The drug Diaskintest is considered more accurate, the consequences of unaccounted for contraindications or violations of the test technique will more likely affect the result than the patient's health. With it, you can quickly confirm or refute the result obtained after Mantoux or on a fluorographic image.

Any diagnostic procedures make it possible to identify pathology at the very beginning of its development, when the disease is much easier to treat. Tuberculosis is especially true, insidious pathology can lead to serious complications.

Attention!
The content of the page is not an official instruction for the use of the drug and is provided for informational purposes only.
Before use, consult your doctor.

Pharmacological group

Diagnostic medicines

Name: Diaskintest (Diaskintest)

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 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 the Diaskintest preparation 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 phthisiatrician 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 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 conduct 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.
For patients with a history of manifestations of nonspecific allergies, it is recommended that the test be carried out while taking desensitizing drugs (desensitizing drugs are selected by the 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 lot 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 tuberculosis is suspected.
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.

Interaction with other drugs:
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 a 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.

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.

Name:

Diaskintest (Diaskintest)

Pharmacological
action:

Diaskintest - recombinant tuberculosis allergen in standard breeding.
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.
Mechanism of action 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
application:

Designed for setting up an intradermal test in all age groups in order to:
- diagnosing tuberculosis, assessing the activity of the process and identifying individuals 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 diagnosis of tuberculosis infection, an intradermal test with Diaskintest is used as prescribed by a phthisiatrician or with his methodological support.
For identification (diagnosis) of tuberculosis infection a test with the drug Diaskintest is carried out:
- persons sent 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 the differential diagnosis of tuberculosis and other diseases, a test with the Diaskintest preparation is carried out in combination with a clinical, laboratory and X-ray examination in 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, an intradermal test with Diaskintest is carried out during a control examination in all groups of dispensary registration with an interval of 3-6 months.
Due to the fact that the drug does not cause a delayed-type hypersensitivity reaction associated with BCG vaccination, a test with Diaskintest cannot be used instead of a tuberculin test to select individuals for primary vaccination and BCG revaccination.

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 conduct 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.
For patients with a history of manifestations of nonspecific allergies, it is recommended that the test be carried out while taking desensitizing drugs (desensitizing drugs are selected by the 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 lot 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:

General reactions: in some cases, for a short time - malaise, headache, fever.