Diaskintest: instructions for use. Instructions for using 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:

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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 mcg, sodium phosphate disubstituted 2-water, sodium chloride, potassium phosphate disubstituted, 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 antigens specific to Mycobacterium tuberculosis. 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 performing an intradermal test 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 persons at high risk of developing active tuberculosis (latent tuberculosis infection) * ;
differential diagnosis of post-vaccination (BCG) and infectious allergies (delayed-type hypersensitivity);
assessing 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 test with the drug 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 the differential diagnosis of tuberculosis, a test with the drug Diaskintest ® is carried out in combination with a clinical, laboratory and x-ray examination. To monitor patients registered with a phthisiatrician with various manifestations of tuberculosis infection, in an anti-tuberculosis institution, an intradermal test with the drug 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 the antigens of Mycobacterium tuberculosis, in the absence of clinical manifestations of the active form of tuberculosis.

Contraindications

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

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. The Diaskintest ® skin test in the complex diagnosis of tuberculosis in pregnant women can only be used if the expected benefit to the mother outweighs the potential risk to the fetus. There is no data on the penetration of the drug into the milk of women during lactation.

Directions for use and doses

The test is carried out as prescribed by a doctor for children, adolescents and adults by a specially trained nurse who is authorized to conduct intradermal tests. The drug is administered strictly intradermally. To carry out the test, tuberculin syringes and thin short needles with an oblique cut are used. Before use, you must check their release date and expiration date.

Once opened, the bottle with the drug can be stored for no more than 2 hours. Use a syringe to draw 0.2 ml (two doses) of the drug Diaskintest ® and release the solution to the 0.1 ml mark into a sterile cotton swab.

The test is carried out with 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 the test is performed, as a rule, a papule in the form of a “lemon peel” is formed in the skin, 7-10 mm in diameter, whitish in color.

For persons with a history of nonspecific allergies, 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 assessed by a doctor or trained nurse 72 hours after its placement, by measuring with a transparent ruler the transverse (relative to the axis of the forearm) size of the hyperemia and infiltrate (papules), in mm. Hyperemia is taken into account only in the absence of infiltration.

The criteria for assessing the response to the Diaskintest ® test are presented below:

Reaction category	Evaluation criteria
Negative	Complete absence of infiltration and hyperemia or the presence of a “puncture reaction” of up to 2 mm.
Doubtful	The presence of hyperemia without infiltration.
Positive	The presence of 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 a delayed-type hypersensitivity reaction, skin manifestations of a nonspecific allergy (mainly hyperemia) to the drug are usually observed immediately after the test and usually disappear after 48-72 hours. Diaskintest ® does not cause a delayed-type hypersensitivity reaction associated with BCG vaccination.

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

Not all infected individuals 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 a severe course of the process; concomitant diseases accompanied by an immunodeficiency state.

The accounting documents used to register sample results indicate: a) the name of the drug; b) manufacturer, batch number, expiration date; c) date of sample collection; d) site of drug administration (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 individuals with a negative test result, preventive vaccinations (except BCG) can be carried out immediately after assessing and recording the test result.

A test with Diaskintest ® should be planned before preventive vaccinations. If preventive vaccinations have been carried out, then a test with the drug 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 particularities for use in patients with impaired liver and kidney function.

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

Impact on the ability to drive vehicles and operate machinery:

There is no data on the adverse effects of the drug on the ability to drive vehicles and operate machinery.

Release form

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

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 along with instructions for use - in a cardboard pack.

Storage conditions

Under “cold chain” conditions 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.

Single storage is allowed at a temperature no higher than 15 °C - no more than 15 days or no higher than 25 °C - no more than 7 days.

Keep out of the reach of children.

Best before date

Do not use after the expiration date indicated on the package!

Conditions for dispensing from pharmacies

For medical and preventive and sanitary institutions.

Active ingredient

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 disubstituted - 63 mcg, polysorbate 80 - 5 mcg, phenol - 250 mcg, water for injection - up to 0.1 ml.

3 ml (30 doses) - glass bottles (1) - contour cell packaging (1) - cardboard packs.
3 ml (30 doses) - glass bottles (5) - contour cell packaging (1) - cardboard packs.
3 ml (30 doses) - glass bottles (5) - contour cell packaging (2) - cardboard packs.

* 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), containing two antigens CFP10 and ESAT6.

Pharmacological action

Tuberculosis 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 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

Designed for intradermal testing in all age groups for the purpose of:

— 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);

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

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

To identify (diagnosis) 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 tuberculosis, 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, a test with the drug Diaskintest 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 an anti-tuberculosis institution, an intradermal test with the drug 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 the drug Diaskintest cannot be used instead of a tuberculin test to select individuals for primary vaccination and revaccination with BCG.

Contraindications

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

- somatic and other diseases during 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 a doctor children, teenagers and adults a specially trained nurse authorized to conduct intradermal tests.

The drug is administered strictly intradermally. To carry out the test, tuberculin syringes and thin short needles with an oblique cut are used. Before use, you must check their release date and expiration date. Use a syringe to draw 0.2 ml (two doses) of the Diaskintest drug and release the solution to the 0.1 ml mark into a sterile cotton swab.

The test is carried out with the subject in a sitting position. After treating 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 the test is performed, as a rule, a papule in the form of a “lemon peel” is formed in the skin, measuring 7-10 mm in diameter and whitish in color.

For persons with a history of nonspecific allergies, 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 assessed by a doctor or trained nurse 72 hours after it is performed by measuring the transverse (relative to the axis of the forearm) size of the hyperemia and infiltrate (papules) in millimeters with a transparent ruler. Hyperemia is taken into account only in the absence of infiltration.

The response to the test is considered:

negative - in the complete absence of infiltration and hyperemia or in the presence of a “puncture reaction” of up to 2 mm;

dubious - in the presence of hyperemia without infiltration;

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

Positive reactions to Diaskintest conditionally vary in severity:

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

moderate reaction- when the infiltrate size is 5-9 mm;

pronounced reaction- with an infiltrate size of 10-14 mm;

hyperergic reaction- when the size of the infiltrate is 15 mm or more, with vesicular-necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

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

The drug 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 process activity;

- in persons cured of tuberculosis.

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

Collapse

Doctors are constantly searching for new diagnostic and preventive measures to prevent serious diseases. These include tuberculosis. Despite the enormous work of scientists and doctors, the number of patients and carriers of mycobacteria is not decreasing.

The insidiousness of the pathology lies in the fact that in the early stages it is asymptomatic, which complicates diagnosis. 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 have in their bodies such a resident as Koch's bacillus. This is an inactive form of tuberculosis that does not pose a threat to human health.

But this cannot always continue, and under the influence of certain factors, the pathology can become active. Diaskintest allows you to detect the presence of tuberculosis bacteria in the body when there are still no external 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. Fears that the drug may cause harm to health or cause infection with mycobacteria are vain and unfounded.

The annotation for 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 has shown a positive response of the immune system, and it is necessary to find out the reason for this.

Indications for use

The test for tuberculosis can be used at almost any age. The indications are as follows:

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

It is also given to persons referred to a tuberculosis clinic for additional examination if they are at high risk for this disease.

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

Test instructions

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

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

Frequency in children and adults

How often can Diaskintest be performed on a child or adult patient? The requirements are recorded in recommendations signed by the Ministry of Health:

For children from 8 to 17 years old, the test is done 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.
For nonspecific pathologies of the chronic form of the respiratory system.
Young patients treated with corticosteroids undergoing radiation therapy.
HIV-infected.

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

From what age and until what age?

At what age can Diaskintest be done? If the body’s result on the Mantoux test is positive, then Diaskintest is allowed for children from one year of age.

The question may arise: up to what age is the test done? This diagnosis 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 repeat test, then the recommendations are as follows:

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

Parents must give consent for the test, but the decision on its advisability is made by a specialist. Mommy is better to rely on the experience of a specialist and not refuse the test.

Preparation

No special preparation is required before Diaskintest. If a child has a tendency to allergic reactions, the doctor may recommend starting to take 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, and the time intervals between vaccination and test must be observed.

Administration technique

The test is permitted only to medical personnel who have access to intradermal testing. How is Diaskintest performed? The algorithm is as follows:

Is it painful to do Diaskintest? Given the shallow penetration of the needle with a thin tip, the procedure does not cause pain.

Actions after injection

After Diaskintest, to obtain a more reliable result, it is important to adhere to some rules:

It is not recommended to wet the injection site, although experts believe that if Diaskintest is exposed to moisture, the result should not be distorted.
Do not rub or scratch the injection site.
Do not cover it with a band-aid; sweat released irritates the skin and can cause redness and irritation.
After administering the drug, it is better not to swim in open water to prevent dirt from getting into the wound.
Do not treat with antiseptic agents.

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 go away in a couple of days:

General weakness.
Increased fatigue.
Development of hyperemia.
Slight increase in temperature.
Hyperergic reaction when the body is prone to allergic manifestations.

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

How long does it take to evaluate results?

The final interpretation of the body's response to the administration of Diaskintest is carried out only in 72 hours after administration of the drug. It makes no sense to do this earlier; skin reactions may change during this time, but even later it will not be possible to obtain a reliable result.

Consequences of incorrect setting

The Diaskintest must be performed in compliance with special rules; if the test technique is violated, then the following consequences can be expected:

Conclusion

The Diaskintest drug is considered more accurate; the consequences of unaccounted for contraindications or violations of the test technique are more likely to affect the result than the patient’s health. With its help, 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. This is especially true for tuberculosis; this insidious pathology can lead to serious complications.

Attention!
The contents of the page do not constitute official instructions for use of the drug and are provided for informational purposes only.
Consult your physician before use.

Pharmacological group

Diagnostic medicines

Name: Diaskintest

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

The mechanism of action of the drug Diaskintest is based on the detection of a cellular immune response to antigens specific to Mycobacterium tuberculosis. In patients with tuberculosis infection, administration of the drug 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 for the purpose of diagnosing tuberculosis, assessing the activity of the process and identifying patients at high risk of developing an active tuberculosis process.
Diaskintest is used for differential diagnosis of tuberculosis, infectious and post-vaccination allergies (delayed hypersensitivity reactions), as well as for assessing 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 to select patients for revaccination and primary BCG vaccination.

To carry out individual and screening diagnostics of tuberculosis, an intradermal test using the drug Diaskintest is used as prescribed by a phthisiatrician or with his methodological support.
To diagnose tuberculosis infection, a test using the drug Diaskintest is recommended for patients sent to an anti-tuberculosis institution 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 differential diagnosis of tuberculosis, a test using the drug Diaskintest should be carried out in combination with x-ray and clinical laboratory studies in an anti-tuberculosis institution.
In order to monitor patients registered with a phthisiatrician with manifestations of tuberculosis infection, a test should be carried out in an anti-tuberculosis institution using the drug Diaskintest during a control examination of all dispensary registration groups at intervals of 3-6 months.

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

To carry out the test, draw two doses of the Diaskintest drug (0.2 ml of solution) into a syringe and release the solution into a sterile cotton swab to the 0.1 ml mark. The patient must be in a sitting position during the test. 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 perform the test, 0.1 ml of Diaskintest solution is injected into the upper layers of the stretched skin. The injection should be 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 nonspecific allergies, the test is recommended to be carried out while taking desensitizing drugs (desensitizing drugs are selected by a doctor and, as a rule, are taken within 5 days before the test using the drug Diaskintest and within 2 days after).

Accounting for results:
The test result using the Diaskintest drug is assessed by a doctor or nurse 72 hours after the test. The assessment is carried out by measuring the size of hyperemia and papules (infiltrate) transverse to the axis of the forearm. The size is calculated in millimeters using a transparent ruler, but it must be taken into account that hyperemia is considered only if there is no infiltrate.
The reaction to the test is considered negative if there is a complete absence of infiltration and hyperemia or if their size does not exceed 2 mm.
The response to the test is considered questionable if the patient has hyperemia without infiltration.

The reaction to the test is considered positive if there is a papule (infiltrate) of any size (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 moderate; with a papule size of 10 to 14 mm, a pronounced reaction is considered. A hyperergic reaction is considered to be the presence of an infiltrate larger than 15 mm, as well as the development of vesiculo-necrotic changes, lymphangitis or lymphadenitis, regardless of the size of the papule.
Patients with a questionable and positive reaction to a test using the drug 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 hypersensitivity reactions that are associated with BCG vaccination.

Cases of no reaction 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 can be obtained 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 a test with the drug Diaskintest may be negative in patients with tuberculosis who have severe immunopathological disorders that are caused by a severe course of the tuberculosis process. Detection 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 when conducting a 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 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. Isolated cases of the development of systemic adverse reactions have been reported, in particular, after the test, the development of weakness, hyperthermia and headache is possible.

Contraindications:
Diaskintest is not used for testing in patients with acute and chronic (during relapse) diseases of infectious etiology, except in cases where tuberculosis is suspected.
You should not test with the drug Diaskintest 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 prohibited to test using the drug Diaskintest (the test is carried out only after the quarantine is lifted).

Pregnancy:
During pregnancy, the decision to perform the Diaskintest test is made by the doctor.

Interaction with other drugs:
It is recommended to carry out a test with the drug Diaskintest before carrying out preventive vaccinations. Moreover, in case of a negative result, vaccination tests (excluding BCG) can be carried out immediately after evaluation and recording of the test results.
After preventive vaccinations, a test with the drug Diaskintest is allowed no earlier than 1 month after the preventive vaccination.

Overdose:
There is 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 a rolling aluminum cap with first opening control, in a cardboard pack of 1, 5 or 10 glass bottles, enclosed in contour packaging made of polymer materials.

Storage conditions:
Diaskintest is suitable for use for 2 years after release, subject to storage and transportation at temperatures from 2 to 8 degrees Celsius. It is forbidden to freeze Diaskintest solution.
After opening the bottle, the solution can be used within 2 hours.
After the expiration date, Diaskintest should be discarded.

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

Pharmacological
action:

Diaskintest – recombinant tuberculosis allergen in standard breeding.
Diaskintest solution for intradermal administration is a recombinant protein produced by genetically modified cultures of Escherichia coli BL21(DE3)/pCFP-ESAT, diluted in an isotonic sterile phosphate buffer solution using a preservative (phenol).
Diaskintest contains two antigens that are present in virulent strains of Mycobacterium tuberculosis and are absent in the BCG vaccine strain.
Mechanism of action The Diaskintest drug is based on identifying the cellular immune response to antigens specific to Mycobacterium tuberculosis.
In patients with tuberculosis infection, administration of the drug Diaskintest leads to the development of a specific skin reaction, which is a manifestation of delayed-type hypersensitivity.

Indications for
application:

Designed for performing an intradermal test in all age groups for the purpose of:
- 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);
- assessing the effectiveness of anti-tuberculosis treatment in combination with other methods.
For individual and screening diagnosis of tuberculosis infection, an intradermal test with the drug 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 tuberculosis, 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, a test with the drug Diaskintest 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 an anti-tuberculosis institution, an intradermal test with the drug 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 the drug Diaskintest cannot be used instead of a tuberculin test to select individuals for primary vaccination and revaccination with BCG.

Directions for use:

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

To carry out the test, draw two doses of the Diaskintest drug (0.2 ml of solution) into a syringe and release the solution into a sterile cotton swab to the 0.1 ml mark. The patient must be in a sitting position during the test.
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 perform the test, 0.1 ml of Diaskintest solution is injected into the upper layers of the stretched skin. The injection should be 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 nonspecific allergies, the test is recommended to be carried out while taking desensitizing drugs (desensitizing drugs are selected by a doctor and, as a rule, are taken within 5 days before the test using the drug Diaskintest and within 2 days after).

Accounting for results
The test result using the Diaskintest drug is assessed by a doctor or nurse 72 hours after the test.
The assessment is carried out by measuring the size of hyperemia and papules (infiltrate) transverse to the axis of the forearm.
The size is calculated in millimeters using a transparent ruler, but it must be taken into account that hyperemia is considered only if there is no infiltrate.
The reaction to the test is considered negative if there is a complete absence of infiltration and hyperemia or if their size does not exceed 2 mm.
The response to the test is considered questionable if the patient has hyperemia without infiltration.

The reaction to the test is considered positive if there is a papule (infiltrate) of any size (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 moderate; with a papule size of 10 to 14 mm, a pronounced reaction is considered. A hyperergic reaction is considered to be the presence of an infiltrate larger than 15 mm, as well as the development of vesiculo-necrotic changes, lymphangitis or lymphadenitis, regardless of the size of the papule.
Patients with a questionable and positive reaction to a test using the drug 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 hypersensitivity reactions that are associated with BCG vaccination.

Cases of lack of reaction 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 can be obtained 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 a test with the drug Diaskintest may be negative in patients with tuberculosis who have severe immunopathological disorders that are caused by a severe course of the tuberculosis process.
Detection 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 when conducting a 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 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:

General reactions: in some cases, short-term - malaise, headache, increased body temperature.