Diaskintest instructions for use. How do diaskintest and mantoux test relate to each other

The Mantoux reaction helps to detect the presence of a tubercle bacillus in the blood of a child or an adult. But the result is not always accurate, since an excess of antibodies and the initial form of the disease give a similar reaction. How to distinguish an infected child from a healthy one? A more accurate test, a new generation, comes to the rescue. What is Diaskintest (DST), in what cases it is used, is not known to the ordinary reader. Meanwhile, the drug is useful, but every second person in Russia will encounter it. Instructions for the use of DST and what to do if a woman during pregnancy or a child is infected, we will tell our readers.

What is Diaskintest, in what cases is it prescribed

With the help of Diaskintest, a more accurate test for a tubercle bacillus is performed. But unlike the mantoux, it is aimed at active form diseases. With the help of BCG vaccination, microbacteria enter the body in a passive form. The immune system reacts to infection and produces antibodies. But not always infection occurs with a weak tubercle bacillus. If the patient has been in contact with a sick person, then the reaction of active bacteria is guaranteed. Not only children are susceptible to rapid infection, but also pregnant women and the elderly. They perform the DST reaction for free, in the clinic.

Among microorganisms, forms of tuberculosis are dangerous, which adapt to medications and resist treatment. In this case, there is a slow development of the disease, which is almost impossible to cure. In 6 out of 10 cases, the patient's immunity is able to overcome the initial form of infection, the body acquires strong immunity. In the remaining 4 cases, the patient cannot cope with the disease. And there are not so many drugs for tuberculosis in Russia.

Features and composition

BCG vaccination is able to develop in a baby passive immunity to a stick, which is easy to confuse with initial form Koch's bacillus infection. A simple Mantoux reaction cannot always give an accurate result. The Diaskintest test is designed to establish a more accurate picture. It is similar in form to a Mantoux injection and also consists of allergens that react and show the disease at its initial stage. The protein that is part of the drug will only react to active tuberculosis bacteria, ignoring passive antibodies. The allergen composition is similar to mantoux, but the protein is more active. Therefore, in cases where Mantoux showed a positive result, it is worth going through Diaskintest.

The reaction rates of DST and Mantoux are shown in the table:

How to make a test - instructions

The use and dosage of the drug Diaskintest resembles a manta. The drug is administered to the patient subcutaneously, in the pre-shoulder zone. It is done together with the "button" in different hands. The procedure is safe and you need to prepare for it in the same way as for a mantoux.

The result can be found after 72 hours using a ruler. Mantoux at a positive result more than 2.7 cm, DST more than 1 cm.

With a positive Mantoux reaction and a negative Diaskintest, there are no active rods in the body. It's just that the patient has developed too many passive antibodies that react. In this case, the doctor will prescribe drugs for the prevention of tuberculosis, which must be drunk strictly, as stated in the instructions for use. Do not delay treatment, as the form of the disease can become active. You need to do the test several more times during the treatment.

If the mantoux reaction is positive, and the Diaskintest sample turns red, has swelling or vesicles, then the patient is infected with Koch's tubercle bacillus. But do not panic, at the initial stage, tuberculosis is treatable.

You need to take an anti-tuberculosis composition daily, during the first year, according to the scheme that the instructions for use or the doctor will tell you. If treated carelessly, tuberculosis will quickly spread to all internal organs. Irregular use of drugs will cause addiction and resistance to the drug in microorganisms. Do not flatter yourself that you can replace one medicine with another, there are not so many medicines against tuberculosis. And in the end, the doctor can do nothing.

During treatment, a Diaskintest test is regularly performed until its result becomes negative. The disease will go into a passive form.

Testing women in position

The situation is more complicated for women during pregnancy. If there was contact with an infected patient, then a DST test is taken. But with a positive result, tomography and fluorography cannot be performed during pregnancy. This will affect the development of the fetus. It is necessary to protect the fetus from infection, therefore, during pregnancy, a woman is registered and placed in a special hospital.

Throughout pregnancy, anti-tuberculosis drugs are prescribed to help protect the fetus. After pregnancy, feeding the baby, as well as contact with him, is prohibited. First, you need to conduct a survey of the mother and child completely. If the mother's test reaction is negative, and the child's test is positive, then the patient is deregistered, the baby begins to be treated. In sick patients, children are often born with already developed antibodies to the disease, their test will be negative.

Children's examinations

In children, DST test can be performed after BCG vaccination. Vaccination is necessary to develop passive antibodies to the disease in children. It happens that antibodies in children are more than expected and the reaction of a simple test is positive. The result can be assessed only after the antibody test and the DST reaction are performed together. In children, the Diaskintest test is done in exactly the same way as a “button”. The reaction is assigned free of charge, through the clinic. The result is evaluated after 2.5 months after BCG vaccination in children. If the mantoux is positive, and the DST is negative, it means that the baby just developed antibodies in large quantities.

With a positive DST in children, the doctor will suggest hospitalization in a specialized hospital. In children, in addition to fluorography, they take an analysis of urine, feces, and prescribe an ultrasound scan. Ultrasounds are needed to make sure that children are developing normally. The bacterium, getting inside the body of children, affects some organs and the baby will not be able to develop normally.

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 tuberculosis;
differential diagnosis of post-vaccination and infectious (delayed-type hypersensitivity);
evaluating 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 tuberculin test for the selection of individuals for primary vaccination and BCG revaccination.

Contraindications

acute and chronic (during an exacerbation) infectious diseases, except in 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 specially trained nurse approved for intradermal testing.

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 setting up the sample, as a rule, a papule is formed in the skin in the form of a "lemon crust" 7-10 mm in size in diameter, whitish in color.

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 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 doubtful and positive reaction on Diaskintest are examined for tuberculosis.

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

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

One dose (0.1 ml) of the drug contains:

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

excipients: disodium hydrogen phosphate dihydrate, sodium chloride, potassium dihydrogen phosphate, polysorbate-80, phenol, water for injection.

Description

Colorless transparent liquid

Pharmacotherapeutic group

Allergens. Allergen extract. other allergens.

ATX code V01AA20

Pharmacological properties"type="checkbox">

Pharmacological properties

DIASKINTEST® tuberculosis allergen 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 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 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

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 differential diagnosis of tuberculosis and other diseases, a test with DIASKINTEST® is carried out

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

During the control examination in all groups of dispensary registration with an interval of 3-6 months.

Dosage and administration

The test is carried out according to the doctor's prescription 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 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.

Side effects"type="checkbox">

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"type="checkbox">

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 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

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

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.

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 infiltration and hyperemia or in the presence of a "prick reaction" up to 2 mm;

Doubtful - 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;

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 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 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 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.

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.

Diaskintest® (Allergen tuberculosis recombinant in standard dilution) is an innovative intradermal diagnostic test, which is a recombinant protein containing two interconnected antigens - ESAT6 and CFP10, characteristic of pathogenic strains of mycobacterium tuberculosis (Mycobacterium tuberculosis) 1 . These antigens are absent in the Mycobacterium bovis BCG vaccine strain and in most non-tuberculous mycobacteria, therefore Diaskintest® causes immune response only on Mycobacterium tuberculosis and does not give a reaction associated with BCG vaccination. Thanks to these qualities, Diaskintest® has almost 100% sensitivity and specificity 2 , minimizing the likelihood of false positive reactions, which in 40-60% of cases are observed when using the traditional intradermal tuberculin test (Mantoux test) 3 . The technique for setting up Diaskintest and recording the results is identical to the Mantoux test with tuberculin 4.

In Russia, the use of Diaskintest was approved in 2009 by the Order of the Ministry of Health of the Russian Federation 855 dated October 29, 2009 4

Since 2017, the use of Diaskintest in the screening of tuberculosis in children over 7 years of age and adolescents has been regulated by the Order of the Ministry of Health of Russia No. 124n dated March 21, 2017 5.

Diaskintest is highly sensitive and highly informative: it allows you to exclude false positive reactions that occur during the Mantoux test in vaccinated individuals (post-vaccination immunity). According to various estimates and in different regions of Russia, the sensitivity of Diaskintest is about 96%.

HOW HIGH ACCURACY OF DIASKINTEST IS ACHIEVED

Diaskintest is a diagnostic test based on the formation of a delayed-type hypersensitivity reaction (DHRT), which manifests itself in the form of a seal (papules) at the injection site in the presence of Mycobacterium tuberculosis, pathogenic for the human body, with the presence in its structure of two antigens ESAT-6 and CFP-10 . These antigens are not present in vaccine mycobacteria (BCG) and nontuberculous bacteria.

If a person has tuberculosis (active or latent (hidden) tuberculosis infection), then a seal (papule) is formed at the injection site of Diaskintest - a positive test. In this case, a thorough additional examination is necessary to exclude active tuberculous lesions. In the absence of reliable signs of the disease, a positive test indicates that a person has a latent (hidden) tuberculosis infection and there is a high risk of the disease becoming active in the near future. Therefore, a special preventive treatment anti-tuberculosis drugs.

If a person is healthy, while having immunity from tuberculosis after BCG vaccination (post-vaccination immunity), then Diaskintest will be negative.

To evaluate the performance of any test sample, two main characteristics are taken into account: sensitivity and specificity. The higher these indicators, the more qualitatively the test detects the infection.

The sensitivity of the test is the presence of positive reactions in individuals with a reliably confirmed diagnosis.

The sensitivity of Diaskintest is 96.0% 6 .

The specificity of the test is a negative reaction to the test in absolutely healthy people.

The specificity of Diaskintest is 99.0% 6 .

All this allowed Diaskintest to become reliable and highly informative method diagnosis of both latent and active tuberculosis. High accuracy of diagnostics allows avoiding unnecessary and often harmful treatment courses and studies.

ADVANTAGES OF DIASKINTEST OVER OTHER TESTS

High specificity and high sensitivity;
Absence of false positive results in case of BCG vaccination;
No special laboratory equipment required;
Less traumatic for children of any age;
Effective at any age: children, teenagers, adults.

WHEN DIASKINTEST IS USED

For children under 7 years of age:

differential diagnosis of post-vaccination and infectious allergies;
assessment of the activity of the tuberculosis process (if calcifications and traces of a previous infection are detected) in combination with other clinical, laboratory and radiological methods;

In children over 7 years of age and adolescents:

diagnosis of tuberculosis and identification of persons at high risk of developing active tuberculosis (screening) 7 ;
differential diagnosis of tuberculosis in combination with other clinical, laboratory and radiological studies;
evaluation of the effectiveness of anti-tuberculosis treatment in combination with other methods.

In adults:

diagnosing tuberculosis and identifying individuals at high risk of developing active tuberculosis;
assessment of the activity of the tuberculosis process;
differential diagnosis of tuberculosis in combination with other clinical, laboratory and radiological studies;
evaluation of the effectiveness of anti-tuberculosis treatment in combination with other methods;
Attention! BCG vaccination does not affect the results of Diaskintest.

HOW TO PREPARE FOR DIASKINTEST

The test is carried out according to the doctor's prescription for children, adolescents and adults by a specially trained nurse who has access to intradermal tests.

ACCOUNT OF THE RESULTS OF DIASKINTEST

The result of the test is evaluated by a doctor or a trained nurse after 72 hours (3 days) from its setting.

Criteria for evaluating the response to the Diaskintest sample:

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

REGULATORY DOCUMENTS REGULATING THE USE OF DIASKINTEST:

Order of the Ministry of Health and Social Development of the Russian Federation No. 855 of October 29, 2009 “On Amendments to Appendix No. 4 to the Order of the Ministry of Health of Russia No. 109 of March 21, 2003”
Federal Clinical Guidelines for the Diagnosis and Treatment of Latent Tuberculosis Infection in Children, approved by the Russian Society of Phthisiologists, ed. MD prof. V.A. Aksenova, 2015
Recommendations for screening and monitoring of tuberculosis infection in patients receiving genetically engineered biological products, approved by the Association of Rheumatologists of the Russian Federation in 2013 with additions from 2016, ed. Borisova S.E., Lukina G.V.
Clinical guidelines "Latent tuberculosis infection (LTBI) in children", 2016
Clinical guidelines "Detection and diagnosis of tuberculosis in children entering and studying in educational institutions", ed. MD prof. V.A. Aksenova, 2017
Order of the Ministry of Health of the Russian Federation of March 21, 2017 No. 124n “On approval of the procedure and terms for conducting preventive medical examinations of citizens in order to detect tuberculosis”

1 Kiselev V.I., Baranovsky P.M., Pupyshev S.A. A new skin test for the diagnosis of tuberculosis based on the recombinant protein ESAT-CFP. Mol. honey. -2008. - No. 4. - S. 28–34

2 Kiselev V.I., Baranovsky P.M., Rudykh I.V. and etc. Clinical researches new skin test "DIASKINTEST ®" for the diagnosis of tuberculosis. Tuberculosis problems and lung diseases. - 2009. - No. 2.- P. 1–8

3 Lebedeva L.V., Gracheva S.G. Sensitivity to tuberculin and infection with mycobacterium tuberculosis in children. Probl. tub. and lung diseases. - 2007. - No. 1.- S. 43–49

4 Order of the Ministry of Health and social development RF No. 855 dated 10.29.09 "On Amendments to Appendix No. 4 to the Order of the Ministry of Health of Russia No. 109 dated 03.21.03"

5 Order of the Ministry of Health of the Russian Federation of March 21, 2017 No. 124n “On approval of the procedure and timing of preventive medical examinations citizens in order to detect tuberculosis”

6 Slogotskaya L.V., Senchikhina O.Yu., Nikitina G.V., Bogorodskaya E.M. The effectiveness of skin test with recombinant tuberculosis allergen in detecting tuberculosis in children and adolescents in Moscow in 2013 // Pediatric Pharmacology, 2015. - N 1. - P. 99-103

7 Order of the Ministry of Health of the Russian Federation dated March 21, 2017 No. 124n “On approval of the procedure and terms for conducting preventive medical examinations of citizens in order to detect tuberculosis”

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 processed the area skin 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 if total absence 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.
A negative test may be detected in patients with early stages 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:

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