Diaskintest release form. Diaskintest ® is a modern immunological test for tuberculosis screening. Actions after injection

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 an immune reaction only to 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, it is necessary to conduct special preventive treatment with 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 a reliable and highly informative method for diagnosing 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 previously transferred 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.

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).

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:

1. 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”
2. 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
3. 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.
4. Clinical guidelines "Latent tuberculosis infection (LTBI) in children", 2016
5. Clinical guidelines "Detection and diagnosis of tuberculosis in children entering and studying in educational institutions", ed. MD prof. V.A. Aksenova, 2017
6. 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. Clinical studies of a 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 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”

5 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”

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”

pharmachologic effect

Tuberculosis allergen 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

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 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.

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 examinations 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, the test with Diaskintest ® cannot be used instead of the tuberculin test to select individuals for primary vaccination and BCG revaccination.

Dosing regimen

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 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 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 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.

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

As a rule, there is 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.

In accounting documents note: 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.

After opening, the bottle with the drug can be stored for no more than 2 hours.

Side effect

Contraindications for use

- 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.

Use during pregnancy and lactation

Data on the use of the drug Diaskintest ® during pregnancy and lactation (breastfeeding) are not provided.

Overdose

Data on an overdose of the drug Diaskintest ® are not provided.

drug interaction

Testing with Diaskintest ® should be planned before prophylactic vaccinations. If preventive vaccinations are carried out, then a test with Diaskintest ® is carried out no earlier than 1 month after vaccination.

Terms of dispensing from pharmacies

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

Terms and conditions of storage

The drug is transported and stored in accordance with SP 3.3.2. 1248-03 at temperatures from 2° to 8°C. Do not freeze. Shelf life - 2 years. An expired drug should not be used.

The drug should be stored out of the reach of children.

special instructions

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.

What is Diaskintest? How is it used and when is it applied? Diaskintest instructions for use will give answers to the questions posed. Generally speaking, diaskintest is an additional Mantoux reaction method for diagnosing tuberculosis. The possibility of its use was fixed by order of the Ministry of Health of the Russian Federation eight years ago. What are its main characteristics? Is it an alternative to Mantoux or does it have other indications for use, side effects, composition of the drug?

During a medical examination using a sample using Diaskintest (DST), the most accurate medical diagnosis is carried out for tuberculosis to enter an adult organism or a child's organism. At the same time, its diagnostic action is focused on the disease of the active form.

After inoculation with the BCG vaccine, weakly active tuberculosis mycobacteria enter the human body. The human immune system immediately responds to the appearance of the pathogen and produces antibodies to it. The BCG vaccine contains weakened microbial bodies. However, infection can occur not only with the weak bacteria of the Koch bacillus. With close contact with a person suffering from tuberculosis, the reaction of bacteria of the active form is ensured. Young children, women during pregnancy, and the elderly are most at high risk of infection. State clinics should provide them with the opportunity to conduct a free diagnosis with diaskintest.

BCG vaccination leads to the development of passive immunity in children to tubercle bacillus. It can be difficult to distinguish from early TB infection. The Mantoux test cannot always accurately diagnose the presence of tuberculosis in the body. DST was created to determine a more correct test result. In form and composition, it is similar to Mantoux. The bacteria in its composition give an allergic reaction and indicate an initial stage disease. The protein included in it (more active than in Mantoux) reacts only to tuberculosis bacteria in an active form, without reacting to passive ones. Therefore, diaskintest MMNA is prescribed when Mantoux is positive.

• the main active ingredient (substance) is a recombinant protein;
• solution isotonic sterile phosphate;
• preservative (phenol);
• polysorbate;
• phosphate disubstituted Na;
• phosphate monosubstituted K;
• water.

A recombinant protein is an allergen produced by a genetically altered culture. The protein contains antigens that are in the forms of Mycobacterium tuberculosis, but which are not present in the BCG vaccine.

Manufacturer and release

This Russian medicinal product is produced in the form of a colorless transparent solution, packaged in small containers of 3 ml, grouped into contour cells and then in cartons of 30 doses each.

Mechanism of action, manufacturer. The production of this drug has been established in Russia in the Vladimir region at a modern full-cycle scientific enterprise "Generium".

From pharmacies, the drug is produced for sanitary and other medical institutions.

DST is a drug that is used to administer an intradermal allergy test in patients of all ages.

• detection of infection;
• assessment of the degree of infection;
• diagnosis of sick citizens with an increased degree of threat of the active course of the disease.

Additionally, it is used in checking for tuberculosis infection, checking for possible allergies after BCG vaccination, in the implementation of a comprehensive assessment of the degree of effectiveness of therapy against Koch's bacillus, in combination with other methods of treatment.
DST does not cause specific delayed-type hypersensitivity reactions caused by the BCG vaccine, and therefore cannot be used instead of the Mantoux tuberculin test for the purposes of screening citizens for revaccination and the first BCG vaccination. That's why
priority is not given in favor of diaskintest alone.

To carry out an individual test for tuberculosis, a test is made by injecting the drug into the skin. The phthisiatrician determines the instructions for the use of the drug.

• by referral to a tuberculosis dispensary for a comprehensive examination of citizens belonging to high-risk categories for the incidence of tuberculosis (based on medical, epidemiological and social characteristics);
• citizens who were referred to a doctor in the field of "Phthisiology" based on the results of a general diagnosis of tuberculosis.

For the most accurate check, a sample using the specified drug is done in conjunction with fluorography and taking tests on an outpatient (inpatient) basis in a tuberculosis dispensary.
For the purposes of monitoring patients registered with phthisiatrics with manifestations of the disease, it is recommended to do a diaskintest during a periodic examination of various categories of patients registered in a tuberculosis dispensary at intervals of 90 to 180 days.

The drug must be administered intradermally. Otherwise, there may be serious consequences. For the injection, special tuberculin syringes with small thin needles (tip with an oblique cut) are used. Prior to use, checking the shelf life and integrity of the vials is mandatory.

Opened ampoules are stored for no more than 120 minutes. The drug is drawn up with a syringe in a volume of two parts (0.2 ml). One part - one dose. One part is introduced into sterile cotton wool.

This procedure is performed by the patient sitting. After treating the skin with alcohol, one part of the medicine from the prepared syringe is injected strictly parallel to the surface layer of the pre-stretched skin from the inside of the patient's arm. After correct injection, a papule with a whitish tint no more than 1 cm in diameter appears on the skin at the injection site.

Patients who have previously shown allergies, the test is done while taking antihistamines. You need to take them for about a week: five days before the test and two after.

The effect of testing is checked by a doctor or specialized medical staff after three days after the test. During this time, the injection site should not be wetted. The check is carried out by measuring the papule and redness with a transparent ruler in millimeters. Redness is taken into account only in the absence of papule.

1. Negative (no papule, no redness).
2. Doubtful (there is redness, but no papule).
3. Positive (there is a papule of any size).
4. Slightly expressed (papule up to 5 mm).
5. Expressed moderately (papule up to 9 mm).
6. Expressed (papule 10-14 mm).

A skin reaction of reddening of the skin around the insertion of the needle usually appears immediately after the injection and disappears after 72 hours.

Citizens with a positive and dubious type of reaction must undergo a comprehensive test for tuberculosis.

• in patients who do not have an infection;
• in previously infected patients with an inactive form of infection;
• in patients with infection in the process of completing the changes associated with tuberculosis, if at the same time there are no other factors for the activity of the process (X-ray, tomography, tests);
• in fully recovered people.

At the same time, a reaction with a negative type DST drug is observed in patients infected with tuberculosis with obvious pathologies in the body caused by a complicated course of tuberculosis. Plus in citizens with an early stage of infection with mycobacteria, or in people with immunodeficiency.

According to the results of testing, the registration data indicates the name of the drug, manufacturer, series, “best before”, when and where the sample was delivered, and the assessment of the result.

The effect of the drug on pregnant and lactating women has not been studied. What effect it has on the child in utero is not exactly known.

The drug, when tuberculosis is detected in women who are expecting a child, is offered for use only in situations where the expected benefit to the mother is higher than the possible risk to the fetus.

If there was close contact with a person infected with tuberculosis, then a reaction is made with diaskintest. But during pregnancy and a positive result, it is unacceptable to carry out additional diagnostics using fluorography and x-rays. This will have a detrimental effect on the fetus. To protect the child from infection, because the mother can transmit the infection to the child, a pregnant woman is placed in a hospital and put on a dispensary.

Throughout pregnancy, a woman must take prescribed anti-TB drugs to protect the fetus. After childbirth, you can’t feed the baby, you can’t contact him either, so the baby is isolated from the mother. First of all, a complete examination of the mother and baby is carried out. When the mother's test is negative, and the child's is positive, the woman is removed from the dispensary, the child begins treatment. In infected women, often newly born children already have antibodies to the disease, that is, they are born with already developed antibodies to the disease, respectively, their test should be negative.

In childhood, the reaction with diaskintest is carried out after BCG vaccination. The BCG vaccine is needed so that children have passive antibodies to the disease. It happens that a child has more antibodies than necessary, and a simple test gives a positive reaction. In this case, an accurate answer can only be obtained with a joint test for antibodies and a diaskintest reaction. The procedure is the same as Mantoux. The appointment is made by the doctor free of charge through the clinic. The final result is accepted for evaluation 2.5 months after the child is vaccinated with BCG. When Mantoux is positive and diaskintest is negative, it means that the child simply has too many antibodies.

If DST in children is positive, then the doctor will recommend hospitalization in the appropriate medical facility. In addition to fluorography, children are given an analysis of urine, feces, and ultrasound. An ultrasound is required to make sure that the development of the child is age appropriate. Mycobacteria, being inside the child's body, have a negative effect on the organs, which can prevent the child from developing properly.

There is no information on the penetration of diaskintest into human milk during breastfeeding.

Physically healthy people with a “Negative” result can be vaccinated (except for BCG) immediately after it is assessed and recorded in the relevant documents.

A test with diaskintest must be planned in advance before the scheduled vaccination. When the vaccination has already been done, then the test with DST is done no earlier than 30 days after the next vaccination.

Since the solution is necessarily administered intradermally in the smallest dose, it almost does not enter the bloodstream at all. For this reason, there are no special conditions for use in patients with kidney and liver problems.

The drug has no age restrictions. There is also no information about the negative effect of the drug on driving and other vehicles.

The drug has contraindications:

• infectious diseases of an acute or chronic form during an exacerbation;
• psychosomatic diseases during exacerbation;
• skin infections;
• allergic manifestations;
• epileptic seizures.

In general, DST is well tolerated by patients. There are some reports of side effects. These are short-term manifestations of general malaise: headache, hyperthermia.

In children's institutions, during quarantine for infectious childhood diseases, it is impossible to do a test using the drug Diaskintest (it is possible only after the end of quarantine). This is another contraindication.

There is no information on cases of overdose of the drug DST.

1. Expiration date - 24 months after production.
2. Temperature during transportation and storage - 2-8 degrees Celsius.
3. Not subject to freezing.
4. After the expiration date has expired, the drug must be withdrawn from circulation and can no longer be used.

According to experts, Diaskintest has no analogues.

The price in pharmacies is about 1700-1800 rubles.

Take a free online TB test

Time limit: 0

Navigation (job numbers only)

0 of 17 tasks completed

Information

You have already taken the test before. You cannot run it again.

Test is loading...

You must login or register in order to start the test.

You must complete the following tests to start this one:

results

Time is over

• Congratulations! The chances of you being over TB are close to zero.

  But do not forget to also monitor your body and regularly undergo medical examinations and you are not afraid of any disease!
  We also recommend that you read the article on.

• There is reason to think.

  It’s impossible to say with accuracy that you have tuberculosis, but there is such a possibility, if it’s not, then something is clearly wrong with your health. We recommend that you immediately undergo a medical examination. We also recommend that you read the article on.

• Contact a specialist immediately!

  The likelihood that you are affected is very high, but remote diagnosis is not possible. You should immediately contact a qualified specialist and undergo a medical examination! We also strongly recommend that you read the article on.

1. With an answer
2. Checked out

1. Task 1 of 17

   1 .

   Does your lifestyle involve heavy physical activity?

2. Task 2 of 17

   2 .

   How often do you have a TB test (eg mantoux)?

3. Task 3 of 17

   3 .

   Do you carefully observe personal hygiene (shower, hands before eating and after walking, etc.)?

4. Task 4 of 17

   4 .

   Are you taking care of your immunity?

5. Task 5 of 17

   5 .

   Have any of your relatives or family members suffered from tuberculosis?

6. Task 6 of 17

   6 .

   Do you live or work in an unfavorable environment (gas, smoke, chemical emissions from enterprises)?

7. Task 7 of 17

   7 .

   How often are you in a damp or dusty environment with mold?

8. Task 8 of 17

   8 .

   How old are you?

9. Task 9 of 17

   9 .

   What gender are you?

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);
• 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, the Diaskintest test cannot be used instead of the 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 suspected of 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 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 treatment of the skin area on the inner surface of the middle third of the forearm 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 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.

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.

Instructions for use:

Diaskintest is a tool used to diagnose tuberculosis.

Release form and composition

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

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

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

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

Indications for use

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

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

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

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

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

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

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

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

Contraindications

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

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

Method of application and dosage

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

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

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

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

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

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

Accounting for results

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

Reaction results:

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

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

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

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

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

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

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

In addition, the test may be negative:

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

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

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

Side effects

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

special instructions

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

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

drug interaction

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

Analogues

There is no information about analogues of Diaskintest.

Terms and conditions of storage

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

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

Terms of dispensing from pharmacies

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