Mantoux or Diaskintest: the right to choose and the right to refuse

Advantages of diagnosing tuberculosis with Diaskintest in children:

• has the highest sensitivity (98 - 100%)
• has the highest specificity (90 - 100%)
• greater safety and higher accuracy compared to the Mantoux test
• higher specificity than the imported allergen T-Spot
• accurate diagnosis of infection occurring in a latent form
• contains two antigens present in virulent strains of Mycobacterium tuberculosis and absent in the BCG vaccine strain
• When using Diaskintest, allergic reactions practically do not occur

Why is the sample and patient preparation needed?

Diaskintest causes redness either immediately or on the second day after the injection. Based on the reaction, the doctor will be able to judge the result. The test is considered an innovative screening method for diagnosing tuberculosis. Doctors and patients have already been able to appreciate the new way of identifying an insidious disease.

Mantoux type screening is carried out. Like this injection, Diaskintest cannot be wetted, scratched, heated, or overcooled for three days. Unlike the old method, the new one is the safest and most accurate for humans. Its results are considered the most truthful, allergic reactions and individual intolerances are minimized.

This technique cannot be prescribed to children under one year of age; it can be used to control the disease in schoolchildren and adult patients.

How does the test work?

1. A person is given an injection under the skin, that is, a recombined protein, which is obtained by modifying the DNA of pathogens.
2. When this protein enters the body, it causes a certain reaction, similar to an allergic one.
3. If the body has already encountered foreign tuberculosis organisms, it will begin to produce special antibodies.
4. An active reaction to the test indicates whether the patient is a carrier of the disease or not.
5. The operating principle is reminiscent of Mantoux. The required dose of the drug is injected into the area between the wrist and elbow. Right-handed people are given an injection in the left arm, and left-handed people - in the right, to reduce the impact on the papule.

Diagnosis of tuberculosis in children is also carried out using this technique. It is not a vaccination, but tests the reaction for the presence of protein. The Mantoux test is done annually for children from one year of age. Diaskintest is considered an additional technique if the first one does not provide comprehensive data. It is recommended to be carried out from 8 to 17 years of age every year.

The test is carried out following certain rules. If the diaskintest test is negative, it is done after two months; if the patient has had an acute infectious disease, then a month after recovery. All patients who are registered with a TB doctor are tested once every six months.

Indications for use of "Diaskintest"

"Diaskintest" is used to conduct an intradermal test in children over 8 years of age, instead of the Mantoux test, for the purpose of diagnosing tuberculosis of exclusively pulmonary localization, assessing the activity of the process and identifying patients at high risk of developing an active tuberculosis process. "Diaskintest" is intended for performing an intradermal test for the following purposes:

• children from high-risk groups for tuberculosis who are not subject to dispensary registration by a phthisiatrician
• to identify patients at high risk of developing active tuberculosis (latent tuberculosis infection)
• for differential diagnosis of post-vaccination (BCG) and infectious allergies (delayed-type hypersensitivity)
• to evaluate the effectiveness of anti-tuberculosis treatment in combination with other methods
• in patients suffering from diabetes mellitus, peptic ulcer disease
• in patients with chronic nonspecific purulent-inflammatory diseases of the bronchopulmonary system and kidneys
• in HIV-infected patients
• in patients receiving long-term immunosuppressive therapy (cytostatics, corticosteroids, genetically engineered biological drugs (GEBP), etc.)

How is the DST test performed?

Knowing what kind of vaccination Diaskintest is for children, it is important to carry out this diagnosis of tuberculosis on time and correctly.

When is a DST test done?

The DST test is performed for both children and adults.

In children, the indications are:

• positive Mantoux test - to exclude the possibility of a reaction to the BCG vaccination, drug components, etc.;
• clinical signs of tuberculosis;
• high risk of developing tuberculosis (upon contact with a patient);
• monitoring the effectiveness of tuberculosis treatment.

If the DST is negative with a positive Mantoux, it is recommended to repeat it after 2 months.

The principle of action of the drug "Diaskintest"

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

To identify (diagnosis) tuberculosis infection, a test with Diaskintest is carried out:

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

Important! A test with the drug "Diaskintest" cannot be used instead of a tuberculin test (Mantoux) to select individuals for primary vaccination and revaccination with BCG

What is Diaskintest and what is it for?

Diaskintest is a development of Russian scientists. The principle is the same as the Mantoux test - an injection in the arm, after three days the redness is measured.

Every year in Russia, doctors identify about 70 thousand patients with tuberculosis. Three thousand of them are children. Tuberculosis has long ceased to be a social disease. Anyone can become infected, anywhere: in a store, on transport, at school. Moreover, infection can occur in childhood, and a person learns about it many years later.

Diaskintest well identifies the same old tuberculosis, which is not detected either by the mantoux test or by ordinary radiographs.

Diaskintest is an allergen that consists of two proteins, which are natural antigens specific to Mycobacterium tuberculosis (“foreign” substances that can cause an immune response in the human body in the form of an allergic reaction). These protein substances are synthesized using genetic engineering methods and are more specific (high probability of obtaining a negative diagnostic test result in the absence of disease) than tuberculin, which is traditionally used for intradermal Mantoux test.

Attention! Not to be confused with GMOs. Genetically modified organisms are completely new organisms that do not exist in nature, but are produced artificially through genetic engineering. The proteins that make up the drug Diaskintest are natural substances and are produced only during the proliferation of Mycobacterium tuberculosis after penetration into the human body.

Diaskintest is intended for performing an intradermal test, which is carried out according to the same rules as the Mantoux test with tuberculin.

The principle of action of the drug Diaskintest is based on the development of an immune response to specific proteins-antigens of Mycobacterium tuberculosis, which are formed only in the case of active reproduction of mycobacteria in the body. A delayed-type allergic reaction, characteristic of an immune response during tuberculosis infection, develops at the injection site of the drug.

A test with the drug Diaskintest is placed on the forearm using a tuberculin syringe, which allows the diagnostic drug to be administered intradermally in anti-tuberculosis dispensaries, specialized rooms in children's clinics, kindergartens and schools by specially trained medical workers. When the test is carried out correctly, a “button” is formed at the injection site in the form of a whitish “lemon peel”, with a diameter of no more than 7–9 mm.

The reaction at the injection site begins to form after 6–9 hours and reaches its maximum severity after 72 hours. Therefore, the child must be shown to a TB doctor only 3 days after the test (but not later, since the reaction begins to fade).

IMPORTANT!

The algorithm for using Diaskintest and Mantoux is the same. In children, DST is given only 30 days after a previous vaccination, and the child must be absolutely healthy.

NOTE TO PARENTS. RULES OF CONDUCT AFTER A DIASKINTEST TEST.

It should be remembered that improper care may affect the assessment of the results of an intradermal test with the drug Diaskintest. Therefore, after performing the test, do not allow the child to scratch the injection site. Do not cover the inflammatory area with adhesive tape or wrap it in bandages, steam it, treat it with brilliant green, iodine, hydrogen peroxide, or creams. You should not take water procedures, despite the fact that it is allowed to wet the injection site.

You should postpone sports training - sweat can distort the course of the reaction, changing a minus to a plus. You should refrain from sunbathing and walking in severe frost.

Avoid contact of the skin at the injection site with chemical irritants - shampoos, shower gels, etc.

Some individuals may experience short-term malaise, headache, or increased body temperature after the test. There is no danger in this! These are signs of a general reaction of the body that can occur in any individual to drugs containing substances of a protein nature.

RESULTS EVALUATION

Both Mantoux and Diaskintest, when assessing reactions, rely on the same criteria. Three days after testing, the amount of hyperemia and infiltration at the injection site is analyzed. There are three reaction options:

Negative – there is no redness and papule or the red spot does not exceed two millimeters in diameter;

Doubtful - with obvious redness there is no papule;

Positive – a papule is visible.

THE TESTING SHOULD BE EVALUATED BY A SPECIALIST!!!

The norm for both adults and children is one DST result – negative. The reaction to Diaskintest by day does not play a role. Hyperemia can appear on the first day and on the third.

If redness (hyperemia) of any size or a local inflammatory reaction in the form of an infiltrate (papule) appears at the injection site, an intradermal test with Diaskintest is considered doubtful or positive. Quantitative assessment of the reaction is carried out by the size of the papule - the more pathogens in the body, the larger the papule!

Note to parents! Patients with a questionable and positive reaction to an intradermal test with the drug Diaskintest must be sent to specialized anti-tuberculosis institutions for a consultation with a TB doctor for additional examination for the purpose of early detection of tuberculosis and timely implementation of anti-tuberculosis treatment and preventive measures (order of the Ministry of Health and Social Development of the Russian Federation No. 855 dated October 29, 2009 “On amendments to Appendix No. 4 to the order of the Ministry of Health of Russia dated March 21, 2003 No. 109”).

CONTRAINDICATIONS FOR INTRADUTANAL TEST WITH DIASKINTEST:

• pronounced skin changes (eczema, neurodermatitis, etc.);
• acute and chronic viral and somatic diseases during exacerbation;
• vaccination period (within 1 month);
• epilepsy.

You can find out more information about Diaskintest on the website https://www.diaskintest.ru/

Evaluation of test results with Diaskintest

The result of the test is assessed by a doctor or trained nurse 72 hours after it was performed by measuring the transverse (relative to the axis of the forearm) size of the hyperemia (redness) 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;
• doubtful - in the presence of hyperemia without infiltration;
• positive - in the presence of infiltrate (papules) of any size.

Positive reactions conditionally vary in severity:

• mild reaction - in the presence of 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 vesicular-necrotic changes and (or) lymphangitis, lymphadenitis, regardless of the size of the infiltrate.

Persons with questionable and positive reactions are examined for tuberculosis.

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;
• in persons with extrapulmonary localization 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.

What's in it

Vaccination D-test - what is it, what is the composition of the drug:

• proteins with two surface antigens of the human tuberculosis pathogen;
• preservative - phenol (in a safe amount);
• stabilizer - polysorbate;
• potassium and sodium phosphates;
• sodium chloride.

The drug DST is a transparent, colorless solution for subcutaneous administration. Available in glass bottles of 1.2 or 3 ml, i.e. 12 or 30 doses (one dose - 0.1 ml).

DST is done in clinics, tuberculosis dispensaries, schools (once a year) and paid clinics.

Diaskintest is sold in pharmacies with a prescription. Price - from 1500 rubles (30 doses). The cost of the procedure (along with the drug) in commercial medical centers is about 2,500 rubles.

Contraindications

Only a doctor can decide whether Diaskintest is suitable for testing for tuberculosis.

The Diaskintest test is not recommended and is not performed on children under 7 years of age inclusive.

"Diaskintest" is contraindicated for persons with allergic and autoimmune diseases! Also, the use of Diaskintest is contraindicated in the following cases:

• Acute diseases or exacerbation of chronic diseases (except for cases of suspected tuberculosis).
• Skin diseases.
• Epilepsy.
• In children's groups where there is a quarantine for childhood infections, the test is carried out only after the quarantine is lifted.

Diaskintest: general information

Diaskintest (DST) is a drug for conducting skin tests for tuberculosis, an analogue of the well-known Mantoux test.

This is not a vaccination, a DST is a test (like Mantoux); it is not a vaccine against tuberculosis, but only helps to detect it.

For adults, the main method for diagnosing tuberculosis is fluorography. Children are prohibited from doing it; they are given tests - tests for tuberculin, an extract isolated from mycobacterium tuberculosis. A positive test result means that the body is familiar with this substance, that is, it is infected or sick.

Possible side effects

For most, the test process is asymptomatic.

Headaches, general weakness, sleep disturbances, and increased body temperature may occur. Individuals with altered reactivity experience allergic reactions. Considering the possibility of developing immediate allergic reactions (anaphylactic shock, Quincke's edema, urticaria) in particularly sensitive individuals, vaccinated persons must be provided with medical supervision for 30 minutes.

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Preparation and carrying out the procedure

Diaskintest is done only for absolutely healthy people. No special preparation is needed; for allergy sufferers, antihistamines are recommended a week before the procedure and several days after.

Alcohol is prohibited for adults three days before the test and before checking the results.

The drug is injected under the skin of the inner forearm.

A small white papule forms at the injection site.

Possible side effects are weakness, headache, slight fever. They are harmless and pass quickly.

DST does not provide for a strict requirement not to wet the injection site, but it is not advisable to do this. The injection mark cannot be rubbed, soaped, smeared with ointments and creams, sealed or bandaged.

Before assessing the test results (3 days), you should not sunbathe, overcool, or play sports, as sweat causes irritation at the injection site.

Why does redness occur?

An allergy to the Mantoux test can be a direct indication for diaskintest. Within a few hours after the injection, the color of the skin changes. At first it is pale red and then acquires a bluish tint. There is no need to worry in this case. However, the occurrence of swelling and compaction should alert you.

Subcutaneous hemorrhage may be the result of an incorrectly administered injection if a blood vessel is hit. Diaskintest is an excellent prevention of tuberculosis in childhood. It can be considered as such, since the technique allows you to detect the disease in the early stages, continue to monitor it, and also prescribe adequate treatment.

Symptoms that indicate an allergy to the sample:

• at the injection site, a rash appears, a red spot, one or several, which can spread throughout the entire arm, moving to the face and body;
• discomfort, severe itching occurs;
• hyperemia of the papule;
• body temperature rises;
• in advanced cases - shortness of breath, rhinitis, swelling of the mucous membranes of the eyes, severe cough.

If an allergic reaction occurs, an antihistamine must be administered. The result is also influenced by the presence of parasites in the body. In this case, the test gives a positive result, and the immune system fails. The results can be judged on the second day of drug administration. In case of a negative reaction, only a trace of the injection remains on the skin without redness, swelling or other unpleasant symptoms.