Purified tuberculosis allergen - instructions for use. Tuberculin - what is it? Purified tuberculin in standard dilution

The most important drug intended to maintain physical health and prevent the development of tuberculosis is Tuberculin. The instructions for use of the medicine describe in detail what components the medicine consists of, how it is used and whether it can cause any side effects. Not all adults know that Tuberculin is a drug used in childhood vaccinations to diagnose tuberculosis. Such vaccination will not help prevent the development of the disease, but it will make it much easier, which is why the Mantoux test is given to children from an early age.

Initially, the vaccine is a mixture of filtrates of certain Mycobacterium tuberculosis (human and bovine species), artificially killed by high temperature exposure. To ensure that the bacteria used to produce the drug are not life-threatening and are properly absorbed by the body, they are additionally precipitated with trichloroacetic acid and mixed with ethyl alcohol and ethers. Finally, the resulting substance is dissolved in a specific phosphate buffer solution, which also contains a stabilizer and preservative, which allows the drug to be purified.

1. Tuberculoprotein.
2. Sodium phosphate dodecahydrate.
3. Potassium dihydrogen phosphate.
4. Phenol.
5. Sodium chloride.
6. Polysorbate.
7. Water intended for internal injection.

Externally, the medication is a colorless liquid and has no distinct odor. Tuberculin is produced in glass ampoules; depending on the dosage, the drug contains 0.1 ml or 2 tuberculin units (in professional language it is called TE). In the standard release, each package contains 10 ampoules with an active solution.

Dry Tuberculin, which is a white powder, is sometimes used for vaccination. The drug is also available in ampoules of 50,000 TE, in addition to which a solvent is included.

pharmachologic effect

In international medicine, Tuberculin is classified as a diagnostic agent. Vaccination with the drug is carried out in all developed countries of the world, as it helps determine the likelihood of developing tuberculosis.

• in children aged 7 to 16 years;
• in citizens at risk who are susceptible to pathology;
• to identify the need for revaccination.

Experts warn that the Mantoux test does not apply to vaccinations and does not guarantee that a person will not develop tuberculosis. Such a test helps to identify the presence of Koch's bacillus at the initial stage, before the disease begins to progress and becomes more dangerous.

When studying a medication intended for internal administration, doctors always pay special attention to pharmacodynamics and pharmacokinetics. What is meant by this terminology?

• pharmacodynamics. The effect of medicine on the human body, studying the effect on biological and chemical processes;
• pharmacokinetics. The reaction that occurs with the molecules of the administered substance.

Since the use of Tuberculin is mandatory in our country, parents must understand and imagine what happens to the child’s body after Mantoux vaccination.

Pharmacodynamics

When introduced into the body, the tuberculin test goes through several stages and begins to react. After 3 days after vaccination, the body’s reaction to tuberculosis will fully manifest itself; based on this data, doctors will be able to evaluate the clinical picture and understand whether a person has a predisposition to the disease.

• the introduced antigen provokes the accumulation of pathogenic cells that provoke the inflammatory process;
• microphages are sent to the area where the drug was injected;
• pathogenic cells react with microphages, and as a result of this interaction, cytokines are formed.

After the injection, cytokines appear on the surface of the epidermis, and it is they that form the “red spot” from Mantoux. The more of them are produced, the larger the tumor will be. Doctors judge the reaction to the vaccine by its size. Doctors assure that it will be possible to talk about the result no earlier than after 72 hours, since during this time many different processes occur in the body.

Indications for use

In what cases is the use of Tuberculin prescribed? Today, this medicine is used only for diagnosing tuberculosis and determining the presence of pathogenic mycobacteria in the body.

1. Identification of citizens who require BCG vaccination (anti-tuberculosis drug).
2. Preparing infants for primary vaccination.
3. Calculation of the number of residents who are carriers of the virus.
4. Identification of local forms of tuberculosis in minors.
5. Identification of citizens who have a large number of bacteria that are in an inactive state. The Mantoux test easily allows you to control the process.

As a rule, a tuberculin test is performed on children who study in schools. It is also advisable to give this injection to citizens who have had pulmonary tuberculosis.

There is no medicine in the world that does not have contraindications, and Tuberculin is no exception.

• if a person suffers from epileptic seizures;
• in the presence of skin diseases that may provoke an incorrect reaction of the drug or worsen;
• somatic diseases during exacerbation;
• presence of chronic infectious diseases;
• tendency to allergic reactions;
• bronchial asthma;
• quarantine for infectious diseases in the team.

Doctors say that a contraindication to the Mantoux test is associated solely with the body’s incorrect reaction to the drug, but not with intolerance to the components. Some diseases can lead to an incorrect reaction, as a result of which the result will be distorted and unreliable.

To eliminate the risk of complications, it is recommended to perform a tuberculin test one month after other vaccinations.

Application in homeopathy

In the history of medicine, Tuberculin is considered an amazing and unique substance; another area of ​​application is homeopathy. Several decades ago, this medicine was even used against tuberculosis (such therapy was considered alternative). Currently, treatment with the drug is considered ineffective and more radical medications, such as chemotherapy, are usually used to combat the pathology.

• to prevent the development of tuberculosis (in patients with an increased susceptibility to the disease);
• with deterioration and slowdown of regeneration;
• in case of weather dependence;
• with fragility and underdevelopment of connective tissues.

It is worth noting that treatment with this specific remedy is most often prescribed only when other methods have failed.

Side effects

In most cases, the drug is well tolerated by the body; side effects from Turerculin are extremely rare. But even if a person develops any complication, it almost always occurs within the first day after vaccination.

• discomfort and pain at the injection site;
• increased body temperature;
• lymphadenitis;
• headache;
• allergy.

If a side effect occurs, do not panic. Doctors say that this reaction usually goes away on its own within a few hours. But if the discomfort does not go away, and the condition worsens, you need to consult a doctor. If a child suffers from side effects (especially if the baby has a fever), you should visit a doctor immediately.

The instructions for use of Tuberculin state: the most important point is the correct interpretation of the data obtained. As practice shows, inexperienced doctors often violate the advice described in the instructions, as a result of which the body gives the wrong reaction. The manufacturer assures that before taking active steps, you must carefully read and study the manual, only in this case can you count on reliable results.

1. An overdose of this medication has not been identified. None of the patients also ever experienced symptoms of increased drug concentrations.
2. To get an accurate result, the drug must be administered in its pure form, without mixing it with other medicinal substances. This criterion is one of the most important.

Doctors assure that it is impossible to get an overdose of Tuberculin, since the drug goes through multiple stages of purification and is essentially completely safe. A completely different reaction may occur if the medication is mixed with third-party substances; in this case, it is impossible to predict the body’s reaction. The consequences of such actions will also be unpredictable.

Tuberculin does not interact with other drugs, so vaccination can be carried out even if a person is being treated with third-party medications.

Both the injection solution and the dry powder are always used in the same way; the drug is administered exclusively subcutaneously.

• Vaccination must be carried out in a sitting position, since emotional and mentally ill citizens may faint during vaccination;
• To prevent infection and ensure maximum comfort during injection, it is recommended to use one-gram tuberculin syringes intended for single use. The syringe should have short and thin needles;
• To perform a Mantoux test, it is prohibited to use insulin syringes and needles that have expired;
• before unpacking, the ampoule with the substance will need to be wiped with gauze soaked in 70% ethyl alcohol, then carefully file its neck and break it;
• You need to draw 0.2 ml of tuberculin into the syringe and inject it to the 0.1 ml mark into a sterile cotton swab;
• after opening, the ampoule can be stored for no more than 2 hours (only under completely aseptic conditions).

Once everything is ready, the doctor will need to clean the surface of the hand with alcohol and wipe off the excess with a cotton swab. Next, the needle is carefully inserted into the surface layers of the skin, strictly parallel. A person is given 1 dose of the drug, after which the syringe is removed. Immediately after the injection, a white protruding papule with a diameter of up to 10 mm is formed on the skin. To obtain reliable information, only a nurse who has undergone special training should perform the Mantoux test.

The results of the tuberculin vaccination should be assessed by a doctor or registered nurse. It must be remembered that you should see the result only 72 hours after vaccination. To accurately determine the size of the papules, it is recommended to use a transparent plastic ruler with millimeter divisions. The test results must be noted on a special medical form.

• negative. It is diagnosed in the complete absence of a papule or if only an injection mark is observed on the surface. The diameter of the neoplasm should be within 0-1 mm;
• doubtful. A similar reaction is recorded if the size of the infiltrate varies from 2 to 4 mm. Similar data will also be indicated only for hyperemia (regardless of size) without infiltration;
• hyperergic. This diagnosis is made in children and adolescents if the size of the infiltrate reaches 15 mm or more. In adults - more than 21 mm.

It is impossible to predict exactly what the effect of tuberculin will be, since everything depends on the individual characteristics of the organism. Doctors also note that citizens with hypersensitivity (delayed action) to this drug may experience specific reactions. After the injection, some patients complain of severe headaches, general weakness and increased body temperature.

Patients with a questionable or positive reaction to the vaccine and babies with a negative reaction, but not subject to BCG vaccination, can be vaccinated only after a complete and detailed interpretation of the Mantoux result.

Terms of sale, storage conditions and expiration date

Despite the fact that the medicine belongs to the category of diagnostic agents and is not considered a medicine, according to the RLS (medicine register), it must be stored in appropriate conditions.

This product is not publicly available and can only be purchased with a doctor's prescription. In most cases, the drug is supplied directly to clinics.

1. It is better to keep the box with ampoules in a dark room at a temperature of 2 to 8 degrees Celsius. A refrigerator is also suitable as a storage place.
2. The drug should not be used after the expiration date. For Tuberculin it is exactly one year. If the vaccination is carried out with an expired drug, the body’s reaction will be incorrect. In addition, the possibility of side effects cannot be ruled out.
3. After opening the ampoule, the product remains suitable for no more than 2 hours; after this time, the unused solution must be disposed of.

It is important to remember that if you store medicine in an inappropriate environment (for example, at a temperature of more than 20 degrees), it will also become unusable and you will no longer be able to use it.

Tuberculin can rightfully be considered a unique remedy, since the drug has no analogues. This specificity is also due to the fact that Tuberculin is not a vaccine, but is merely a diagnostic tool. It is also surprising that today the animal world is also subject to a similar test; very often, a test for tuberculosis is carried out on cattle, which subsequently helps to prevent the spread of infection.

1. General blood and urine analysis.
2. Radiography.
3. PCR studies carried out after removing sputum from the stomach.

Such diagnostics are less common; usually they are used only if a standard test is carried out.

According to social surveys, the majority of parents have a positive attitude towards diagnosing tuberculosis in this way. This is due to the fact that the Mantoux test has been performed for many years; side effects are detected in the rarest cases. Of course, there is a certain percentage of parents who prevent such vaccination, but usually the reluctance to carry out diagnostics is explained by the presence of contraindications or chronic diseases in the child. Even though it is possible to avoid such diagnostics, most experts recommend diagnostic testing because it is very effective and helps to identify predisposition to tuberculosis.

• how the body reacts to this or that type of treatment;
• at what speed do mycobacteria spread and in what stage they are (dormant or active).

This substance was used to diagnose tuberculosis several decades ago, and today it also remains in demand. Experimental synthetic analogues also proved ineffective

Price, where to buy

The drug can be purchased exclusively in pharmacies; pharmacists do not dispense it without a prescription. The price of the product differs in large cities and small towns, and the cost may also vary from manufacturer to manufacturer and from a specific pharmacy. In Russia, the approximate cost of a package of Tuberculin with 10 ampoules ranges from 650 to 800 rubles. It is important to remember that diagnostics can only be carried out using a high-quality drug.

1. The medicine is not sold in online stores; it is supplied exclusively to pharmacies and hospitals.
2. Tuberculin cannot be purchased without a prescription, so the first step is to get it.

Since large groups of people are being diagnosed at once, the drug is often purchased in bulk rather than in one package.

Today, Tuberculin is the best and most accurate means of diagnosing tuberculosis. Numerous years of use and the lack of analogues confirm this fact. If a person has no contraindications to the Mantoux test, and after the injection he follows all medical recommendations, the risk of complications will be minimized, and the interpretation of the results will be reliable.

But, despite the fact that the drug is very well absorbed in most cases, if side effects occur, doctors advise immediately contacting the clinic and having tests done.

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• Congratulations! The likelihood that you will develop tuberculosis is close to zero.

  But don’t forget to also take care of your body and undergo regular medical examinations and you won’t be afraid of any disease!
  We also recommend that you read the article on.

• There is reason to think.

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

• Contact a specialist urgently!

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

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   Does your lifestyle involve heavy physical activity?

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

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   Do you take care of your immunity?

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   Have any of your relatives or family members had tuberculosis?

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   How old are you?

, diagnostic drugs used to detect an allergic reaction in individuals infected with tuberculosis bacteria. First obtained by R. Koch. In the USSR they produce: liquid tuberculin, or Koch's alttuberculin (ATK), - obtained by evaporating the liquid medium on which tuberculosis bacteria were grown; dry purified tuberculin (PPD) - by adding protein-precipitating chemicals to the bacterial filtrate, followed by purification; liquid purified tuberculin (PPD-L) - by standard dilutions of dry purified tuberculin. Used for (reaction, Pirquet reaction), through which individuals are identified who are subject to vaccination against tuberculosis, as a method of early diagnosis and assessment of the course of the tuberculosis process. For mass examinations in the USSR, only intradermal is used.

In veterinary medicine, tuberculin is used for allergic diagnosis of tuberculosis. The drug is administered subcutaneously (rarely changed), intradermally and into the conjunctival sac. Animals that react positively (inflammatory edema with intradermal injection and purulent conjunctivitis with an eye test) are considered to have tuberculosis.
Great Soviet Encyclopedia

Tuberculin in its classic form was invented in 1890 by the famous German doctor Robert Koch, who also discovered the causative agent of tuberculosis - mycobacterium, named Koch's bacillus in his honor. At first, tuberculin was a decay product of Mycobacterium tuberculosis, which was deprived of activity by heating, and it contained many impurities: remnants of the nutrient medium on which the bacteria were grown, salts and other substances that affected the purity of the reaction and made it difficult to evaluate the result of the samples.
Since the late 60s of the 20th century, purer tuberculin preparations have been developed, devoid of impurities, containing the protein component of the tuberculosis bacillus, the so-called PPD (Purified Protein Derivate). In all republics of the former Soviet Union, the drug PPD-L-tuberculin, purified from protein fractions of the nutrient medium, obtained by the Russian scientist M.A. Linnikova in 1965, is still used to this day.

A modern tuberculin preparation for mass tuberculin diagnostics is a purified tuberculosis allergen and in a standard dilution contains 2 TU (tuberculin units) in 0.1 ml. It is a mixture of filtrates of tuberculosis cultures (human and bovine), which are killed by heat, precipitated with trichloroacetic acid, treated with ethyl alcohol and anesthetic ether, dissolved in a phosphate buffer solution (plays the role of a stabilizer) and phenol (plays the role of a preservative).

The active principle of tuberculin is the allergen tuberculoprotein, which, when administered intradermally in infected or vaccinated patients, causes a specific delayed-type hypersensitivity reaction, which manifests itself as a local reaction - hyperemia and infiltrates (papules).

Indications for the use of tuberculin

Tuberculin is intended for mass tuberculin diagnostics of the population in order to:
select a contingent for revaccination, and also before the first vaccination of children aged 2 months and older;
diagnose, including to identify early and local forms of tuberculosis in young children and adolescents;
determine infection with Mycobacterium tuberculosis.

Contraindications to the use of tuberculin

According to the instructions for Tuberculin, vaccination with the drug cannot be carried out for: common skin diseases, epilepsy, acute, chronic infectious and somatic diseases during exacerbation, allergic conditions (rheumatism in the acute and subacute phase, bronchial asthma, idiosyncrasy, which has pronounced skin manifestations during exacerbations). The test can be performed a month after all clinical symptoms disappear or immediately after quarantine has been lifted. It cannot be carried out in children's institutions where there is a quarantine period for childhood infections. Preventive vaccinations have the ability to influence hypersensitivity to tuberculin. In this regard, tuberculin diagnostics should be planned before preventive vaccinations against various infections are carried out. In the case of preventive vaccination, tuberculin diagnostics should be carried out no earlier than a month after it. To identify contraindications, a doctor or nurse, on the day when the tuberculin test is performed, conducts an examination and interview of the persons undergoing the test.

Side effects of Tuberculin

The reaction to the administered Tuberculin is directly dependent on the level of specific reactivity at which the given organism is located.
According to reviews of Tuberculin, in some patients who have a high degree of delayed-type hypersensitivity to tuberculin, local reactions can occur together with lymphadenitis and lymphangitis. Also, sometimes a general reaction is observed in the form of general malaise, headaches, and fever. Healthy individuals who have a test reaction

Table of Contents

FS.3.3.1.0023.15 Purified tuberculin (PPD) (purified tuberculosis allergen)

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

PHARMACOPOEIAL ARTICLE

Purified tuberculin (PPD) FS.3.3.1.0023.15

(purified tuberculosis allergen) Instead of GF X, Art. 705,

FS 42-3302-96,

FS 42-3303-96

This pharmacopoeial monograph applies to purified tuberculin (purified tuberculosis allergen), which is a purified tuberculoprotein PPD (PPD - purified protein derivative), obtained from heat-inactivated filtrates of human and bovine Mycobacterium tuberculosis (MBT) cultures, purified from bacterial cells by ultrafiltration or another adequate method, followed by precipitation with trichloroacetic acid (TCA). Intradermal administration of tuberculin (Mantoux test) reveals the presence of delayed-type hypersensitivity, which is a consequence of sensitization of the body during BCG vaccination or infection with Mycobacterium tuberculosis. The drug is intended for the diagnosis of tuberculosis, determination of infection of the population with Mycobacterium tuberculosis and selection of populations for vaccination and revaccination against tuberculosis.

PRODUCTION

Work with mycobacteria should be carried out in rooms equipped with autonomous supply and exhaust ventilation, isolated from rooms where the presence of mycobacteria is not allowed. Before inoculating mycobacteria, culture media must be tested for sterility. Mycobacterial cultures grown on the surface of a liquid synthetic medium in the form of folded films are inactivated by autoclaving at a temperature of 121 °C for at least 30 minutes or with flowing steam at a temperature of 100 °C for 1 hour, filtered and concentrated by ultrafiltration.

Tuberculoprotein precipitation is carried out with a 50% TCA solution; the sediment is washed with decreasing concentrations of TCA, treated with alcohol and ether, dried, and checked for sterility and authenticity. After receiving positive results, they are combined into a single series of semi-finished powder (substance). The subsequent consolidation of such series into a single series of the substance is one of the methods for obtaining a standard drug with a long shelf life (20 years or more). The substance is used for the production of purified tuberculin in a standard dilution (2 TU in 0.1 ml), intended for mass tuberculin diagnostics, or purified tuberculin, lyophilisate, intended for individual tuberculin diagnostics (50,000 TU in an ampoule).

Previously, a series of substances is tested for sterility, lack of sensitizing properties, specific safety (absence of living mycobacterium tuberculosis), specific activity - determination of a weighed dose containing 50,000 TU. The specific activity of tuberculins is expressed in tuberculin units (TU), equivalent to international tuberculin units (TU).

The container with the mixture of powders (substance) is stored in a desiccator in a dark, dry place. Every 5 years, the substance is subject to re-testing for sterility and specific activity in animals (dose-weight confirmation).

SUBSTANCE TESTS

Sterility

The substance must be sterile. The substance is dissolved in 0.9% sodium chloride solution at the rate of 1 mg per 1 ml. The determination is carried out in accordance with.

Protein content

Must be at least 75%. The determination is carried out using the colorimetric method in accordance with the General Pharmacopoeia Monograph “Determination of total nitrogen with Nessler’s reagent in immunobiological medicinal products.”

Specific activity

Establishing a weighed dose of a PPD substance containing 50,000 TU. The determination is carried out on 18 sensitized guinea pigs by comparing the activity of dilutions of weighed powder (substance) with the activity of a standard sample (RM) of PPD (RM of the specific biological activity of purified tuberculin). Animals are sensitized by intradermal injection into the abdominal area (in 2–4 places) of the BCG vaccine or heat-killed tuberculosis mycobacteria in incomplete Freund’s adjuvant (0.5–1 mg of mycobacteria per 1 animal).

Three weighed portions of the test substance PPD, weighing at least 50 mg each, are dissolved in a phosphate buffer solution, pH (7.4 ± 0.05) so that 1 ml of the substance PPD contains 20% lower and higher than the dose of the weighed portion of CO PPD ( get 3 basic solutions). The specific activity of the stock solution is compared with CO PPD by testing on 6 sensitized guinea pigs. To do this, dilutions of 1:40 are prepared from the main solution; 1:200 and 1:1000 and titrated against 5; 25 and 125 TE CO, injecting 0.1 ml of each dilution intradermally into sensitized guinea pigs in a group using a random sampling method (for example, the Latin square method). Responses are taken into account after 24 hours. Statistical analysis is based on the fact that the log dose-effect relationship is linear. The average slope of the lines is calculated and the logarithm of relative activity (log R) is calculated - the distance between parallel lines of the dose-effect relationship. Relative activity (R) should be equal to (1.0 ± 0.2) with confidence limits ranging from 75 to 130% ( R= 0.95). The confidence limits are taken to be ± 2 standard errors of the logarithm of the relative activity. If a larger test portion has a smaller value compared to the RM PPD, the portions should be increased and titration should be performed. If reactions to a smaller portion are of a larger magnitude compared to CO PPD, then titration should be carried out using reduced portions of the powder of the substance being tested.

Specific harmlessness

The absence of live Mycobacterium tuberculosis is determined on guinea pigs kept in conditions that exclude their contamination with live Mycobacterium tuberculosis. A solution of a substance containing 50,000 TE/ml in phosphate buffer without a preservative and stabilizer in a volume of 10 ml is centrifuged at 3000 rpm for 30 minutes. The top layer of the supernatant liquid (about 8 ml) is removed, the sediment is resuspended and 1 ml is injected intraperitoneally into 2 guinea pigs weighing 250 - 300 g, which are observed for 42 days. Animals must remain healthy. After 42 days, guinea pigs are opened and macroscopic, histological and bacteriological examination of internal organs (spleen, lungs, liver and lymph nodes) is carried out. Macroscopic and microscopic examination should not reveal pathological signs characteristic of tuberculosis infection. For bacteriological (cultural) research, the lymph nodes (all together), the spleen, ¼ of the liver and one lung are carefully homogenized. Homogenizates are treated for 10 minutes with a 5% sulfuric acid solution, centrifuged at 3000 rpm for 15 minutes, resuspended in a 0.9% sodium chloride solution and inoculated on Lowenstein-Jensen egg medium (at least 5 tubes for each organ). The crops are kept for 45 days at a temperature of 37 °C. There should be no growth of mycobacterial colonies on the surface of the medium.

Sensitizing properties

Must be missing. Guinea pigs (3 individuals) weighing 300 - 350 g are injected intradermally three times with an interval of 5 days, 125 TU in 0.1 ml of dilution of the substance. After 15 days, these and 3 intact guinea pigs are injected intradermally with 500 TU in 0.1 ml of the test substance. Dilutions of 125 and 500 TE are prepared from the main solution of the substance using 0.9% sodium chloride solution. The response is taken into account after 24 hours, measuring 2 mutually perpendicular diameters of the erythema. The reactions in the first 3 guinea pigs should not differ from the reactions in control animals ( p> 05). Animals are kept in conditions that exclude contamination with mycobacteria.

TUBERCULIN TEST

Description

Purified tuberculin in standard dilution is a colorless transparent liquid without foreign inclusions. Purified tuberculin (lyophilisate) is a porous mass or amorphous powder of grayish-white or cream color, which is diluted in 1 ml of the supplied solvent for testing.

Authenticity

Causes when administered intradermally to guinea pigs sensitized with the BCG vaccine, a 12-16 day BCG culture, or killed Mycobacterium tuberculosis, positive reactions (as described in the section “Specific activity”).

Transparency

Must be transparent. The determination is carried out visually in accordance with.

Chroma

Should be colorless. The determination is carried out visually in accordance with.

pH

From 7.35 to 7.45. The determination is carried out by the potentiometric method in accordance with the General Pharmacopoeia Monograph “Ionometry”.

Sterility

Must be sterile. Determination is carried out in accordance with the method of direct seeding or membrane filtration.

Abnormal toxicity b

Must be non-toxic. The determination is carried out in accordance with. A test dose in a volume of 0.5 ml is administered intraperitoneally to 5 white mice weighing 17 - 20 g; subcutaneously to 2 guinea pigs weighing 250–300 g, test dose in a volume of 1 ml. The observation period for animals is 7 days.

Specific activity

The index of specific activity (I) of purified tuberculin in standard dilution (the ratio of the sum of reactions to the test drug to the sum of reactions to CO PPD should be in the range from 0.95 to 1.05 in the absence of significant differences between the average reactions to the standard and test samples. Test carried out on 6 guinea pigs, white-skinned or albino, weighing (350 ± 50) g, sensitized as described above, to determine the dose-weight of the substance.On each side, 4 samples are placed (in separate syringes) with 2 TE in 0.1 ml test series and 2 TE SO PPD, alternating 8 syringes with drugs pre-coded using the random sampling method. Reactions are recorded after 24 hours.

The relative activity (R) of purified tuberculin, lyophilisate, should be equal to (1.0 ± 0.2) with confidence limits ranging from 75 to 130% ( R= 0.95). From the main dilution of the test series, containing 50,000 TE in 1 ml (1 ml of the supplied solvent is added to the ampoule), 3 dilutions are prepared: 5; 25 and 125 TE in 0.1 ml, using 0.9% sodium chloride solution for this purpose. The determination is carried out according to the section “Specific activity - determination of the dose of a weighed substance”, using 5; 25 and 125 TE in 0.1 ml CO PPD.

If the test result is outside the acceptable limits, the test is repeated. The results of the first and repeated tests are averaged.

Production strains

Tuberculinogenic strains of Mycobacterium tuberculosis are used for preparation. M. tuberculosis Dt/Strain, and/or T-3480 and M. bovis “Vallee” from the State Collection of the PBA. Use no more than 2 passages on a solid nutrient medium for growing mycobacteria, no more than 2 passages on a liquid potato medium and no more than 8 passages on a synthetic Linnikova-Mogilevsky medium.

How can you maintain your physical health at the proper level in today’s difficult conditions? After all, absolutely everyone wants to feel good and not allow illnesses to disrupt the usual course of life. To achieve this, children are vaccinated from an early age against a variety of diseases in the hope that this will prevent infection in the future or, at least, make it easier. In this article we will not discuss the effectiveness of this kind, but we will pay attention to the means that help diagnose dangerous infectious diseases in the early stages. Detection of diseases at such stages helps to avoid risk to life and ensure full recovery. One of these drugs is Tuberculin. What's this? How should the product in question be used? Is its use dangerous for children and teenagers? In what cases should you stop using the medication in question? All these nuances will be discussed in this article.

The drug "Tuberculin": composition

At its core, the drug in question is a mix of filtrates of certain mycobacterium tuberculosis, which were killed using high temperatures and precipitated. These organisms are carefully treated with ethyl alcohol and ether, which is intended for anesthesia, and then dissolved in a special solution. The latter is a mixture of Tween-80 (an effective stabilizer) and phenol (a quality preservative). Homeopathy also uses "Tuberculin". However, before proceeding to this type of treatment, it is necessary to consult with your doctor.

Release form

The drug "Tuberculin" is available in the form of an injection solution. This ensures the fastest possible action of the product.

Package

The Tuberculin vaccine can be produced exclusively in ampoules of one tenth of a milliliter (or two tuberculin units), one milliliter (ten doses), two milliliters (twenty doses) or three milliliters (thirty doses). Each package contains ten individual ampoules.

Indications for use

In what cases is purified “Tuberculin” used? It is usually used for tuberculin diagnostics (for a large number of the population). This is done in order to:

• select groups of patients who require repeated BCG vaccination;
• prepare two-month-old children for primary vaccination;
• to identify the presence of infection with Mycobacterium tuberculosis;
• to identify initial (or local) forms of tuberculosis in minors.

Mode of application

For people, the instructions for use recommend that the drug "Tuberculin" be administered exclusively intradermally for the purpose of performing the Mantoux test. The injection should only be given if the patient is sitting, as it sometimes causes fainting in emotionally labile individuals. To administer the “Tuberculin” product, the instructions strongly recommend using only specialized syringes (one-gram). They are disposable with short thin needles. Insulin syringes or materials that have already expired are not suitable for administering the drug.

The bottle with the medication must be carefully wiped with gauze, which is thoroughly soaked in seventy-degree ethyl alcohol. After this, use a clean knife designed for opening glass ampoules to file down the neck of the ampoule and then break it off. Using a syringe, the medicine is removed from the vial, taking two doses of the vaccine (that is, two tenths of a milliliter). After this, you need to insert a thin needle and release half of the collected amount of liquid into a sterile cotton swab. An opened ampoule must not be stored for more than two hours.

Before making the injection, it is important to wipe the required area of ​​skin with seventy-degree ethyl alcohol, and then dry it thoroughly using sterile cotton wool. The needle should be carefully inserted parallel to the surface of the skin. One dose is administered strictly according to the divisions of the syringe, which is two tuberculin units (or one tenth of a milliliter).

There is another group of patients who need the administration of the drug "Tuberculin" - cattle (cattle). Animals need to be injected with 0.2 cubic centimeters intradermally or 0.1 cubic centimeter of the drug palpebrally.

How are the results taken into account?

How should the diagnostic results using the drug "Tuberculin" be analyzed? The instructions strongly recommend that you contact specialists for this, since only a competent medical professional can do this in the correct way. The results must be assessed seventy-two hours after the injection by measuring the papule, the size of which is taken into account in millimeters (formed immediately after the administration of the Tuberculin drug). This action is carried out with a ruler specially designed for this purpose.

When you can focus on the following classification. The reaction is considered negative if a papule has not formed at all; doubtful - if there is an infiltrate, the size of which ranges from two to four millimeters. If the papule is larger than six millimeters in size, then the result is considered positive, and if it exceeds seventeen millimeters in a child or teenager and twenty-one millimeters in an adult, it is hyperergic.

Reaction to substance administration

This indicator directly depends only on how the body is individually able to react to a given stimulus. Sometimes, in patients with hypersensitivity to the substance in question, unpleasant reactions such as lymphadenitis or lymphangitis may occur. Other adverse reactions are headache, general malaise, and a significant increase in temperature.

For some patients (for example, children with a negative reaction to tuberculin who cannot undergo BCG, and healthy adults whose reaction is positive or doubtful), any preventive vaccinations can be carried out only after a competent assessment of the results of the Mantoux test.

"Tuberculin" is the most important part of diagnosis.

Contraindications

However, not everyone can easily use the vaccine in question. So, there are certain restrictions on taking the drug "Tuberculin". Instructions for use prohibit the use of the drug in the following cases: in the presence of epilepsy, bronchial asthma, skin diseases, idiosyncrasy, acute rheumatism, chronic or acute infectious or somatic diseases (especially in moments of exacerbation).

And only one month after all the symptoms of the above conditions disappear, the Mantoux test can be performed. Or it should be done after the official lifting of quarantine.

It is prohibited to administer Manta to children if their team is quarantined for any infectious diseases.

Any preventive vaccinations affect the effectiveness of Tuberculin. Diagnosis using this drug should be made either before this type of vaccination, or a month later.

Before performing the procedure, the specialist must examine patients and interview them to identify contraindications. This will help avoid many unpleasant consequences.

Bottom line

With the help of the above material it will be easier to understand the following questions. "Tuberculin" - what is it? How should it be used? In what cases would it be reasonable to avoid using the remedy in question? How to properly carry out this type of injection? This information will become indispensable for those for whom the use of the drug "Tuberculin" is indicated. It is important to carefully follow all the recommendations that specialists provide to their patients so as not to harm yourself or your child. Also, this kind of manipulation should be carried out exclusively by trained, competent medical professionals. Compliance with all these points will ensure the success of this procedure.

Among other things, it is important to remember general recommendations for the use of vaccines. For example, vaccinating a child or adult whose body is currently weakened by some kind of infection or who has recently suffered a similar disease can lead to harmful consequences (the body's reaction to such an injection can become extremely severe and require medical attention). If any side effects occur, it is important to contact a specialist immediately.

Choose quality treatments for yourself and your family. Diagnostics using the drug “Tuberculin” discussed today can become part of such an effective therapy that will help maintain good physical condition. Don't neglect yourself and be healthy!

Almost everyone is familiar with tuberculin. Almost every one of us was given a “button” at least once in kindergarten or school. This drug has saved more than one human life from a deadly disease called tuberculosis. Let's see how effective and safe it is. We will also learn the principle of action and what analogues of tuberculin diagnostics are available, including Diaskintest.

To better understand what Tuberculin is, let's delve a little into the history of its creation. It all started with the fact that in 1882 the world learned about the existence of the tuberculosis bacillus, which is the causative agent of a serious disease. This happened thanks to the German microbiologist Robert Koch. In honor of him, the bacterium was named “Koch’s bacillus.” After 8 years of various tests, in 1890 he invented Tuberculin, with which he planned to fight the disease. In reality, everything turned out not quite as planned. The medicine turned out to be not only harmless, but also completely ineffective.
Fortunately, Austrian pediatrician Clemens Pirke became interested in the drug. After numerous studies and observations, he noticed that the reaction of healthy people differs from that of sick people. In 1907, he officially announced that it was a kind of catalyst and could be used as a diagnostic tool.

Many have heard of the Pirquet test, named after the above-mentioned Austrian. It was done subcutaneously, that is, a drop of the substance was rubbed through a small scratch on the skin. The familiar method of administration was already proposed by the French physician Charles Mantoux. Observing patients, he came to the conclusion that subcutaneous administration gives a more accurate result. This method was quickly adopted throughout the world as more convenient and less painful. This is how the Mantoux test of the same name appeared in 1908. Over time, an analogue of Diaskintest was invented with greater accuracy in determining the viral bacterium in the body.

Composition and release form

The main composition of tuberculin is a filtrate of non-living, human and bovine tuberculosis microbacteria, which are preliminarily killed by heating. Only the products of their vital activity remain. They are then purified by ultrafiltration or other means and precipitated with trichloroacetic acid. Then they are treated with ethyl alcohol and ether, which is used for anesthesia, and dissolved in a stabilizing phosphate-buffered liquid. Finally, phenol is added as a preservative. Thus, the main active substance is obtained - the allergen-tuberculoprotein. It causes a reaction in the presence of a live virus in the body after administration of Tuberculin or an analogue such as Diaskintest.

The drug is a clear solution for injection and is packaged in glass ampoules of 0.6 ml, 1 ml or 3 ml.

Indications for use

The drug is neither a vaccine nor a cure. It does not heal or protect. Its purpose is to identify a dangerous disease at an early stage, long before visible symptoms appear.

An annual tuberculin test is carried out:

• children from 2 months before BCG placement;
• before revaccination;
• for early diagnosis of tuberculosis.

Twice a year:

• in contact with patients;
• in the absence of vaccination against tuberculosis;
• in the presence of diseases that reduce immunity: diabetes mellitus, HIV, blood diseases, with corticosteroid therapy for more than 1 month, peptic ulcers, oncological pathologies, etc.;
• children from social risk groups.

And also when symptoms characteristic of tuberculosis appear, in order to refute or confirm infection. This is done regardless of the timing and results of the previous test.

How does tuberculin work?

The basis of the drug is non-living tuberculosis mycobacteria. Their viability is so weak that they are simply unable to provoke infection. When it gets under the skin, the solution does not immediately dissolve, but remains in one place for some time. Lymphocytes that are located nearby in the blood vessels immediately react to it. This causes redness and induration, which is called a papule or infiltrate. If there are tuberculous mycobacteria in the body, it means that the lymphocytes have already managed to “get to know” it. Their number increases and they begin to work more actively. When new elements of a familiar virus appear, they rush towards them and begin to attack. Since all the provocative particles are concentrated in the papule, the reaction occurs precisely there. This significantly increases its size. In a word, an allergy to Tuberculin occurs.

Tryout calendar

Tuberculin and its analog Diaskintest are intended for early diagnosis of the presence of tubercle bacilli in children. The first test is performed no earlier than the child turns 12 months old. Before this age, the immune system has its own characteristics that greatly distort the result. The exception is babies older than 2 months, who for some reason could not be given. In this case, they must first be checked for the presence of a pathogen in the body, and only if the reaction is negative, they are vaccinated. This is done in order to avoid the introduction of an additional dose of pathogens, which can greatly aggravate the situation.
Further diagnosis using Tuberculin is carried out once a year until 15-16 years of age. For those children who live in an area with an unfavorable situation for tuberculosis, or have infected people in the family or immediate environment, the drug is administered twice a year, that is, every 6 months, until the threat of infection passes. If a child has tuberculosis, tuberculin diagnostics are carried out 3-4 times a year until the symptoms disappear completely. A similar scheme applies to Diaskintest.

According to the instructions for use of Tuberculin, the correct administration is carried out as follows: the forearm is visually divided into three parts and the required dose is injected strictly subcutaneously into the center of the middle part. In this case, a watery tubercle is immediately formed, which is popularly called a “button”. After 48-72 hours, the reaction is checked using a stationery ruler and, depending on the size, conclusions are drawn about the presence or absence of a tuberculosis bacillus.

As a rule, the size of the papule is measured using a transparent ruler. Through it, the edges of the seal are more clearly visible.

There are three main types of reactions to this drug:

• negative, in which the size of the papule is up to 1 mm or completely absent;
• doubtful – from 2 to 4 mm;
• positive – over 5 mm.

A positive reaction to Tuberculin, in turn, is divided into:

• weakly positive (5-9 mm);
• medium (10-14 mm), which manifests itself in children at risk and in contact with patients with open tuberculosis;
• pronounced (15-16 mm);
• pronounced or hyperergic (from 17 mm);
• visiculonecrotic, in which tissue necrosis and the formation of pustules are observed.

In addition, there is a false positive reaction. It is considered dubious and can occur if the child is allergic to something. It is also caused by any recent infectious disease. In these cases, monitoring the child’s condition is recommended, and drugs are often prescribed to enhance immunity.

In some cases, especially in a child prone to allergies, general malaise, lymphadenitis and lymphangitis, itching and pain at the injection site, headache, and fever may appear. In case of hypersensitivity to the drug, blisters and necrosis of adjacent tissues, as well as anaphylactic shock, may appear.

How to care for your sample

Until the measurements are taken, the injection site should not be scratched, smeared with cream or rubbed with a washcloth while bathing. You can wet the sample, but try to take a shower these days. At the same time, it does not need to be sealed with adhesive tape or wrapped with film, as our mothers and grandmothers used to do. Water will not affect the result in any way. This prejudice remained after Pirquet, when Tuberculin was rubbed into a scratch on the skin. Now the injection site for this drug or its analog Diaskintest is closed with a kind of plug made from a coagulated drop of blood. The only thing that is not recommended is to take a bath and, if possible, refrain from swimming in open water and visiting the pool.

Contraindications

The procedure is not performed in the following cases:

• infectious quarantine in a child care facility;
• manifestation of allergies;
• exacerbation of chronic or somatic diseases, as well as 30 days after the disappearance of symptoms;
• epilepsy;
• individual intolerance to the drug;
• skin diseases;
• bronchial asthma;

The test is coordinated with, since at least 30 days must pass after the administration of the prophylactic injection. Before administering Tuberculin or its analog Diaskintest, it is advisable not to consume new products in order to exclude the possibility of an allergic reaction and, accordingly, distorted results. For the same reason, a couple of days before the procedure, try not to give your child those foods that can obviously have a negative effect. This especially applies to children with allergies.

Alternative to Tuberculin

One of the more informative analogues of Tuberculin is Diaskintest, which has already been mentioned more than once above. It is also administered subcutaneously and is the same colorless liquid. It contains artificially created proteins ESAT6/CFP10. They are the ones who react to the presence of Koch’s bacillus in the body, detect the virus with an accuracy of 90% and almost completely eliminate a false positive reaction.

Diaskintest is used to diagnose the disease in all age categories, starting from 1 year.

A screen test with its help is carried out as an analogue of Tuberculin if there is individual intolerance, as well as in the following cases:

• if the patient is at risk;
• with a positive reaction to a Mantoux test to confirm or deny the presence of the virus;
• to monitor and adjust treatment for tuberculosis;
• through direct contact with a carrier of the virus.

Diaskintest is not used to select patients for primary BCG or revaccination. It is administered to pregnant women with caution, only for medical reasons, and is completely permitted during lactation. Other contraindications are the same factors as for Tuberculin.

In addition to Diaskintest, a high-precision analogue of a test for diagnosing tuberculosis is a polymer chain reaction, which makes it possible to detect mycobacteria in any biological material. This method is not widely used due to its high cost and technical complexity. Another analogue is an enzyme immunoassay, which examines venous blood. This method is ineffective in areas where tuberculosis infection is widespread.

Video

The earlier the disease is detected, the easier it is to treat. This also applies to such a dangerous and deadly disease as tuberculosis. Thanks to tuberculin diagnostics and Diaskintest, it became possible to detect it at the earliest stages and begin treatment. Watch the video to see how the diagnostic drug works and why it is so important not to abandon this procedure.

Are you familiar with Tuberculin or its analog Diaskintest first-hand? Then we are waiting for your comments, from which our visitors will be able to gain a lot of useful information.