Diaskintest - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Diaskintest

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Diaskintest is a tool used to diagnose tuberculosis.

Release form and composition

Diaskintest is produced in the form of a transparent colorless solution for intradermal administration [3 ml (30 doses) in glass vials, 1 or 5 vials in a blister strip, in a cardboard box 1 package with 1 vial, 1 or 2 packaging 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 setting an intradermal test in people of all ages. Indications for use are:

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

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

To diagnose (identify) tuberculosis infection, the sample is carried out for the following categories of persons:

• sent to a phthisiatrician based on the results of mass tuberculin diagnostics;
• those belonging to groups at high risk of 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 differential diagnosis of tuberculosis and other diseases, the test is carried out in an anti-tuberculosis institution in combination with X-ray and clinical laboratory examinations.

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

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

Contraindications

• allergic conditions;
• common skin diseases;
• any diseases (including somatic ones) during an exacerbation;
• acute infectious diseases and exacerbation of chronic diseases, with the exception of cases of suspected tuberculosis.

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

Method of administration and dosage

The Diaskintest test is carried out for children, adolescents and adults as prescribed by a doctor. Only a specially trained nurse who is approved for intradermal testing is allowed to inject.

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 issue and the expiration date.

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

The drug is administered in a sitting position. The injection site is the inner surface of the middle third of the right or left forearm. Before the introduction, 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 sample is taken, a whitish papule resembling a "lemon peel" is usually formed in the skin, measuring 7-10 ml in diameter.

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

Accounting for results

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

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 a papule, regardless of its size.

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

• poorly expressed: the size of the infiltrate is 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 is from 15 mm, the presence of vesicular-necrotic changes and / or lymphangitis, the presence of lymphadenitis, regardless of the size of the infiltrate.

Persons with a dubious and positive reaction are referred 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 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;
• recovered from tuberculosis;
• patients with tuberculosis in the period of completion of the involution of tuberculous changes in the absence of laboratory, X-ray tomographic, instrumental and clinical signs of the process activity.

In addition, the sample may be negative:

• in patients with tuberculosis with severe immunopathological disorders due to the severe course of the tuberculous 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 performed the test notes:

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

Side effects

Diaskintest is generally well tolerated. Some patients have 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 the assessment and recording of the test result.

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

Drug interactions

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

Analogs

There is no information about Diaskintest analogues.

Terms and conditions of storage

Store and transport at 2–8 ° C. Avoid freezing. Keep out of the reach of children.

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

Terms of dispensing from pharmacies

Released for treatment-and-prophylactic and sanitary-preventive institutions.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!