Human leukocyte interferon 1000 IU

Diakintest is a recombinant protein produced by a genetically modified Escherichia coli BL21(DE3)/pCFP-ESAT culture. It contains 2 antigens present in virulent strains of Mycobacterium tuberculosis and absent in the BCG vaccine strain.

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

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Indications

The Diakintest is intended to be used for intradermal testing in all age groups for the purpose of:

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

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Composition

one dose (0.1 ml) of the drug contains:

the recombinant protein CFP10-ESAT6 – 0.2 µg,

sodium phosphate divalent 2-water – 0.3876 mg,

sodium chloride – 0.46 mg,

potassium phosphoric acid monosubstituted – 0.063 mg,

polysorbate 80 – 0.005 mg,

phenol – 0.25 mg,

water for injection – up to 0.1 ml.

How to take, the dosage

The test is administered by prescription to children, adolescents and adults by a specially trained nurse authorized to perform intradermal tests. The drug is administered strictly intradermally. Tuberculin syringes and thin short needles with oblique cut are used for the test. Before using, check their manufacture date and expiration date.

The bottle with the drug after opening can be stored for no more than 2 hours. The syringe draws 0.2 ml (two doses) of the drug Diakintest and releases the solution to the mark of 0.1 ml into a sterile cotton swab.

The test is performed by the subject in the sitting position. After treating an area of skin on the inner surface of the middle third of the forearm with 70% ethyl alcohol, 0.1 ml of Dyskintest drug is injected into the upper layers of the stretched skin parallel to its surface.

In case of the test, as a rule, a papule in the form of “lemon crust” 7-10 mm in diameter and whitish in color is formed in the skin.
People with a history of non-specific allergies are recommended to perform the test against the background of taking desensitizing drugs for 7 days (5 days before the test and 2 days after it).

The results of the test are evaluated by the doctor or trained nurse 72 hours after the test by measuring the transverse (relative to the axis of the forearm) size of the hyperemia and infiltrate (papule) in millimeters with a transparent ruler. Hyperemia is counted only if there is no infiltrate.

The response to the test counts:

• negative if there is no infiltrate and hyperemia or a “prick reaction” up to 2 mm;
• doubtful if there is hyperemia without an infiltrate;
• positive if there is an infiltrate (papule) of any size.

Positive reactions to DIAKINTEST conditionally differ in severity:

• weakly expressed reaction – with an infiltrate up to 5 mm in size;
• moderately expressed reaction – with an infiltrate size of 5-9 mm;
• expressed reaction – with an infiltrate size of 10-14 mm;
• hyperergic reaction – when the size of the infiltrate is 15 mm or more, with vesiculo-necrotic changes and (or) lymphangioitis, lymphadenitis regardless of the size of the infiltrate.

Persons with suspicious and positive reactions to Diascintest are examined for tuberculosis.
In contrast to delayed-type hypersensitivity reaction, cutaneous manifestations of non-specific allergy (mostly hyperemia) to the drug are usually observed immediately after the test and usually disappear 48-72 hours later.
Diakintest does not cause delayed hypersensitivity reactions associated with BCG vaccination.

There is usually no reaction to Diakintest:

• in persons not infected with Mycobacterium tuberculosis;
• in persons previously infected with Mycobacterium tuberculosis with inactive tuberculosis infection;
• in persons who have been cured of tuberculosis.

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Interaction

Healthy individuals who test negative can be given prophylactic vaccinations (except BCG) immediately after the test result has been evaluated and recorded.

The Diakintest test should be scheduled prior to preventive vaccinations. If prophylactic vaccinations have been performed, the Dyskintest test must not be performed until one month after the vaccination at the earliest.

Special Instructions

Healthy individuals with a negative test result can be given prophylactic vaccinations (except BCG) immediately after the test result has been evaluated and recorded.

Contraindications

• common skin diseases;
• allergic conditions;
• acute and chronic (during exacerbation) infectious diseases except for cases of suspected tuberculosis;
• somatic and other diseases.
• Epilepsy.

In children’s communities where there is a quarantine for childhood infections, the test is conducted only after the quarantine is lifted.

Side effects

In some individuals there may be short-term signs of a general reaction: malaise, headache, increased body temperature.