Диаскинтест®

General characteristics. Structure:

One dose (0,1 ml) of drug contains: recombinant protein CFP10-ESAT6 - 0,2 mkg, sodium phosphate disubstituted 2-water – 0,3876 mg, sodium chloride – 0,46 mg, potassium phosphate monosubstituted – 0,063 mg, polysorbate of 80 - 0,005 mg, phenol - 0,25mg, water for injections – to 0,1 ml.

Description: Colourless transparent liquid.

Pharmacological properties:

Allergen tubercular recombinant in standard cultivation represents the recombinant protein produced by genetically modified culture of Escherichia coli BL21(DE3)/pCFP-ESAT, divorced in sterile isotonic phosphatic buffered solution with preservative (phenol). Contains two antigens which are present at virulent strains of mycobacteria of tuberculosis and absent in a vaccinal strain of BTsZh.

Effect of drug is based on identification of a cellular immune response on antigens, specific to Mycobacterium tuberculosis. At intradermal introduction ДИАСКИНТЕСТ® causes in persons with a tuberculosis infection the specific skin reaction which is manifestation of hypersensitivity of the slowed-down type.

Indications to use:

It is intended for statement of an intracutaneous test in all age groups on purpose:

· diagnoses of tuberculosis, assessment of activity of process and identification of persons with high risk of development of active tuberculosis;
· differential diagnosis of tuberculosis;
· differential diagnosis of a postvaccinal and infectious allergy (hypersensitivity of the slowed-down type);
· estimates of efficiency of antitubercular treatment in a complex with other methods.

Because drug does not cause the reaction of hypersensitivity of the slowed-down type connected with vaccination of BTsZh, test with the drug DIASKINTEST® cannot be used instead of the tuberkulinovy test for selection of persons for primary immunization and a revaccination of BTsZh.

Intracutaneous test with drug apply to individual and screening diagnosis of a tuberculosis infection on doctor's orders the phthisiatrician or at his methodical providing.

For identification (diagnosis) of a tuberculosis infection test with drug is carried out:

· to the persons sent to TB facility for additional inspection on existence of tubercular process;
· to the persons belonging to groups of high risk on a disease of tuberculosis taking into account epidemiological, medical and social factors of risk;
· to the persons sent to the phthisiatrician by results of a mass tuberculinodiagnosis.

For differential diagnosis of tuberculosis and other diseases test with the drug DIASKINTEST® is carried out in a complex with clinical laboratory and radiological inspection in the conditions of TB facility.

For observation of the patients staying on the registry at the phthisiatrician with various displays of a tuberculosis infection in the conditions of TB facility the intracutaneous test with the drug DIASKINTEST® is carried out at control inspection in all groups of the dispensary account with an interval of 3-6 months.

Route of administration and doses:

Test is carried out on doctor's orders to children, teenagers and adults by specially trained nurse having the admission to carrying out intradermal tests. The drug is administered strictly vnutrikozhno. Use tuberkulinovy syringes and fine short needles with a slanting cut to conducting test. Before the use it is necessary to check date of their release and a period of validity.

The bottle with drug after opening is allowed to store no more than 2 hours. The syringe gain 0,2 ml (two doses) of the drug DIASKINTEST® and produce solution to a tag of 0,1 ml in a sterile cotton plug.

Test is carried out inspected in a sitting position. After processing of the site of skin on an internal surface of an average third of a forearm of 70% alcohol, parallel to its surface enter 0,1 ml of the drug DIASKINTEST® into upper layers of the tense skin.

At test statement, as a rule, in skin the papule in the form of "a lemon crust" 7-10 mm in size in the diameter of whitish color is formed.

Persons who in the anamnesis had displays of a nonspecific allergy are recommended to carry out test against the background of reception of the desensibilizing drugs within 7 days (5 days to statement of test and 2 days after it).

Features of use:

Accounting of results

The result of test is estimated by the doctor or the trained nurse in 72 h from the moment of her carrying out by measurement cross (after the relation to a forearm axis) the size of a hyperemia and infiltrate (papule) in millimeters a transparent ruler. The hyperemia is considered only in case of lack of infiltrate.
Response to test is considered:

· negative – at total absence of infiltrate and a hyperemia or in the presence of "ukolochny reaction" to 2 mm;
· doubtful – in the presence of a hyperemia without infiltrate;
· positive – in the presence of infiltrate (papule) of any size.

 

Positive reactions on ДИАСКИНТЕСТ® conditionally differ on degree of manifestation:

· poorly expressed reaction – in the presence of infiltrate up to 5 mm in size;
· moderately expressed reaction – at the size of infiltrate of 5-9 mm;
· the expressed reaction – at the size of infiltrate of 10-14 mm;
· giperergichesky reaction – at the size of infiltrate of 15 mm and more, at vezikulo-necrotic changes and (or) a lymphangitis, lymphadenitis irrespective of the infiltrate size.

Persons with doubtful and positive reaction on ДИАСКИНТЕСТ® are inspected on tuberculosis.

Unlike reaction of hypersensitivity of the slowed-down type, skin displays of a nonspecific allergy (generally a hyperemia) on drug are, as a rule, observed right after statement of test and in 48-72 hours usually disappear.

The drug DIASKINTEST® does not cause reaction of hypersensitivity of the slowed-down type of BTsZh connected with vaccination.

Reaction on ДИАСКИНТЕСТ® as a rule is absent:

· at the persons who are not infected with Mycobacterium tuberculosis;
· at the persons who are earlier infected with Mycobacterium tuberculosis with an inactive tuberculosis infection;
· at TB patients during completion of involution of tubercular changes in the absence of clinical, X-ray-tomographic, tool and laboratory signs of activity of process;
· at the persons who recovered from tuberculosis.

At the same time with the drug DIASKINTEST® TB patients can have a negative test with the expressed immunopathological disturbances caused by the heavy course of tubercular process, persons at early stages of infection have Mycobacterium tuberculosis, at early stages of tubercular process at the persons having the associated diseases which are followed by an immunodeficiency.

In registration documents note: a) name of drug; b) manufacturer, number of a series, period of validity; c) date of test; d) administration of drug in the left or right forearm; e) result of test.

Side effects:

At individuals short-term signs of the general reaction can be observed: indisposition, headache, fervescence.

Contraindications:

• acute and chronic (in the period of an aggravation) infectious diseases except for cases suspicious on tuberculosis;
• somatic, etc. diseases in the period of an aggravation;
• widespread skin diseases;
• allergic states;
• epilepsy.

In children's collectives where there is a quarantine on children's infections, test is carried out only after removal of a quarantine.

Storage conditions:

Period of storage - 2 years. Drug is not subject to expired use.

Conditions of transportation and storage

Drug is transported and stored according to the joint venture 3.3.2.1248-03 at a temperature from 2 °C to 8 °C. Not to freeze. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 3 ml (30 doses) in the glass bottles corked by rubber bungs with a running in caps aluminum with control of the first opening.
1 or 5 bottles in a blister strip packaging from a film polyvinyl chloride.

1 or 2 blister strip packagings with 5 bottles or 1 blister strip packaging with 1 bottle together with the application instruction in a pack from a cardboard.