Diaskintest® (recombinant tuberculous allergen in standard dilution) - innovative intradermal diagnostic test, which is a recombinant protein, containing two related antigens - ESAT6 and CFP10, typical for pathogenic strains of mycobacterium tuberculosis (Mycobacterium tuberculosis)^[1]. These antigens are absent in the Mycobacterium bovis BCG vaccine strain and in most non-tuberculous mycobacteria, therefore Diaskintest® induces an immune response only to mycobacterium tuberculosis and does not give a reaction, associated with BCG vaccination. Thanks to these qualities, Diaskintest® has practically 100% sensitivity and specificity^[2], minimizing the likelihood of developing false positive reactions, which in 40-60% of cases are observed when using the traditional intradermal tuberculin test (Mantoux test)^[3]. The technique of setting Diaskintest and recording the results is identical to the Mantoux test with tuberculin^[4].

In Russia, the use of Diaskintest is approved in 2009 year by the Order of the Ministry of Health of the Russian Federation 855 from 29 october 2009 r.⁴

FROM 2017 years the use of Diaskintest in the screening of tuberculosis in children older 7 years and adolescents are regulated by Order No. 124n of 21 Martha 2017 of the year[5].

Diaskintest is very sensitive and informative, it allows you to exclude false positive reactions, which can be during the Mantoux test in vaccinated individuals (post-vaccination immunity). According to various estimates and in different regions of Russia, the sensitivity of Diaskintest is estimated at about 96%.

HOW A HIGH DIASKINTEST ACCURACY IS ACHIEVED

Diaskintest is a diagnostic test, based on the formation of a delayed-type hypersensitivity reaction (GCHZT), manifested as a seal (papules) at the injection site in the presence of mycobacterium tuberculosis pathogenic for the human body in the body with the presence of two antigens ESAT6 and CFP in its structure 10. These antigens are not present in vaccine mycobacteria (BCG) and non-tuberculous bacteria.

If a person is sick with tuberculosis (active or latent (hidden) tuberculosis infection), then a seal is formed at the injection site of Diaskintest (papules) - positive test. In this case, a thorough examination is necessary to exclude active tuberculous lesions.. In the absence of reliable signs of the disease, a positive test indicates that, that a person has a latent (hidden) tuberculosis infection and there is a high risk of the disease becoming active in the near future. Therefore, it is necessary to carry out special preventive treatment with anti-tuberculosis drugs..

If a person is healthy, at the same time has immunity from tuberculosis after BCG vaccination (post-vaccination immunity), then Diaskintest will be negative.

To assess the effectiveness of any test sample, two main characteristics are taken into account.: sensitivity and specificity. The higher these indicators, the more qualitatively the test detects infection.

The sensitivity of the test is the presence of positive reactions in persons with a reliably confirmed diagnosis.

Diaskintest sensitivity 96,5%^[6].

The specificity of the test is a negative reaction to the sample in absolutely healthy people..

Diaskintest specificity 99,0%⁶.

All this allowed Diaskintest to become a reliable and highly informative method of diagnostics as latent, and active tuberculosis. High diagnostic accuracy avoids unnecessary and often harmful treatments and studies.

ADVANTAGES OF DIASKINTEST OVER OTHER TESTS

• High specificity and high sensitivity
• No false positives in case of BCG vaccination
• No special laboratory equipment required
• Low-traumatic for children of any age
• Effective at any age: children, teenagers, adults

WHEN DIASKINTEST IS USED

Diaskintest® is intended for setting an intradermal test in all age groups in order to:

• diagnosis of tuberculosis in combination with other methods;
• identifying individuals at high risk of developing active tuberculosis (latent tuberculosis infection)*;
• differential diagnosis of post-vaccination (BCG) and infectious allergies (delayed-type hypersensitivity);
• evaluating the effectiveness of anti-tuberculosis treatment in combination with other methods.

Attention! BCG vaccination does not affect the results of Diaskintest.

HOW TO PREPARE FOR INSTALLING A DIASKINTEST

The test is carried out according to the doctor's prescription for children, adolescents and adults with a specially trained nurse, approved for intradermal testing.

For persons, with a history of nonspecific allergy manifestations, the test is recommended to be carried out while taking desensitizing drugs for 7 days (5 days before sampling and 2 days after her).

ACCOUNTING THE RESULTS OF DIASKINTEST

• The result of the sample is assessed by a doctor or trained nurse through 72 h (3 days) from her production

• Criteria for evaluating the response to the Diaskintest test:

Attention! Persons with a dubious and positive reaction to Diaskintest® are subject to a comprehensive examination for tuberculosis.

REGULATIONS, REGULATORY APPLICATION OF DIASKINTEST IN THE REPUBLIC OF BELARUS:

Order No. 977 from 02.10.15 Ministry of Health of the Republic of Belarus "On approval of the instruction on the procedure for immunodiagnostics and chemoprophylaxis of tuberculosis among children":

For early detection of tuberculosis infection, Diaskintest should be carried out:

• Every year, children aged from 8 to 17 years at risk
• Children with suspected tuberculosis due to clinical, laboratory and / or radiological signs
• For children, sent to a phthisiatrician based on the results of the Mantoux test for additional medical diagnostics

[1] Kiselev V.I., Baranovsky P.M., Pupyshev S.A.. etc. New skin test for the diagnosis of tuberculosis based on the recombinant protein ESAT-CFP. Like. honey. -2008. — № 4. - WITH. 28–34

[2] Kiselev V.I., Baranovsky P.M., Rudykh I.V.. etc. Clinical studies of the new skin test "DIASKINTEST^®"For the diagnosis of tuberculosis. Probl. tub. and lung diseases. — 2009. — № 2.- FROM. 1–8

[3] L.V. Lebedeva, Gracheva S. G. Tuberculin sensitivity and infection with Mycobacterium tuberculosis in children. Probl. tub. and lung diseases. — 2007. — № 1.- FROM. 43–49

[4] Order of the Ministry of Health and Social Development of the Russian Federation No. 855 from 29.10.09 "On amendments to Appendix No. 4 to the order of the Ministry of Health of Russia No. 109 from 21.03.03 »

[5] Order of the Ministry of Health of the Russian Federation from 21 Martha 2017 r. No. 124n "On approval of the procedure and timing of preventive medical examinations of citizens in order to detect tuberculosis"

[6] Slogotskaya LV, Senchikhina O.Yu., Nikitina G.V., Bogorodskaya E.M.. The effectiveness of a skin test with a recombinant tuberculosis allergen in detecting tuberculosis in children and adolescents Moscow in 2013 r. // Pediatric Pharmacology, 2015. – N 1. - S.99-103