MONITORING AND EVALUATION OF MICROBIOLOGICAL DIAGNOSTICS OF TUBERCULOSIS: RESOURCES AND PERFORMANCE OF MICROBIOLOGICAL LABORATORIES
Authors:   Federal research institute for Health organization and informatics of Ministry of Health of the Russian Federation, Moscow, Russia, Mikhaylova Yuliya , Mezentseva Nadezhda ,   Center for External Quality Control of Clinical Laboratory Research, Moscow, Russia, Sterlikov Sergey ,   Federal research institute for Health organization and informatics of Ministry of Health of the Russian Federation, Moscow, Russia,   Russian Medical Academy of Continuous Professional Education, Ministry of Health of the Russian Federation, Mikhaylov Aleksandr ,   Federal research institute for Health organization and informatics of Ministry of Health of the Russian Federation, Moscow, Russia, Pankova Yana ,   Federal research institute for Health organization and informatics of Ministry of Health of the Russian Federation, Moscow, Russia
Published: September 2023

Significance. The system of microbiological diagnostics is of key importance for organizing microbiological diagnostics in accordance with the modern recommendations, and fulfilling political commitments of the Russian Federation within the framework of the End TB Strategy Purpose: to assess the availability, use and results of the modern methods of microbiological diagnostics of tuberculosis in Russia in 2021. Material and methods. The study has analyzed forms #7-TB, ВР-4БЛ, ВР-1Ф of official statistical observation, results of external quality assessment of laboratories (Interlaboratory comparison system “Federal System of External Quality Assessment of Clinical Laboratory Testing (FSEQA)”). Results. The share of patients with pulmonary tuberculosis with a smear positive Ziehl-Nelsen, detected in medical organizations providing primary health care (PHC) decreased to 12.8%, while the share of new smear positive pulmonary TB patients increased to 37.4%; the share of newly diagnosed patients with pulmonary tuberculosis with a positive result of sputum bacterioscopy among patients with cavities increased to 60.6%.The share of laboratories with satisfactory results of the FSEQA participation regarding smear microscopy increased to 92.8%; the share of laboratories with the confirmed quality increased to 14.3%. The culture coverage of new pulmonary TB patients equaled to 98.0%. Culture-based confirmation of the diagnosis was obtained in 55.3% of the patients; the share of smear positive new pulmonary TB patients with the negative culture result decreased to 3.8%. The share of laboratories participating in FSEQA increased to 44.5%; the share of laboratories that showed satisfactory results - up to 90.8%, the share of laboratories with the confirmed quality - up to 40.4%. The coverage with molecular genetic testing added up to 90.8%. The drug susceptibility testing (DST) coverage equaled to 97.7%. The patient coverage with rifampicin resistance DST to fluoroquinolones reached 93.2%; coverage with pre-XDR-TB DST to linezolid - 35.0%, bedaquiline - 12.4%. Conclusion. Microbiological diagnostics of tuberculosis in PHC by smear microscopy is ineffective in modern conditions; there are prospects for its use in new Russian regions. The COVID-19 pandemic failed to produce any significant negative impact on the patient coverage with microbiological examination methods. In 2020–2021, the quality of bacterioscopic and culture testing for tuberculosis increased. DST coverage for bedaquiline and linezolid is poor; this does not allow to meet the current clinical guideline requirements. The cost of consumables per patient increased 3.1 times between 2015 and 2021.In the structure of financial expenses on TB microbiological diagnostics, consumables that require import substitution prevail. Scope of application. The study results can be used by heads of health authorities, chief physicians of TB facilities, heads of microbiological laboratories in order to increase effectiveness of TB care, timely detection of people excreting bacteria and MBT drug susceptibility testing.