A Comparative Study of Six Immunological Tests for the Diagnosis of Tuberculosis in Different Patient Groups

The objective: to compare results of six tests for immunological diagnosis of tuberculosis infection (TBI): intradermal tests (Mantoux with 2 TU PPD-L; test with tuberculous recombinant allergen (Diaskintest)) and IGRA laboratory tests (T-SPOT^®. TB, QuantiFERON^®-TB Gold Plus, STANDARD Е TB-Feron, and IGRA-TB) in groups of individuals with high and low risk of TBI and pulmonary tuberculosis patients.

Subjects and Methods. The study was conducted in June of 2023. 100 people above 18 years old were enrolled in the study. The low probability group (TBI LPG), n=50, included regularly examined healthcare workers who had not responded positively to Diaskintest skin or any IGRA test for the previous 2 years. The high probability group (TBI HPG), n=25, included individuals who had responded positively to Diaskintest or any IGRA test for the previous 2 years. The PTB Group, n=25, included patients with pulmonary tuberculosis who were admitted to hospital.

Results. The results of Diaskintest correlated well (at a level of 88-92%) with the results of IGRA tests (STANDARD E TB-Feron, QuantiFERON^®-TB Gold Plus, and IGRA-TB), the results of which also coincided with each other in 86-88% of cases. The consistency of Mantoux test with 2 TU PPD-L with other tests was lower (57.9-70.5%). The results of T-SPOT^®.TB coincided with skin tests in only 61.5-64.2% of cases, and with other IGRA tests in 72.3-75.9% of cases. It has been established that the results were best interpreted when using STANDARD E TB-Feron IGRA, QuantiFERON^®-TB Gold Plus, and IGRA-TB (100/100, 100/100, and 99/100, respectively), and worse when using Diaskintest (95/100) and T-SPOT^®. TB (83/100) and Mantoux test (78/100). The T-SPOT^®.TB test and Mantoux test with 2 TU PPD-L showed the best results in the PTB group (88% and 76% positive results, respectively), but in the high probability group (presumably without TBI), only 50% and 32% negative results were observed, respectively. When screening conditionally healthy study participants (TBI LPG), Diaskintest and all IGRA tests (except T-SPOT^®.TB) showed good agreement of negative results (at 88-90%).  

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