Observational studyThe Indian journal of medical research2026
Diagnostic accuracy and safety of Cy-Tb for detection of tuberculosis infection: A multicentric study from India.
Observational study in The Indian journal of medical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background and objectives Only 10% of the individuals infected with Mycobacterium tuberculosis (MTB) manifest active tuberculosis. Interferon-γ release assay (IGRA) and tuberculin skin test using purified protein derivative (PPD) are used to identify tuberculosis (TB) infection. We aimed to study the comparative performance of Cy-Tb (the SIILTIBCY skin test) and PPD with IGRA as the reference standard. Methods In step-I, 30 TB patients and 32 IGRA-negative health controls; in step-II, 2651 participants aged 1 to 85 yr; and in step- III, 647 household contacts of TB patients aged 1-18 years old were enrolled. Blood for IGRA was drawn immediately prior to intra-dermal administration of Cy-Tb (the SIILTIBCY skin test) or PPD. The size of induration of Cy-Tb ≥5 mm or PPD ≥ 10mm after 48 to 72 h were considered positive. Combined Data from step II and step III were analysed for sensitivity, specificity, agreement, and kappa-coefficient with IGRA as the reference standard using Stata version 14.2. Results The step-I results for Cy-Tb showed 90% specificity, 93.8% specificity, and an agreement of 91.9% with IGRA and a Cohen's kappa coefficient of 0.83. Combined analysis of step-II and step-III data revealed sensitivity of 82.6% (95% CI 79.1-85.8), specificity of 71.1% (95% CI 68.2-73.8), agreement of 74.8%, and kappa of 0.5 for Cy-Tb. PPD showed sensitivity and specificity of 71.0% (95% CI 66.7-75.0) and 71.9% (95% CI 69.0-74·6), respectively with 71.6% agreement and kappa of 0.4 with IGRA. Interpretation and conclusions Performance of Cy-Tb was comparable to that of PPD with IGRA as reference standard. Cy-Tb skin test can be used for diagnosis of TB infection.
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