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The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Siiltibcy, a next-generation skin test that uses recombinant proteins to identify Mycobacterium tuberculosis infection with higher specificity than current methods. The reaction is typically assessed 48-72 hours post-injection by measuring the induration size to determine the presence of M tuberculosis infection or active disease. Clinical Evidence Three main studies involving 2625 individuals, including children, compared Siiltibcy with two authorised diagnostic tests for identifying M tuberculosis: PPD, which uses the same skin injection technique as Siiltibcy, and QuantiFERON-TB Gold in-Tube (QFT), a blood-based test. Safety Profile and Contraindications The most common side effects include pruritus (itching) at the injection site, which may affect about 1 in 5 people, and bruising or pain at the site, which may affect up to 1 in 10.