全国范围内结核菌素皮肤试验抗原短缺：疾控中心关于患者护理和公共卫生实践的建议。
Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice.
出版信息
MMWR Morb Mortal Wkly Rep. 2019 Jun 21;68(24):552-553. doi: 10.15585/mmwr.mm6824a4.
CDC is expecting a 3-10 month nationwide shortage of Aplisol, a product of Par Pharmaceuticals, and one of two purified-protein derivative (PPD) tuberculin antigens licensed by the Food and Drug Administration (FDA) for use in performing tuberculin skin tests. This time frame is the manufacturer's current estimate and is subject to change. The manufacturer notified CDC that they anticipate an interruption of supply of Aplisol 5 mL (50 multidose vials) beginning in June 2019, followed by an interruption of the supply of Aplisol 1 mL (10 multidose vials) in November 2019. The expected shortage of Aplisol 1 mL could occur before November 2019 if demand increases before then. Information on the status of this supply interruption will be updated at FDA's Center for Biologics Evaluation and Research-Regulated Products: Current Shortages website (https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages). This report includes CDC recommendations for mitigating a reduction in tuberculosis (TB) testing capability resulting from the anticipated Aplisol shortage (1).
美国疾病控制与预防中心（CDC）预计，Par 制药公司生产的 Aplisol 将在全国范围内短缺 3-10 个月，这是食品和药物管理局（FDA）批准的两种纯化蛋白衍生物（PPD）结核菌素中的一种，用于进行结核菌素皮肤试验。这一时间框架是制造商目前的估计，可能会发生变化。制造商通知 CDC，他们预计从 2019 年 6 月开始，Aplisol 5 mL（50 支多剂量小瓶）供应将中断，随后，2019 年 11 月将中断 Aplisol 1 mL（10 支多剂量小瓶）的供应。如果在此之前需求增加，Aplisol 1 mL 的预期短缺可能会在 11 月之前发生。有关此供应中断状况的信息将在 FDA 的生物制品评价和研究中心-监管产品：当前短缺网站（https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages）上更新。本报告包括 CDC 针对预期的 Aplisol 短缺（1）导致结核病（TB）检测能力下降而提出的缓解建议。
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